Download PDF

Clinical Trial Results:
A Phase 2B, Randomised, Double Blind, Vehicle-controlled, Parallel-Group, Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream Applied Once or Twice Daily for 12 Weeks in Subjects With Mild to Moderate Chronic Plaque Psoriasis

Summary
EudraCT number	2018-003051-38
Trial protocol	LV DE HU BG PL DK
Global end of trial date	20 Apr 2021

Results information
Results version number	v2(current)
This version publication date	14 Jul 2022
First version publication date	22 Apr 2022
Other versions	v1
Version creation reason

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

B7931023

ISRCTN number

US NCT number

NCT03850483

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

235 E 42nd Street, New York, United States, NY 10017

Public contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

30 Aug 2021

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

20 Apr 2021

Was the trial ended prematurely?

Main objective of the trial

To compare the efficacy of multiple dose levels of PF-06700841 versus vehicle on change from baseline in psoriasis area and severity index (PASI) score in subjects with mild to moderate plaque psoriasis.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

08 Apr 2019

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 26

Country: Number of subjects enrolled

Bulgaria: 31

Country: Number of subjects enrolled

Canada: 25

Country: Number of subjects enrolled

Germany: 45

Country: Number of subjects enrolled

Hungary: 5

Country: Number of subjects enrolled

Japan: 27

Country: Number of subjects enrolled

Latvia: 19

Country: Number of subjects enrolled

Poland: 12

Country: Number of subjects enrolled

United States: 153

Worldwide total number of subjects

343

EEA total number of subjects

112

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

293

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

Screening details

Overall 344 subjects were enrolled and 343 were treated.

Period 1 title

Overall Period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Vehicle Once Daily (QD)

Arm description

During stage 1 of the study subjects topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied placebo cream matched to PF-06700841 QD for a maximum of 12 weeks.

PF-06700841 0.1% QD

Arm description

During stage 1 of the study subjects topically applied PF-06700841 0.1 percent (%) cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

Brepocitinib

Investigational medicinal product code

PF-06700841

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied brepocitinib 0.1% cream QD for a maximum of 12 weeks.

PF-06700841 0.3% QD

Arm description

During stage 1 of the study subjects topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

Brepocitinib

Investigational medicinal product code

PF-06700841

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied brepocitinib 0.3% cream QD for a maximum of 12 weeks.

PF-06700841 1.0% QD

Arm description

During stage 1 of the study subjects topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

Brepocitinib

Investigational medicinal product code

PF-06700841

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied brepocitinib 1.0% cream QD for a maximum of 12 weeks.

PF-06700841 3.0% QD

Arm description

During stage 1 of the study subjects topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

Brepocitinib

Investigational medicinal product code

PF-06700841

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied brepocitinib 3.0% cream QD for a maximum of 12 weeks.

Pooled Vehicle Twice Daily (BID)

Arm description

During stage 1 and 2 of the study subjects topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied placebo cream matched to PF-06700841 BID for a maximum of 12 weeks.

PF-06700841 0.3% BID

Arm description

During stage 1 of the study subjects topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

Brepocitinib

Investigational medicinal product code

PF-06700841

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied brepocitinib 0.3% cream BID for a maximum of 12 weeks.

PF-06700841 1.0% BID

Arm description

During stage 1 of the study subjects topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

Brepocitinib

Investigational medicinal product code

PF-06700841

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied brepocitinib 1.0% cream BID for a maximum of 12 weeks.

PF-06700841 3.0% BID

Arm description

During stage 2 of the study subjects topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

Brepocitinib

Investigational medicinal product code

PF-06700841

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied brepocitinib 3.0% cream BID for a maximum of 12 weeks.

Number of subjects in period 1	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Started	37	37	37	36	37	49	36	36	38
Completed	37	37	37	36	37	49	36	36	38

Period 2 title

Treatment for Stage 1

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Stage 1: Vehicle Once Daily (QD)

Arm description

During stage 1 of the study subjects topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied placebo cream matched to PF-06700841 QD for a maximum of 12 weeks.

Stage 1: PF-06700841 0.1% QD

Arm description

During stage 1 of the study subjects topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

Brepocitinib

Investigational medicinal product code

PF-06700841

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied brepocitinib 0.1% cream QD for a maximum of 12 weeks.

Stage 1: PF-06700841 0.3% QD

Arm description

During stage 1 of the study subjects topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

Brepocitinib

Investigational medicinal product code

PF-06700841

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied brepocitinib 0.3% cream QD for a maximum of 12 weeks.

Stage 1: PF-06700841 1.0% QD

Arm description

During stage 1 of the study subjects topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

Brepocitinib

Investigational medicinal product code

PF-06700841

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied brepocitinib 1.0% cream QD for a maximum of 12 weeks.

Stage 1: PF-06700841 3.0% QD

Arm description

During stage 1 of the study subjects topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

Brepocitinib

Investigational medicinal product code

PF-06700841

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied brepocitinib 3.0% cream QD for a maximum of 12 weeks.

Stage 1: Vehicle BID

Arm description

During stage 1 of the study subjects topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied placebo cream matched to PF-06700841 BID for a maximum of 12 weeks.

Stage 1: PF-06700841 0.3% BID

Arm description

During stage 1 of the study subjects topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

Brepocitinib

Investigational medicinal product code

PF-06700841

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied brepocitinib 0.3% cream BID for a maximum of 12 weeks.

Stage 1: PF-06700841 1.0% BID

Arm description

During stage 1 of the study subjects topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

Brepocitinib

Investigational medicinal product code

PF-06700841

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied brepocitinib 1.0% cream BID for a maximum of 12 weeks.

Number of subjects in period 2	Stage 1: Vehicle Once Daily (QD)	Stage 1: PF-06700841 0.1% QD	Stage 1: PF-06700841 0.3% QD	Stage 1: PF-06700841 1.0% QD	Stage 1: PF-06700841 3.0% QD	Stage 1: Vehicle BID	Stage 1: PF-06700841 0.3% BID	Stage 1: PF-06700841 1.0% BID
Started	37	37	37	36	37	38	36	36
Treated	37	37	37	36	37	37	36	36
Completed	29	29	26	30	28	27	25	30
Not completed	8	8	11	6	9	11	11	6
Adverse event, serious fatal	-	-	-	-	-	1	-	-
Consent withdrawn by subject	4	4	2	2	2	1	2	3
Physician decision	-	-	-	-	-	1	-	-
Adverse event, non-fatal	1	1	3	-	2	-	2	2
Non-Compliance With Study Drug	-	-	1	-	-	-	-	-
No Longer Met Eligibility Criteria	-	-	-	-	-	1	-	-
Randomized but not Treated	-	-	-	-	-	1	-	-
Unspecified	-	-	-	-	2	1	-	-
Refused Further Treatment	1	-	2	-	1	-	1	-
Lost to follow-up	-	1	1	1	-	1	2	-
Protocol deviation	1	-	-	-	-	-	1	-
Lack of efficacy	1	2	2	3	2	4	3	1

Period 3 title

Follow-up for Stage 1

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Stage 1: Vehicle Once Daily (QD)

Arm description

During stage 1 of the study subjects topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied placebo cream matched to PF-06700841 QD for a maximum of 12 weeks.

Stage 1: PF-06700841 0.1% QD

Arm description

During stage 1 of the study subjects topically applied PF-06700841 0.1 % cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

Brepocitinib

Investigational medicinal product code

PF-06700841

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied brepocitinib 0.1% cream QD for a maximum of 12 weeks.

Stage 1: PF-06700841 0.3% QD

Arm description

During stage 1 of the study subjects topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

Brepocitinib

Investigational medicinal product code

PF-06700841

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied brepocitinib 0.3% cream QD for a maximum of 12 weeks.

Stage 1: PF-06700841 1.0% QD

Arm description

During stage 1 of the study subjects topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

Brepocitinib

Investigational medicinal product code

PF-06700841

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied brepocitinib 1.0% cream QD for a maximum of 12 weeks.

Stage 1: PF-06700841 3.0% QD

Arm description

During stage 1 of the study subjects topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

Brepocitinib

Investigational medicinal product code

PF-06700841

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied brepocitinib 3.0% cream QD for a maximum of 12 weeks.

Stage 1: Vehicle Twice Daily (BID)

Arm description

During stage 1 of the study subjects topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied placebo cream matched to PF-06700841 BID for a maximum of 12 weeks.

Stage 1: PF-06700841 0.3% BID

Arm description

During stage 1 of the study subjects topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

Brepocitinib

Investigational medicinal product code

PF-06700841

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied brepocitinib 0.3% cream BID for a maximum of 12 weeks.

Stage 1: PF-06700841 1.0% BID

Arm description

During stage 1 of the study subjects topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

Brepocitinib

Investigational medicinal product code

PF-06700841

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied brepocitinib 1.0% cream BID for a maximum of 12 weeks.

Number of subjects in period 3	Stage 1: Vehicle Once Daily (QD)	Stage 1: PF-06700841 0.1% QD	Stage 1: PF-06700841 0.3% QD	Stage 1: PF-06700841 1.0% QD	Stage 1: PF-06700841 3.0% QD	Stage 1: Vehicle Twice Daily (BID)	Stage 1: PF-06700841 0.3% BID	Stage 1: PF-06700841 1.0% BID
Started	37	37	37	36	37	37	36	36
Completed	37	34	35	34	34	33	34	33
Not completed	0	3	2	2	3	4	2	3
Physician decision	-	-	-	-	1	-	1	-
Consent withdrawn by subject	-	-	-	-	-	-	1	2
Refused Further Study Procedures	-	1	-	-	2	2	-	-
Adverse event, non-fatal	-	-	1	-	-	1	-	-
Unspecified	-	2	-	2	-	1	-	-
Lack of efficacy	-	-	1	-	-	-	-	1

Period 4 title

Treatment for Stage 2

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Stage 2: Vehicle BID

Arm description

During stage 2 of the study subjects topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied placebo cream matched to PF-06700841 BID for a maximum of 12 weeks.

Stage 2: PF-06700841 3.0% BID

Arm description

During stage 2 of the study subjects topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Placebo

Investigational medicinal product name

Brepocitinib

Investigational medicinal product code

PF-06700841

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied brepocitinib 3.0% cream BID for a maximum of 12 weeks.

Number of subjects in period 4	Stage 2: Vehicle BID	Stage 2: PF-06700841 3.0% BID
Started	12	38
Completed	7	27
Not completed	5	11
Consent withdrawn by subject	2	5
Physician decision	-	1
Adverse event, non-fatal	-	1
Refused Further Treatment	1	-
Lost to follow-up	-	3
No Longer Meets Eligibility Criteria	-	1
Lack of efficacy	1	-
Protocol deviation	1	-

Period 5 title

Follow-up For Stage 2

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Stage 2: Vehicle BID

Arm description

During stage 2 of the study subjects topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied placebo cream matched to PF-06700841 BID for a maximum of 12 weeks.

Stage 2: PF-06700841 3.0% BID

Arm description

During stage 2 of the study subjects topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

Brepocitinib

Investigational medicinal product code

PF-06700841

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subjects applied brepocitinib 3.0% cream BID for a maximum of 12 weeks.

Number of subjects in period 5	Stage 2: Vehicle BID	Stage 2: PF-06700841 3.0% BID
Started	12	38
Completed	12	36
Not completed	0	2
Unspecified	-	1
Lost to follow-up	-	1

Baseline characteristics

Top of page

Reporting group title

Vehicle Once Daily (QD)

Reporting group description

During stage 1 of the study subjects topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 0.1% QD

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 0.1 percent (%) cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 0.3% QD

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 1.0% QD

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 3.0% QD

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Pooled Vehicle Twice Daily (BID)

Reporting group description

During stage 1 and 2 of the study subjects topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 0.3% BID

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 1.0% BID

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 3.0% BID

Reporting group description

During stage 2 of the study subjects topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group values	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID	Total
Number of subjects	37	37	37	36	37	49	36	36	38	343
Age categorical
Units: Subjects
In utero	0	0	0	0	0	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0	0	0	0	0	0
Children (2-11 years)	0	0	0	0	0	0	0	0	0	0
Adolescents (12-17 years)	0	0	0	0	0	0	0	0	0	0
Adults (18-64 years)	31	31	33	31	35	41	31	25	35	293
From 65-84 years	6	6	4	5	2	8	5	11	3	50
85 years and over	0	0	0	0	0	0	0	0	0	0
Age Continuous
Units: Years
arithmetic mean (standard deviation)	48.6 ± 15.83	51.8 ± 12.49	51.4 ± 12.26	49.4 ± 15.30	48.4 ± 12.37	50.9 ± 12.85	48.2 ± 13.58	50.9 ± 16.45	48.9 ± 12.93	-
Sex: Female, Male
Units: Subjects
Female	12	10	7	6	13	18	11	11	14	102
Male	25	27	30	30	24	31	25	25	24	241
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	1	0	1	0	0	0	0	2
Asian	6	4	6	6	4	3	6	3	2	40
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	0
Black or African American	1	0	2	0	0	1	0	1	2	7
White	30	33	28	30	32	45	30	31	34	293
More than one race	0	0	0	0	0	0	0	1	0	1
Unknown or Not Reported	0	0	0	0	0	0	0	0	0	0
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	5	2	4	1	2	8	3	3	7	35
Not Hispanic or Latino	32	35	33	35	35	39	33	33	31	306
Unknown or Not Reported	0	0	0	0	0	2	0	0	0	2

End points

Top of page

Reporting group title

Vehicle Once Daily (QD)

Reporting group description

During stage 1 of the study subjects topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 0.1% QD

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 0.1 percent (%) cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 0.3% QD

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 1.0% QD

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 3.0% QD

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Pooled Vehicle Twice Daily (BID)

Reporting group description

During stage 1 and 2 of the study subjects topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 0.3% BID

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 1.0% BID

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 3.0% BID

Reporting group description

During stage 2 of the study subjects topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Stage 1: Vehicle Once Daily (QD)

Reporting group description

During stage 1 of the study subjects topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Stage 1: PF-06700841 0.1% QD

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Stage 1: PF-06700841 0.3% QD

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Stage 1: PF-06700841 1.0% QD

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Stage 1: PF-06700841 3.0% QD

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Stage 1: Vehicle BID

Reporting group description

During stage 1 of the study subjects topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Stage 1: PF-06700841 0.3% BID

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Stage 1: PF-06700841 1.0% BID

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Stage 1: Vehicle Once Daily (QD)

Reporting group description

During stage 1 of the study subjects topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Stage 1: PF-06700841 0.1% QD

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 0.1 % cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Stage 1: PF-06700841 0.3% QD

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Stage 1: PF-06700841 1.0% QD

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 1.0% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Stage 1: PF-06700841 3.0% QD

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 3.0% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Stage 1: Vehicle Twice Daily (BID)

Reporting group description

During stage 1 of the study subjects topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Stage 1: PF-06700841 0.3% BID

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Stage 1: PF-06700841 1.0% BID

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 1.0% cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Stage 2: Vehicle BID

Reporting group description

During stage 2 of the study subjects topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Stage 2: PF-06700841 3.0% BID

Reporting group description

During stage 2 of the study subjects topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Stage 2: Vehicle BID

Reporting group description

During stage 2 of the study subjects topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Stage 2: PF-06700841 3.0% BID

Reporting group description

During stage 2 of the study subjects topically applied PF-06700841 3.0% cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Subject analysis set title

Vehicle Once Daily (QD)

Subject analysis set type

Safety analysis

Subject analysis set description

During stage 1 of the study subjects topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Subject analysis set title

PF-06700841 0.1% QD

Subject analysis set type

Safety analysis

Subject analysis set description

During stage 1 of the study subjects topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Subject analysis set title

PF-06700841 0.3% QD

Subject analysis set type

Safety analysis

Subject analysis set description

During stage 1 of the study subjects topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Subject analysis set title

PF-06700841 1.0% QD

Subject analysis set type

Safety analysis

Subject analysis set description

During stage 1 of the study subjects topically applied PF-06700841 1% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Subject analysis set title

PF-06700841 3.0% QD

Subject analysis set type

Safety analysis

Subject analysis set description

During stage 1 of the study subjects topically applied PF-06700841 3% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Subject analysis set title

Pooled Vehicle BID

Subject analysis set type

Safety analysis

Subject analysis set description

During stage 1 and 2 of the study subjects topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Subject analysis set title

PF-06700841 0.3% BID

Subject analysis set type

Safety analysis

Subject analysis set description

During stage 1 of the study subjects topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Subject analysis set title

PF-06700841 1.0% BID

Subject analysis set type

Safety analysis

Subject analysis set description

During stage 1 of the study subjects topically applied PF-06700841 1% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Subject analysis set title

PF-06700841 3.0% BID

Subject analysis set type

Safety analysis

Subject analysis set description

During stage 2 of the study subjects topically applied PF-06700841 3% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Primary: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12

Top of page

End point title

Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12

End point description

PASI score (0-72, higher score = greater severity) measured severity and extent of psoriasis. The 4 regions of the body parts are head (10%),arms (20%),trunk (30%) and legs (40%). In each region, area is expressed as a score of 0 (nothing),1 (1-9%),2 (10-29%),3 (30-49%),4 (50-69%),5 (70-89%) or 6 (90-100%). Within each area, tdegree of severity for erythema, induration and scaling are estimated between 0 and 4 (highest severity). The final score combines disease severity and effected BSA from for 4 regions using the formula PASI=0.1Ah(Eh+Ih+Sh)+ 0.2Au(Eu+Iu+Su)+0.3At(Et+It+St)+0.4Al(El+Il+Sl) where A=Area Score; E=erythema; I=induration; S=scaling;h=head; u=upper limbs;t=trunk;l=lower limbs. Efficacy analysis set (EAS): all randomised subjects who received at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic.

End point type

Primary

End point timeframe

Baseline, Week 12

End point values	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Number of subjects analysed	36	37	37	36	37	49	36	35	38
Units: Unit on a scale
least squares mean (standard error)	-1.6 ± 0.46	-2.2 ± 0.46	-1.4 ± 0.46	-2.2 ± 0.46	-2.4 ± 0.45	-2.2 ± 0.42	-2.5 ± 0.53	-3.0 ± 0.51	-2.8 ± 0.48

Vehicle QD versus PF-06700841 0.1% QD

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1641 ^[1]

Method

ANCOVA

Parameter type

Least square (LS) mean difference

Point estimate

-0.6

Confidence interval

level

90%

sides

2-sided

lower limit

-1.71

upper limit

0.43

Variability estimate

Standard error of the mean

Dispersion value

0.65

Notes
[1] - Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.

Vehicle QD versus PF-06700841 0.3% QD

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.61 ^[2]

Method

ANCOVA

Parameter type

LS mean difference

Point estimate

0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-0.89

upper limit

1.26

Variability estimate

Standard error of the mean

Dispersion value

0.65

Notes
[2] - Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.

Vehicle QD versus PF-06700841 1.0% QD

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1686 ^[3]

Method

ANCOVA

Parameter type

LS mean difference

Point estimate

-0.6

Confidence interval

level

90%

sides

2-sided

lower limit

-1.7

upper limit

0.45

Variability estimate

Standard error of the mean

Dispersion value

0.65

Notes
[3] - Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.

Vehicle QD versus PF-06700841 3.0% QD

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1051 ^[4]

Method

ANCOVA

Parameter type

LS mean difference

Point estimate

-0.8

Confidence interval

level

90%

sides

2-sided

lower limit

-1.87

upper limit

0.25

Variability estimate

Standard error of the mean

Dispersion value

0.64

Notes
[4] - Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.

Pooled Vehicle BID versus PF-06700841 0.3% BID

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3583 ^[5]

Method

ANCOVA

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-1.37

upper limit

0.88

Variability estimate

Standard error of the mean

Dispersion value

0.68

Notes
[5] - Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.

Pooled Vehicle BID versus PF-06700841 1.0% BID

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1131 ^[6]

Method

ANCOVA

Parameter type

LS mean difference

Point estimate

-0.8

Confidence interval

level

90%

sides

2-sided

lower limit

-1.88

upper limit

0.29

Variability estimate

Standard error of the mean

Dispersion value

0.66

Notes
[6] - Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.

Pooled Vehicle BID versus PF-06700841 3.0% BID

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1812 ^[7]

Method

ANCOVA

Parameter type

LS mean difference

Point estimate

-0.6

Confidence interval

level

90%

sides

2-sided

lower limit

-1.64

upper limit

0.47

Variability estimate

Standard error of the mean

Dispersion value

0.64

Notes
[7] - Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.

Secondary: Percentage of Subjects With Physician Global Assessment (PGA) Score Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12

Top of page

End point title

Percentage of Subjects With Physician Global Assessment (PGA) Score Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12

End point description

PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category. Scale for PGA: 0= clear, 1= almost clear, 2= mild, 3= moderate and 4= severe. Higher scores indicate more severity. EAS included all randomised subjects who received at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, number of subjects analysed (N)=subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Number of subjects analysed	29	29	26	29	28	34	24	29	28
Units: Percentage of subjects
number (confidence interval 90%)	6.9 (1.8 to 20.0)	10.3 (3.9 to 22.9)	15.4 (6.9 to 29.9)	10.3 (3.9 to 22.9)	21.4 (9.8 to 36.6)	14.7 (7.3 to 26.9)	20.8 (10.5 to 37.0)	27.6 (14.5 to 42.5)	17.9 (8.9 to 33.3)

Vehicle QD versus PF-06700841 0.1% QD

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3747

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

3.4

Confidence interval

level

90%

sides

2-sided

lower limit

-10.6

upper limit

17.9

Vehicle QD versus PF-06700841 0.3% QD

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.243

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

8.5

Confidence interval

level

90%

sides

2-sided

lower limit

-6.6

upper limit

25.9

Vehicle QD versus PF-06700841 1.0% QD

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3747

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

3.4

Confidence interval

level

90%

sides

2-sided

lower limit

-10.6

upper limit

17.9

Vehicle QD versus PF-06700841 3.0% QD

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0665

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

14.5

Confidence interval

level

0.07%

sides

2-sided

lower limit

-1.3

upper limit

31.5

Pooled Vehicle BID versus PF-06700841 0.3% BID

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3423

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

6.1

Confidence interval

level

90%

sides

2-sided

lower limit

-12.1

upper limit

25.5

Pooled Vehicle BID versus PF-06700841 1.0% BID

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1271

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

12.9

Confidence interval

level

90%

sides

2-sided

lower limit

-4.7

upper limit

30.9

Pooled Vehicle BID versus PF-06700841 3.0% BID

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.401

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

3.2

Confidence interval

level

90%

sides

2-sided

lower limit

-13.2

upper limit

21.1

Secondary: Percentage of Subjects With 75% Reduction From Baseline in PASI at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16

Top of page

End point title

Percentage of Subjects With 75% Reduction From Baseline in PASI at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16

End point description

PASI score (0-72, higher score = greater severity) measured severity and extent of psoriasis. The 4 regions of the body parts are head (10%),arms (20%),trunk (30%) and legs (40%). In each region, area is expressed as a score of 0 (nothing),1 (1-9%),2 (10-29%),3 (30-49%),4 (50-69%),5 (70-89%) or 6 (90-100%). Within each area, tdegree of severity for erythema, induration and scaling are estimated between 0 and 4 (highest severity). The final score combines disease severity and effected BSA from for 4 regions using the formula PASI=0.1Ah(Eh+Ih+Sh)+ 0.2Au(Eu+Iu+Su)+0.3At(Et+It+St)+0.4Al(El+Il+Sl) where A=Area Score; E=erythema; I=induration; S=scaling;h=head; u=upper limbs;t=trunk;l=lower limbs. EAS: all randomised subjects who received at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. N=subjects evaluable for this endpoint; n=subjects evaluable for the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, and 16

End point values	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Number of subjects analysed	32	36	34	35	35	45	35	34	37
Units: Percentage of subjects
number (confidence interval 90%)
Week 1 (n=32, 33, 34, 35, 35, 45, 32, 34, 37)	3.1 (0.3 to 13.1)	3.0 (0.3 to 12.7)	0 (0.0 to 8.0)	0 (0.0 to 7.7)	0 (0.0 to 7.7)	0 (0.0 to 6.0)	0 (0.0 to 8.5)	2.9 (0.3 to 12.3)	2.7 (0.3 to 11.2)
Week 2 (n=32, 36, 31, 35, 35, 45, 35, 32, 35)	3.1 (0.3 to 13.1)	0 (0.0 to 7.5)	0 (0.0 to 8.8)	2.9 (0.3 to 11.9)	0 (0.0 to 7.7)	2.2 (0.2 to 9.2)	0 (0.0 to 7.7)	6.3 (1.7 to 18.0)	5.7 (1.5 to 16.4)
week 4 (n=32, 32, 28, 34, 34, 45, 30, 33, 33)	3.1 (0.3 to 13.1)	0 (0.0 to 8.5)	3.6 (0.4 to 15.1)	0 (0.0 to 8.0)	0 (0.0 to 8.0)	8.9 (3.9 to 18.0)	6.7 (1.8 to 19.3)	3.0 (0.3 to 12.7)	12.1 (5.4 to 25.1)
Week 6 (n=31, 31, 27, 31, 29, 36, 28, 28, 29)	3.2 (0.3 to 13.5)	0 (0.0 to 8.8)	7.4 (2.0 to 20.4)	6.5 (1.7 to 18.7)	10.3 (3.9 to 22.9)	13.9 (6.9 to 25.4)	10.7 (4.0 to 23.8)	10.7 (4.0 to 23.8)	10.3 (3.9 to 22.9)
Week 8 (n=30, 30, 27, 31, 28, 36, 25, 29, 28)	6.7 (1.8 to 19.3)	6.7 (1.8 to 19.3)	7.4 (2.0 to 20.4)	6.5 (1.7 to 18.7)	14.3 (6.4 to 28.4)	13.9 (6.9 to 25.4)	16.0 (7.2 to 30.7)	13.8 (6.2 to 27.9)	14.3 (6.4 to 28.4)
Week 10 (29, 30, 25, 29, 28, 33, 24, 28, 26)	10.3 (3.9 to 22.9)	3.3 (0.4 to 14.0)	8.0 (2.1 to 21.4)	17.2 (8.6 to 32.0)	14.3 (6.4 to 28.4)	18.2 (8.2 to 31.3)	20.8 (10.5 to 37.0)	10.7 (4.0 to 23.8)	15.4 (6.9 to 29.9)
Week 12 (n=29, 29, 26, 29, 28, 34, 24, 29, 28)	10.3 (3.9 to 22.9)	10.3 (3.9 to 22.9)	7.7 (2.1 to 20.9)	20.7 (9.4 to 35.2)	17.9 (8.9 to 33.3)	20.6 (11.3 to 34.9)	12.5 (4.7 to 28.2)	24.1 (13.4 to 38.5)	17.9 (8.9 to 33.3)
Week 14 (n=29, 26, 23, 28, 28, 29, 23, 25, 27)	3.4 (0.4 to 14.5)	7.7 (2.1 to 20.9)	8.7 (2.3 to 22.8)	21.4 (9.8 to 36.6)	14.3 (6.4 to 28.4)	10.3 (3.9 to 22.9)	13.0 (4.9 to 29.6)	20.0 (10.1 to 36.2)	14.8 (6.6 to 29.1)
Week 16 (n=29, 27, 23, 28, 26, 31, 23, 24, 26)	3.4 (0.4 to 14.5)	11.1 (4.2 to 24.8)	17.4 (7.8 to 33.5)	25.0 (13.9 to 40.0)	15.4 (6.9 to 29.9)	16.1 (8.1 to 29.7)	13.0 (4.9 to 29.6)	12.5 (4.7 to 28.2)	15.4 (6.9 to 29.9)

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 1

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4225

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-0.1

Confidence interval

level

90%

sides

2-sided

lower limit

-11.2

upper limit

10.4

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 1

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7483

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-3.1

Confidence interval

level

90%

sides

2-sided

lower limit

-14

upper limit

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 1

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7539

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-3.1

Confidence interval

level

90%

sides

2-sided

lower limit

-14

upper limit

4.8

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 1

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7539

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-3.1

Confidence interval

level

90%

sides

2-sided

lower limit

-14

upper limit

4.8

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 1

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-6.4

upper limit

8.9

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 1

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2125

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

2.9

Confidence interval

level

90%

sides

2-sided

lower limit

-3.4

upper limit

13.2

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 1

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2267

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

2.7

Confidence interval

level

90%

sides

2-sided

lower limit

-3.5

upper limit

12.2

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 2

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7592

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-3.1

Confidence interval

level

90%

sides

2-sided

lower limit

-14

upper limit

4.6

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 2

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7299

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-3.1

Confidence interval

level

90%

sides

2-sided

lower limit

-14

upper limit

5.5

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 2

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4463

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-0.3

Confidence interval

level

90%

sides

2-sided

lower limit

-11.3

upper limit

9.4

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 2

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7539

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-3.1

Confidence interval

level

90%

sides

2-sided

lower limit

-14

upper limit

4.8

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 2

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7009

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-2.2

Confidence interval

level

90%

sides

2-sided

lower limit

-10.1

upper limit

5.9

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 2

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2507

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-4.5

upper limit

15.6

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 2

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2993

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

3.5

Confidence interval

level

90%

sides

2-sided

lower limit

-4.8

upper limit

14.3

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 4

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7363

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-3.1

Confidence interval

level

90%

sides

2-sided

lower limit

-14

upper limit

5.5

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 4

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5369

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

0.4

Confidence interval

level

90%

sides

2-sided

lower limit

-10.5

upper limit

12.3

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 4

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7483

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-3.1

Confidence interval

level

90%

sides

2-sided

lower limit

-14

upper limit

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 4

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.599

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-2.2

Confidence interval

level

90%

sides

2-sided

lower limit

-13.7

upper limit

11.6

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 4

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7483

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-3.1

Confidence interval

level

90%

sides

2-sided

lower limit

-14

upper limit

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 4

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7926

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-5.9

Confidence interval

level

90%

sides

2-sided

lower limit

-16.4

upper limit

4.9

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 4

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3402

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

3.2

Confidence interval

level

90%

sides

2-sided

lower limit

-9

upper limit

17.6

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 6

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3009

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

4.2

Confidence interval

level

90%

sides

2-sided

lower limit

-7.4

upper limit

17.7

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 6

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7364

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-3.2

Confidence interval

level

90%

sides

2-sided

lower limit

-14.4

upper limit

5.7

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 6

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.34

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

3.2

Confidence interval

level

90%

sides

2-sided

lower limit

-8.1

upper limit

15.9

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 6

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1631

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

7.1

Confidence interval

level

90%

sides

2-sided

lower limit

-4.8

upper limit

21.1

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 6

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6214

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-3.2

Confidence interval

level

90%

sides

2-sided

lower limit

-17.8

upper limit

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 6

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6214

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-3.2

Confidence interval

level

90%

sides

2-sided

lower limit

-17.8

upper limit

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 6

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6413

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-3.5

Confidence interval

level

90%

sides

2-sided

lower limit

-17.9

upper limit

11.7

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 8

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-13.1

upper limit

13.1

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 8

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5134

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

0.7

Confidence interval

level

90%

sides

2-sided

lower limit

-12.6

upper limit

15.2

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 8

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4468

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-13.4

upper limit

12.5

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 8

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2778

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

7.6

Confidence interval

level

90%

sides

2-sided

lower limit

-6.8

upper limit

23.9

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 8

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4571

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

2.1

Confidence interval

level

90%

sides

2-sided

lower limit

-14.5

upper limit

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 8

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5153

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

0.4

Confidence interval

level

90%

sides

2-sided

lower limit

-14.8

upper limit

16.7

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 8

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4741

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-0.1

Confidence interval

level

90%

sides

2-sided

lower limit

-15.3

upper limit

16.7

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 10

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.8287

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-7

Confidence interval

level

90%

sides

2-sided

lower limit

-21.1

upper limit

5.3

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 10

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5675

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-2.3

Confidence interval

level

90%

sides

2-sided

lower limit

-17.8

upper limit

14.2

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 10

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3792

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

3.9

Confidence interval

level

90%

sides

2-sided

lower limit

-11.8

upper limit

20.8

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 10

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2648

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

6.9

Confidence interval

level

90%

sides

2-sided

lower limit

-9.8

upper limit

23.2

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 10

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4438

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

2.7

Confidence interval

level

90%

sides

2-sided

lower limit

-16.3

upper limit

23.1

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 10

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7014

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-7.5

Confidence interval

level

90%

sides

2-sided

lower limit

-23.3

upper limit

9.4

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 10

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5841

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-2.8

Confidence interval

level

90%

sides

2-sided

lower limit

-19.7

upper limit

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 12

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-15.3

upper limit

15.3

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 12

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5834

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-2.7

Confidence interval

level

90%

sides

2-sided

lower limit

-17.5

upper limit

12.3

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 12

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1534

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

10.3

Confidence interval

level

90%

sides

2-sided

lower limit

-6.4

upper limit

27.2

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 12

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.272

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

7.5

Confidence interval

level

90%

sides

2-sided

lower limit

-8.8

upper limit

24.9

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 12

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6815

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-8.1

Confidence interval

level

90%

sides

2-sided

lower limit

-25.1

upper limit

10.4

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 12

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.39

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

3.5

Confidence interval

level

90%

sides

2-sided

lower limit

-14.4

upper limit

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 12

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5865

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-2.7

Confidence interval

level

90%

sides

2-sided

lower limit

-20

upper limit

15.9

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 14

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3087

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

4.2

Confidence interval

level

90%

sides

2-sided

lower limit

-8.2

upper limit

18.9

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 14

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3137

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

5.2

Confidence interval

level

90%

sides

2-sided

lower limit

-8.2

upper limit

20.9

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 14

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0245

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

2.7

upper limit

34.8

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 14

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1119

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

10.8

Confidence interval

level

90%

sides

2-sided

lower limit

-3

upper limit

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 14

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.414

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

2.7

Confidence interval

level

90%

sides

2-sided

lower limit

-13.2

upper limit

20.4

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 14

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3638

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

4.5

Confidence interval

level

90%

sides

2-sided

lower limit

-11.5

upper limit

21.5

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 16

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1613

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

7.7

Confidence interval

level

90%

sides

2-sided

lower limit

-5.2

upper limit

22.9

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 16

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0557

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

13.9

Confidence interval

level

90%

sides

2-sided

lower limit

-0.5

upper limit

31.4

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 16

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0114

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

21.6

Confidence interval

level

90%

sides

2-sided

lower limit

5.6

upper limit

38.3

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 16

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0753

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

11.9

Confidence interval

level

90%

sides

2-sided

lower limit

-1.8

upper limit

28.1

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 16

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5635

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-3.1

Confidence interval

level

90%

sides

2-sided

lower limit

-20.1

upper limit

15.2

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 16

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6201

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-3.6

Confidence interval

level

90%

sides

2-sided

lower limit

-20.3

upper limit

14.5

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 16

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4792

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-0.7

Confidence interval

level

90%

sides

2-sided

lower limit

-17.6

upper limit

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 14

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2356

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

9.7

Confidence interval

level

90%

sides

2-sided

lower limit

-7.2

upper limit

28.5

Secondary: Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12

Top of page

End point title

Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12

End point description

PASI score (0-72, higher score = greater severity) measured severity and extent of psoriasis. The 4 regions of the body parts are head (10%),arms (20%),trunk (30%) and legs (40%). In each region, area is expressed as a score of 0 (nothing),1 (1-9%),2 (10-29%),3 (30-49%),4 (50-69%),5 (70-89%) or 6 (90-100%). Within each area, tdegree of severity for erythema, induration and scaling are estimated between 0 and 4 (highest severity). The final score combines disease severity and effected BSA from for 4 regions using the formula PASI=0.1Ah(Eh+Ih+Sh)+ 0.2Au(Eu+Iu+Su)+0.3At(Et+It+St)+0.4Al(El+Il+Sl) where A=Area Score; E=erythema; I=induration; S=scaling;h=head; u=upper limbs;t=trunk;l=lower limbs. EAS: all randomised subjects who received at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. N=subjects evaluable for this endpoint; n=subjects evaluable for the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week (Wk) 1, 2, 4, 6, 8, 10 and 12

End point values	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Number of subjects analysed	32	36	34	35	35	45	35	34	37
Units: Unit on a scale
least squares mean (standard error)
Change at Wk 1: n=32,33,34,35,35,45,32,34,37	-0.9 ± 0.22	-0.7 ± 0.22	-0.6 ± 0.22	-0.9 ± 0.22	-0.8 ± 0.22	-0.5 ± 0.19	-0.7 ± 0.23	-0.7 ± 0.22	-0.8 ± 0.22
Change at Wk 2: n=32,36,31,35,35,45,35,32,35	-1.4 ± 0.26	-0.7 ± 0.26	-0.9 ± 0.27	-1.4 ± 0.26	-1.3 ± 0.26	-0.8 ± 0.25	-1.4 ± 0.29	-1.6 ± 0.29	-1.7 ± 0.29
Change at Wk 4: n=32,32,28,34,34,45,30,33,33	-1.4 ± 0.31	-1.2 ± 0.31	-1.2 ± 0.33	-1.4 ± 0.31	-1.6 ± 0.31	-1.0 ± 0.35	-2.3 ± 0.42	-1.7 ± 0.41	-2.2 ± 0.41
Change at Wk 6: n=31,31,27,31,29,36,28,28,29	-1.5 ± 0.35	-1.4 ± 0.35	-1.2 ± 0.37	-1.6 ± 0.35	-2.4 ± 0.36	-1.2 ± 0.37	-2.5 ± 0.45	-2.1 ± 0.44	-2.1 ± 0.43
Change at Wk 8: n=30,30,27,31,28,36,25,29,28	-1.6 ± 0.39	-1.9 ± 0.39	-0.9 ± 0.41	-2.1 ± 0.39	-2.3 ± 0.40	-1.3 ± 0.42	-2.4 ± 0.50	-2.3 ± 0.48	-2.5 ± 0.48
Change at Wk 10: n=29,30,25,29,28,33,24,28,26	-1.6 ± 0.41	-2.1 ± 0.40	-1.6 ± 0.42	-2.3 ± 0.40	-2.4 ± 0.41	-1.1 ± 0.46	-2.4 ± 0.55	-2.4 ± 0.53	-2.4 ± 0.53
Change at Wk 12: n=29,29,26,29,28,34,24,29,28	-1.4 ± 0.49	-2.1 ± 0.48	-1.2 ± 0.51	-2.2 ± 0.48	-2.4 ± 0.49	-0.9 ± 0.51	-2.5 ± 0.62	-2.5 ± 0.59	-2.3 ± 0.59

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 1: Mixed-effect model with repeated measures (MMRM) analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.8038

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.3

Confidence interval

level

90%

sides

2-sided

lower limit

-0.25

upper limit

0.79

Variability estimate

Standard error of the mean

Dispersion value

0.31

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.8267

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.3

Confidence interval

level

90%

sides

2-sided

lower limit

-0.22

upper limit

0.81

Variability estimate

Standard error of the mean

Dispersion value

0.31

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6039

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.1

Confidence interval

level

90%

sides

2-sided

lower limit

-0.43

upper limit

0.6

Variability estimate

Standard error of the mean

Dispersion value

0.31

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6339

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.1

Confidence interval

level

90%

sides

2-sided

lower limit

-0.41

upper limit

0.62

Variability estimate

Standard error of the mean

Dispersion value

0.31

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2666

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-0.68

upper limit

0.31

Variability estimate

Standard error of the mean

Dispersion value

0.3

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2257

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-0.7

upper limit

0.26

Variability estimate

Standard error of the mean

Dispersion value

0.29

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1306

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.3

Confidence interval

level

90%

sides

2-sided

lower limit

-0.81

upper limit

0.15

Variability estimate

Standard error of the mean

Dispersion value

0.29

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.9704

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.7

Confidence interval

level

90%

sides

2-sided

lower limit

0.09

upper limit

1.31

Variability estimate

Standard error of the mean

Dispersion value

0.37

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.889

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.5

Confidence interval

level

90%

sides

2-sided

lower limit

-0.16

upper limit

1.09

Variability estimate

Standard error of the mean

Dispersion value

0.38

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4506

Method

MMRM

Parameter type

LS mean difference

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-0.66

upper limit

0.57

Variability estimate

Standard error of the mean

Dispersion value

0.37

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.584

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.1

Confidence interval

level

90%

sides

2-sided

lower limit

-0.53

upper limit

0.69

Variability estimate

Standard error of the mean

Dispersion value

0.37

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0769

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.5

Confidence interval

level

90%

sides

2-sided

lower limit

-1.17

upper limit

0.08

Variability estimate

Standard error of the mean

Dispersion value

0.38

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0242

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.8

Confidence interval

level

90%

sides

2-sided

lower limit

-1.39

upper limit

-0.13

Variability estimate

Standard error of the mean

Dispersion value

0.38

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0127

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.9

Confidence interval

level

90%

sides

2-sided

lower limit

-1.49

upper limit

-0.23

Variability estimate

Standard error of the mean

Dispersion value

0.38

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6693

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-0.54

upper limit

0.93

Variability estimate

Standard error of the mean

Dispersion value

0.44

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6742

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-0.55

upper limit

0.96

Variability estimate

Standard error of the mean

Dispersion value

0.45

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4486

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.1

Confidence interval

level

90%

sides

2-sided

lower limit

-0.79

upper limit

0.67

Variability estimate

Standard error of the mean

Dispersion value

0.44

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3219

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-0.93

upper limit

0.53

Variability estimate

Standard error of the mean

Dispersion value

0.44

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0096

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1.3

Confidence interval

level

90%

sides

2-sided

lower limit

-2.21

upper limit

-0.39

Variability estimate

Standard error of the mean

Dispersion value

0.55

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0862

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.7

Confidence interval

level

90%

sides

2-sided

lower limit

-1.64

upper limit

0.15

Variability estimate

Standard error of the mean

Dispersion value

0.54

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0111

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1.3

Confidence interval

level

90%

sides

2-sided

lower limit

-2.15

upper limit

-0.36

Variability estimate

Standard error of the mean

Dispersion value

0.54

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6107

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.1

Confidence interval

level

90%

sides

2-sided

lower limit

-0.68

upper limit

0.97

Variability estimate

Standard error of the mean

Dispersion value

0.5

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.724

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.3

Confidence interval

level

90%

sides

2-sided

lower limit

-0.54

upper limit

1.15

Variability estimate

Standard error of the mean

Dispersion value

0.51

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.43

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.1

Confidence interval

level

90%

sides

2-sided

lower limit

-0.91

upper limit

0.74

Variability estimate

Standard error of the mean

Dispersion value

0.5

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0501

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.8

Confidence interval

level

90%

sides

2-sided

lower limit

-1.66

upper limit

Variability estimate

Standard error of the mean

Dispersion value

0.5

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0157

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1.3

Confidence interval

level

90%

sides

2-sided

lower limit

-2.23

upper limit

-0.3

Variability estimate

Standard error of the mean

Dispersion value

0.58

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0645

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.9

Confidence interval

level

90%

sides

2-sided

lower limit

-1.83

upper limit

0.07

Variability estimate

Standard error of the mean

Dispersion value

0.57

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0621

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.9

Confidence interval

level

90%

sides

2-sided

lower limit

-1.84

upper limit

0.06

Variability estimate

Standard error of the mean

Dispersion value

0.57

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2959

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.3

Confidence interval

level

90%

sides

2-sided

lower limit

-1.21

upper limit

0.62

Variability estimate

Standard error of the mean

Dispersion value

0.55

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.9043

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.7

Confidence interval

level

90%

sides

2-sided

lower limit

-0.19

upper limit

1.69

Variability estimate

Standard error of the mean

Dispersion value

0.57

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2014

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.5

Confidence interval

level

90%

sides

2-sided

lower limit

-1.38

upper limit

0.45

Variability estimate

Standard error of the mean

Dispersion value

0.55

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0948

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.7

Confidence interval

level

90%

sides

2-sided

lower limit

-1.66

upper limit

0.19

Variability estimate

Standard error of the mean

Dispersion value

0.56

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0416

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1.1

Confidence interval

level

90%

sides

2-sided

lower limit

-2.21

upper limit

-0.06

Variability estimate

Standard error of the mean

Dispersion value

0.65

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0454

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1.1

Confidence interval

level

90%

sides

2-sided

lower limit

-2.14

upper limit

-0.03

Variability estimate

Standard error of the mean

Dispersion value

0.64

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0256

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1.3

Confidence interval

level

90%

sides

2-sided

lower limit

-2.31

upper limit

-0.2

Variability estimate

Standard error of the mean

Dispersion value

0.64

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2326

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.4

Confidence interval

level

90%

sides

2-sided

lower limit

-1.36

upper limit

0.53

Variability estimate

Standard error of the mean

Dispersion value

0.57

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5141

Method

MMRM

Parameter type

LS mean difference

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-0.95

upper limit

0.99

Variability estimate

Standard error of the mean

Dispersion value

0.59

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1124

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.7

Confidence interval

level

90%

sides

2-sided

lower limit

-1.64

upper limit

0.25

Variability estimate

Standard error of the mean

Dispersion value

0.57

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0983

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.7

Confidence interval

level

90%

sides

2-sided

lower limit

-1.7

upper limit

0.21

Variability estimate

Standard error of the mean

Dispersion value

0.58

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0412

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1.3

Confidence interval

level

90%

sides

2-sided

lower limit

-2.46

upper limit

-0.07

Variability estimate

Standard error of the mean

Dispersion value

0.72

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.034

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1.3

Confidence interval

level

90%

sides

2-sided

lower limit

-2.47

upper limit

-0.13

Variability estimate

Standard error of the mean

Dispersion value

0.71

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0379

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1.3

Confidence interval

level

90%

sides

2-sided

lower limit

-2.44

upper limit

-0.09

Variability estimate

Standard error of the mean

Dispersion value

0.71

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1291

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.8

Confidence interval

level

90%

sides

2-sided

lower limit

-1.91

upper limit

0.36

Variability estimate

Standard error of the mean

Dispersion value

0.68

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5776

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.1

Confidence interval

level

90%

sides

2-sided

lower limit

-1.03

upper limit

1.3

Variability estimate

Standard error of the mean

Dispersion value

0.7

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1044

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.9

Confidence interval

level

90%

sides

2-sided

lower limit

-2

upper limit

0.27

Variability estimate

Standard error of the mean

Dispersion value

0.69

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0608

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1.1

Confidence interval

level

90%

sides

2-sided

lower limit

-2.23

upper limit

0.07

Variability estimate

Standard error of the mean

Dispersion value

0.69

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0309

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1.5

Confidence interval

level

90%

sides

2-sided

lower limit

-2.84

upper limit

-0.18

Variability estimate

Standard error of the mean

Dispersion value

0.8

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0242

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1.6

Confidence interval

level

90%

sides

2-sided

lower limit

-2.85

upper limit

-0.26

Variability estimate

Standard error of the mean

Dispersion value

0.78

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0394

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1.4

Confidence interval

level

90%

sides

2-sided

lower limit

-2.69

upper limit

-0.09

Variability estimate

Standard error of the mean

Dispersion value

0.78

Secondary: Change From Baseline in PASI Scores at Week 14 and 16

Top of page

End point title

Change From Baseline in PASI Scores at Week 14 and 16

End point description

PASI score (0-72, higher score = greater severity) measured severity and extent of psoriasis. The 4 regions of the body parts are head (10%),arms (20%),trunk (30%) and legs (40%). In each region, area is expressed as a score of 0 (nothing),1 (1-9%),2 (10-29%),3 (30-49%),4 (50-69%),5 (70-89%) or 6 (90-100%). Within each area, tdegree of severity for erythema, induration and scaling are estimated between 0 and 4 (highest severity). The final score combines disease severity and effected BSA from for 4 regions using the formula PASI=0.1Ah(Eh+Ih+Sh)+ 0.2Au(Eu+Iu+Su)+0.3At(Et+It+St)+0.4Al(El+Il+Sl) where A=Area Score; E=erythema; I=induration; S=scaling;h=head; u=upper limbs;t=trunk;l=lower limbs. EAS: all randomised subjects who received at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, n=subjects evaluable for the specified time points.

End point type

Secondary

End point timeframe

Baseline, Wk 14 and 16

End point values	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Number of subjects analysed	36	37	37	36	37	49	36	35	38
Units: Unit on a scale
arithmetic mean (standard deviation)
Baseline: n=36,37,37,36,37,49,36,35,38	6.12 ± 2.870	7.19 ± 3.370	6.46 ± 2.932	6.63 ± 3.468	6.83 ± 3.137	6.08 ± 2.558	7.07 ± 3.579	5.80 ± 2.765	7.94 ± 4.071
Change at Wk 14: n=29,26,23,28,28,29,23,25,27	-0.83 ± 2.379	-2.24 ± 2.945	-0.72 ± 4.107	-1.81 ± 3.228	-1.87 ± 2.942	-0.82 ± 3.581	-1.04 ± 3.732	-2.06 ± 3.343	-1.19 ± 3.323
Change at Wk 16: n=29,27,23,28,26,31,23,24,26)	-0.46 ± 2.603	-2.06 ± 3.252	-0.78 ± 4.223	-2.10 ± 3.666	-1.68 ± 3.255	-0.67 ± 4.008	-0.71 ± 3.455	-1.75 ± 3.887	-1.03 ± 3.351

No statistical analyses for this end point

Secondary: Percent Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12

Top of page

End point title

Percent Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12

End point description

PASI score (0-72, higher score = greater severity) measured severity and extent of psoriasis. The 4 regions of the body parts are head (10%),arms (20%),trunk (30%) and legs (40%). In each region, area is expressed as a score of 0 (nothing),1 (1-9%),2 (10-29%),3 (30-49%),4 (50-69%),5 (70-89%) or 6 (90-100%). Within each area, tdegree of severity for erythema, induration and scaling are estimated between 0 and 4 (highest severity). The final score combines disease severity and effected BSA from for 4 regions using the formula PASI=0.1Ah(Eh+Ih+Sh)+ 0.2Au(Eu+Iu+Su)+0.3At(Et+It+St)+0.4Al(El+Il+Sl) where A=Area Score; E=erythema; I=induration; S=scaling;h=head; u=upper limbs;t=trunk;l=lower limbs. EAS: all randomised subjects who received at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. N=subjects evaluable for this endpoint; n=subjects evaluable for the specified time points.

End point type

Secondary

End point timeframe

Baseline, Wk 1, 2, 4, 6, 8, 10 and 12

End point values	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Number of subjects analysed	32	36	34	35	35	45	35	34	37
Units: Percent change
least squares mean (standard error)
Change at Wk 1: n=32,33,34,35,35,45,32,34,37	-15.5 ± 3.62	-12.9 ± 3.57	-8.2 ± 3.56	-10.4 ± 3.49	-13.0 ± 3.51	-7.4 ± 3.10	-9.0 ± 3.64	-13.7 ± 3.58	-13.5 ± 3.52
Change at Wk 2: n=32,36,31,35,35,45,35,32,35)	-21.6 ± 4.25	-12.4 ± 4.10	-12.6 ± 4.34	-17.9 ± 4.13	-19.8 ± 4.14	-11.7 ± 3.99	-20.7 ± 4.60	-23.3 ± 4.68	-24.7 ± 4.58
Change at Wk 4: n=32,32,28,34,34,45,30,33,33)	-24.1 ± 4.69	-20.5 ± 4.65	-15.6 ± 4.90	-17.6 ± 4.59	-25.1 ± 4.61	-13.2 ± 5.69	-33.9 ± 6.85	-24.1 ± 6.66	-29.2 ± 6.64
Change at Wk 6: n=31,31,27,31,29,36,28,28,29	-23.7 ± 5.88	-20.3 ± 5.83	-18.4 ± 6.18	-21.8 ± 5.83	-36.0 ± 5.92	-17.8 ± 6.10	-36.6 ± 7.31	-31.2 ± 7.12	-27.5 ± 7.08
Change at Wk 8: n=30,30,27,31,28,36,25,29,28)	-25.3 ± 6.48	-25.6 ± 6.44	-14.3 ± 6.78	-30.5 ± 6.41	-35.9 ± 6.57	-18.1 ± 6.70	-35.2 ± 8.07	-32.4 ± 7.76	-34.3 ± 7.76
Change at Wk 10: n=29,30,25,29,28,33,24,28,26	-26.8 ± 6.42	-27.6 ± 6.34	-22.9 ± 6.73	-35.3 ± 6.36	-36.1 ± 6.48	-12.5 ± 7.62	-33.4 ± 9.12	-35.1 ± 8.75	-34.6 ± 8.77
Change at Wk 12: n=29,29,26,29,28,34,24,29,28	-20.0 ± 7.36	-29.1 ± 7.30	-18.5 ± 7.70	-33.7 ± 7.30	-39.0 ± 7.47	-9.6 ± 8.61	-34.1 ± 10.35	-35.7 ± 9.84	33.7 ± 9.88

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6917

Method

MMRM

Parameter type

LS mean difference

Point estimate

2.6

Confidence interval

level

90%

sides

2-sided

lower limit

-5.86

upper limit

10.97

Variability estimate

Standard error of the mean

Dispersion value

5.09

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.9241

Method

MMRM

Parameter type

LS mean difference

Point estimate

7.3

Confidence interval

level

90%

sides

2-sided

lower limit

-1.09

upper limit

15.69

Variability estimate

Standard error of the mean

Dispersion value

5.07

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.8443

Method

MMRM

Parameter type

LS mean difference

Point estimate

5.1

Confidence interval

level

90%

sides

2-sided

lower limit

-3.21

upper limit

13.42

Variability estimate

Standard error of the mean

Dispersion value

5.03

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6911

Method

MMRM

Parameter type

LS mean difference

Point estimate

2.5

Confidence interval

level

90%

sides

2-sided

lower limit

-5.82

upper limit

10.86

Variability estimate

Standard error of the mean

Dispersion value

5.04

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3676

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1.6

Confidence interval

level

90%

sides

2-sided

lower limit

-9.56

upper limit

6.31

Variability estimate

Standard error of the mean

Dispersion value

4.79

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 1: Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0915

Method

MMRM

Parameter type

LS mean difference

Point estimate

-6.3

Confidence interval

level

90%

sides

2-sided

lower limit

-14.13

upper limit

1.5

Variability estimate

Standard error of the mean

Dispersion value

4.72

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.097

Method

MMRM

Parameter type

LS mean difference

Point estimate

-6.2

Confidence interval

level

90%

sides

2-sided

lower limit

-13.96

upper limit

1.65

Variability estimate

Standard error of the mean

Dispersion value

4.72

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.9389

Method

MMRM

Parameter type

LS mean difference

Point estimate

9.2

Confidence interval

level

90%

sides

2-sided

lower limit

-0.59

upper limit

18.97

Variability estimate

Standard error of the mean

Dispersion value

5.91

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.9295

Method

MMRM

Parameter type

LS mean difference

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-1.06

upper limit

19.02

Variability estimate

Standard error of the mean

Dispersion value

6.07

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7308

Method

MMRM

Parameter type

LS mean difference

Point estimate

3.7

Confidence interval

level

90%

sides

2-sided

lower limit

-6.15

upper limit

13.45

Variability estimate

Standard error of the mean

Dispersion value

5.92

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6199

Method

MMRM

Parameter type

LS mean difference

Point estimate

1.8

Confidence interval

level

90%

sides

2-sided

lower limit

-8.01

upper limit

11.64

Variability estimate

Standard error of the mean

Dispersion value

5.94

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0699

Method

MMRM

Parameter type

LS mean difference

Point estimate

-9

Confidence interval

level

90%

sides

2-sided

lower limit

-19.13

upper limit

1.04

Variability estimate

Standard error of the mean

Dispersion value

6.09

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.03

Method

MMRM

Parameter type

LS mean difference

Point estimate

-11.6

Confidence interval

level

90%

sides

2-sided

lower limit

-21.79

upper limit

-1.48

Variability estimate

Standard error of the mean

Dispersion value

6.14

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0168

Method

MMRM

Parameter type

LS mean difference

Point estimate

-13.1

Confidence interval

level

90%

sides

2-sided

lower limit

-23.15

upper limit

-2.98

Variability estimate

Standard error of the mean

Dispersion value

6.09

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7083

Method

MMRM

Parameter type

LS mean difference

Point estimate

3.6

Confidence interval

level

90%

sides

2-sided

lower limit

-7.3

upper limit

14.57

Variability estimate

Standard error of the mean

Dispersion value

6.61

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.8955

Method

MMRM

Parameter type

LS mean difference

Point estimate

8.5

Confidence interval

level

90%

sides

2-sided

lower limit

-2.66

upper limit

19.75

Variability estimate

Standard error of the mean

Dispersion value

6.77

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.8386

Method

MMRM

Parameter type

LS mean difference

Point estimate

6.5

Confidence interval

level

90%

sides

2-sided

lower limit

-4.35

upper limit

17.37

Variability estimate

Standard error of the mean

Dispersion value

6.56

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4371

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1

Confidence interval

level

90%

sides

2-sided

lower limit

-11.93

upper limit

9.84

Variability estimate

Standard error of the mean

Dispersion value

6.58

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0108

Method

MMRM

Parameter type

LS mean difference

Point estimate

-20.7

Confidence interval

level

90%

sides

2-sided

lower limit

-35.42

upper limit

-5.92

Variability estimate

Standard error of the mean

Dispersion value

8.91

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1066

Method

MMRM

Parameter type

LS mean difference

Point estimate

-10.9

Confidence interval

level

90%

sides

2-sided

lower limit

-25.43

upper limit

3.55

Variability estimate

Standard error of the mean

Dispersion value

8.75

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0344

Method

MMRM

Parameter type

LS mean difference

Point estimate

-16

Confidence interval

level

90%

sides

2-sided

lower limit

-30.54

upper limit

-1.55

Variability estimate

Standard error of the mean

Dispersion value

8.76

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6594

Method

MMRM

Parameter type

LS mean difference

Point estimate

3.4

Confidence interval

level

90%

sides

2-sided

lower limit

-10.3

upper limit

17.13

Variability estimate

Standard error of the mean

Dispersion value

8.29

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7307

Method

MMRM

Parameter type

LS mean difference

Point estimate

5.3

Confidence interval

level

90%

sides

2-sided

lower limit

-8.85

upper limit

19.36

Variability estimate

Standard error of the mean

Dispersion value

8.52

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5914

Method

MMRM

Parameter type

LS mean difference

Point estimate

1.9

Confidence interval

level

90%

sides

2-sided

lower limit

-11.78

upper limit

15.61

Variability estimate

Standard error of the mean

Dispersion value

8.28

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0709

Method

MMRM

Parameter type

LS mean difference

Point estimate

-12.3

Confidence interval

level

90%

sides

2-sided

lower limit

-26.13

upper limit

1.49

Variability estimate

Standard error of the mean

Dispersion value

8.34

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0253

Method

MMRM

Parameter type

LS mean difference

Point estimate

-18.8

Confidence interval

level

90%

sides

2-sided

lower limit

-34.55

upper limit

-3.01

Variability estimate

Standard error of the mean

Dispersion value

9.53

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.078

Method

MMRM

Parameter type

LS mean difference

Point estimate

-13.4

Confidence interval

level

90%

sides

2-sided

lower limit

-28.89

upper limit

2.15

Variability estimate

Standard error of the mean

Dispersion value

9.38

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1516

Method

MMRM

Parameter type

LS mean difference

Point estimate

-9.7

Confidence interval

level

90%

sides

2-sided

lower limit

-25.17

upper limit

5.83

Variability estimate

Standard error of the mean

Dispersion value

9.36

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4861

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.3

Confidence interval

level

90%

sides

2-sided

lower limit

-15.45

upper limit

14.81

Variability estimate

Standard error of the mean

Dispersion value

9.14

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.8795

Method

MMRM

Parameter type

LS mean difference

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-4.48

upper limit

26.55

Variability estimate

Standard error of the mean

Dispersion value

9.38

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2867

Method

MMRM

Parameter type

LS mean difference

Point estimate

-5.1

Confidence interval

level

90%

sides

2-sided

lower limit

-20.22

upper limit

9.94

Variability estimate

Standard error of the mean

Dispersion value

9.11

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1267

Method

MMRM

Parameter type

LS mean difference

Point estimate

-10.6

Confidence interval

level

90%

sides

2-sided

lower limit

-25.86

upper limit

4.69

Variability estimate

Standard error of the mean

Dispersion value

9.23

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0526

Method

MMRM

Parameter type

LS mean difference

Point estimate

-17.1

Confidence interval

level

90%

sides

2-sided

lower limit

-34.48

upper limit

0.26

Variability estimate

Standard error of the mean

Dispersion value

10.49

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0827

Method

MMRM

Parameter type

LS mean difference

Point estimate

-14.3

Confidence interval

level

90%

sides

2-sided

lower limit

-31.26

upper limit

2.68

Variability estimate

Standard error of the mean

Dispersion value

10.25

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0592

Method

MMRM

Parameter type

LS mean difference

Point estimate

-16.1

Confidence interval

level

90%

sides

2-sided

lower limit

-33.12

upper limit

0.86

Variability estimate

Standard error of the mean

Dispersion value

10.26

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4657

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.8

Confidence interval

level

90%

sides

2-sided

lower limit

-15.72

upper limit

14.16

Variability estimate

Standard error of the mean

Dispersion value

9.03

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6612

Method

MMRM

Parameter type

LS mean difference

Point estimate

3.9

Confidence interval

level

90%

sides

2-sided

lower limit

-11.52

upper limit

19.26

Variability estimate

Standard error of the mean

Dispersion value

9.3

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1749

Method

MMRM

Parameter type

LS mean difference

Point estimate

-8.5

Confidence interval

level

90%

sides

2-sided

lower limit

-23.42

upper limit

6.48

Variability estimate

Standard error of the mean

Dispersion value

9.03

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1548

Method

MMRM

Parameter type

LS mean difference

Point estimate

-9.3

Confidence interval

level

90%

sides

2-sided

lower limit

-24.39

upper limit

5.8

Variability estimate

Standard error of the mean

Dispersion value

9.12

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.04

Method

MMRM

Parameter type

LS mean difference

Point estimate

-21

Confidence interval

level

90%

sides

2-sided

lower limit

-40.67

upper limit

-1.28

Variability estimate

Standard error of the mean

Dispersion value

11.89

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0267

Method

MMRM

Parameter type

LS mean difference

Point estimate

-22.6

Confidence interval

level

90%

sides

2-sided

lower limit

-41.82

upper limit

-3.39

Variability estimate

Standard error of the mean

Dispersion value

11.6

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0295

Method

MMRM

Parameter type

LS mean difference

Point estimate

-22.2

Confidence interval

level

90%

sides

2-sided

lower limit

-41.42

upper limit

-2.89

Variability estimate

Standard error of the mean

Dispersion value

11.63

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1903

Method

MMRM

Parameter type

LS mean difference

Point estimate

-9.1

Confidence interval

level

90%

sides

2-sided

lower limit

-26.3

upper limit

8.05

Variability estimate

Standard error of the mean

Dispersion value

10.38

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.553

Method

MMRM

Parameter type

LS mean difference

Point estimate

1.4

Confidence interval

level

90%

sides

2-sided

lower limit

-16.21

upper limit

19.06

Variability estimate

Standard error of the mean

Dispersion value

10.65

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0933

Method

MMRM

Parameter type

LS mean difference

Point estimate

-13.8

Confidence interval

level

90%

sides

2-sided

lower limit

-30.92

upper limit

3.4

Variability estimate

Standard error of the mean

Dispersion value

10.37

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.036

Method

MMRM

Parameter type

LS mean difference

Point estimate

-19

Confidence interval

level

90%

sides

2-sided

lower limit

-36.37

upper limit

-1.65

Variability estimate

Standard error of the mean

Dispersion value

10.49

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0354

Method

MMRM

Parameter type

LS mean difference

Point estimate

-24.5

Confidence interval

level

90%

sides

2-sided

lower limit

-46.85

upper limit

-2.23

Variability estimate

Standard error of the mean

Dispersion value

13.46

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0239

Method

MMRM

Parameter type

LS mean difference

Point estimate

-26.1

Confidence interval

level

90%

sides

2-sided

lower limit

-47.77

upper limit

-4.46

Variability estimate

Standard error of the mean

Dispersion value

13.07

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0342

Method

MMRM

Parameter type

LS mean difference

Point estimate

-24.1

Confidence interval

level

90%

sides

2-sided

lower limit

-45.84

upper limit

-2.38

Variability estimate

Standard error of the mean

Dispersion value

13.11

Secondary: Percent Change From Baseline in PASI Scores at Week 14 and 16

Top of page

End point title

Percent Change From Baseline in PASI Scores at Week 14 and 16

End point description

PASI score (0-72, higher score = greater severity) measured severity and extent of psoriasis. The 4 regions of the body parts are head (10%),arms (20%),trunk (30%) and legs (40%). In each region, area is expressed as a score of 0 (nothing),1 (1-9%),2 (10-29%),3 (30-49%),4 (50-69%),5 (70-89%) or 6 (90-100%). Within each area, tdegree of severity for erythema, induration and scaling are estimated between 0 and 4 (highest severity). The final score combines disease severity and effected BSA from for 4 regions using the formula PASI=0.1Ah(Eh+Ih+Sh)+ 0.2Au(Eu+Iu+Su)+0.3At(Et+It+St)+0.4Al(El+Il+Sl) where A=Area Score; E=erythema; I=induration; S=scaling;h=head; u=upper limbs;t=trunk;l=lower limbs. EAS: all randomised subjects who received at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, n=subjects evaluable for the specified time points.

End point type

Secondary

End point timeframe

Baseline, Wk 14 and 16

End point values	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Number of subjects analysed	36	37	37	36	37	49	36	35	38
Units: Percent change
arithmetic mean (standard deviation)
Baseline: n=36,37,37,36,37,49,36,35,38	6.12 ± 2.870	7.19 ± 3.370	6.46 ± 2.932	6.63 ± 3.468	6.83 ± 3.137	6.08 ± 2.558	7.07 ± 3.579	5.80 ± 2.765	7.94 ± 4.071
Change at Wk 14: n=29,26,23,28,28,29,23,25,27	-12.76 ± 49.660	-25.94 ± 40.339	-8.58 ± 59.407	-23.14 ± 47.501	-30.07 ± 40.222	-5.74 ± 74.846	-14.18 ± 58.599	-27.56 ± 45.370	-19.74 ± 49.727
Change at Wk 16: n=29,27,23,28,26,31,23,24,26	-4.72 ± 56.401	-23.01 ± 44.766	-9.00 ± 60.088	-29.24 ± 52.608	-27.17 ± 41.153	-3.75 ± 83.415	-9.99 ± 60.306	-24.09 ± 48.685	-21.12 ± 52.521

No statistical analyses for this end point

Secondary: Absolute Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Baseline, Week 1, 2, 4, 6, 8, 10 and 12

Top of page

End point title

Absolute Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Baseline, Week 1, 2, 4, 6, 8, 10 and 12

End point description

Subjects were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch. EAS included all randomised subjects who received at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, number of subjects analysed=subjects evaluable for this endpoint and n=subjects evaluable for the specified time points.

End point type

Secondary

End point timeframe

Baseline, Week 1, 2, 4, 6, 8, 10 and 12

End point values	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Number of subjects analysed	35	36	34	36	36	48	35	35	31
Units: Unit on a scale
least squares mean (standard error)
Baseline (n=33, 34, 33, 29, 36, 43, 33, 32, 30)	4.6 ± 0.31	4.4 ± 0.30	4.5 ± 0.31	4.1 ± 0.33	4.5 ± 0.29	4.9 ± 0.28	4.8 ± 0.32	4.4 ± 0.32	5.4 ± 0.34
Week 1 (n=35, 36, 34, 36, 36, 47, 34, 34, 29)	4.1 ± 0.31	3.9 ± 0.30	3.6 ± 0.31	3.5 ± 0.33	3.6 ± 0.30	4.0 ± 0.28	3.8 ± 0.32	3.4 ± 0.32	3.7 ± 0.35
Week 2 (n=35, 36, 33, 35, 35, 48, 35, 35, 31)	3.6 ± 0.31	3.5 ± 0.31	3.3 ± 0.31	3.2 ± 0.33	3.5 ± 0.30	3.5 ± 0.28	3.6 ± 0.32	2.9 ± 0.32	3.4 ± 0.35
Week 4 (n=31, 31, 27, 33, 34, 45, 29, 31, 31)	3.5 ± 0.32	3.7 ± 0.32	3.2 ± 0.33	3.2 ± 0.34	3.2 ± 0.30	3.4 ± 0.29	3.0 ± 0.34	3.0 ± 0.34	3.4 ± 0.36
Week 6 (n=32, 30, 25, 31, 28, 38, 27, 27, 27)	3.5 ± 0.32	4.0 ± 0.32	3.5 ± 0.34	3.2 ± 0.34	2.9 ± 0.32	3.6 ± 0.31	2.8 ± 0.35	3.0 ± 0.35	2.9 ± 0.38
Week 8 (n=30, 31, 26, 31, 26, 36, 24, 27, 27)	3.1 ± 0.32	3.4 ± 0.32	3.2 ± 0.33	3.1 ± 0.34	2.8 ± 0.32	3.3 ± 0.32	2.7 ± 0.37	2.9 ± 0.35	2.7 ± 0.38
Week 10 (n=29, 28, 25, 29, 28, 31, 24, 28, 24)	3.3 ± 0.33	3.0 ± 0.33	3.0 ± 0.34	3.1 ± 0.35	2.3 ± 0.32	4.1 ± 0.33	2.8 ± 0.36	2.9 ± 0.35	3.6 ± 0.39
Week 12 (n=29, 29, 26, 29, 27, 31, 23, 28, 25)	3.4 ± 0.33	3.1 ± 0.33	3.1 ± 0.33	3.0 ± 0.35	2.6 ± 0.32	4.0 ± 0.32	2.7 ± 0.37	3.0 ± 0.35	3.2 ± 0.40

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3279

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-0.91

upper limit

0.52

Variability estimate

Standard error of the mean

Dispersion value

0.43

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3566

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-0.88

upper limit

0.56

Variability estimate

Standard error of the mean

Dispersion value

0.44

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1165

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.5

Confidence interval

level

90%

sides

2-sided

lower limit

-1.29

upper limit

0.21

Variability estimate

Standard error of the mean

Dispersion value

0.45

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3633

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.1

Confidence interval

level

90%

sides

2-sided

lower limit

-0.85

upper limit

0.55

Variability estimate

Standard error of the mean

Dispersion value

0.43

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3766

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.1

Confidence interval

level

90%

sides

2-sided

lower limit

-0.83

upper limit

0.56

Variability estimate

Standard error of the mean

Dispersion value

0.42

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1179

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.5

Confidence interval

level

90%

sides

2-sided

lower limit

-1.22

upper limit

0.2

Variability estimate

Standard error of the mean

Dispersion value

0.43

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.8647

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.5

Confidence interval

level

90%

sides

2-sided

lower limit

-0.24

upper limit

1.2

Variability estimate

Standard error of the mean

Dispersion value

0.44

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3294

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-0.9

upper limit

0.52

Variability estimate

Standard error of the mean

Dispersion value

0.43

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1231

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.5

Confidence interval

level

90%

sides

2-sided

lower limit

-1.23

upper limit

0.21

Variability estimate

Standard error of the mean

Dispersion value

0.44

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0878

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.6

Confidence interval

level

90%

sides

2-sided

lower limit

-1.37

upper limit

0.13

Variability estimate

Standard error of the mean

Dispersion value

0.45

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1225

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.5

Confidence interval

level

90%

sides

2-sided

lower limit

-1.2

upper limit

0.21

Variability estimate

Standard error of the mean

Dispersion value

0.43

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3663

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.1

Confidence interval

level

90%

sides

2-sided

lower limit

-0.85

upper limit

0.56

Variability estimate

Standard error of the mean

Dispersion value

0.43

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0929

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.6

Confidence interval

level

90%

sides

2-sided

lower limit

-1.27

upper limit

0.14

Variability estimate

Standard error of the mean

Dispersion value

0.43

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3111

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-0.95

upper limit

0.51

Variability estimate

Standard error of the mean

Dispersion value

0.44

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4745

Method

MMRM

Parameter type

LS mean difference

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-0.74

upper limit

0.69

Variability estimate

Standard error of the mean

Dispersion value

0.43

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2409

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.3

Confidence interval

level

90%

sides

2-sided

lower limit

-1.03

upper limit

0.42

Variability estimate

Standard error of the mean

Dispersion value

0.44

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2018

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.4

Confidence interval

level

90%

sides

2-sided

lower limit

-1.13

upper limit

0.37

Variability estimate

Standard error of the mean

Dispersion value

0.45

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3925

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.1

Confidence interval

level

90%

sides

2-sided

lower limit

-0.83

upper limit

0.59

Variability estimate

Standard error of the mean

Dispersion value

0.43

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5348

Method

MMRM

Parameter type

LS mean difference

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-0.66

upper limit

0.73

Variability estimate

Standard error of the mean

Dispersion value

0.42

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0739

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.6

Confidence interval

level

90%

sides

2-sided

lower limit

-1.33

upper limit

0.09

Variability estimate

Standard error of the mean

Dispersion value

0.43

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4014

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.1

Confidence interval

level

90%

sides

2-sided

lower limit

-0.84

upper limit

0.62

Variability estimate

Standard error of the mean

Dispersion value

0.44

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6588

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-0.56

upper limit

0.93

Variability estimate

Standard error of the mean

Dispersion value

0.45

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2997

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-1

upper limit

0.52

Variability estimate

Standard error of the mean

Dispersion value

0.46

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 4:MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2518

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.3

Confidence interval

level

90%

sides

2-sided

lower limit

-1.08

upper limit

0.46

Variability estimate

Standard error of the mean

Dispersion value

0.47

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2634

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.3

Confidence interval

level

90%

sides

2-sided

lower limit

-1

upper limit

0.45

Variability estimate

Standard error of the mean

Dispersion value

0.44

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1999

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.4

Confidence interval

level

90%

sides

2-sided

lower limit

-1.11

upper limit

0.36

Variability estimate

Standard error of the mean

Dispersion value

0.45

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1847

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.4

Confidence interval

level

90%

sides

2-sided

lower limit

-1.13

upper limit

0.33

Variability estimate

Standard error of the mean

Dispersion value

0.44

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4569

Method

MMRM

Parameter type

LS mean difference

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-0.81

upper limit

0.71

Variability estimate

Standard error of the mean

Dispersion value

0.46

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.8536

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.5

Confidence interval

level

90%

sides

2-sided

lower limit

-0.27

upper limit

1.22

Variability estimate

Standard error of the mean

Dispersion value

0.45

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 6:MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4812

Method

MMRM

Parameter type

LS mean difference

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-0.79

upper limit

0.74

Variability estimate

Standard error of the mean

Dispersion value

0.46

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2276

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.4

Confidence interval

level

90%

sides

2-sided

lower limit

-1.13

upper limit

0.42

Variability estimate

Standard error of the mean

Dispersion value

0.47

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0895

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.6

Confidence interval

level

90%

sides

2-sided

lower limit

-1.34

upper limit

0.14

Variability estimate

Standard error of the mean

Dispersion value

0.45

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0411

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.8

Confidence interval

level

90%

sides

2-sided

lower limit

-1.58

upper limit

-0.04

Variability estimate

Standard error of the mean

Dispersion value

0.47

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0928

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.6

Confidence interval

level

90%

sides

2-sided

lower limit

-1.4

upper limit

0.15

Variability estimate

Standard error of the mean

Dispersion value

0.47

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0799

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.7

Confidence interval

level

90%

sides

2-sided

lower limit

-1.48

upper limit

0.12

Variability estimate

Standard error of the mean

Dispersion value

0.49

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7872

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.4

Confidence interval

level

90%

sides

2-sided

lower limit

-0.39

upper limit

1.11

Variability estimate

Standard error of the mean

Dispersion value

0.46

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6294

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-0.61

upper limit

0.92

Variability estimate

Standard error of the mean

Dispersion value

0.47

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5174

Method

MMRM

Parameter type

LS mean difference

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-0.76

upper limit

0.8

Variability estimate

Standard error of the mean

Dispersion value

0.48

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3136

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-0.98

upper limit

0.53

Variability estimate

Standard error of the mean

Dispersion value

0.46

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.102

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.6

Confidence interval

level

90%

sides

2-sided

lower limit

-1.42

upper limit

0.18

Variability estimate

Standard error of the mean

Dispersion value

0.48

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1923

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.4

Confidence interval

level

90%

sides

2-sided

lower limit

-1.2

upper limit

0.37

Variability estimate

Standard error of the mean

Dispersion value

0.47

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0997

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.6

Confidence interval

level

90%

sides

2-sided

lower limit

-1.44

upper limit

0.18

Variability estimate

Standard error of the mean

Dispersion value

0.49

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2497

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.3

Confidence interval

level

90%

sides

2-sided

lower limit

-1.08

upper limit

0.45

Variability estimate

Standard error of the mean

Dispersion value

0.47

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2568

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.3

Confidence interval

level

90%

sides

2-sided

lower limit

-1.08

upper limit

0.47

Variability estimate

Standard error of the mean

Dispersion value

0.47

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.373

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-0.95

upper limit

0.64

Variability estimate

Standard error of the mean

Dispersion value

0.48

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0137

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1

Confidence interval

level

90%

sides

2-sided

lower limit

-1.76

upper limit

-0.26

Variability estimate

Standard error of the mean

Dispersion value

0.46

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0055

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1.3

Confidence interval

level

90%

sides

2-sided

lower limit

-2.06

upper limit

-0.44

Variability estimate

Standard error of the mean

Dispersion value

0.49

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0069

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1.2

Confidence interval

level

90%

sides

2-sided

lower limit

-1.99

upper limit

-0.4

Variability estimate

Standard error of the mean

Dispersion value

0.48

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1648

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.5

Confidence interval

level

90%

sides

2-sided

lower limit

-1.34

upper limit

0.34

Variability estimate

Standard error of the mean

Dispersion value

0.51

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2931

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.3

Confidence interval

level

90%

sides

2-sided

lower limit

-1.02

upper limit

0.51

Variability estimate

Standard error of the mean

Dispersion value

0.46

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3047

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-1.01

upper limit

0.53

Variability estimate

Standard error of the mean

Dispersion value

0.47

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1924

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.4

Confidence interval

level

90%

sides

2-sided

lower limit

-1.22

upper limit

0.38

Variability estimate

Standard error of the mean

Dispersion value

0.48

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0465

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.8

Confidence interval

level

90%

sides

2-sided

lower limit

-1.52

upper limit

-0.02

Variability estimate

Standard error of the mean

Dispersion value

0.46

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0048

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1.3

Confidence interval

level

90%

sides

2-sided

lower limit

-2.08

upper limit

-0.47

Variability estimate

Standard error of the mean

Dispersion value

0.49

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0186

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1

Confidence interval

level

90%

sides

2-sided

lower limit

-1.78

upper limit

-0.21

Variability estimate

Standard error of the mean

Dispersion value

0.48

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0675

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.8

Confidence interval

level

90%

sides

2-sided

lower limit

-1.61

upper limit

0.08

Variability estimate

Standard error of the mean

Dispersion value

0.51

Secondary: Absolute PP-NRS Score at Week 14 and 16

Top of page

End point title

Absolute PP-NRS Score at Week 14 and 16

End point description

End point type

Secondary

End point timeframe

Week 14 and 16

End point values	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Number of subjects analysed	28	27	24	24	27	30	23	25	23
Units: Unit on a scale
arithmetic mean (standard deviation)
Week 14 (n=28, 25, 24, 24, 27, 27, 23, 25, 27)	5.2 ± 3.02	2.6 ± 2.52	2.8 ± 2.38	2.4 ± 2.39	3.2 ± 2.38	4.0 ± 2.77	3.5 ± 2.89	2.8 ± 2.57	5.5 ± 2.81
Week 16 (n=27, 27, 23, 24, 25, 30, 22, 22, 19)	4.9 ± 2.93	3.2 ± 2.75	3.1 ± 2.63	2.5 ± 2.45	3.2 ± 2.42	3.8 ± 2.69	3.4 ± 2.77	3.5 ± 2.91	5.8 ± 2.76

No statistical analyses for this end point

Secondary: Change From Baseline in PP-NRS Score at Week 1, 2, 4, 6, 8, 10 and 12

Top of page

End point title

Change From Baseline in PP-NRS Score at Week 1, 2, 4, 6, 8, 10 and 12

End point description

End point type

Secondary

End point timeframe

Baseline, Wk 1, 2, 4, 6, 8, 10 and 12

End point values	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Number of subjects analysed	33	34	32	29	35	43	33	32	28
Units: Unit on a scale
least squares mean (standard error)
Change at Wk 1: n=33,34,32,29,35,43,32,32,28)	-0.4 ± 0.23	-0.6 ± 0.23	-0.9 ± 0.23	-0.9 ± 0.25	-0.9 ± 0.22	-0.9 ± 0.24	-1.0 ± 0.27	-1.4 ± 0.28	-1.2 ± 0.30
Change at Wk 2: n=33,33,31,29,34,43,33,32,28	-0.9 ± 0.28	-0.9 ± 0.27	-1.1 ± 0.28	-1.2 ± 0.30	-1.0 ± 0.27	-1.3 ± 0.25	-1.3 ± 0.29	-1.9 ± 0.30	-1.5 ± 0.32
Change at Wk 4: n=29,28,26,27,33,40,27,28,25	-1.0 ± 0.33	-0.8 ± 0.33	-1.0 ± 0.34	-1.2 ± 0.36	-1.2 ± 0.32	-1.3 ± 0.32	-1.7 ± 0.38	-1.7 ± 0.38	-1.6 ± 0.41
Change at Wk 6: n=30,28,24,25,28,32,25,25,22	-0.9 ± 0.36	-0.4 ± 0.36	-1.0 ± 0.38	-1.2 ± 0.39	-1.6 ± 0.36	-1.1 ± 0.31	-1.9 ± 0.36	-1.8 ± 0.36	-2.1 ± 0.39
Change at Wk 8: n=28,28,25,25,26,30,22,25,22	-1.4 ± 0.38	-1.1 ± 0.38	-1.2 ± 0.39	-1.3 ± 0.41	-1.6 ± 0.38	-1.2 ± 0.38	-2.2 ± 0.44	-1.8 ± 0.43	-2.2 ± 0.46
Change at Wk 10: n=27,25,24,23,28,26,23,26,20	-1.1 ± 0.43	-1.4 ± 0.44	-1.3 ± 0.45	-1.2 ± 0.46	-2.1 ± 0.42	-0.5 ± 0.39	-2.1 ± 0.44	-1.9 ± 0.42	-1.2 ± 0.47
Change at Wk 12: n=27,26,25,23,27,28,22,26,19	-1.0 ± 0.42	-1.3 ± 0.43	-1.2 ± 0.44	-1.3 ± 0.45	-1.8 ± 0.42	-0.6 ± 0.41	-2.3 ± 0.47	-1.8 ± 0.44	-1.5 ± 0.49

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3232

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-0.69

upper limit

0.39

Variability estimate

Standard error of the mean

Dispersion value

0.33

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0736

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.5

Confidence interval

level

90%

sides

2-sided

lower limit

-1.03

upper limit

0.07

Variability estimate

Standard error of the mean

Dispersion value

0.33

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0743

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.5

Confidence interval

level

90%

sides

2-sided

lower limit

-1.07

upper limit

0.07

Variability estimate

Standard error of the mean

Dispersion value

0.35

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0641

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.5

Confidence interval

level

90%

sides

2-sided

lower limit

-1.03

upper limit

0.04

Variability estimate

Standard error of the mean

Dispersion value

0.32

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3887

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.1

Confidence interval

level

90%

sides

2-sided

lower limit

-0.71

upper limit

0.5

Variability estimate

Standard error of the mean

Dispersion value

0.36

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0767

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.5

Confidence interval

level

90%

sides

2-sided

lower limit

-1.15

upper limit

0.08

Variability estimate

Standard error of the mean

Dispersion value

0.37

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2529

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.3

Confidence interval

level

90%

sides

2-sided

lower limit

-0.89

upper limit

0.38

Variability estimate

Standard error of the mean

Dispersion value

0.38

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5304

Method

MMRM

Parameter type

LS mean difference

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-0.61

upper limit

0.67

Variability estimate

Standard error of the mean

Dispersion value

0.39

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.292

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-0.87

upper limit

0.43

Variability estimate

Standard error of the mean

Dispersion value

0.39

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2593

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.3

Confidence interval

level

90%

sides

2-sided

lower limit

-0.7

upper limit

0.57

Variability estimate

Standard error of the mean

Dispersion value

0.41

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.431

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.1

Confidence interval

level

90%

sides

2-sided

lower limit

-0.7

upper limit

0.57

Variability estimate

Standard error of the mean

Dispersion value

0.38

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5477

Method

MMRM

Parameter type

LS mean difference

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-0.59

upper limit

0.69

Variability estimate

Standard error of the mean

Dispersion value

0.39

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0696

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.6

Confidence interval

level

90%

sides

2-sided

lower limit

-1.24

upper limit

0.07

Variability estimate

Standard error of the mean

Dispersion value

0.39

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3583

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.1

Confidence interval

level

90%

sides

2-sided

lower limit

-0.82

upper limit

0.53

Variability estimate

Standard error of the mean

Dispersion value

0.41

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6826

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-0.56

upper limit

1.01

Variability estimate

Standard error of the mean

Dispersion value

0.47

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.457

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.1

Confidence interval

level

90%

sides

2-sided

lower limit

-0.84

upper limit

0.74

Variability estimate

Standard error of the mean

Dispersion value

0.48

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3265

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-1.03

upper limit

0.59

Variability estimate

Standard error of the mean

Dispersion value

0.49

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3039

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-1

upper limit

0.53

Variability estimate

Standard error of the mean

Dispersion value

0.46

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2086

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.4

Confidence interval

level

90%

sides

2-sided

lower limit

-1.23

upper limit

0.42

Variability estimate

Standard error of the mean

Dispersion value

0.5

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2172

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.4

Confidence interval

level

90%

sides

2-sided

lower limit

-1.22

upper limit

0.44

Variability estimate

Standard error of the mean

Dispersion value

0.5

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2855

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.3

Confidence interval

level

90%

sides

2-sided

lower limit

-1.16

upper limit

0.57

Variability estimate

Standard error of the mean

Dispersion value

0.52

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.8372

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.5

Confidence interval

level

90%

sides

2-sided

lower limit

-0.34

upper limit

1.36

Variability estimate

Standard error of the mean

Dispersion value

0.51

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4792

Method

MMRM

Parameter type

LS mean difference

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-0.89

upper limit

0.84

Variability estimate

Standard error of the mean

Dispersion value

0.52

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3331

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-1.12

upper limit

0.65

Variability estimate

Standard error of the mean

Dispersion value

0.53

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.108

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.6

Confidence interval

level

90%

sides

2-sided

lower limit

-1.47

upper limit

0.21

Variability estimate

Standard error of the mean

Dispersion value

0.51

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0455

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.8

Confidence interval

level

90%

sides

2-sided

lower limit

-1.61

upper limit

-0.02

Variability estimate

Standard error of the mean

Dispersion value

0.48

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0761

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.7

Confidence interval

level

90%

sides

2-sided

lower limit

-1.49

upper limit

0.1

Variability estimate

Standard error of the mean

Dispersion value

0.48

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0273

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1

Confidence interval

level

90%

sides

2-sided

lower limit

-1.8

upper limit

-0.14

Variability estimate

Standard error of the mean

Dispersion value

0.5

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7214

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.3

Confidence interval

level

90%

sides

2-sided

lower limit

-0.57

upper limit

1.2

Variability estimate

Standard error of the mean

Dispersion value

0.54

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6132

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-0.75

upper limit

1.06

Variability estimate

Standard error of the mean

Dispersion value

0.55

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5704

Method

MMRM

Parameter type

LS mean difference

Point estimate

0.1

Confidence interval

level

90%

sides

2-sided

lower limit

-0.83

upper limit

1.02

Variability estimate

Standard error of the mean

Dispersion value

0.56

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3449

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-1.1

upper limit

0.67

Variability estimate

Standard error of the mean

Dispersion value

0.53

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0493

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1

Confidence interval

level

90%

sides

2-sided

lower limit

-1.94

upper limit

Variability estimate

Standard error of the mean

Dispersion value

0.58

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.149

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.6

Confidence interval

level

90%

sides

2-sided

lower limit

-1.55

upper limit

0.35

Variability estimate

Standard error of the mean

Dispersion value

0.57

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.054

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1

Confidence interval

level

90%

sides

2-sided

lower limit

-1.96

upper limit

0.02

Variability estimate

Standard error of the mean

Dispersion value

0.6

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3119

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.3

Confidence interval

level

90%

sides

2-sided

lower limit

-1.32

upper limit

0.71

Variability estimate

Standard error of the mean

Dispersion value

0.61

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3947

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-1.2

upper limit

0.86

Variability estimate

Standard error of the mean

Dispersion value

0.62

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4205

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.1

Confidence interval

level

90%

sides

2-sided

lower limit

-1.18

upper limit

0.93

Variability estimate

Standard error of the mean

Dispersion value

0.64

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0472

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1

Confidence interval

level

90%

sides

2-sided

lower limit

-2.02

upper limit

-0.02

Variability estimate

Standard error of the mean

Dispersion value

0.6

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0044

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1.6

Confidence interval

level

90%

sides

2-sided

lower limit

-2.55

upper limit

-0.6

Variability estimate

Standard error of the mean

Dispersion value

0.59

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0098

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1.4

Confidence interval

level

90%

sides

2-sided

lower limit

-2.32

upper limit

-0.41

Variability estimate

Standard error of the mean

Dispersion value

0.58

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1285

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.7

Confidence interval

level

90%

sides

2-sided

lower limit

-1.71

upper limit

0.32

Variability estimate

Standard error of the mean

Dispersion value

0.61

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3243

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.3

Confidence interval

level

90%

sides

2-sided

lower limit

-1.27

upper limit

0.72

Variability estimate

Standard error of the mean

Dispersion value

0.6

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3795

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-1.2

upper limit

0.82

Variability estimate

Standard error of the mean

Dispersion value

0.61

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.307

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.3

Confidence interval

level

90%

sides

2-sided

lower limit

-1.35

upper limit

0.72

Variability estimate

Standard error of the mean

Dispersion value

0.62

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1014

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.8

Confidence interval

level

90%

sides

2-sided

lower limit

-1.74

upper limit

0.22

Variability estimate

Standard error of the mean

Dispersion value

0.59

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0033

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1.7

Confidence interval

level

90%

sides

2-sided

lower limit

-2.75

upper limit

-0.69

Variability estimate

Standard error of the mean

Dispersion value

0.62

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.028

Method

MMRM

Parameter type

LS mean difference

Point estimate

-1.2

Confidence interval

level

90%

sides

2-sided

lower limit

-2.18

upper limit

-0.17

Variability estimate

Standard error of the mean

Dispersion value

0.6

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0781

Method

MMRM

Parameter type

LS mean difference

Point estimate

-0.9

Confidence interval

level

90%

sides

2-sided

lower limit

-1.98

upper limit

0.15

Variability estimate

Standard error of the mean

Dispersion value

0.64

Secondary: Change From Baseline in PP-NRS Score at Week 14 and 16

Top of page

End point title

Change From Baseline in PP-NRS Score at Week 14 and 16

End point description

End point type

Secondary

End point timeframe

Baseline, Wk 14 and 16

End point values	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Number of subjects analysed	26	24	23	20	27	27	21	23	18
Units: Unit on a scale
arithmetic mean (standard deviation)
Change at Wk 14: n=26,23,23,20,27,24,21,23,18	-0.4 ± 3.18	-1.4 ± 1.64	-1.8 ± 3.16	-1.2 ± 2.52	-1.1 ± 2.38	-1.0 ± 2.93	-1.1 ± 2.57	-1.3 ± 2.31	-0.1 ± 4.18
Change at Wk 16: n=25,24,22,19,25,27,20,20,16	-0.6 ± 2.97	-0.9 ± 1.82	-1.2 ± 3.21	-0.7 ± 2.02	-1.0 ± 2.52	-0.9 ± 2.99	-1.0 ± 2.29	-0.9 ± 2.25	0.4 ± 3.54

No statistical analyses for this end point

Secondary: Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2

Top of page

End point title

Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2

End point description

PSI was a self-administered 8-item questionnaire that measured the severity of psoriasis symptoms over the past 24 hours and the past 7 days. PSI included following 8 items: itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Each item was rated on a scale from 0 to 4, where 0= not at all severe, 1= mild, 2= moderate, 3= severe and 4= very severe. Scores from all items were summed to give PSI score range from 0 (no severity) to 32 (maximum severity), higher PSI score indicated greater severity. EAS included all randomised subjects who received at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic Here, number of subjects analysed=subjects evaluable for this endpoint and n=subjects evaluable for the specified time points. '99999' indicates that standard deviation could not be estimated as there was only 1 subject evaluable.

End point type

Secondary

End point timeframe

Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET (Prior to Week 12), ET Follow-up Visit 1 (2 weeks post ET) and 2 (4 weeks post ET)

End point values	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Number of subjects analysed	35	36	34	36	37	48	35	35	31
Units: Unit on a scale
arithmetic mean (standard deviation)
Baseline (n=33, 34, 33, 29, 36, 43, 33, 33, 30)	14.2 ± 5.96	12.3 ± 7.18	13.2 ± 6.55	10.3 ± 5.00	12.3 ± 6.48	14.0 ± 6.60	13.0 ± 6.09	10.1 ± 5.70	16.6 ± 7.01
Week 1 (n=35, 36, 34, 36, 37, 47, 35, 34, 29)	11.2 ± 4.17	9.1 ± 5.85	9.7 ± 5.29	7.8 ± 4.23	8.9 ± 6.10	9.6 ± 4.86	9.5 ± 4.86	7.0 ± 4.96	9.7 ± 4.24
Week 2 (n=35, 36, 33, 35, 35, 48, 35, 35, 31)	10.3 ± 4.57	8.4 ± 5.07	9.2 ± 5.03	7.1 ± 4.01	8.2 ± 5.17	8.4 ± 4.52	9.1 ± 5.47	6.0 ± 4.30	8.4 ± 3.62
Week 4 (n=32, 31, 27, 33, 34, 46, 29, 31, 31)	11.6 ± 5.81	9.2 ± 5.25	9.9 ± 5.29	7.3 ± 3.97	8.1 ± 4.89	9.6 ± 6.96	7.9 ± 5.57	6.6 ± 4.60	8.3 ± 3.99
Week 6 (n=32, 30, 25, 31, 28, 38, 27, 27, 27)	11.6 ± 6.61	9.7 ± 5.79	10.4 ± 6.20	6.2 ± 3.79	7.6 ± 4.69	8.8 ± 5.96	6.1 ± 3.23	6.9 ± 5.06	8.2 ± 4.23
Week 8 (n=30, 31, 26, 31, 26, 36, 24, 28, 27)	11.3 ± 5.82	8.7 ± 5.87	9.7 ± 6.62	6.1 ± 3.73	7.0 ± 4.61	8.4 ± 5.46	7.2 ± 4.75	7.5 ± 4.92	8.0 ± 4.68
Week 10 (n=29, 28, 25, 29, 28, 31, 24, 28, 24)	11.7 ± 7.09	8.0 ± 6.29	9.5 ± 5.89	6.5 ± 3.66	6.4 ± 4.87	7.8 ± 4.92	6.7 ± 3.13	6.7 ± 4.60	9.5 ± 4.97
Week 12 (n=29, 29, 26, 29, 27, 31, 23, 28, 25)	11.7 ± 7.40	7.8 ± 6.41	9.7 ± 6.45	5.9 ± 3.38	6.2 ± 4.69	8.0 ± 5.13	6.1 ± 3.67	6.8 ± 5.14	8.3 ± 4.79
Week 14 (n=28, 25, 24, 24, 27, 27, 23, 25, 23)	14.3 ± 8.09	8.1 ± 6.37	8.9 ± 6.09	6.8 ± 5.00	9.2 ± 6.12	10.4 ± 5.98	11.2 ± 7.54	8.5 ± 6.04	11.5 ± 5.26
Week 16 (n=27, 27, 23, 24, 25, 30, 22, 22, 19)	14.0 ± 7.60	8.6 ± 6.30	9.8 ± 5.47	7.4 ± 5.03	8.9 ± 6.77	10.4 ± 6.18	11.5 ± 7.20	10.2 ± 6.82	11.9 ± 7.33
ET (n=3, 3, 5, 3, 4, 6, 6, 4, 3)	7.7 ± 4.04	13.0 ± 1.00	12.8 ± 6.76	13.3 ± 7.02	15.8 ± 11.73	18.7 ± 10.23	18.0 ± 11.87	11.0 ± 8.21	19.3 ± 8.14
ET follow-up visit 1 (n=2, 1, 2, 1, 1, 2, 2, 1, 1)	7.0 ± 4.24	9.0 ± 99999	6.0 ± 4.24	4.0 ± 99999	2.0 ± 99999	19.0 ± 15.56	8.5 ± 2.12	4.0 ± 99999	7.0 ± 99999
ET follow-up visit 2 (n=2, 1, 2, 1, 2, 4, 2, 4, 2)	8.0 ± 5.66	7.0 ± 99999	4.5 ± 2.12	4.0 ± 99999	22.5 ± 9.19	17.8 ± 11.41	4.0 ± 0.00	13.0 ± 13.74	15.5 ± 10.61

No statistical analyses for this end point

Secondary: Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2

Top of page

End point title

Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2

End point description

PSI was a self-administered 8-item questionnaire that measured the severity of psoriasis symptoms over the past 24 hours and the past 7 days. PSI included following 8 items: itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Each item was rated on a scale from 0 to 4, where 0= not at all severe, 1= mild, 2= moderate, 3= severe and 4= very severe. Scores from all items were summed to give PSI score range from 0 (no severity) to 32 (maximum severity), higher PSI score indicated greater severity. EAS included all randomised subjects who received at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, number of subjects analysed=subjects evaluable for this endpoint and n=subjects evaluable for the specified time points. '99999' indicates that standard deviation could not be estimated as there was only 1 subject evaluable.

End point type

Secondary

End point timeframe

Baseline, Wk 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET (Prior to Week 12), ET Follow-up Visit 1 (ET-FV 1) (2 weeks post ET) and 2 (ET-FV 2) (4 weeks post ET)

End point values	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Number of subjects analysed	33	34	32	29	36	43	33	33	28
Units: Unit on a scale
arithmetic mean (standard deviation)
Change at Wk 1: n=33,34,32,29,36,43,33,33,28	-3.3 ± 4.94	-2.8 ± 3.35	-3.0 ± 3.84	-2.6 ± 2.95	-3.4 ± 4.17	-3.9 ± 5.00	-3.7 ± 3.49	-3.4 ± 3.18	-6.6 ± 4.80
Change at Wk 2: n=33,33,31,29,34,43,33,33,28	-4.0 ± 5.46	-3.9 ± 4.91	-4.1 ± 4.36	-3.1 ± 3.63	-3.8 ± 4.62	-5.1 ± 5.85	-4.2 ± 3.91	-4.3 ± 4.12	-7.8 ± 5.37
Change at Wk 4: n=30,28,26,27,33,40,27,29,25	-3.0 ± 6.33	-3.4 ± 5.09	-3.5 ± 5.12	-2.6 ± 3.91	-4.1 ± 4.55	-3.9 ± 6.50	-4.6 ± 5.44	-3.7 ± 4.57	-6.5 ± 5.44
Change at Wk 6: n=30,28,24,25,28,32,25,26,22	-3.5 ± 7.09	-3.1 ± 5.30	-2.0 ± 6.20	-3.5 ± 5.22	-4.0 ± 4.64	-5.1 ± 7.40	-6.3 ± 5.05	-3.4 ± 4.60	-6.5 ± 5.75
Change at Wk 8: n=28,28,25,25,26,30,22,27,22	-4.1 ± 7.20	-3.5 ± 4.60	-3.2 ± 6.56	-3.7 ± 5.01	-4.1 ± 5.01	-5.2 ± 8.12	-5.8 ± 5.35	-3.2 ± 4.90	-7.0 ± 6.64
Change at Wk 10: n=27,25,24,23,28,26,23,27,20	-4.0 ± 7.57	-4.0 ± 4.90	-3.4 ± 6.24	-3.3 ± 6.12	-5.3 ± 5.69	-5.5 ± 8.08	-5.1 ± 5.12	-3.9 ± 4.82	-5.8 ± 7.62
Change at Wk 12: n=27,26,25,23,27,28,22,27,19	-3.8 ± 7.74	-4.1 ± 4.98	-3.2 ± 5.63	-3.7 ± 6.13	-5.2 ± 6.04	-5.0 ± 8.15	-5.2 ± 4.82	-3.7 ± 5.67	-6.6 ± 7.82
Change at Wk 14: n=26,23,23,20,27,24,21,24,18	-0.7 ± 7.86	-2.9 ± 4.68	-4.4 ± 7.49	-3.1 ± 6.87	-2.2 ± 5.49	-3.5 ± 7.87	-1.4 ± 5.53	-2.3 ± 4.98	-2.9 ± 7.98
Change at Wk 16: n=25,24,22,19,25,27,20,21,16	-0.9 ± 7.61	-2.4 ± 5.02	-3.2 ± 6.37	-2.4 ± 7.27	-2.1 ± 6.05	-2.6 ± 7.12	-0.8 ± 4.29	-0.8 ± 5.28	-2.7 ± 8.40
Change at ET: n=3,3,4,3,4,6,5,3,2	-2.7 ± 2.52	0.7 ± 6.11	-1.0 ± 8.29	0.3 ± 2.08	-1.3 ± 6.85	0.7 ± 5.16	1.8 ± 7.40	-4.0 ± 3.00	-5.0 ± 1.41
Change at ET-FV 1: n=2,1,2,1,1,2,2,1,1	-2.5 ± 0.71	-9.0 ± 99999	-5.0 ± 7.07	-4.0 ± 99999	-3.0 ± 99999	2.0 ± 9.90	-2.5 ± 0.71	-7.0 ± 99999	-9.0 ± 99999
Change at ET-FV 2: n=2,1,2,1,2,4,2,4,2	-1.5 ± 2.12	-11.0 ± 99999	-6.5 ± 4.95	-4.0 ± 99999	6.5 ± 9.19	0.8 ± 7.14	-11.0 ± 4.24	-0.3 ± 8.26	-1.0 ± 9.90

No statistical analyses for this end point

Secondary: Percentage of Subjects With PGA Score Clear (0) or Almost clear (1) and >=2 Points Improvement From Baseline at Week 1, 2, 4, 6, 8, 10, 14, and 16

Top of page

End point title

Percentage of Subjects With PGA Score Clear (0) or Almost clear (1) and >=2 Points Improvement From Baseline at Week 1, 2, 4, 6, 8, 10, 14, and 16

End point description

End point type

Secondary

End point timeframe

Baseline, Week 1, 2, 4, 6, 8, 10, 14, and 16

End point values	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Number of subjects analysed	36	37	37	36	37	49	36	35	38
Units: Percentage of subjects
number (confidence interval 90%)
Week 1 (n=36, 37, 37, 36, 37, 49, 36, 35, 38)	2.8 (0.3 to 11.6)	2.7 (0.3 to 11.2)	2.7 (0.3 to 11.2)	0 (0.0 to 7.5)	0 (0.0 to 7.3)	0 (0.0 to 5.5)	0 (0.0 to 7.5)	5.7 (1.5 to 16.4)	5.3 (1.4 to 15.0)
Week 2 (n=36, 37, 37, 36, 37, 49, 36, 35, 38)	2.8 (0.3 to 11.6)	0 (0.0 to 7.3)	0 (0.0 to 7.3)	2.8 (0.3 to 11.6)	2.7 (0.3 to 11.2)	2.0 (0.2 to 8.4)	0 (0.0 to 7.5)	5.7 (1.5 to 16.4)	10.5 (4.7 to 21.6)
Week 4 (n=36, 37, 37, 36, 37, 49, 36, 35, 38)	5.6 (1.5 to 15.9)	5.4 (1.4 to 15.5)	0 (0.0 to 7.3)	5.6 (1.5 to 15.9)	5.4 (1.4 to 15.5)	8.2 (3.6 to 16.5)	8.3 (3.1 to 18.9)	11.4 (5.1 to 23.6)	21.1 (10.9 to 33.3)
Week 6 (n=36, 37, 37, 36, 37, 49, 36, 35, 38)	8.3 (3.1 to 18.9)	5.4 (1.4 to 15.5)	2.7 (0.3 to 11.2)	8.3 (3.1 to 18.9)	13.5 (6.7 to 24.8)	8.2 (3.6 to 16.5)	8.3 (3.1 to 18.9)	5.7 (1.5 to 16.4)	13.2 (6.5 to 24.3)
Week 8 (n=36, 37, 37, 36, 37, 49, 36, 35, 38)	11.1 (4.9 to 22.9)	5.4 (1.4 to 15.5)	5.4 (1.4 to 15.5)	2.8 (0.3 to 11.6)	10.8 (4.8 to 22.2)	6.1 (2.3 to 14.8)	13.9 (6.9 to 25.4)	5.7 (1.5 to 16.4)	18.4 (10.1 to 30.9)
Week 10 (n=36, 37, 37, 36, 37, 49, 36, 35, 38)	8.3 (3.1 to 18.9)	5.4 (1.4 to 15.5)	8.1 (3.0 to 18.5)	8.3 (3.1 to 18.9)	16.2 (7.3 to 29.3)	16.3 (8.4 to 27.1)	16.7 (7.5 to 30.2)	8.6 (3.2 to 19.3)	13.2 (6.5 to 24.3)
Week 14 (n=36, 37, 36, 35, 37, 48, 34, 34, 37)	2.8 (0.3 to 11.6)	13.5 (6.7 to 24.8)	5.6 (1.5 to 15.9)	8.6 (3.2 to 19.3)	13.5 (6.7 to 24.8)	6.3 (2.3 to 15.1)	8.8 (3.3 to 19.7)	11.8 (5.2 to 24.3)	8.1 (3.0 to 18.5)
Week 16 (n=36, 35, 35, 35, 37, 49, 34, 34, 37)	5.6 (1.5 to 15.9)	11.4 (5.1 to 23.6)	8.6 (3.2 to 19.3)	14.3 (7.1 to 26.0)	16.2 (7.3 to 29.3)	8.2 (3.6 to 16.5)	14.7 (7.3 to 26.9)	11.8 (5.2 to 24.3)	16.2 (7.3 to 29.3)

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 1

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4216

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-0.1

Confidence interval

level

90%

sides

2-sided

lower limit

-9.4

upper limit

9.1

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 1

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4216

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-0.1

Confidence interval

level

90%

sides

2-sided

lower limit

-9.4

upper limit

9.1

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 1

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7362

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-2.8

Confidence interval

level

90%

sides

2-sided

lower limit

-12.5

upper limit

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 1

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7417

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-2.8

Confidence interval

level

90%

sides

2-sided

lower limit

-12.5

upper limit

4.7

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 1

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-5.9

upper limit

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 1

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0714

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

5.7

Confidence interval

level

90%

sides

2-sided

lower limit

-0.8

upper limit

16.9

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 1

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0813

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

5.3

Confidence interval

level

90%

sides

2-sided

lower limit

-1.1

upper limit

15.7

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 2

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7417

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-2.8

Confidence interval

level

90%

sides

2-sided

lower limit

-12.5

upper limit

4.7

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 2

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-9.6

upper limit

9.6

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 2

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7417

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-2.8

Confidence interval

level

90%

sides

2-sided

lower limit

-12.5

upper limit

4.7

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 2

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4216

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-0.1

Confidence interval

level

90%

sides

2-sided

lower limit

-9.4

upper limit

9.1

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 2

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6894

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-2

Confidence interval

level

90%

sides

2-sided

lower limit

-9.4

upper limit

5.9

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 2

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0565

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

8.5

Confidence interval

level

90%

sides

2-sided

lower limit

-0.3

upper limit

20.3

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 2

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2518

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

3.7

Confidence interval

level

90%

sides

2-sided

lower limit

-4.2

upper limit

14.3

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 4

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.9001

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-5.6

Confidence interval

level

90%

sides

2-sided

lower limit

-16.5

upper limit

1.9

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 4

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4446

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-11

upper limit

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 4

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4446

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-11

upper limit

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 4

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-11

upper limit

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 4

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5054

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-10.5

upper limit

12.5

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 4

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3401

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

3.3

Confidence interval

level

90%

sides

2-sided

lower limit

-8.2

upper limit

16.9

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 4

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0489

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

12.9

Confidence interval

level

90%

sides

2-sided

lower limit

0.1

upper limit

27.5

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 6

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.8253

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-5.6

Confidence interval

level

90%

sides

2-sided

lower limit

-17.2

upper limit

4.4

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 6

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6349

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-2.9

Confidence interval

level

90%

sides

2-sided

lower limit

-14.8

upper limit

8.4

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 6

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2709

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

5.2

Confidence interval

level

90%

sides

2-sided

lower limit

-8.3

upper limit

19.1

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 6

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5054

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-10.5

upper limit

12.5

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 6

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-12.5

upper limit

12.5

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 6

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6319

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-2.4

Confidence interval

level

90%

sides

2-sided

lower limit

-12.9

upper limit

9.3

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 6

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3199

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-6.4

upper limit

18.1

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 8

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7306

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-5.7

Confidence interval

level

90%

sides

2-sided

lower limit

-19.1

upper limit

6.1

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 8

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7306

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-5.7

Confidence interval

level

90%

sides

2-sided

lower limit

-19.1

upper limit

6.1

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 8

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.8808

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-8.3

Confidence interval

level

90%

sides

2-sided

lower limit

-20.6

upper limit

2.7

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 8

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4644

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-0.3

Confidence interval

level

90%

sides

2-sided

lower limit

-13.7

upper limit

13.7

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 8

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1534

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

7.8

Confidence interval

level

90%

sides

2-sided

lower limit

-3.4

upper limit

20.9

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 8

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4867

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-0.4

Confidence interval

level

90%

sides

2-sided

lower limit

-10

upper limit

11.4

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 8

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0435

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

12.3

Confidence interval

level

90%

sides

2-sided

lower limit

0.4

upper limit

25.9

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 10

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6349

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-2.9

Confidence interval

level

90%

sides

2-sided

lower limit

-14.8

upper limit

8.4

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 10

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4565

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-0.2

Confidence interval

level

90%

sides

2-sided

lower limit

-12.6

upper limit

12.5

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 10

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-12.5

upper limit

12.5

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 10

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1765

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

7.9

Confidence interval

level

90%

sides

2-sided

lower limit

-5.7

upper limit

21.8

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 10

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5013

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

0.3

Confidence interval

level

90%

sides

2-sided

lower limit

-14

upper limit

15.2

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 10

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6424

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-3.2

Confidence interval

level

90%

sides

2-sided

lower limit

-16.4

upper limit

10.6

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 10

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7969

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-7.8

Confidence interval

level

90%

sides

2-sided

lower limit

-20.7

upper limit

5.9

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 14

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.062

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

10.7

Confidence interval

level

90%

sides

2-sided

lower limit

-0.7

upper limit

23.6

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 14

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3402

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

2.8

Confidence interval

level

90%

sides

2-sided

lower limit

-7

upper limit

13.4

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 14

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1743

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

5.8

Confidence interval

level

90%

sides

2-sided

lower limit

-4.5

upper limit

17.6

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 14

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.062

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

10.7

Confidence interval

level

90%

sides

2-sided

lower limit

-0.7

upper limit

23.6

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 14

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3534

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

2.6

Confidence interval

level

90%

sides

2-sided

lower limit

-7.8

upper limit

15.4

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 14

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2508

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

5.5

Confidence interval

level

90%

sides

2-sided

lower limit

-5.5

upper limit

18.8

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 14

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4238

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

1.9

Confidence interval

level

90%

sides

2-sided

lower limit

-8.2

upper limit

13.6

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 16

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2696

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

5.9

Confidence interval

level

90%

sides

2-sided

lower limit

-6.2

upper limit

19.3

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 16

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3648

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-8.6

upper limit

15.3

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 16

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1267

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

8.7

Confidence interval

level

90%

sides

2-sided

lower limit

-3.8

upper limit

22.2

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 16

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0832

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

10.7

Confidence interval

level

90%

sides

2-sided

lower limit

-2.5

upper limit

24.4

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 16

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2099

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

6.5

Confidence interval

level

90%

sides

2-sided

lower limit

-5.7

upper limit

21.3

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 16

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2124

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

8.1

Confidence interval

level

90%

sides

2-sided

lower limit

-4

upper limit

21.6

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 16

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3474

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

3.6

Confidence interval

level

90%

sides

2-sided

lower limit

-8

upper limit

17.4

Secondary: Percentage of Subjects who Achieved PSI Score of 0 (not at all) or 1 (Mild) on all Items at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16

Top of page

End point title

Percentage of Subjects who Achieved PSI Score of 0 (not at all) or 1 (Mild) on all Items at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16

End point description

PSI was a self-administered 8-item questionnaire that measured the severity of psoriasis symptoms over the past 24 hours and the past 7 days. PSI included following 8 items: itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Each item was rated on a scale from 0 to 4, where 0= not at all severe, 1= mild, 2= moderate, 3= severe and 4= very severe. Scores from all items were summed to give PSI score range from 0 (no severity) to 32 (maximum severity), higher PSI score indicated greater severity. EAS included all randomised subjects who received at least 1 dose of investigational product (PF-06700841 or placebo) and Week 12 visits were not missing due to COVID-19 pandemic. Here, number of subjects analysed=subjects evaluable for this endpoint and n=subjects evaluable for the specified time points.

End point type

Secondary

End point timeframe

Week 1, 2, 4, 6, 8, 10, 12, 14, and 16

End point values	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Number of subjects analysed	35	36	34	36	37	48	35	35	31
Units: Percentage of subjects
number (confidence interval 90%)
Week 1 (n=35, 36, 34, 36, 37, 47, 35, 34, 29)	5.7 (1.5 to 16.4)	19.4 (10.7 to 32.8)	11.8 (5.2 to 24.3)	22.2 (11.6 to 35.3)	13.5 (6.7 to 24.8)	19.1 (11.2 to 30.3)	11.4 (5.1 to 23.6)	26.5 (15.9 to 40.5)	24.1 (13.4 to 38.5)
Week 2 (n=35, 36, 33, 35, 35, 48, 35, 35, 31)	8.6 (3.2 to 19.3)	22.2 (11.6 to 35.3)	18.2 (8.2 to 31.3)	34.3 (22.0 to 47.8)	31.4 (19.3 to 44.8)	20.8 (11.8 to 31.5)	25.7 (15.4 to 39.2)	31.4 (19.3 to 44.8)	32.3 (18.7 to 48.2)
Week 4 (n=32, 31, 27, 33, 34, 46, 29, 31, 31)	15.6 (7.8 to 28.7)	29.0 (17.6 to 45.0)	29.6 (15.7 to 45.3)	48.5 (34.4 to 63.9)	38.2 (24.3 to 53.8)	26.1 (15.8 to 37.7)	31.0 (18.9 to 46.3)	51.6 (36.8 to 67.3)	35.5 (21.3 to 51.8)
Week 6 (n=32, 30, 25, 31, 28, 38, 27, 27, 27)	18.8 (8.5 to 32.0)	26.7 (14.0 to 41.6)	32.0 (17.0 to 50.0)	54.8 (39.9 to 70.3)	42.9 (28.4 to 60.0)	31.6 (19.9 to 45.9)	66.7 (50.0 to 79.6)	48.1 (32.6 to 65.3)	33.3 (20.4 to 50.0)
Week 8 (n=30, 31, 26, 31, 26, 36, 24, 28, 27)	23.3 (12.9 to 37.6)	35.5 (21.3 to 51.8)	46.2 (29.9 to 63.8)	67.7 (51.8 to 81.3)	50.0 (34.2 to 65.8)	41.7 (29.0 to 56.0)	62.5 (44.7 to 77.9)	35.7 (20.8 to 52.7)	59.3 (41.7 to 75.2)
Week 10 (n=29, 28, 25, 29, 28, 31, 24, 28, 24)	31.0 (18.9 to 46.3)	42.9 (28.4 to 60.0)	40.0 (24.6 to 58.3)	62.1 (46.3 to 77.1)	64.3 (47.3 to 79.2)	45.2 (29.7 to 60.1)	50.0 (31.9 to 68.1)	46.4 (31.0 to 63.4)	33.3 (17.8 to 52.1)
Week 12 (n=29, 29, 26, 29, 27, 31, 23, 28, 25)	24.1 (13.4 to 38.5)	51.7 (35.2 to 68.0)	50.0 (34.2 to 65.8)	62.1 (46.3 to 77.1)	55.6 (38.2 to 70.9)	35.5 (21.3 to 51.8)	56.5 (38.1 to 72.7)	46.4 (31.0 to 63.4)	36.0 (21.4 to 54.4)
Week 14 (n=28, 25, 24, 24, 27, 27, 23, 25, 23)	7.1 (1.9 to 20.1)	44.0 (27.0 to 61.1)	45.8 (28.2 to 63.0)	54.2 (37.0 to 71.8)	37.0 (22.1 to 54.7)	25.9 (14.5 to 41.7)	30.4 (17.3 to 47.9)	36.0 (21.4 to 54.4)	17.4 (7.8 to 33.5)
Week 16 (n=27, 27, 23, 24, 25, 30, 22, 22, 19)	7.4 (2.0 to 20.4)	44.4 (29.1 to 61.8)	30.4 (17.3 to 47.9)	54.2 (37.0 to 71.8)	52.0 (36.0 to 69.3)	36.7 (22.1 to 52.4)	18.2 (8.2 to 35.3)	22.7 (11.5 to 39.5)	31.6 (15.1 to 53.0)

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 1

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2697

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

6.1

Confidence interval

level

90%

sides

2-sided

lower limit

-6.3

upper limit

19.6

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 1

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0544

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

13.7

Confidence interval

level

90%

sides

2-sided

lower limit

-0.3

upper limit

27.9

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 1

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0286

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

16.5

Confidence interval

level

90%

sides

2-sided

lower limit

upper limit

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 1

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1512

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

7.8

Confidence interval

level

90%

sides

2-sided

lower limit

-4.7

upper limit

20.8

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 1

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3137

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

7.3

Confidence interval

level

90%

sides

2-sided

lower limit

-8.5

upper limit

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 1

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.79

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-7.7

Confidence interval

level

90%

sides

2-sided

lower limit

-21.9

upper limit

7.4

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 1

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3789

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-10.9

upper limit

22.6

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 2

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0636

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

13.7

Confidence interval

level

90%

sides

2-sided

lower limit

-1

upper limit

28.5

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 2

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1435

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

9.6

Confidence interval

level

90%

sides

2-sided

lower limit

-4.9

upper limit

24.5

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 2

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0058

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

25.7

Confidence interval

level

90%

sides

2-sided

lower limit

8.9

upper limit

42.4

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 2

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0112

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

22.9

Confidence interval

level

90%

sides

2-sided

lower limit

6.5

upper limit

38.9

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 2

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3349

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

4.9

Confidence interval

level

90%

sides

2-sided

lower limit

-10.8

upper limit

21.3

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 2

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2065

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

10.6

Confidence interval

level

90%

sides

2-sided

lower limit

-6.1

upper limit

27.7

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 2

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1871

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

11.4

Confidence interval

level

90%

sides

2-sided

lower limit

-5.6

upper limit

29.1

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 4

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1245

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

13.4

Confidence interval

level

90%

sides

2-sided

lower limit

-4.9

upper limit

31.4

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 4

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.128

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-4.7

upper limit

33.7

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 4

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0235

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

22.6

Confidence interval

level

90%

sides

2-sided

lower limit

3.1

upper limit

40.6

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 4

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

32.9

Confidence interval

level

90%

sides

2-sided

lower limit

12.4

upper limit

50.5

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 4

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3728

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

4.9

Confidence interval

level

90%

sides

2-sided

lower limit

-13.6

upper limit

24.1

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 4

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0153

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

25.5

Confidence interval

level

90%

sides

2-sided

lower limit

upper limit

43.6

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 6

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2785

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

7.9

Confidence interval

level

90%

sides

2-sided

lower limit

-10.2

upper limit

26.4

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 4

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2543

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

9.4

Confidence interval

level

90%

sides

2-sided

lower limit

-8.8

upper limit

27.8

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 6

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1434

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

13.3

Confidence interval

level

90%

sides

2-sided

lower limit

-7.4

upper limit

33.7

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 6

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0015

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

36.1

Confidence interval

level

90%

sides

2-sided

lower limit

12.8

upper limit

54.1

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 6

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0242

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

24.1

Confidence interval

level

90%

sides

2-sided

lower limit

3.4

upper limit

43.9

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 6

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0037

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

35.1

Confidence interval

level

90%

sides

2-sided

lower limit

upper limit

54.1

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 6

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1037

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

16.6

Confidence interval

level

90%

sides

2-sided

lower limit

-4.9

upper limit

36.7

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 6

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4607

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

1.8

Confidence interval

level

90%

sides

2-sided

lower limit

-17.7

upper limit

22.5

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 8

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1725

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

12.2

Confidence interval

level

90%

sides

2-sided

lower limit

-8

upper limit

31.9

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 8

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0451

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

22.8

Confidence interval

level

90%

sides

2-sided

lower limit

0.2

upper limit

43.6

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 8

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0003

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

44.4

Confidence interval

level

90%

sides

2-sided

lower limit

21.3

upper limit

62.9

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 8

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0239

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

26.7

Confidence interval

level

90%

sides

2-sided

lower limit

3.8

upper limit

47.6

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 8

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0643

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

20.8

Confidence interval

level

90%

sides

2-sided

lower limit

-2.1

upper limit

41.2

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 8

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6676

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-6

Confidence interval

level

90%

sides

2-sided

lower limit

-25.9

upper limit

15.9

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 8

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0898

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

17.6

Confidence interval

level

90%

sides

2-sided

lower limit

-4.2

upper limit

37.8

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 10

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2707

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

11.8

Confidence interval

level

90%

sides

2-sided

lower limit

-10.1

upper limit

32.9

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 10

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2981

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-14.2

upper limit

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 10

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.011

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

upper limit

51.4

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 10

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0083

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

33.3

Confidence interval

level

90%

sides

2-sided

lower limit

9.1

upper limit

53.2

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 10

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4217

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

4.8

Confidence interval

level

90%

sides

2-sided

lower limit

-18.3

upper limit

27.5

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 10

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5152

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

1.3

Confidence interval

level

90%

sides

2-sided

lower limit

-20.8

upper limit

23.2

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 10

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7002

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-11.8

Confidence interval

level

90%

sides

2-sided

lower limit

-33.1

upper limit

11.7

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 12

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0169

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

27.6

Confidence interval

level

90%

sides

2-sided

lower limit

5.2

upper limit

47.9

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 12

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0283

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

25.9

Confidence interval

level

90%

sides

2-sided

lower limit

3.2

upper limit

46.2

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 12

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

37.9

Confidence interval

level

90%

sides

2-sided

lower limit

14.3

upper limit

57.1

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 12

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0095

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

31.4

Confidence interval

level

90%

sides

2-sided

lower limit

8.4

upper limit

51.5

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 12

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0798

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-2.7

upper limit

42.6

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 12

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2848

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

10.9

Confidence interval

level

90%

sides

2-sided

lower limit

-11.3

upper limit

31.8

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 12

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5062

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

0.5

Confidence interval

level

90%

sides

2-sided

lower limit

-21.1

upper limit

23.1

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 14

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0012

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

36.9

Confidence interval

level

90%

sides

2-sided

lower limit

16.7

upper limit

55.3

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 14

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0007

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

38.7

Confidence interval

level

90%

sides

2-sided

lower limit

17.3

upper limit

57.4

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 14

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0001

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

24.6

upper limit

65.1

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 14

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0039

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

29.9

Confidence interval

level

90%

sides

2-sided

lower limit

9.5

upper limit

48.7

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 14

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3895

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

4.5

Confidence interval

level

90%

sides

2-sided

lower limit

-17.5

upper limit

26.5

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 14

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2793

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

10.1

Confidence interval

level

90%

sides

2-sided

lower limit

-11.8

upper limit

31.8

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 14

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7027

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-8.5

Confidence interval

level

90%

sides

2-sided

lower limit

-28.4

upper limit

12.2

Vehicle QD versus PF-06700841 0.1% QD

Statistical analysis description

Week 16

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.1% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0009

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

15.4

upper limit

55.2

Vehicle QD versus PF-06700841 0.3% QD

Statistical analysis description

Week 16

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 0.3% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0205

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

4.1

upper limit

43.2

Vehicle QD versus PF-06700841 1.0% QD

Statistical analysis description

Week 16

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 1.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0001

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

46.8

Confidence interval

level

90%

sides

2-sided

lower limit

24.6

upper limit

65.7

Vehicle QD versus PF-06700841 3.0% QD

Statistical analysis description

Week 16

Comparison groups

Vehicle Once Daily (QD) v PF-06700841 3.0% QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0002

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

44.6

Confidence interval

level

90%

sides

2-sided

lower limit

21.5

upper limit

62.9

Pooled Vehicle BID versus PF-06700841 0.3% BID

Statistical analysis description

Week 16

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 0.3% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.9209

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-18.5

Confidence interval

level

90%

sides

2-sided

lower limit

-38.3

upper limit

3.2

Pooled Vehicle BID versus PF-06700841 1.0% BID

Statistical analysis description

Week 16

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 1.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.793

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-13.9

Confidence interval

level

90%

sides

2-sided

lower limit

-34.4

upper limit

8.7

Pooled Vehicle BID versus PF-06700841 3.0% BID

Statistical analysis description

Week 16

Comparison groups

Pooled Vehicle Twice Daily (BID) v PF-06700841 3.0% BID

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6156

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

-5.1

Confidence interval

level

90%

sides

2-sided

lower limit

-28

upper limit

20.1

Secondary: Number of Subjects With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and SAEs

Top of page

End point title

Number of Subjects With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and SAEs

End point description

An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalisation; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and all non-SAEs. Treatment emergent AEs (TEAEs) were events that occurred between first dose of study drug and up to 4 weeks after last dose that were absent before treatment or that worsened relative to pretreatment state. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a subject who received study drug. Relatedness to study drug was assessed by the investigator. Safety analysis set (SAS) included subjects who received at least 1 dose of investigational product.

End point type

Secondary

End point timeframe

Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)

End point values	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Number of subjects analysed	37	37	37	36	37	49	36	36	38
Units: Subjects
Treatment-emergent AEs	17	16	14	17	14	20	13	18	12
Treatment-emergent SAEs	1	0	0	1	0	1	1	2	0
Treatment-related AEs	1	0	2	2	3	2	3	3	1
Treatment-related SAEs	0	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Number of Subjects With TEAEs by Severity

Top of page

End point title

Number of Subjects With TEAEs by Severity

End point description

An AE was any untoward medical occurrence in a subjects who received investigational product without regard to possibility of causal relationship. AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to AE) and severe (caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to AE). SAS included subjects who received at least 1 dose of investigational product.

End point type

Secondary

End point timeframe

Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)

End point values	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Number of subjects analysed	37	37	37	36	37	49	36	36	38
Units: Subjects
Mild	12	9	11	11	7	8	7	11	6
Moderate	5	7	3	5	7	11	6	5	6
Severe	0	0	0	1	0	1	0	2	0

No statistical analyses for this end point

Secondary: Number of Subjects who Discontinued From Study due to Adverse Events

Top of page

End point title

Number of Subjects who Discontinued From Study due to Adverse Events

End point description

An AE was any untoward medical occurrence in a subjects who received investigational product without regard to possibility of causal relationship. SAS included subjects who received at least 1 dose of investigational product.

End point type

Secondary

End point timeframe

Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)

End point values	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Number of subjects analysed	37	37	37	36	37	49	36	36	38
Units: Subjects	1	1	3	0	2	1	1	2	1

No statistical analyses for this end point

Secondary: Number of Subjects With Laboratory Abnormalities Meeting Specified Criteria

Top of page

End point title

Number of Subjects With Laboratory Abnormalities Meeting Specified Criteria

End point description

Bilirubin: greater than (>) 1.5* upper limit normal (ULN); aspartate aminotransferase, alanine aminotransferase: >2.5*ULN; creatinine, cystatin C: >1.3*ULN; creatine kinase: >2.0*ULN; glomerular filtration rate (GFR) CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) Equat: less than (<) 60 milliliter (mL)/minute (min)/1.73 meter(m)^2, greater than or equal to (>=) 30% decrease from baseline; GFR: <60 mL/min/1.73m^2. SAS included subjects who received at least 1 dose of investigational product. Here, number of subjects analysed=subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)

End point values	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Number of subjects analysed	37	36	36	36	37	49	36	36	38
Units: Subjects	7	6	11	7	5	12	5	6	15

No statistical analyses for this end point

Secondary: Number of Subjects With Categorical Summary of Post-Baseline Electrocardiogram (ECG) Data

Top of page

End point title

Number of Subjects With Categorical Summary of Post-Baseline Electrocardiogram (ECG) Data

End point description

Following were ECG criteria used for categorical summary:1) PR interval: percentage change >=25/50%, QRS interval: value >140 msec, and QT interval corrected using the Fridericia's formula (QTcF): 450 msec < value less than equal to (<=) 480 and 30 < change <=60. SAS included subjects who received at least 1 dose of investigational product.

End point type

Secondary

End point timeframe

Post-baseline to Wk 6, Post-baseline to Wk 12

End point values	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Number of subjects analysed	37	37	37	36	37	49	36	36	38
Units: Subjects
Post-baseline to Wk 6:PR interval >=25/50%	0	0	0	1	0	1	0	0	0
Post-baseline to Wk 6:QRS interval >=140 msec	0	1	0	0	0	1	0	0	0
Post-baseline to Wk 6:QTcF interval 30<Change<=60	1	0	0	1	1	0	0	0	2
Post-baseline to Wk 12:PR interval >=25/50%	0	0	0	1	1	1	0	0	0
Post-baseline to Wk 12:QRS interval >=140 msec	0	1	0	0	0	2	0	1	0
Post-baseline to Wk12:QTcF interval 450<Value<=480	0	0	0	0	0	2	1	1	1
Post-baseline to Wk 12:QTcF interval 30<Change<=60	2	0	0	0	0	2	0	0	1

No statistical analyses for this end point

Secondary: Number of Subjects With Categorical Summary of Post-Baseline Vital Signs Data

Top of page

End point title

Number of Subjects With Categorical Summary of Post-Baseline Vital Signs Data

End point description

Following were the vital signs criteria: 1) Pulse rate: value <40 beats per min (bpm), value >120 bpm; 2) Sitting (Sit.) diastolic blood pressure (DBP): value <50 mmHg; change >=20 mmHg increase (inc.); change >=20 mmHg decrease (dec.); 3) Sit. systolic blood pressure (SBP): value <90 mmHg, change >=30 mmHg inc., change >=30 mmHg dec.; 4) Supine (Sup.) DBP: value <50 mmHg, change >=20 mmHg inc., change >=20 mmHg dec.; 5) Sup. SBP: value <90 mmHg, change >=30 mmHg inc., change >=30 mmHg dec.. SAS included subjects who received at least 1 dose of investigational product. Here, number of subjects analysed=subjects evaluable for this endpoint and n=subjects evaluable for the specified time points.

End point type

Secondary

End point timeframe

Post-baseline to Week 12

End point values	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Number of subjects analysed	35	34	33	33	34	47	32	36	34
Units: Subjects
Pulse rate <40 bpm: n=35,34,33,33,34,47,32,36,34	0	0	0	0	0	0	0	0	0
Pulse rate >120 bpm: n=35,34,33,33,34,47,32,36,34	0	0	0	0	0	0	0	0	0
Sit. DBP <50mmHg: n=3,11,5,5,6,5,8,6,5	0	0	0	0	0	0	0	0	0
Sit. DBP >=20mmHg inc.: n=3,11,5,5,6,5,8,6,5	0	0	0	0	0	0	0	0	0
Sit. DBP >=20mmHg dec.: n=3,11,5,5,6,5,8,6,5	0	0	0	0	0	0	0	0	0
Sit. SBP <90mmHg: n=3,11,5,5,6,5,8,6,5	0	0	0	0	0	0	0	0	0
Sit. SBP >= 30mmHg inc.: n=3,11,5,5,6,5,8,6,5	0	0	0	0	0	0	0	0	1
Sit. SBP >=30mmHg dec.: n=3,11,5,5,6,5,8,6,5	0	0	0	0	0	0	0	1	0
Sup.DBP <50mmHg:n=32,25,29,29,28,42,25,31,31	0	0	0	0	0	0	0	0	0
Sup.DBP>= 20mmHg inc.:n=32,25,29,29,28,42,25,31,31	0	1	1	1	0	0	0	2	2
Sup.DBP>=20mmHg dec.:n=32,25,29,29,28,42,25,31,31	0	2	0	0	1	4	0	0	0
Sup.SBP <90mmHg:n=32,25,29,29,28,42,25,31,31	1	0	0	0	0	0	0	0	0
Sup.SBP>=30mmHg inc.:n=32,25,29,29,28,42,25,31,31	1	0	1	2	0	2	0	2	1
Sup.SBP>= 30mmHg dec.:n=32,25,29,29,28,42,25,31,31	1	0	1	1	0	0	1	1	1

No statistical analyses for this end point

Secondary: Number of Subjects Classified per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16

Top of page

End point title

Number of Subjects Classified per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16

End point description

At the site of study drug application, skin tolerability was assessed for non-lesional skin surrounding the plaques on a scale from 0 to 4. Grade 0= none (no evidence of local intolerance), Grade 1= mild (minimal erythema and/or edema, slight glazed appearance), Grade 2= moderate (definite erythema and/or oedema with peeling and/or cracking but needs no adaptation of posology), Grade 3= severe, reported as AE (erythema, oedema glazing with fissures, few vesicles or papules: consider removing topical agent [if still in place]), Grade 4= very severe, reported as AE (strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent [if still in place]). SAS included subjects who received at least 1 dose of investigational product. Here, n=subjects evaluable for the specified time points.

End point type

Secondary

End point timeframe

Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16

End point values	Vehicle Once Daily (QD)	PF-06700841 0.1% QD	PF-06700841 0.3% QD	PF-06700841 1.0% QD	PF-06700841 3.0% QD	Pooled Vehicle Twice Daily (BID)	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Number of subjects analysed	37	37	37	36	37	49	36	36	38
Units: Subjects
Day 1: None (n=37,37,37,36,37,49,36,36,38)	36	37	36	36	36	48	35	36	37
Day 1: Mild (n=37,37,37,36,37,49,36,36,38)	1	0	1	0	1	0	0	0	1
Day 1: Moderate (n=37,37,37,36,37,49,36,36,38)	0	0	0	0	0	0	1	0	0
Day 1: Severe (n=37,37,37,36,37,49,36,36,38)	0	0	0	0	0	0	0	0	0
Day 1:Very severe (n=37,37,37,36,37,49,36,36,38)	0	0	0	0	0	0	0	0	0
Day 1: Missing (n=37,37,37,36,37,49,36,36,38)	0	0	0	0	0	1	0	0	0
Week 1: None (n=36,36,37,36,37,49,36,36,37)	32	35	32	34	35	44	32	32	35
Week 1: Mild (n=36,36,37,36,37,49,36,36,37)	1	0	1	2	0	1	0	2	1
Week 1: Moderate (n=36,36,37,36,37,49,36,36,37)	0	0	0	0	0	0	0	0	0
Week 1: Severe (n=36,36,37,36,37,49,36,36,37)	0	0	0	0	0	0	0	0	0
Week 1:Very severe (n=36,36,37,36,37,49,36,36,37)	0	0	0	0	0	0	0	0	0
Week 1: Missing (n=36,36,37,36,37,49,36,36,37)	3	1	4	0	2	4	4	2	1
Week 2: None (n=35,36,36,36,36,48,35,36,37)	33	35	30	34	35	45	34	35	33
Week 2: Mild (n=35,36,36,36,36,48,35,36,37)	1	0	1	1	0	1	0	0	2
Week 2: Moderate (n=35,36,36,36,36,48,35,36,37)	0	0	0	0	0	0	1	0	0
Week 2: Severe (n=35,36,36,36,36,48,35,36,37)	0	0	0	0	0	0	0	0	0
Week 2:Very severe (n=35,36,36,36,36,48,35,36,37)	0	0	0	0	0	0	0	0	0
Week 2: Missing (n=35,36,36,36,36,48,35,36,37)	1	1	5	1	1	2	0	1	2
Week 4: None (n=34,34,34,35,35,47,32,35,35)	34	32	29	32	34	44	30	32	30
Week 4: Mild (n=34,34,34,35,35,47,32,35,35)	0	0	0	2	0	1	0	0	3
Week 4: Moderate (n=34,34,34,35,35,47,32,35,35)	0	0	0	0	0	0	0	0	0
Week 4: Severe (n=34,34,34,35,35,47,32,35,35)	0	0	0	0	0	0	0	0	0
Week 4:Very severe (n=34,34,34,35,35,47,32,35,35)	0	0	0	0	0	0	0	0	0
Week 4: Missing (n=34,34,34,35,35,47,32,35,35)	0	2	5	1	1	2	2	3	2
Week 6: None (n=33,32,32,35,31,44,31,35,32)	32	31	26	30	27	37	28	31	30
Week 6: Mild (n=33,32,32,35,31,44,31,35,32)	0	0	1	1	1	0	0	0	0
Week 6: Moderate (n=33,32,32,35,31,44,31,35,32)	0	0	0	0	0	0	0	0	0
Week 6: Severe (n=33,32,32,35,31,44,31,35,32)	0	0	0	0	0	0	0	0	0
Week 6:Very severe (n=33,32,32,35,31,44,31,35,32)	0	0	0	0	0	0	0	0	0
Week 6: Missing (n=33,32,32,35,31,44,31,35,32)	1	1	5	4	3	7	3	4	2
Week 8: None (n=32,32,33,35,31,41,29,34,32)	29	30	27	30	26	34	26	30	28
Week 8: Mild (n=32,32,33,35,31,41,29,34,32)	0	0	0	0	1	1	0	0	0
Week 8: Moderate (n=32,32,33,35,31,41,29,34,32)	1	0	0	1	0	0	0	0	0
Week 8: Severe (n=32,32,33,35,31,41,29,34,32)	0	0	0	0	0	0	0	0	0
Week 8:Very severe (n=32,32,33,35,31,41,29,34,32)	0	0	0	0	0	0	0	0	0
Week 8: Missing (n=32,32,33,35,31,41,29,34,32)	2	2	6	4	4	6	3	4	4
Week 10: None (n=32,31,32,33,31,40,28,34,30)	29	30	24	29	27	34	24	27	26
Week 10: Mild (n=32,31,32,33,31,40,28,34,30)	0	0	1	1	1	0	0	0	0
Week 10: Moderate (n=32,31,32,33,31,40,28,34,30)	0	0	0	0	0	0	0	0	0
Week 10: Severe (n=32,31,32,33,31,40,28,34,30)	0	0	0	0	0	0	0	0	0
Week 10:Very severe (n=32,31,32,33,31,40,28,34,30)	0	0	0	0	0	0	0	0	0
Week 10: Missing (n=32,31,32,33,31,40,28,34,30)	3	1	7	3	3	6	4	7	4
Week 12: None (n=36,36,36,35,35,46,34,36,35)	33	32	30	31	30	43	30	32	29
Week 12: Mild (n=36,36,36,35,35,46,34,36,35)	0	0	0	1	1	0	0	0	0
Week 12: Moderate (n=36,36,36,35,35,46,34,36,35)	0	0	0	0	0	0	1	1	1
Week 12: Severe (n=36,36,36,35,35,46,34,36,35)	0	0	0	0	0	0	0	0	0
Week 12:Very severe (n=36,36,36,35,35,46,34,36,35)	0	0	0	0	0	0	0	0	0
Week 12: Missing (n=36,36,36,35,35,46,34,36,35)	3	4	6	3	4	3	3	3	5
Week 14: None (n=36,34,34,34,34,45,34,35,33)	31	27	24	27	30	34	26	26	28
Week 14: Mild (n=36,34,34,34,34,45,34,35,33)	0	0	0	0	0	0	0	0	0
Week 14: Moderate (n=36,34,34,34,34,45,34,35,33)	0	0	0	0	0	0	0	0	0
Week 14: Severe (n=36,34,34,34,34,45,34,35,33)	0	0	0	0	0	0	0	0	0
Week 14:Very severe (n=36,34,34,34,34,45,34,35,33)	0	0	0	0	0	0	0	0	0
Week 14: Missing (n=36,34,34,34,34,45,34,35,33)	5	7	10	5	4	11	8	9	5
Week 16: None (n=35,35,35,35,32,45,34,35,33)	31	28	26	28	28	35	26	28	26
Week 16: Mild (n=35,35,35,35,32,45,34,35,33)	0	0	0	0	0	0	0	1	0
Week 16: Moderate (n=35,35,35,35,32,45,34,35,33)	0	0	0	0	0	0	0	0	0
Week 16: Severe (n=35,35,35,35,32,45,34,35,33)	0	0	0	0	0	0	0	0	0
Week 16:Very severe (n=35,35,35,35,32,45,34,35,33)	0	0	0	0	0	0	0	0	0
Week 16: Missing (n=35,35,35,35,32,45,34,35,33)	4	7	9	7	4	10	8	6	7

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Day 1 of study drug dose to maximum of 4 weeks post last dose (maximum up to 16 weeks)

Adverse event reporting additional description

Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be classified as serious in 1 subject and as non-serious in another subject, or 1 subject may have experienced both a SAE and non-SAE during the study. SAS included subjects who received at least 1 dose of investigational product.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

24.0

Reporting group title

PF-06700841 0.1% QD

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 0.1% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Vehicle Once Daily (QD)

Reporting group description

During stage 1 of the study subjects topically applied vehicle cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 1.0% QD

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 1% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 0.3% QD

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 0.3% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 3.0% QD

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 3% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

Pooled Vehicle BID

Reporting group description

During stage 1 and 2 of the study subjects topically applied vehicle cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 0.3% BID

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 0.3% cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 1.0% BID

Reporting group description

During stage 1 of the study subjects topically applied PF-06700841 1% cream on psoriatic areas BID for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 3.0% BID

Reporting group description

During stage 2 of the study subjects topically applied PF-06700841 3% cream on psoriatic areas QD for a maximum of 12 weeks. Subjects were followed up for 4 weeks after last dose.

Serious adverse events	PF-06700841 0.1% QD	Vehicle Once Daily (QD)	PF-06700841 1.0% QD	PF-06700841 0.3% QD	PF-06700841 3.0% QD	Pooled Vehicle BID	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 37 (0.00%)	1 / 37 (2.70%)	1 / 36 (2.78%)	0 / 37 (0.00%)	0 / 37 (0.00%)	1 / 49 (2.04%)	1 / 36 (2.78%)	2 / 36 (5.56%)	0 / 38 (0.00%)
number of deaths (all causes)	0	0	0	0	0	1	0	0	0
number of deaths resulting from adverse events
Investigations
Aspiration bursa
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 49 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Cardiopulmonary failure
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)	1 / 49 (2.04%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Nervous system disorders
Lethargy
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 49 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 49 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Depression
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 49 (0.00%)	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 38 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Bacteraemia
subjects affected / exposed	0 / 37 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 49 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Thrombophlebitis septic
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 49 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 49 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	PF-06700841 0.1% QD	Vehicle Once Daily (QD)	PF-06700841 1.0% QD	PF-06700841 0.3% QD	PF-06700841 3.0% QD	Pooled Vehicle BID	PF-06700841 0.3% BID	PF-06700841 1.0% BID	PF-06700841 3.0% BID
Total subjects affected by non serious adverse events
subjects affected / exposed	7 / 37 (18.92%)	7 / 37 (18.92%)	9 / 36 (25.00%)	7 / 37 (18.92%)	8 / 37 (21.62%)	10 / 49 (20.41%)	4 / 36 (11.11%)	10 / 36 (27.78%)	2 / 38 (5.26%)
Investigations
Blood creatine phosphokinase increased
subjects affected / exposed	0 / 37 (0.00%)	1 / 37 (2.70%)	2 / 36 (5.56%)	0 / 37 (0.00%)	1 / 37 (2.70%)	0 / 49 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)
occurrences all number	0	1	2	0	1	0	0	0	0
Vascular disorders
Hypertension
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)	2 / 37 (5.41%)	2 / 49 (4.08%)	0 / 36 (0.00%)	2 / 36 (5.56%)	1 / 38 (2.63%)
occurrences all number	0	0	0	1	2	2	0	2	1
Nervous system disorders
Headache
subjects affected / exposed	2 / 37 (5.41%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 49 (0.00%)	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 38 (0.00%)
occurrences all number	3	0	0	0	0	0	1	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	0 / 37 (0.00%)	1 / 37 (2.70%)	1 / 36 (2.78%)	2 / 37 (5.41%)	0 / 37 (0.00%)	2 / 49 (4.08%)	2 / 36 (5.56%)	2 / 36 (5.56%)	0 / 38 (0.00%)
occurrences all number	0	1	1	2	0	2	2	2	0
Skin and subcutaneous tissue disorders
Pruritus
subjects affected / exposed	0 / 37 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	1 / 37 (2.70%)	0 / 37 (0.00%)	1 / 49 (2.04%)	0 / 36 (0.00%)	2 / 36 (5.56%)	1 / 38 (2.63%)
occurrences all number	0	1	0	1	0	1	0	2	1
Infections and infestations
Nasopharyngitis
subjects affected / exposed	3 / 37 (8.11%)	4 / 37 (10.81%)	6 / 36 (16.67%)	1 / 37 (2.70%)	3 / 37 (8.11%)	3 / 49 (6.12%)	1 / 36 (2.78%)	7 / 36 (19.44%)	0 / 38 (0.00%)
occurrences all number	4	5	6	2	3	3	1	7	0
Rhinitis
subjects affected / exposed	1 / 37 (2.70%)	0 / 37 (0.00%)	0 / 36 (0.00%)	2 / 37 (5.41%)	0 / 37 (0.00%)	1 / 49 (2.04%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)
occurrences all number	1	0	0	2	0	1	0	0	0
Upper respiratory tract infection
subjects affected / exposed	2 / 37 (5.41%)	1 / 37 (2.70%)	0 / 36 (0.00%)	1 / 37 (2.70%)	2 / 37 (5.41%)	2 / 49 (4.08%)	1 / 36 (2.78%)	0 / 36 (0.00%)	1 / 38 (2.63%)
occurrences all number	3	1	0	1	2	2	1	0	1

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

20 Apr 2020

Addition of an option to add an additional cohort of subjects in BID dosing arm (and corresponding vehicle arm) as stage 2 of the study.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12

Primary: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12

Secondary: Percentage of Subjects With Physician Global Assessment (PGA) Score Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12

Secondary: Percentage of Subjects With Physician Global Assessment (PGA) Score Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12

Secondary: Percentage of Subjects With 75% Reduction From Baseline in PASI at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16

Secondary: Percentage of Subjects With 75% Reduction From Baseline in PASI at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16

Secondary: Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12

Secondary: Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12

Secondary: Change From Baseline in PASI Scores at Week 14 and 16

Secondary: Change From Baseline in PASI Scores at Week 14 and 16

Secondary: Percent Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12

Secondary: Percent Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12

Secondary: Percent Change From Baseline in PASI Scores at Week 14 and 16

Secondary: Percent Change From Baseline in PASI Scores at Week 14 and 16

Secondary: Absolute Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Baseline, Week 1, 2, 4, 6, 8, 10 and 12

Secondary: Absolute Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Baseline, Week 1, 2, 4, 6, 8, 10 and 12

Secondary: Absolute PP-NRS Score at Week 14 and 16

Secondary: Absolute PP-NRS Score at Week 14 and 16

Secondary: Change From Baseline in PP-NRS Score at Week 1, 2, 4, 6, 8, 10 and 12

Secondary: Change From Baseline in PP-NRS Score at Week 1, 2, 4, 6, 8, 10 and 12

Secondary: Change From Baseline in PP-NRS Score at Week 14 and 16

Secondary: Change From Baseline in PP-NRS Score at Week 14 and 16

Secondary: Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2

Secondary: Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2

Secondary: Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2

Secondary: Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2

Secondary: Percentage of Subjects With PGA Score Clear (0) or Almost clear (1) and >=2 Points Improvement From Baseline at Week 1, 2, 4, 6, 8, 10, 14, and 16

Secondary: Percentage of Subjects With PGA Score Clear (0) or Almost clear (1) and >=2 Points Improvement From Baseline at Week 1, 2, 4, 6, 8, 10, 14, and 16

Secondary: Percentage of Subjects who Achieved PSI Score of 0 (not at all) or 1 (Mild) on all Items at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16

Secondary: Percentage of Subjects who Achieved PSI Score of 0 (not at all) or 1 (Mild) on all Items at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16

Secondary: Number of Subjects With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and SAEs

Secondary: Number of Subjects With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and SAEs

Secondary: Number of Subjects With TEAEs by Severity

Secondary: Number of Subjects With TEAEs by Severity

Secondary: Number of Subjects who Discontinued From Study due to Adverse Events

Secondary: Number of Subjects who Discontinued From Study due to Adverse Events

Secondary: Number of Subjects With Laboratory Abnormalities Meeting Specified Criteria

Secondary: Number of Subjects With Laboratory Abnormalities Meeting Specified Criteria

Secondary: Number of Subjects With Categorical Summary of Post-Baseline Electrocardiogram (ECG) Data

Secondary: Number of Subjects With Categorical Summary of Post-Baseline Electrocardiogram (ECG) Data

Secondary: Number of Subjects With Categorical Summary of Post-Baseline Vital Signs Data

Secondary: Number of Subjects With Categorical Summary of Post-Baseline Vital Signs Data

Secondary: Number of Subjects Classified per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16

Secondary: Number of Subjects Classified per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information