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Clinical Trial Results:
A Phase 2b, Randomized, Double Blind, Vehicle Controlled, Parallel Group, Dose Ranging Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Cream Applied Once or Twice Daily for 6 Weeks in Participants With Mild or Moderate Atopic Dermatitis

Summary
EudraCT number	2018-003050-24
Trial protocol	LV DE HU BG PL DK
Global end of trial date	07 May 2020

Results information
Results version number	v1
This version publication date	12 Nov 2020
First version publication date	12 Nov 2020
Other versions	v2

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

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Trial information

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Sponsor protocol code

B7931022

ISRCTN number

US NCT number

NCT03903822

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 Inc., Pfizer ClinicalTrials.gov Call Center, 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, 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

03 Sep 2020

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

07 May 2020

Was the trial ended prematurely?

Main objective of the trial

To compare the efficacy of multiple dose levels of PF-06700841 topical cream versus vehicle, applied once daily (QD) or twice daily (BID), on percent change from baseline in eczema area and severity Index (EASI) in subjects with mild or moderate atopic dermatitis (AD).

Protection of trial subjects

The study was conducted 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 trial subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

13 May 2019

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 27

Country: Number of subjects enrolled

Bulgaria: 17

Country: Number of subjects enrolled

Canada: 10

Country: Number of subjects enrolled

Denmark: 1

Country: Number of subjects enrolled

Germany: 28

Country: Number of subjects enrolled

Hungary: 9

Country: Number of subjects enrolled

Japan: 38

Country: Number of subjects enrolled

Latvia: 10

Country: Number of subjects enrolled

Poland: 11

Country: Number of subjects enrolled

United States: 141

Worldwide total number of subjects

292

EEA total number of subjects

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)

261

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

The study was conducted at 77 sites in the 10 countries from 13 May 2019 to 07 May 2020. A total of 292 subjects were enrolled.

Period 1 title

Treatment Phase (6 Weeks)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Vehicle Cream Once Daily (QD)

Arm description

Subjects or caregivers of subjects, topically applied vehicle cream on all eligible AD areas (of subjects) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subject received vehicle cream once daily for maximum of 6 weeks.

PF-06700841 0.1% Cream QD

Arm description

Subjects or caregivers of subjects, topically applied of PF-06700841 0.1 percent (%) cream on all eligible AD areas (of subjects) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subject received PF-06700841 0.1 % cream once daily for maximum of 6 weeks.

PF-06700841 0.3% Cream QD

Arm description

Subjects or caregivers of subjects, topically applied of PF-06700841 0.3 % cream on all eligible AD areas (of subjects) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subject received PF-06700841 0.3 % cream once daily for maximum of 6 weeks.

PF-06700841 1.0% Cream QD

Arm description

Subjects or caregivers of subjects, topically applied of PF-06700841 1.0 % cream on all eligible AD areas (of subjects) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subject received PF-06700841 1.0 % cream once daily for maximum of 6 weeks.

PF-06700841 3.0% Cream QD

Arm description

Subjects or caregivers of subjects, topically applied of PF-06700841 3.0 % cream on all eligible AD areas (of subjects) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subject received PF-06700841 3.0% cream once daily for maximum of 6 weeks.

Vehicle Cream Twice Daily (BID)

Arm description

Subjects or caregivers of subjects, topically applied vehicle cream on all eligible AD areas (of subjects) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subject received vehicle cream twice daily for maximum of 6 weeks.

PF-06700841 0.3% Cream BID

Arm description

Subjects or caregivers of subjects topically applied PF-06700841 0.3% cream on all eligible AD areas (of subjects) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subject received PF-06700841 0.3% cream twice daily for maximum of 6 weeks.

PF-06700841 1.0% Cream BID

Arm description

Subjects or caregivers of subjects topically applied PF-06700841 1.0% cream on all eligible AD areas (of subjects) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subject received PF-06700841 1.0 % cream twice daily for maximum of 6 weeks.

Number of subjects in period 1	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Started	37	37	36	37	36	36	36	37
Completed	28	27	33	32	31	25	31	33
Not completed	9	10	3	5	5	11	5	4
Consent withdrawn by subject	2	4	2	2	1	2	3	3
Physician decision	-	2	-	-	-	-	-	-
Adverse event, non-fatal	3	3	1	1	1	6	1	-
Pregnancy	-	-	-	1	1	-	-	-
Unspecified	2	1	-	-	1	1	-	-
Refused Further Treatment	2	-	-	-	-	1	-	-
Lost to follow-up	-	-	-	-	-	-	1	1
Protocol deviation	-	-	-	1	-	-	-	-
Lack of efficacy	-	-	-	-	1	1	-	-

Period 2 title

Follow up Phase (4 Weeks)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Vehicle Cream Once Daily (QD)

Arm description

Subjects or caregivers of subjects topically applied vehicle cream on all eligible atopic dermatitis (AD) areas (of subjects) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subject received vehicle cream once daily for maximum of 6 weeks.

PF-06700841 0.1% Cream QD

Arm description

Subjects or caregivers of subjects topically applied of PF-06700841 0.1 percent (%) cream on all eligible AD areas (of subjects) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subject received PF-06700841 0.1 % cream once daily for maximum of 6 weeks.

PF-06700841 0.3% Cream QD

Arm description

Subjects or caregivers of subjects topically applied of PF-06700841 0.3 % cream on all eligible AD areas (of subjects) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subject received PF-06700841 0.3 % cream once daily for maximum of 6 weeks.

PF-06700841 1.0% Cream QD

Arm description

Subjects or caregivers of subjects topically applied of PF-06700841 1.0 % cream on all eligible AD areas (of subjects) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subject received PF-06700841 1.0 % cream once daily for maximum of 6 weeks.

PF-06700841 3.0% Cream QD

Arm description

Subjects or caregivers of subjects topically applied of PF-06700841 3.0 % cream on all eligible AD areas (of subjects) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subject received PF-06700841 3.0 % cream once daily for maximum of 6 weeks.

Vehicle Cream Twice Daily (BID)

Arm description

Subjects or caregivers of subjects topically applied vehicle cream on all eligible AD areas (of subjects) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Subjects were followed up for 4 weeks after last dose.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subject received vehicle cream twice daily for maximum of 6 weeks.

PF-06700841 0.3% Cream BID

Arm description

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subject received PF-06700841 0.3% cream twice daily for maximum of 6 weeks.

PF-06700841 1.0% Cream BID

Arm description

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Topical use

Dosage and administration details

Subject received PF-06700841 1.0 % cream twice daily for maximum of 6 weeks.

Number of subjects in period 2	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Started	28	27	33	32	31	25	31	33
Completed	29	29	32	33	32	28	31	31
Not completed	8	8	4	4	4	8	5	6
Consent withdrawn by subject	2	5	3	2	2	2	3	3
Refused Further Study Procedures	-	-	-	-	-	1	-	-
Adverse event, non-fatal	3	2	1	1	-	5	1	-
Pregnancy	-	-	-	1	1	-	-	-
Unspecified	1	1	-	-	-	-	-	-
Lost to follow-up	2	-	-	-	-	-	1	3
Lack of efficacy	-	-	-	-	1	-	-	-
Joined	9	10	3	5	5	11	5	4
Continue to follow up	9	10	3	5	5	11	5	4

Baseline characteristics

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Reporting group title

Vehicle Cream Once Daily (QD)

Reporting group description

Reporting group title

PF-06700841 0.1% Cream QD

Reporting group description

Reporting group title

PF-06700841 0.3% Cream QD

Reporting group description

Reporting group title

PF-06700841 1.0% Cream QD

Reporting group description

Reporting group title

PF-06700841 3.0% Cream QD

Reporting group description

Reporting group title

Vehicle Cream Twice Daily (BID)

Reporting group description

Reporting group title

PF-06700841 0.3% Cream BID

Reporting group description

Reporting group title

PF-06700841 1.0% Cream BID

Reporting group description

Reporting group values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID	Total
Number of subjects	37	37	36	37	36	36	36	37	292
Age categorical
Units: Subjects
In utero	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
Newborns (0-27 days)	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
Children (2-11 years)	0	0	0	0	0	0	0	0	0
Adolescents (12-17 years)	2	1	1	1	0	1	0	0	6
Adults (18-64 years)	31	32	31	36	34	29	33	35	261
From 65-84 years	4	4	4	0	2	6	3	2	25
85 years and over	0	0	0	0	0	0	0	0	0
Age Continuous
Units: Years
arithmetic mean (standard deviation)	39.1 ± 16.80	40.8 ± 15.35	43.4 ± 16.43	38.4 ± 12.90	40.5 ± 12.30	42.3 ± 18.18	39.4 ± 17.27	38.1 ± 15.34	-
Sex: Female, Male
Units: Subjects
Female	20	19	24	23	15	19	16	20	156
Male	17	18	12	14	21	17	20	17	136
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0
Asian	4	8	4	8	10	9	9	7	59
Native Hawaiian or Other Pacific Islander	0	0	0	1	0	1	0	0	2
Black or African American	8	7	9	6	4	6	5	6	51
White	24	22	21	20	21	20	22	24	174
More than one race	0	0	2	2	1	0	0	0	5
Unknown or Not Reported	1	0	0	0	0	0	0	0	1
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	0	0	3	2	1	3	0	4	13
Not Hispanic or Latino	37	37	32	35	35	33	35	33	277
Unknown or Not Reported	0	0	1	0	0	0	1	0	2

End points

Top of page

Reporting group title

Vehicle Cream Once Daily (QD)

Reporting group description

Reporting group title

PF-06700841 0.1% Cream QD

Reporting group description

Reporting group title

PF-06700841 0.3% Cream QD

Reporting group description

Reporting group title

PF-06700841 1.0% Cream QD

Reporting group description

Reporting group title

PF-06700841 3.0% Cream QD

Reporting group description

Reporting group title

Vehicle Cream Twice Daily (BID)

Reporting group description

Reporting group title

PF-06700841 0.3% Cream BID

Reporting group description

Reporting group title

PF-06700841 1.0% Cream BID

Reporting group description

Reporting group title

Vehicle Cream Once Daily (QD)

Reporting group description

Reporting group title

PF-06700841 0.1% Cream QD

Reporting group description

Reporting group title

PF-06700841 0.3% Cream QD

Reporting group description

Reporting group title

PF-06700841 1.0% Cream QD

Reporting group description

Reporting group title

PF-06700841 3.0% Cream QD

Reporting group description

Reporting group title

Vehicle Cream Twice Daily (BID)

Reporting group description

Reporting group title

PF-06700841 0.3% Cream BID

Reporting group description

Reporting group title

PF-06700841 1.0% Cream BID

Reporting group description

Primary: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation

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End point title

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation

End point description

EASI:severity of subject’s AD based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD scored separately for each of 4 body regions on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. FAS:all subjects who were randomly assigned to study drug and applied at least 1 dose of study drug. Missing data were imputed with multiple imputation method based on reason for missing data.

End point type

Primary

End point timeframe

Baseline, Week 6

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	37	37	36	37	36	36	36	37
Units: Percent change
least squares mean (confidence interval 90%)	-44.4 (-57.3 to -31.6)	-58.3 (-71.2 to -45.5)	-64.6 (-77.1 to -52.1)	-70.1 (-82.1 to -58.0)	-67.9 (-80.6 to -55.3)	-47.6 (-57.5 to -37.7)	-58.6 (-67.5 to -49.7)	-75.0 (-83.8 to -66.2)

Vehicle versus (vs) PF-06700841 0.1% Cream QD

Statistical analysis description

Analysis of covariance (ANCOVA) contained fixed factors of treatment and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.104

Method

ANCOVA

Parameter type

Least square (LS) mean difference

Point estimate

-13.9

Confidence interval

level

90%

sides

2-sided

lower limit

-32.1

upper limit

4.3

Variability estimate

Standard error of the mean

Dispersion value

11.04

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

ANCOVA contained fixed factors of treatment and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0334

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-20.2

Confidence interval

level

90%

sides

2-sided

lower limit

-38.3

upper limit

-2.1

Variability estimate

Standard error of the mean

Dispersion value

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

ANCOVA contained fixed factors of treatment and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0086

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-25.6

Confidence interval

level

90%

sides

2-sided

lower limit

-43.3

upper limit

-8

Variability estimate

Standard error of the mean

Dispersion value

10.75

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

ANCOVA contained fixed factors of treatment and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0158

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-23.5

Confidence interval

level

90%

sides

2-sided

lower limit

-41.5

upper limit

-5.5

Variability estimate

Standard error of the mean

Dispersion value

10.93

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

ANCOVA contained fixed factors of treatment and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0879

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-11

Confidence interval

level

90%

sides

2-sided

lower limit

-24.3

upper limit

2.4

Variability estimate

Standard error of the mean

Dispersion value

8.11

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

ANCOVA contained fixed factors of treatment and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0004

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-27.4

Confidence interval

level

90%

sides

2-sided

lower limit

-40.7

upper limit

-14.1

Variability estimate

Standard error of the mean

Dispersion value

8.11

Secondary: Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Score Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( >=2) Points at Week 6: Non-responder Imputation

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End point title

Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Score Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( >=2) Points at Week 6: Non-responder Imputation

End point description

IGA assesses severity of subject’s AD on 5 point scale.0= clear, no inflammatory signs of AD;1= almost clear,AD not fully cleared-light pink residual lesions (except post-inflammatory hyperpigmentation),just perceptible erythema, papulation/induration lichenification,excoriation, and no oozing/crusting; 2=mild AD with light red lesions, slight but definite erythema,papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting and 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting.Higher scores indicating more severity of AD.Assessment excluded soles, palms and scalp. Full analysis set (FAS) was analyzed. Non-Responder Imputation (NRI) method: subjects with missing values were considered to be non-responders.

End point type

Secondary

End point timeframe

Baseline, Week 6

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	37	37	36	37	36	36	36	37
Units: Percentage of subjects
number (confidence interval 90%)	10.8 (4.8 to 22.2)	29.7 (18.5 to 43.3)	33.3 (21.3 to 47.0)	40.5 (28.0 to 54.4)	44.4 (30.2 to 59.1)	13.9 (6.9 to 25.4)	33.3 (21.3 to 47.0)	27.0 (15.5 to 40.2)

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0244

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

18.9

Confidence interval

level

90%

sides

2-sided

lower limit

2.4

upper limit

34.7

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0113

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

22.5

Confidence interval

level

90%

sides

2-sided

lower limit

4.8

upper limit

38.6

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0018

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

29.7

Confidence interval

level

90%

sides

2-sided

lower limit

upper limit

45.7

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0007

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

33.6

Confidence interval

level

90%

sides

2-sided

lower limit

13.7

upper limit

49.9

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0289

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

19.4

Confidence interval

level

90%

sides

2-sided

lower limit

1.8

upper limit

36.5

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1145

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

13.1

Confidence interval

level

90%

sides

2-sided

lower limit

-2.9

upper limit

29.6

Secondary: Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation

Top of page

End point title

Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation

End point description

EASI:severity of subject’s AD based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD scored separately for each of 4 body regions on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. FAS:all subjects who were randomly assigned to study drug and applied at least 1 dose of study drug. Missing data were imputed with multiple imputation method based on reason for missing data.

End point type

Secondary

End point timeframe

Baseline, Week 6

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	37	37	36	37	36	36	36	37
Units: Units on a scale
least squares mean (confidence interval 90%)	-3.2 (-4.1 to -2.3)	-4.5 (-5.4 to -3.6)	-4.6 (-5.5 to -3.7)	-4.8 (-5.7 to -3.9)	-5.5 (-6.4 to -4.7)	-3.6 (-4.3 to -3.0)	-4.4 (-5.0 to -3.8)	-5.3 (-5.9 to -4.7)

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

ANCOVA contained fixed factors of treatment and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0488

Method

ANCOVA

Parameter type

LS mean difference

Point estimate

-1.31

Confidence interval

level

90%

sides

2-sided

lower limit

-2.61

upper limit

-0.01

Variability estimate

Standard error of the mean

Dispersion value

0.79

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

ANCOVA contained fixed factors of treatment and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0413

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-1.37

Confidence interval

level

90%

sides

2-sided

lower limit

-2.66

upper limit

-0.07

Variability estimate

Standard error of the mean

Dispersion value

0.788

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

ANCOVA contained fixed factors of treatment and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.02

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-1.59

Confidence interval

level

90%

sides

2-sided

lower limit

-2.86

upper limit

-0.32

Variability estimate

Standard error of the mean

Dispersion value

0.773

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

ANCOVA contained fixed factors of treatment and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0011

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-2.33

Confidence interval

level

90%

sides

2-sided

lower limit

-3.58

upper limit

-1.08

Variability estimate

Standard error of the mean

Dispersion value

0.758

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

ANCOVA contained fixed factors of treatment and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0727

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-0.78

Confidence interval

level

90%

sides

2-sided

lower limit

-1.66

upper limit

0.1

Variability estimate

Standard error of the mean

Dispersion value

0.535

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

ANCOVA contained fixed factors of treatment and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-1.64

Confidence interval

level

90%

sides

2-sided

lower limit

-2.52

upper limit

-0.77

Variability estimate

Standard error of the mean

Dispersion value

0.534

Secondary: Percentage of Subjects Achieving >=2 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation

Top of page

End point title

Percentage of Subjects Achieving >=2 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation

End point description

The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Subjects at specified time points were asked the following question: “How would you rate your itch due to AD at the worst moment during the previous 24 hours?” The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch. Full analysis set (FAS) included all subjects who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, “number of subjects analysed (N)” signifies number of subjects evaluable for this end point. NRI method: subjects with missing values were considered to be non-responders.

End point type

Secondary

End point timeframe

Baseline, Week 1, 2, 3, 4 and 6

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	37	36	35	37	36	36	35	35
Units: Percentage of subjects
number (confidence interval 90%)
At Week 1	16.2 (7.3 to 29.3)	16.7 (7.5 to 30.2)	20.0 (11.0 to 33.8)	29.7 (18.5 to 43.3)	44.4 (30.2 to 59.1)	13.9 (6.9 to 25.4)	28.6 (16.4 to 41.9)	25.7 (15.4 to 39.2)
At Week 2	24.3 (14.5 to 37.0)	30.6 (18.9 to 44.0)	42.9 (30.0 to 58.1)	48.6 (34.3 to 63.0)	61.1 (47.0 to 74.6)	25.0 (14.9 to 38.0)	45.7 (31.7 to 60.8)	37.1 (23.6 to 52.2)
At Week 3	21.6 (11.2 to 34.3)	38.9 (25.4 to 53.0)	48.6 (33.8 to 63.5)	59.5 (45.6 to 72.0)	58.3 (44.0 to 71.0)	33.3 (21.3 to 47.0)	51.4 (36.5 to 66.2)	57.1 (41.9 to 70.0)
At Week 4	35.1 (22.2 to 49.3)	38.9 (25.4 to 53.0)	51.4 (36.5 to 66.2)	62.2 (48.0 to 75.2)	58.3 (44.0 to 71.0)	30.6 (18.9 to 44.0)	60.0 (44.8 to 74.0)	60.0 (44.8 to 74.0)
At Week 6	40.5 (28.0 to 54.4)	41.7 (29.0 to 56.0)	51.4 (36.5 to 66.2)	56.8 (43.2 to 70.7)	61.1 (47.0 to 74.6)	30.6 (18.9 to 44.0)	60.0 (44.8 to 74.0)	60.0 (44.8 to 74.0)

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

At Week 1: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5246

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

0.5

Confidence interval

level

90%

sides

2-sided

lower limit

-14.7

upper limit

16.4

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

At Week 1: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3906

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

3.8

Confidence interval

level

90%

sides

2-sided

lower limit

-12.5

upper limit

19.9

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

At Week 1: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1193

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

13.5

Confidence interval

level

90%

sides

2-sided

lower limit

-3.2

upper limit

30.6

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

At Week 1: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0048

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

28.2

Confidence interval

level

90%

sides

2-sided

lower limit

8.8

upper limit

45.5

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

At Week 1: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0777

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

14.7

Confidence interval

level

90%

sides

2-sided

lower limit

-2

upper limit

31.1

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

At Week 1: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1245

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

11.8

Confidence interval

level

90%

sides

2-sided

lower limit

-4.3

upper limit

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

At Week 2: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3322

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

6.2

Confidence interval

level

90%

sides

2-sided

lower limit

-12.2

upper limit

24.4

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

At Week 2: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0535

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

18.5

Confidence interval

level

90%

sides

2-sided

lower limit

-0.3

upper limit

36.5

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

At Week 2: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0159

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

24.3

Confidence interval

level

90%

sides

2-sided

lower limit

4.5

upper limit

41.9

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

At Week 2: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0008

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

36.8

Confidence interval

level

90%

sides

2-sided

lower limit

15.4

upper limit

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

At Week 2: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0386

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

20.7

Confidence interval

level

90%

sides

2-sided

lower limit

1.5

upper limit

38.8

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

At Week 2: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1485

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

12.1

Confidence interval

level

90%

sides

2-sided

lower limit

-6.4

upper limit

30.3

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

At Week 3: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.062

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

17.3

Confidence interval

level

90%

sides

2-sided

lower limit

-0.8

upper limit

34.8

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

At Week 3: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0089

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

26.9

Confidence interval

level

90%

sides

2-sided

lower limit

6.5

upper limit

44.4

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

At Week 3: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0005

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

37.8

Confidence interval

level

90%

sides

2-sided

lower limit

17.5

upper limit

54.7

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

At Week 3: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0007

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

36.7

Confidence interval

level

90%

sides

2-sided

lower limit

15.4

upper limit

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

At Week 3: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0711

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

18.1

Confidence interval

level

90%

sides

2-sided

lower limit

-2

upper limit

37.5

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

At Week 3: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0266

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

23.8

Confidence interval

level

90%

sides

2-sided

lower limit

2.7

upper limit

42.5

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

At week 4: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4173

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

3.8

Confidence interval

level

90%

sides

2-sided

lower limit

-15.3

upper limit

23.1

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

At Week 4: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1096

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

16.3

Confidence interval

level

90%

sides

2-sided

lower limit

-4.3

upper limit

35.6

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

At Week 4: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0133

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

6.1

upper limit

45.7

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

At Week 4: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0304

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

23.2

Confidence interval

level

90%

sides

2-sided

lower limit

2.6

upper limit

41.7

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

At Week 4: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0078

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

29.4

Confidence interval

level

90%

sides

2-sided

lower limit

7.2

upper limit

47.6

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

At Week 4: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0078

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

29.4

Confidence interval

level

90%

sides

2-sided

lower limit

7.2

upper limit

47.6

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

At Week 6: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4966

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

1.1

Confidence interval

level

90%

sides

2-sided

lower limit

-18.4

upper limit

20.4

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

At Week 6: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2753

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

10.9

Confidence interval

level

90%

sides

2-sided

lower limit

-9.3

upper limit

30.1

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

At Week 6: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1036

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

16.2

Confidence interval

level

90%

sides

2-sided

lower limit

-4.2

upper limit

35.7

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

At Week 6: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0457

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

20.6

Confidence interval

level

90%

sides

2-sided

lower limit

0.4

upper limit

39.6

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

At Week 6: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0078

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

29.4

Confidence interval

level

90%

sides

2-sided

lower limit

7.2

upper limit

47.6

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

At Week 6: Risk difference = difference in percentage of subjects.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0078

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

29.4

Confidence interval

level

90%

sides

2-sided

lower limit

7.2

upper limit

47.6

Secondary: Percentage of Subjects Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4, 6 and Follow-up Visit: Non-responder Imputation

Top of page

End point title

Percentage of Subjects Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4, 6 and Follow-up Visit: Non-responder Imputation

End point description

The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Subjects at specified time points were asked the following question: “How would you rate your itch due to AD at the worst moment during the previous 24 hours?” The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch. Full analysis set included all subjects who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, “number of subjects analysed” signifies number of subjects evaluable for this end point. NRI method: subjects with missing values were considered to be non-responders.

End point type

Secondary

End point timeframe

Baseline, Week 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	33	30	32	31	28	30	30	27
Units: Percentage of subjects
number (confidence interval 90%)
At Week 1	0.0 (0.0 to 8.2)	3.3 (0.4 to 14.0)	3.1 (0.3 to 13.1)	16.1 (8.1 to 29.7)	10.7 (4.0 to 23.8)	3.3 (0.4 to 14.0)	3.3 (0.4 to 14.0)	11.1 (4.2 to 24.8)
At Week 2	9.1 (3.4 to 20.2)	10.0 (3.7 to 22.1)	9.4 (3.5 to 20.7)	19.4 (8.8 to 32.7)	25.0 (13.9 to 40.0)	10.0 (3.7 to 22.1)	13.3 (5.9 to 27.9)	33.3 (20.4 to 50.0)
At Week 3	12.1 (5.4 to 25.1)	23.3 (12.9 to 37.6)	15.6 (7.8 to 28.7)	32.3 (18.7 to 48.2)	32.1 (19.7 to 47.3)	10.0 (3.7 to 22.1)	20.0 (9.1 to 33.9)	37.0 (22.1 to 54.7)
At Week 4	18.2 (8.2 to 31.3)	26.7 (14.0 to 41.6)	28.1 (17.0 to 43.3)	35.5 (21.3 to 51.8)	50.0 (33.3 to 66.7)	10.0 (3.7 to 22.1)	30.0 (18.2 to 45.5)	37.0 (22.1 to 54.7)
At Week 6	18.2 (8.2 to 31.3)	30.0 (18.2 to 45.5)	34.4 (20.7 to 50.0)	45.2 (29.7 to 60.1)	50.0 (33.3 to 66.7)	16.7 (8.3 to 30.8)	33.3 (19.3 to 49.2)	40.7 (24.8 to 58.3)
At Follow-up visit	9.1 (3.4 to 20.2)	30.0 (18.2 to 45.5)	21.9 (12.1 to 36.2)	19.4 (8.8 to 32.7)	21.4 (9.8 to 36.6)	20.0 (9.1 to 33.9)	20.0 (9.1 to 33.9)	7.4 (2.0 to 20.4)

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

At Week 1

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.245

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

3.3

Confidence interval

level

90%

sides

2-sided

lower limit

-5.4

upper limit

14.9

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

At Week 1

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2575

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

3.1

Confidence interval

level

90%

sides

2-sided

lower limit

-5.3

upper limit

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

At Week 1

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0087

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

16.1

Confidence interval

level

90%

sides

2-sided

lower limit

5.7

upper limit

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

At Week 1

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0392

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

10.7

Confidence interval

level

90%

sides

2-sided

lower limit

0.8

upper limit

25.4

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

At Week 1

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 1

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-11.2

upper limit

11.2

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

At Week 1

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1528

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

7.8

Confidence interval

level

90%

sides

2-sided

lower limit

-4.9

upper limit

22.5

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

At Week 2

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4989

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

0.9

Confidence interval

level

90%

sides

2-sided

lower limit

-12.7

upper limit

15.2

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

At Week 2

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5419

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

0.3

Confidence interval

level

90%

sides

2-sided

lower limit

-13.6

upper limit

14.2

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

At Week 2

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1362

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

10.3

Confidence interval

level

90%

sides

2-sided

lower limit

-5

upper limit

26.2

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

At Week 2

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0541

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

15.9

Confidence interval

level

90%

sides

2-sided

lower limit

-0.4

upper limit

33.9

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

At Week 2

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3945

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

3.3

Confidence interval

level

90%

sides

2-sided

lower limit

-12

upper limit

19.5

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

At Week 2

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0201

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

23.3

Confidence interval

level

90%

sides

2-sided

lower limit

3.9

upper limit

41.8

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

At Week 3

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1372

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

11.2

Confidence interval

level

90%

sides

2-sided

lower limit

-5.4

upper limit

28.2

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

At Week 3

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3924

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

3.5

Confidence interval

level

90%

sides

2-sided

lower limit

-11.6

upper limit

19.1

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

At Week 3

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0311

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

20.1

Confidence interval

level

90%

sides

2-sided

lower limit

2.4

upper limit

38.3

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

At Week 3

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0392

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

0.8

upper limit

38.1

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

At Week 3

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1541

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-6.2

upper limit

26.4

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

At Week 3

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0091

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

6.8

upper limit

45.4

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

At Week 4

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2835

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

8.5

Confidence interval

level

90%

sides

2-sided

lower limit

-9.5

upper limit

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

At Week 4

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.27

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

9.9

Confidence interval

level

90%

sides

2-sided

lower limit

-8.7

upper limit

27.8

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

At Week 4

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0662

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

17.3

Confidence interval

level

90%

sides

2-sided

lower limit

-1.4

upper limit

36.2

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

At Week 4

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.005

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

31.8

Confidence interval

level

90%

sides

2-sided

lower limit

9.2

upper limit

50.4

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

At Week 4

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0302

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

2.2

upper limit

38.3

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

At Week 4

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0091

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

6.8

upper limit

45.4

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

At Week 6

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1561

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

11.8

Confidence interval

level

90%

sides

2-sided

lower limit

-6.5

upper limit

30.2

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

At Week 6

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0753

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

16.2

Confidence interval

level

90%

sides

2-sided

lower limit

-2.7

upper limit

34.8

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

At Week 6

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0108

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

5.7

upper limit

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

At Week 6

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.005

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

31.8

Confidence interval

level

90%

sides

2-sided

lower limit

9.2

upper limit

50.4

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

At Week 6

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0775

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

16.7

Confidence interval

level

90%

sides

2-sided

lower limit

-2.9

upper limit

35.7

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

At Week 6

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0243

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

24.1

Confidence interval

level

90%

sides

2-sided

lower limit

3.4

upper limit

43.4

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

At follow-up visit

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0234

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

20.9

Confidence interval

level

90%

sides

2-sided

lower limit

3.5

upper limit

38.8

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

At follow-up visit

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1134

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

12.8

Confidence interval

level

90%

sides

2-sided

lower limit

-2.8

upper limit

29.3

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

At follow-up visit

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1362

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

10.3

Confidence interval

level

90%

sides

2-sided

lower limit

-5

upper limit

26.2

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

At follow-up visit

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1029

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

12.3

Confidence interval

level

90%

sides

2-sided

lower limit

-3.4

upper limit

29.8

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

At follow-up visit

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 1

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-17.9

upper limit

17.9

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

At follow-up visit

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.8972

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

-12.6

Confidence interval

level

90%

sides

2-sided

lower limit

-28.8

upper limit

3.5

Secondary: Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit

Top of page

End point title

Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit

End point description

4 body regions: head and neck, upper limbs, trunk and lower limbs. Scalp, palms and soles were excluded. BSA calculated using handprint method. Number(No.)of handprints (size of subject’s full palmer hand) fitting in affected area of body region was estimated. Maximum no. of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total no. of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%, with higher values representing greater severity of AD. FAS population was analysed. N=number of subjects evaluable for this endpoint and “n”=subjects evaluable for each specified time point.

End point type

Secondary

End point timeframe

Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	34	36	33	35	34	34	36	36
Units: Percent change
least squares mean (confidence interval 90%)
At Week 1(n=34,36,33,35,34,3436)	-2.4 (-12.2 to 7.4)	-2.9 (-12.5 to 6.8)	-16.2 (-26.2 to -6.2)	-19.9 (-29.6 to -10.2)	-23.0 (-32.8 to -13.1)	8.5 (-8.3 to 25.3)	-16.5 (-32.9 to -0.1)	-17.0 (-33.5 to -0.5)
At Week 2(n=34,33,33,33,32, 32, 33, 32)	-15.3 (-28.0 to -2.6)	-7.2 (-20.2 to 5.8)	-38.1 (-51.0 to -25.2)	-43.6 (-56.5 to -30.8)	-39.0 (-52.1 to -26.0)	-2.5 (-14.0 to 9.1)	-34.2 (-45.4 to -22.9)	-43.1 (-54.5 to -31.6)
At Week 3(n=28,29,32,34,31,23,30,33)	-17.1 (-31.0 to -3.1)	-13.1 (-27.4 to 1.1)	-50.6 (-64.4 to -36.7)	-55.9 (-69.7 to -42.0)	-49.2 (-63.2 to -35.1)	-25.2 (-39.2 to -11.1)	-39.8 (-53.0 to -26.6)	-44.0 (-57.1 to -30.9)
At Week 4(n=30,28,33,32,32,25,32,32)	-25.9 (-39.8 to -12.0)	-20.1 (-34.4 to -5.7)	-55.8 (-69.5 to -42.1)	-57.9 (-71.7 to -44.0)	-56.7 (-70.8 to -42.7)	-34.7 (-46.1 to -23.3)	-46.4 (-56.9 to -35.9)	-57.7 (-68.2 to -47.2)
At Week 6(n=29,28,31,32,31,24,32,33)	-21.6 (-38.0 to -5.3)	-39.4 (-56.1 to -22.7)	-59.4 (-75.4 to -43.5)	-63.6 (-79.5 to -47.6)	-60.3 (-76.4 to -44.1)	-31.2 (-42.5 to -20.0)	-48.9 (-59.3 to -38.6)	-65.0 (-75.3 to -54.7)
At Follow-up visit(n=29,27,32,31,26,28,30,29)	-23.6 (-39.5 to -7.6)	-24.5 (-41.0 to -8.0)	-42.7 (-58.1 to -27.2)	-37.0 (-52.6 to -21.4)	-55.2 (-71.8 to -38.6)	-26.3 (-47.5 to -5.2)	-31.6 (-52.0 to -11.3)	-24.6 (-45.2 to -4.1)

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

At Week 1: Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4781

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-0.5

Confidence interval

level

90%

sides

2-sided

lower limit

-14.2

upper limit

13.3

Variability estimate

Standard error of the mean

Dispersion value

8.33

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0522

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-13.8

Confidence interval

level

90%

sides

2-sided

lower limit

-27.8

upper limit

0.2

Variability estimate

Standard error of the mean

Dispersion value

8.47

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0187

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-17.5

Confidence interval

level

90%

sides

2-sided

lower limit

-31.4

upper limit

-3.7

Variability estimate

Standard error of the mean

Dispersion value

8.37

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.008

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-20.6

Confidence interval

level

90%

sides

2-sided

lower limit

-34.5

upper limit

-6.6

Variability estimate

Standard error of the mean

Dispersion value

8.45

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0401

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-25

Confidence interval

level

90%

sides

2-sided

lower limit

-48.6

upper limit

-1.5

Variability estimate

Standard error of the mean

Dispersion value

14.17

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0379

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-25.5

Confidence interval

level

90%

sides

2-sided

lower limit

-49.2

upper limit

-1.9

Variability estimate

Standard error of the mean

Dispersion value

14.25

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7678

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

8.1

Confidence interval

level

90%

sides

2-sided

lower limit

-10.1

upper limit

26.3

Variability estimate

Standard error of the mean

Dispersion value

11.01

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0193

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-22.8

Confidence interval

level

90%

sides

2-sided

lower limit

-40.9

upper limit

-4.7

Variability estimate

Standard error of the mean

Dispersion value

10.94

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0052

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-28.3

Confidence interval

level

90%

sides

2-sided

lower limit

-46.5

upper limit

-10.2

Variability estimate

Standard error of the mean

Dispersion value

10.95

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0164

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-23.7

Confidence interval

level

90%

sides

2-sided

lower limit

-42

upper limit

-5.5

Variability estimate

Standard error of the mean

Dispersion value

11.03

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0008

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-31.7

Confidence interval

level

90%

sides

2-sided

lower limit

-47.8

upper limit

-15.6

Variability estimate

Standard error of the mean

Dispersion value

9.72

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-40.6

Confidence interval

level

90%

sides

2-sided

lower limit

-57

upper limit

-24.3

Variability estimate

Standard error of the mean

Dispersion value

9.86

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6269

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

3.9

Confidence interval

level

90%

sides

2-sided

lower limit

-16.1

upper limit

23.9

Variability estimate

Standard error of the mean

Dispersion value

12.09

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0027

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-33.5

Confidence interval

level

90%

sides

2-sided

lower limit

-53.1

upper limit

-13.8

Variability estimate

Standard error of the mean

Dispersion value

11.87

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0007

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-38.8

Confidence interval

level

90%

sides

2-sided

lower limit

-58.5

upper limit

-19.2

Variability estimate

Standard error of the mean

Dispersion value

11.89

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0041

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-32.1

Confidence interval

level

90%

sides

2-sided

lower limit

-51.9

upper limit

-12.3

Variability estimate

Standard error of the mean

Dispersion value

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1054

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-14.6

Confidence interval

level

90%

sides

2-sided

lower limit

-33.9

upper limit

4.6

Variability estimate

Standard error of the mean

Dispersion value

11.61

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0542

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-18.8

Confidence interval

level

90%

sides

2-sided

lower limit

-38.1

upper limit

0.5

Variability estimate

Standard error of the mean

Dispersion value

11.62

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6847

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

5.8

Confidence interval

level

90%

sides

2-sided

lower limit

-14.2

upper limit

25.9

Variability estimate

Standard error of the mean

Dispersion value

12.12

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0062

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-29.9

Confidence interval

level

90%

sides

2-sided

lower limit

-49.4

upper limit

-10.3

Variability estimate

Standard error of the mean

Dispersion value

11.82

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-32

Confidence interval

level

90%

sides

2-sided

lower limit

-51.6

upper limit

-12.3

Variability estimate

Standard error of the mean

Dispersion value

11.89

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0054

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-30.8

Confidence interval

level

90%

sides

2-sided

lower limit

-50.6

upper limit

-11

Variability estimate

Standard error of the mean

Dispersion value

11.97

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1076

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-11.7

Confidence interval

level

90%

sides

2-sided

lower limit

-27.2

upper limit

3.9

Variability estimate

Standard error of the mean

Dispersion value

9.35

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0082

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-23

Confidence interval

level

90%

sides

2-sided

lower limit

-38.6

upper limit

-7.3

Variability estimate

Standard error of the mean

Dispersion value

9.42

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1051

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-17.8

Confidence interval

level

90%

sides

2-sided

lower limit

-41.2

upper limit

5.6

Variability estimate

Standard error of the mean

Dispersion value

14.14

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0034

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-37.8

Confidence interval

level

90%

sides

2-sided

lower limit

-60.6

upper limit

-15

Variability estimate

Standard error of the mean

Dispersion value

13.8

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0014

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-41.9

Confidence interval

level

90%

sides

2-sided

lower limit

-64.8

upper limit

-19

Variability estimate

Standard error of the mean

Dispersion value

13.83

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-38.6

Confidence interval

level

90%

sides

2-sided

lower limit

-61.6

upper limit

-15.6

Variability estimate

Standard error of the mean

Dispersion value

13.9

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0289

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-17.7

Confidence interval

level

90%

sides

2-sided

lower limit

-33

upper limit

-2.4

Variability estimate

Standard error of the mean

Dispersion value

9.22

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

At Week 6:MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0002

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-33.8

Confidence interval

level

90%

sides

2-sided

lower limit

-49.2

upper limit

-18.4

Variability estimate

Standard error of the mean

Dispersion value

9.27

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4739

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-0.9

Confidence interval

level

90%

sides

2-sided

lower limit

-23.9

upper limit

Variability estimate

Standard error of the mean

Dispersion value

13.88

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0789

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-19.1

Confidence interval

level

90%

sides

2-sided

lower limit

-41.3

upper limit

3.2

Variability estimate

Standard error of the mean

Dispersion value

13.43

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1611

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-13.4

Confidence interval

level

90%

sides

2-sided

lower limit

-35.7

upper limit

8.9

Variability estimate

Standard error of the mean

Dispersion value

13.5

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0124

Method

Mixed Model Repeated Measure

Parameter type

LS Mean Difference

Point estimate

-31.6

Confidence interval

level

90%

sides

2-sided

lower limit

-54.7

upper limit

-8.5

Variability estimate

Standard error of the mean

Dispersion value

13.94

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3828

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

-5.3

Confidence interval

level

90%

sides

2-sided

lower limit

-34.7

upper limit

24.1

Variability estimate

Standard error of the mean

Dispersion value

17.68

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5383

Method

Mixed Model Repeated Measure

Parameter type

LS Mean difference

Point estimate

1.7

Confidence interval

level

90%

sides

2-sided

lower limit

-27.9

upper limit

31.3

Variability estimate

Standard error of the mean

Dispersion value

17.8

Secondary: Percentage of Subjects Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation

Top of page

End point title

Percentage of Subjects Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation

End point description

EASI:severity of subject’s AD based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD scored separately for each of 4 body regions on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. FAS:all subjects who were randomly assigned to study drug and applied at least 1 dose of study drug. NRI method: subjects with missing values were considered to be non-responders.

End point type

Secondary

End point timeframe

Baseline, Weeks 1, 2, 3, 4 and 6

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	37	37	36	37	36	36	36	37
Units: Percentage of subjects
number (confidence interval 90%)
At Week 1	5.4 (1.4 to 15.5)	0.0 (0.0 to 7.3)	19.4 (10.7 to 32.8)	5.4 (1.4 to 15.5)	16.7 (7.5 to 30.2)	0.0 (0.0 to 7.5)	13.9 (6.9 to 25.4)	21.6 (11.2 to 34.3)
At Week 2	8.1 (3.0 to 18.5)	10.8 (4.8 to 22.2)	27.8 (15.9 to 40.9)	24.3 (14.5 to 37.0)	38.9 (25.4 to 53.0)	13.9 (6.9 to 25.4)	25.0 (14.9 to 38.0)	32.4 (20.6 to 46.4)
At Week 3	5.4 (1.4 to 15.5)	16.2 (7.3 to 29.3)	36.1 (22.9 to 50.0)	43.2 (29.3 to 56.8)	41.7 (29.0 to 56.0)	19.4 (10.7 to 32.8)	19.4 (10.7 to 32.8)	43.2 (29.3 to 56.8)
At Week 4	24.3 (14.5 to 37.0)	21.6 (11.2 to 34.3)	38.9 (25.4 to 53.0)	43.2 (29.3 to 56.8)	50.0 (35.3 to 64.7)	22.2 (11.6 to 35.3)	36.1 (22.9 to 50.0)	48.6 (34.3 to 63.0)
At Week 6	35.1 (22.2 to 49.3)	32.4 (20.6 to 46.4)	52.8 (38.0 to 67.2)	54.1 (40.2 to 68.2)	50.0 (35.3 to 64.7)	16.7 (7.5 to 30.2)	36.1 (22.9 to 50.0)	51.4 (37.0 to 65.7)

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

At Week 1

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.8964

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

-5.4

Confidence interval

level

90%

sides

2-sided

lower limit

-16.1

upper limit

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

At Week 1

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0391

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

upper limit

28.2

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

At Week 1

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 1

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-10.8

upper limit

10.8

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

At Week 1

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0708

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

11.3

Confidence interval

level

90%

sides

2-sided

lower limit

-1.4

upper limit

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

At Week 1

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0122

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

13.9

Confidence interval

level

90%

sides

2-sided

lower limit

4.7

upper limit

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

At Week 1

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0016

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

21.6

Confidence interval

level

90%

sides

2-sided

lower limit

upper limit

35.6

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

At Week 2

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.395

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

2.7

Confidence interval

level

90%

sides

2-sided

lower limit

-9.8

upper limit

16.1

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

At Week 2

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0173

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

19.7

Confidence interval

level

90%

sides

2-sided

lower limit

4.2

upper limit

35.6

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

At Week 2

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0327

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

16.2

Confidence interval

level

90%

sides

2-sided

lower limit

1.4

upper limit

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

At Week 2

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0011

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

30.8

Confidence interval

level

90%

sides

2-sided

lower limit

13.2

upper limit

46.6

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

At Week 2

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1348

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

11.1

Confidence interval

level

90%

sides

2-sided

lower limit

-5

upper limit

27.2

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

At Week 2

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0328

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

18.5

Confidence interval

level

90%

sides

2-sided

lower limit

1.5

upper limit

34.8

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

At Week 3

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0769

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

10.8

Confidence interval

level

90%

sides

2-sided

lower limit

-1.8

upper limit

24.4

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

At Week 3

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0005

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

30.7

Confidence interval

level

90%

sides

2-sided

lower limit

13.2

upper limit

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

At Week 3

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

37.8

Confidence interval

level

90%

sides

2-sided

lower limit

22.1

upper limit

53.1

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

At Week 3

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0001

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

36.3

Confidence interval

level

90%

sides

2-sided

lower limit

19.7

upper limit

51.8

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

At Week 3

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 1

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

-16.5

upper limit

16.5

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

At Week 3

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0173

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

23.8

Confidence interval

level

90%

sides

2-sided

lower limit

4.5

upper limit

41.5

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

At Week 4

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5663

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

-2.7

Confidence interval

level

90%

sides

2-sided

lower limit

-19.9

upper limit

14.2

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

At Week 4

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1243

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

14.6

Confidence interval

level

90%

sides

2-sided

lower limit

-3.8

upper limit

32.6

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

At Week 4

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.046

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

18.9

Confidence interval

level

90%

sides

2-sided

lower limit

-0.5

upper limit

36.6

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

At Week 4

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.013

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

25.7

Confidence interval

level

90%

sides

2-sided

lower limit

4.8

upper limit

43.3

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

At Week 4

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1194

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

13.9

Confidence interval

level

90%

sides

2-sided

lower limit

-4.2

upper limit

31.4

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

At Week 4

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0097

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

26.4

Confidence interval

level

90%

sides

2-sided

lower limit

6.5

upper limit

44.4

Vehicle Cream QD vs PF-06700841 0.1% Cream QD

Statistical analysis description

At Week 6

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5556

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

-2.7

Confidence interval

level

90%

sides

2-sided

lower limit

-21

upper limit

16.1

Vehicle Cream QD vs PF-06700841 0.3% Cream QD

Statistical analysis description

At Week 6

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0761

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

17.6

Confidence interval

level

90%

sides

2-sided

lower limit

-2.5

upper limit

36.5

Vehicle Cream QD vs PF-06700841 1.0% Cream QD

Statistical analysis description

At Week 6

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0583

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

18.9

Confidence interval

level

90%

sides

2-sided

lower limit

-0.8

upper limit

37.6

Vehicle Cream QD vs PF-06700841 3.0% Cream QD

Statistical analysis description

At Week 6

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1245

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

14.9

Confidence interval

level

90%

sides

2-sided

lower limit

-5

upper limit

33.7

Vehicle Cream BID vs PF-06700841 0.3% Cream BID

Statistical analysis description

At Week 6

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0382

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

19.4

Confidence interval

level

90%

sides

2-sided

lower limit

1.5

upper limit

36.5

Vehicle Cream BID vs PF-06700841 1.0% Cream BID

Statistical analysis description

At Week 6

Comparison groups

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

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0011

Method

Chan and Zhang Exact Method

Parameter type

Risk difference (RD)

Point estimate

34.7

Confidence interval

level

90%

sides

2-sided

lower limit

13.2

upper limit

51.4

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

Top of page

End point title

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

End point description

An AE was any untoward medical occurrence in a subject who received investigational product 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 hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent AEs were events between first dose of investigational product and up to 28 days after the last dose of investigational product that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Safety analysis set included all subjects who were randomly assigned to study drug and who applied at least 1 dose of study drug.

End point type

Secondary

End point timeframe

Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	37	37	36	37	36	36	36	37
Units: Subjects
TEAEs	18	17	11	12	10	17	9	14
SAEs	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Number of Subjects With Pre-defined Criteria For Vital Sign

Top of page

End point title

Number of Subjects With Pre-defined Criteria For Vital Sign

End point description

Pre-defined criteria included: 1) Diastolic blood pressure (DBP), a) sitting (S)DBP: change(C) of >= 20 millimeter of mercury (mmHg) increase (inc.), b) sitting DBP: change of >=20mmHg decrease(dec.), c) supine(Sup.) DBP: less than (<) 50 mmHg, d) supine DBP: change of >= 20mmHg increase, e) supine DBP: change of >= 20mmHg decrease; 2) Systolic blood pressure (SBP), a) sitting SBP: <90 mmHg, b) sitting SBP: change of >=30mmHg increase, c) sitting SBP: change of >=30mmHg decrease, d) supine SBP: change of >=30mmHg increase, e) supine SBP: change of >=30mmHg decrease and f) Supine SBP: value(Val.) <90mmHg. Safety analysis set included all subjects who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, “number of subjects analysed:” signifies number of subjects evaluable for this end point and “n” signifies subjects evaluable for the each specified time point.

End point type

Secondary

End point timeframe

Baseline up to Week 6

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	21	20	25	18	21	19	22	22
Units: Subjects
SDBP:Change>=20mmHg inc.(n=12,13,9,15,12,7,12,11)	0	0	1	2	0	0	0	0
SDBP:Change>= 20mmHg dec.(n=12,13,9,15,12,7,12,11)	1	0	0	1	0	1	0	0
Supi.DBP:Val.<50 mmHg(n=21,20,25,18,21,19,22,22)	0	0	0	0	0	1	0	0
Sup.DBP:C>=20mmHg inc.(n=21,20,25,18,21,19,22,22)	0	1	1	2	1	0	1	0
Sup.DBP:C>=20mmHg dec.(n=21,20,25,18,21,19,22,22)	0	0	0	0	0	0	1	0
Sitting SBP: <90mmHg(n=12,13,9,15,12,7,12,11)	0	0	0	1	0	0	0	0
SittingSBP:C>=30mmHg inc.(n=12,13,9,15,12,7,12,11)	0	0	0	1	0	0	0	1
SittingSBP:C>=30mmHgdec.(n=12,13,9,15,12,7,12,11)	0	0	0	0	1	0	0	0
SupineSBP:C>=30mmHginc.(n=21,20,25,18,21,19,22,22)	1	0	1	0	0	1	1	0
SupineSBP:C>=30mmHgdec.(n=21,20,25,18,21,19,22,22)	0	0	1	0	0	0	2	0
Supine SBP:Val.<90mmHg(n=21,20,25,18,21,19,22,22)	0	1	1	0	0	0	0	0

No statistical analyses for this end point

Secondary: Number of Subjects With Laboratory Abnormalities

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End point title

Number of Subjects With Laboratory Abnormalities

End point description

Hemoglobin(HGB),hematocrit,erythrocytes(ery.),HDL cholesterol(chl.)<0.8*lower limit of normal(LLN);reticulocytes (ret.), ret./ery.(%)<0.5*LLN,>1.5*upper limit of normal(ULN);ery.mean corpuscular(EMC) volume,EMC HGB,EMC HGBconcentration,potassium,chloride,calcium,bicarbonate<0.9*LLN,>1.1*ULN;platelets<0.5*LLN,>1.75*ULN;leukocytes (leu.),glucose<0.6*LLN,>1.5*ULN;lymphocytes (lym.),lym./leu.(%),neutrophils(neu.),neu./leu.(%),protein,albumin <0.8*LLN,>1.2*ULN;basophils(bas.),bas./leu.(%),eosinophils(eos.),eos./leu.,monocytes(mon.),mon./leu.(%),urate >1.2*ULN;bilirubin (total,direct,indirect)>1.5*ULN;aspartate/alanine aminotransferase,gamma glutamyl transferase, lactate dehydrogenase,alkaline phosphatase>3.0*ULN;urea nitrogen, creatinine,triglycerides,chl.>1.3*ULN; sodium <0.95*LLN,>1.05*ULN; creatine kinase >2.0*ULN;Urine: pH<4.5,>8;glucose,ketones, protein,HGB,urobilinogen,bilirubin,nitrite,leukocyte esterase>=1;ery.,leu.>= 20;hyaline casts>1;bacteria>20.Safety set.N=subjects evaluable.

End point type

Secondary

End point timeframe

Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	37	35	35	37	35	36	36	36
Units: Subjects	26	22	23	22	16	21	24	24

No statistical analyses for this end point

Secondary: Number of Subjects With Clinically Significant Change in Electrocardiogram (ECG) Findings

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End point title

Number of Subjects With Clinically Significant Change in Electrocardiogram (ECG) Findings

End point description

Clinically significant ECG criteria included PR interval: value greater than (>) 280 millisecond (msec), percentage change greater than equal to (>=) 25/50 percentage, QRS interval: value >120 msec, percentage change >= 50% and QT interval corrected using the Fridericia's formula (QTCF) value 450 msec and 30<=change<60. Safety analysis set included all subjects who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, “number of subjects analysed” signifies number of subjects evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline up to Week 6

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	8	6	7	9	10	6	7	7
Units: Subjects
PR interval : value >280	0	0	0	0	1	0	0	0
PR interval : %change>=25/50%	0	1	1	0	1	0	2	0
QRS interval: value >120	0	0	0	0	0	0	1	1
QRS interval: %Change>=50%	0	0	0	0	0	1	0	0
QTCF: 450	0	0	1	1	0	1	0	0
QTCF: 30<=Change<60	0	1	1	1	1	2	1	0

No statistical analyses for this end point

Secondary: Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

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End point title

Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

End point description

Safety analysis set included all subjects who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, “Number of Subjects Analysed” signifies subjects evaluable for this end point and “n” signifies subjects evaluable for the each specified time point. Change at follow-up= CAF.

End point type

Secondary

End point timeframe

Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	32	32	32	33	32	32	34	33
Units: Units per litre
arithmetic mean (standard deviation)
Change at week 1(n=32,32,32,30,32,32,34,33)	0.4 ± 25.99	-7.4 ± 30.20	-5.3 ± 16.99	-9.3 ± 22.65	-18.4 ± 33.42	-8.0 ± 34.51	-8.0 ± 19.37	-4.3 ± 29.08
Change at week 2(n=32,27,30,33,27,28,31,30)	-8.8 ± 21.56	-7.8 ± 27.99	-1.9 ± 18.18	-8.8 ± 23.70	-15.8 ± 42.19	-0.3 ± 22.81	-8.0 ± 22.31	-4.9 ± 24.49
Change at week 4(n=26,27,30,31,30,24,27,29)	-8.6 ± 23.93	-5.4 ± 22.87	-9.3 ± 19.61	-12.1 ± 28.54	-16.3 ± 33.97	-1.0 ± 29.29	-19.5 ± 19.94	-3.7 ± 24.96
Change at week 6(n=30,26,31,31,28,23,31,32)	-8.8 ± 18.25	-8.1 ± 32.02	-1.5 ± 32.42	-6.4 ± 28.53	-18.2 ± 33.86	-9.7 ± 20.68	-11.2 ± 22.34	-7.0 ± 24.65
CAF visit(n=26,28,31,30,27,30,30,26)	-12.3 ± 24.82	-12.0 ± 28.83	4.0 ± 43.45	-2.7 ± 26.27	-15.1 ± 38.23	-11.3 ± 29.39	-13.3 ± 25.37	0.2 ± 16.48

No statistical analyses for this end point

Secondary: Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

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End point title

Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

End point description

Safety analysis set included all subjects who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, “Number of Subjects Analyzed” signifies subjects evaluable for this end point and “n” signifies subjects evaluable for the each specified time point. CAW: change at week. CAF: change at follow-up.

End point type

Secondary

End point timeframe

Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	34	35	33	35	34	36	36	35
Units: Gram per decilitre
arithmetic mean (standard deviation)
Protein: CAW 1(n=34,35,33,35,34,34,36,35)	-0.01 ± 0.439	-0.04 ± 0.294	-0.14 ± 0.433	-0.04 ± 0.264	-0.03 ± 0.421	-0.10 ± 0.360	-0.01 ± 0.344	-0.02 ± 0.301
Protein:CAW2(n=34,33,32,34,32,30,33,32)	-0.09 ± 0.383	0.03 ± 0.303	-0.18 ± 0.402	-0.01 ± 0.275	0.01 ± 0.561	0.02 ± 0.503	-0.04 ± 0.286	-0.10 ± 0.299
Protein: CAW4(n-29,28,33,31,32,24,31,30)	-0.10 ± 0.380	0.07 ± 0.315	-0.08 ± 0.429	-0.03 ± 0.341	-0.04 ± 0.465	-0.18 ± 0.292	-0.15 ± 0.242	0.03 ± 0.280
Protein: CAW6(n=30,27,31,32,31,24,32,33)	-0.13 ± 0.403	0.13 ± 0.379	-0.19 ± 0.452	0.01 ± 0.368	-0.03 ± 0.405	-0.10 ± 0.424	-0.09 ± 0.368	-0.09 ± 0.310
Protein: CAFvisit(n=30,29,32,32,29,31,32,30)	-0.07 ± 0.341	0.05 ± 0.457	-0.15 ± 0.481	-0.04 ± 0.404	0.03 ± 0.481	-0.18 ± 0.471	-0.09 ± 0.398	0.02 ± 0.299
Albumin:CAW 1(n=34,35,33,35,34,34,36,35)	-0.04 ± 0.269	-0.05 ± 0.205	-0.10 ± 0.283	-0.02 ± 0.177	0.00 ± 0.256	-0.05 ± 0.218	-0.03 ± 0.246	0.00 ± 0.169
Albumin:CAW 2(n=34,33,32,34,32,30,33,32)	-0.06 ± 0.235	0.02 ± 0.201	-0.10 ± 0.256	-0.02 ± 0.204	-0.01 ± 0.283	0.02 ± 0.266	-0.03 ± 0.174	-0.06 ± 0.202
Albumin: CAW4(n-29,28,33,31,32,24,31,30)	-0.08 ± 0.245	0.07 ± 0.172	-0.08 ± 0.285	0.01 ± 0.239	0.04 ± 0.292	-0.10 ± 0.232	-0.08 ± 0.180	0.03 ± 0.224
Albumin:CAW 6(n=30,27,31,32,31,24,32,33)	-0.08 ± 0.259	0.08 ± 0.245	-0.14 ± 0.333	-0.02 ± 0.269	-0.00 ± 0.218	-0.03 ± 0.252	-0.07 ± 0.244	-0.05 ± 0.227
Albumin:CAF visit(n=30,29,32,32,29,31,32,30)	-0.06 ± 0.247	0.10 ± 0.260	-0.09 ± 0.277	-0.04 ± 0.295	-0.01 ± 0.346	-0.09 ± 0.262	-0.02 ± 0.211	0.06 ± 0.181

No statistical analyses for this end point

Secondary: Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

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End point title

Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	34	35	33	35	34	34	36	35
Units: Microgram per decilitre
arithmetic mean (standard deviation)
Urea nitrogen:CAW 1(n=34,35,33,35,34,34,36,35)	0.9 ± 4.57	0.6 ± 3.04	0.1 ± 3.12	1.0 ± 3.19	1.0 ± 3.05	0.2 ± 2.19	0.4 ± 3.38	-0.1 ± 2.65
Urea nitrogen:CAW2(n=34,33,32,34,32,30,33,32)	0.8 ± 3.89	0.0 ± 2.71	0.6 ± 3.54	0.9 ± 3.18	0.5 ± 3.63	0.6 ± 4.19	0.8 ± 2.99	0.4 ± 3.28
Urea nitrogen:CAW4(n-29,28,33,31,32,24,31,30)	0.6 ± 3.39	0.0 ± 3.04	-0.0 ± 2.67	1.4 ± 3.06	0.5 ± 3.84	-0.7 ± 2.96	1.3 ± 2.81	-0.2 ± 3.61
Urea nitrogen:CAW 6(n=30,27,31,32,31,24,32,33)	0.7 ± 2.84	-0.2 ± 3.11	-0.6 ± 3.61	0.9 ± 3.27	0.3 ± 3.82	-0.8 ± 3.24	0.2 ± 3.52	-0.4 ± 3.69
Urea nitrogen:CAFvisit(n=30,29,32,32,29,31,32,30)	0.0 ± 3.17	-0.3 ± 3.13	0.4 ± 2.60	1.2 ± 4.22	0.2 ± 2.87	0.8 ± 3.78	0.5 ± 3.42	0.1 ± 3.78
Urate:CAW1(n=34,35,33,35,34,34,36,35)	0.16 ± 0.807	0.01 ± 0.606	0.16 ± 0.678	-0.01 ± 0.561	0.00 ± 0.739	0.05 ± 0.661	-0.02 ± 0.704	-0.14 ± 0.890
Urate: CAW2(n=34,33,32,34,32,30,33,32)	0.30 ± 0.990	-0.11 ± 0.655	0.12 ± 0.617	-0.03 ± 0.649	-0.15 ± 0.842	0.27 ± 1.025	-0.03 ± 0.718	-0.37 ± 1.059
Urate: CAW 4(n-29,28,33,31,32,24,31,30)	0.21 ± 0.497	0.14 ± 0.731	0.06 ± 0.756	-0.06 ± 0.621	-0.14 ± 0.856	0.22 ± 0.806	-0.21 ± 0.663	-0.16 ± 0.713
Urate: CAW 6(n=30,27,31,32,31,24,32,33)	0.13 ± 0.728	0.07 ± 0.984	-0.02 ± 0.831	0.06 ± 0.630	-0.02 ± 0.649	0.06 ± 0.534	-0.11 ± 0.827	-0.21 ± 1.084
Urate: CAW visit(n=30,29,32,32,29,31,32,30)	-0.11 ± 0.721	-0.33 ± 0.753	0.05 ± 0.763	-0.21 ± 0.554	-0.02 ± 0.810	0.02 ± 0.590	-0.08 ± 0.677	-0.20 ± 0.989
Calcium:CAW 1(n=34,35,33,35,34,34,36,35)	0.01 ± 0.419	0.01 ± 0.259	-0.06 ± 0.377	-0.02 ± 0.248	0.07 ± 0.386	-0.02 ± 0.303	-0.01 ± 0.295	0.09 ± 0.318
Calcium:CAW2(n=34,33,32,34,32,30,33,32)	-0.08 ± 0.417	0.00 ± 0.268	-0.10 ± 0.362	0.05 ± 0.296	0.07 ± 0.423	0.03 ± 0.389	-0.10 ± 0.293	-0.01 ± 0.244
Calcium:CAW4(n-29,28,33,31,32,24,31,30)	-0.04 ± 0.354	0.11 ± 0.329	-0.07 ± 0.345	0.05 ± 0.272	0.00 ± 0.376	-0.08 ± 0.309	-0.03 ± 0.257	0.10 ± 0.341
Calcium:CAW6(n=30,27,31,32,31,24,32,33)	-0.04 ± 0.355	0.10 ± 0.303	-0.21 ± 0.393	0.03 ± 0.315	0.00 ± 0.397	-0.05 ± 0.335	-0.05 ± 0.464	-0.04 ± 0.337
Calcium:CAFvisit(n=30,29,32,32,29,31,32,30)	0.00 ± 0.317	-0.01 ± 0.345	-0.08 ± 0.409	0.00 ± 0.323	0.10 ± 0.441	-0.05 ± 0.419	0.01 ± 0.378	0.05 ± 0.356
Glucose:CAW 1(n=34,35,33,34,34,33,36,35)	4.9 ± 8.73	5.7 ± 13.97	3.4 ± 14.62	4.5 ± 8.60	4.4 ± 16.14	4.5 ± 29.90	5.6 ± 13.14	3.3 ± 13.58
Glucose:CAW2(n=33,33,32,34,32,30,33,32)	9.7 ± 23.71	1.2 ± 17.34	0.6 ± 10.97	3.2 ± 12.63	3.1 ± 10.00	-1.9 ± 13.51	7.9 ± 16.67	2.7 ± 18.07
Glucose:CAW 4(n-29,28,33,31,32,24,31,30)	7.3 ± 15.60	0.5 ± 12.50	-1.2 ± 15.86	4.5 ± 13.99	2.8 ± 20.20	1.3 ± 24.01	10.7 ± 26.13	3.4 ± 18.33
Glucose:CAW6(n=30,27,31,32,31,24,32,33)	3.5 ± 9.19	2.4 ± 17.55	-1.7 ± 10.62	2.1 ± 13.80	-0.5 ± 9.77	-3.4 ± 16.37	4.3 ± 12.23	1.5 ± 12.62
Glucose:CAFvisit(n=30,29,32,32,29,31,32,30)	4.5 ± 11.58	2.2 ± 11.45	4.8 ± 13.28	4.6 ± 14.77	6.0 ± 13.79	6.2 ± 16.75	9.1 ± 17.21	2.0 ± 22.43

No statistical analyses for this end point

Secondary: Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

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End point title

Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	34	35	33	35	34	34	36	35
Units: Milliequivalents per litre
arithmetic mean (standard deviation)
Sodium:CAW 1(n=34,35,33,35,34,34,36,35)	0.1 ± 2.34	-0.0 ± 1.77	-0.7 ± 2.04	-0.6 ± 2.17	-0.4 ± 3.50	0.4 ± 1.97	0.0 ± 2.08	-0.1 ± 3.39
Sodium:CAW2(n=34,33,32,34,32,30,33,32)	-0.5 ± 2.23	-0.3 ± 1.89	-0.1 ± 2.39	-0.2 ± 2.18	-0.4 ± 3.61	-0.2 ± 2.61	-0.5 ± 2.20	-0.3 ± 3.45
Sodium:CAW4(n-29,28,33,31,32,24,31,30)	-0.3 ± 2.70	0.6 ± 1.83	-0.2 ± 2.44	-0.7 ± 2.71	-0.4 ± 3.08	-0.4 ± 2.72	-0.1 ± 1.77	-0.3 ± 3.28
Sodium:CAW6(n=30,27,31,32,31,24,32,33)	-0.8 ± 2.31	0.0 ± 2.39	-0.2 ± 2.23	-0.9 ± 2.40	-0.9 ± 3.55	0.9 ± 2.50	-0.1 ± 2.23	-0.5 ± 2.49
Sodium:CAF visit(n=30,29,32,32,29,31,32,30)	-0.4 ± 3.26	0.5 ± 2.50	-0.1 ± 2.45	-0.3 ± 2.41	-0.8 ± 3.59	0.7 ± 1.94	-0.1 ± 2.46	0.1 ± 3.32
Potassium:CAW1(n=34,35,33,35,34,34,36,34)	-0.00 ± 0.363	0.08 ± 0.282	0.03 ± 0.372	0.02 ± 0.347	0.07 ± 0.343	0.01 ± 0.337	0.00 ± 0.429	0.20 ± 0.464
Potassium:CAW2(n=33,33,32,34,32,30,33,32)	-0.14 ± 0.367	0.04 ± 0.298	-0.07 ± 0.338	0.04 ± 0.359	0.07 ± 0.346	0.00 ± 0.245	-0.16 ± 0.438	-0.02 ± 0.322
Potassium:CAW4(n-29,28,33,31,32,24,31,30)	0.01 ± 0.389	-0.06 ± 0.285	-0.02 ± 0.350	-0.01 ± 0.327	0.05 ± 0.375	-0.09 ± 0.300	-0.03 ± 0.415	0.26 ± 0.350
Potassium:CAW6(n=30,27,31,32,31,24,32,33)	-0.09 ± 0.373	0.03 ± 0.295	-0.06 ± 0.332	0.03 ± 0.407	-0.06 ± 0.262	-0.06 ± 0.309	-0.10 ± 0.355	0.09 ± 0.388
Potassium:CAF visit(n=30,29,32,32,29,31,32,30)	-0.11 ± 0.379	0.10 ± 0.375	0.03 ± 0.394	0.04 ± 0.351	0.12 ± 0.358	0.05 ± 0.293	-0.09 ± 0.475	0.26 ± 0.460
Chloride:CAW1(n=34,35,33,35,34,34,36,35)	0.1 ± 2.11	0.3 ± 1.86	0.3 ± 1.57	0.0 ± 2.54	0.0 ± 2.66	0.6 ± 2.11	0.5 ± 2.02	0.5 ± 2.83
Chloride:CAW2(n=34,33,32,34,32,30,33,32)	-0.2 ± 2.52	-0.2 ± 2.08	0.7 ± 2.03	0.2 ± 2.50	-0.2 ± 2.87	0.4 ± 2.70	0.4 ± 2.15	0.2 ± 2.99
Chloride:CAW4(n-29,28,33,31,32,24,31,30)	0.3 ± 2.05	0.6 ± 1.89	0.2 ± 2.68	-0.4 ± 2.23	-0.3 ± 2.16	0.3 ± 3.28	1.0 ± 2.21	-0.2 ± 2.57
Chloride:CAW6(n=30,27,31,32,31,24,32,33)	-0.6 ± 1.98	0.1 ± 2.27	0.0 ± 2.34	-0.5 ± 2.44	-0.4 ± 3.05	0.5 ± 2.93	0.9 ± 2.73	0.0 ± 2.32
Chloride:CAFvisit(n=30,29,32,32,29,31,32,30)	0.6 ± 2.97	-0.3 ± 2.16	0.8 ± 2.64	0.1 ± 2.41	-0.4 ± 2.90	1.3 ± 2.11	0.3 ± 2.35	0.4 ± 3.16
Bicarbonate:CAW1(n=34,35,33,33,34,33,36,35)	0.13 ± 2.548	-0.38 ± 1.759	-0.20 ± 1.965	-0.18 ± 1.768	0.28 ± 1.638	0.09 ± 2.209	-0.21 ± 2.388	-0.02 ± 1.651
Bicarbonate: CAW2(n=34,33,32,34,31,30,33,32)	0.08 ± 2.229	-0.40 ± 2.151	-0.51 ± 1.956	0.10 ± 2.129	-0.13 ± 1.931	-0.15 ± 2.341	-0.60 ± 2.354	-0.07 ± 1.828
Bicarbonate:CAW4(n-29,28,33,31,32,24,30,30)	0.21 ± 2.739	0.05 ± 2.128	-0.24 ± 2.484	0.34 ± 1.868	0.02 ± 2.011	0.14 ± 1.286	-0.00 ± 2.695	0.02 ± 1.704
Bicarbonate:CAW6(n=30,27,31,32,31,24,32,33)	0.52 ± 2.560	-0.44 ± 2.598	0.66 ± 2.132	0.27 ± 2.204	0.12 ± 2.407	0.63 ± 2.096	-0.19 ± 2.038	-0.20 ± 2.217
Bicarbonate:CAFvisit(n=30,29,32,32,29,31,32,30)	-0.02 ± 2.916	0.66 ± 2.209	0.41 ± 2.056	0.75 ± 2.386	0.43 ± 2.162	0.08 ± 1.643	0.18 ± 2.300	1.09 ± 2.049

No statistical analyses for this end point

Secondary: Change From Baseline in Hematology- Hemoglobin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

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End point title

Change From Baseline in Hematology- Hemoglobin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	34	37	33	34	34	33	35	34
Units: Gram per decilitre
arithmetic mean (standard deviation)
CAW 1(n=34,35,32,34,34,33,35,34)	-0.01 ± 0.790	-0.22 ± 0.620	-0.36 ± 0.775	-0.12 ± 0.678	-0.26 ± 0.726	-0.19 ± 0.698	-0.21 ± 0.584	-0.27 ± 0.679
CAW 2(n=34,33,32,34,32,30,33,31)	-0.16 ± 0.636	-0.09 ± 0.566	-0.64 ± 0.715	-0.24 ± 0.657	-0.22 ± 0.798	-0.16 ± 0.830	-0.25 ± 0.625	-0.32 ± 0.793
CAW 4(n-28,27,33,31,32,25,30,30)	0.03 ± 0.725	-0.17 ± 0.630	-0.48 ± 0.659	-0.25 ± 0.628	-0.06 ± 0.821	-0.27 ± 0.789	-0.32 ± 0.701	-0.20 ± 0.658
CAW 6(n=29,27,31,32,31,24,32,33)	-0.13 ± 0.832	-0.06 ± 0.614	-0.48 ± 0.767	-0.03 ± 0.617	-0.11 ± 0.775	-0.22 ± 0.724	-0.21 ± 0.833	-0.28 ± 0.683
CAF visit(n=30,29,30,32,30,31,32,30)	0.05 ± 0.613	-0.04 ± 0.717	-0.49 ± 0.777	-0.09 ± 0.784	0.00 ± 0.773	-0.27 ± 0.756	-0.12 ± 0.826	-0.18 ± 0.740

No statistical analyses for this end point

Secondary: Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

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End point title

Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	34	35	33	34	34	33	35	34
Units: Percentage of cells
arithmetic mean (standard deviation)
Hematocrit: CAW1(n=34,35,32,34,34,33,35,33)	0.2 ± 2.51	-0.8 ± 2.11	-1.3 ± 2.61	-0.4 ± 2.27	-0.8 ± 2.41	-0.5 ± 1.97	-0.9 ± 2.04	-0.9 ± 2.30
Hematocrit: CAW2(n=34,33,32,34,32,30,33,30)	-0.5 ± 2.19	-0.8 ± 2.12	-1.8 ± 2.42	-0.9 ± 2.32	-0.7 ± 2.58	-0.9 ± 2.55	-0.7 ± 2.24	-1.0 ± 2.61
Hematocrit: CAW4(n=28,27,33,31,30,31,25,30)	0.0 ± 2.45	-0.8 ± 1.96	-1.8 ± 2.06	-0.8 ± 2.34	0.0 ± 2.73	-1.0 ± 2.34	-0.9 ± 2.29	-0.5 ± 2.56
Hematocrit:CAW6(n=29,27,31,32,31,24,32,33)	-0.6 ± 2.47	-0.9 ± 1.93	-1.6 ± 2.64	-0.7 ± 2.23	-0.6 ± 2.51	-1.1 ± 1.98	-1.1 ± 2.84	-0.8 ± 2.60
Hematocrit: CAFvisit(n=30,29,30,32,30,31,32,30)	0.3 ± 2.49	-0.7 ± 2.24	-1.4 ± 3.05	-0.7 ± 2.39	-0.2 ± 2.50	-0.6 ± 2.20	-0.6 ± 2.73	-0.3 ± 2.78
Reticulocytes/Ery.CAW1(n=31,31, 29,29,27,28,31,27)	0.03 ± 0.317	0.14 ± 0.378	0.02 ± 0.483	0.06 ± 0.364	0.11 ± 0.318	0.01 ± 0.320	0.04 ± 0.355	0.01 ± 0.329
Reticulocytes/Ery.CAW2(n=31,30,29,29,25,26,29,24)	-0.03 ± 0.382	0.17 ± 0.325	0.09 ± 0.413	-0.02 ± 0.473	0.19 ± 0.443	-0.10 ± 0.318	0.06 ± 0.315	-0.01 ± 0.389
Reticulocytes/Ery.CAW4(n=25,24,30,27,25,23,26,23)	0.16 ± 0.596	-0.08 ± 0.359	0.01 ± 0.460	0.19 ± 0.429	0.10 ± 0.409	0.03 ± 0.290	0.04 ± 0.446	0.05 ± 0.374
Reticulocytes/Ery.CAW6(n=26,25,28,28,24,22,28,26)	-0.06 ± 0.382	0.02 ± 0.361	0.02 ± 0.473	0.01 ± 0.486	0.15 ± 0.399	-0.15 ± 0.310	-0.01 ± 0.355	0.01 ± 0.463
Ret./Ery.CAFvisit(n=27,25,27, 27, 23, 27, 27, 23)	-0.11 ± 0.396	-0.02 ± 0.384	0.10 ± 0.435	-0.10 ± 0.398	-0.03 ± 0.298	-0.09 ± 0.331	-0.19 ± 0.395	0.11 ± 0.448
Lym./Leuk.CAW1(n=34,35,32,34,3433, 35, 34)	-0.43 ± 6.772	0.68 ± 5.814	2.33 ± 5.616	0.06 ± 4.765	1.31 ± 6.259	0.59 ± 5.179	0.49 ± 5.509	1.79 ± 6.269
Lym./Leukocytes:CAW2(n=34,33,32,34,32,30,33,31)	0.20 ± 6.175	0.84 ± 7.544	1.68 ± 5.208	1.50 ± 5.639	0.23 ± 6.175	0.50 ± 5.405	0.72 ± 6.638	0.86 ± 7.264
Lym./Leukocytes:CAW4(n=28,27,33,31,32,25,20,30)	1.58 ± 7.591	0.51 ± 7.297	1.43 ± 5.298	0.43 ± 7.586	2.41 ± 6.577	-1.38 ± 5.415	1.07 ± 5.739	0.56 ± 7.264
Lym./Leukocytes:CAW6(n=29,27,31,32,31,24,32,33)	-0.92 ± 6.701	-0.06 ± 5.461	0.82 ± 6.685	1.28 ± 5.881	1.65 ± 5.818	0.50 ± 4.452	-0.04 ± 5.300	1.52 ± 7.266
Lym./Leuk.:CAFvisit(n=30,29,30,32,30,31,32,30)	1.53 ± 6.219	1.25 ± 4.974	1.61 ± 6.597	-0.85 ± 6.367	1.34 ± 6.165	0.22 ± 6.315	0.07 ± 5.103	2.48 ± 6.914
Neu./Leukocytes:CAW1(n=34,35,32,34,34,33,35,34)	0.57 ± 7.515	-0.95 ± 6.957	-2.93 ± 6.191	0.30 ± 5.755	-0.96 ± 7.843	-0.17 ± 5.769	-1.87 ± 6.873	-1.44 ± 6.580
Neu./Leukocytes:CAW2(n=34,33,32,34,32,30,33,31)	-0.12 ± 7.827	-0.34 ± 8.219	-1.70 ± 6.037	-1.50 ± 6.578	-0.24 ± 6.146	-0.49 ± 6.665	-1.04 ± 7.376	-0.56 ± 8.017
Neu./Leukocytes:CAW4(n=28,27,33,31,32,25,30,30)	-1.42 ± 8.812	-0.30 ± 7.754	-1.52 ± 6.661	0.06 ± 8.536	-2.25 ± 7.468	1.65 ± 6.622	-1.42 ± 6.498	-0.45 ± 7.362
Neu./Leukocytes:CAW6(n=29,27,31,32,31,24,32,33)	0.95 ± 8.648	-0.58 ± 7.009	-0.64 ± 6.833	-1.14 ± 6.872	-1.15 ± 6.969	-0.56 ± 5.699	0.13 ± 6.029	-1.01 ± 8.445
Neu./Leuk:CAFvisit(n=30,29,30,32,30,31,32,30)	-1.71 ± 7.046	-0.65 ± 6.057	-1.86 ± 6.892	1.32 ± 7.355	-1.32 ± 6.559	-0.41 ± 6.961	-0.71 ± 6.590	-2.04 ± 7.700
Bas./Leukocytes:CAW1(n=34,35,32,34,34,33,35,34)	-0.06 ± 0.431	-0.02 ± 0.690	-0.06 ± 0.524	0.08 ± 0.319	0.03 ± 0.515	-0.03 ± 0.291	-0.01 ± 0.411	-0.01 ± 0.570
Bas/Leukocytes:CAW2(n=34,33,32,34,32,30,33,31)	-0.02 ± 0.304	0.01 ± 0.493	-0.09 ± 0.342	0.02 ± 0.323	-0.03 ± 0.532	0.03 ± 0.355	-0.06 ± 0.624	-0.24 ± 0.709
Bas./Leukocytes:CAW2(n=28,27,33,31,32,25,30,30)	-0.07 ± 0.485	0.06 ± 0.651	-0.03 ± 0.420	0.01 ± 0.402	-0.08 ± 0.712	-0.05 ± 0.362	-0.01 ± 0.465	-0.10 ± 0.464
Bas./Leukocytes:CAW6(n=29,27,31,32,31,24,32,33)	-0.07 ± 0.272	0.11 ± 0.809	-0.12 ± 0.480	0.08 ± 0.458	-0.16 ± 0.557	-0.05 ± 0.296	-0.12 ± 0.576	-0.17 ± 0.750
Bas./Leuk.:CAF visit(n=30,29,30,32,30,31,32,30)	-0.04 ± 0.360	-0.15 ± 0.476	-0.13 ± 0.443	0.02 ± 0.512	-0.25 ± 0.541	-0.05 ± 0.449	0.01 ± 0.472	-0.25 ± 0.572
Eos./Leukocytes:CAW1(n=34,35,32,34,34,33,35,34)	-0.09 ± 1.390	0.17 ± 1.840	0.17 ± 0.934	-0.37 ± 1.549	-0.31 ± 1.607	-0.19 ± 1.410	0.89 ± 1.850	-0.23 ± 1.339
Eos./Leukocytes:CAW2(n=34,33,32,34,32,30,33,32)	-0.11 ± 1.801	-0.20 ± 1.298	-0.16 ± 1.284	0.11 ± 1.460	-0.27 ± 1.131	-0.14 ± 1.199	0.16 ± 1.304	-0.05 ± 1.531
Eos./Leukocytes:CAW4(n=28,27,33,31,32,25,30,31)	0.42 ± 1.982	-0.12 ± 1.725	0.15 ± 1.884	-0.37 ± 1.729	-0.35 ± 1.431	-0.34 ± 1.258	0.40 ± 1.468	-0.37 ± 1.747
Eos./Leukocytes:CAW6(n=29,27,27,31,32,31,24,32,33)	-0.03 ± 1.522	0.22 ± 1.570	-0.04 ± 1.213	0.02 ± 2.126	-0.15 ± 1.714	-0.01 ± 1.767	0.05 ± 1.229	-0.19 ± 1.840
Eos./Leuk:CAFvisit(n=30,29,30,32,30,31,32,30)	0.16 ± 1.754	-0.24 ± 1.860	-0.09 ± 1.155	-0.41 ± 2.188	0.12 ± 1.954	-0.05 ± 2.805	0.50 ± 1.986	-0.13 ± 2.021
Mon/Leukocytes:CAW1(n=34,35,32,34,34,33,35,34)	0.02 ± 1.913	0.12 ± 1.391	0.50 ± 1.428	-0.06 ± 1.409	-0.01 ± 1.593	-0.19 ± 1.043	0.51 ± 1.275	-0.11 ± 1.251
Mon/Leukocytes:CAW2(n=34,33,32,34,32,30,33,31)	0.04 ± 2.055	-0.31 ± 1.502	0.30 ± 1.522	-0.13 ± 1.267	0.38 ± 1.362	0.11 ± 1.318	0.22 ± 1.414	-0.01 ± 1.755
Mon/Leukocytes:CAW4(n=28,27,33,31,32,25,30,30)	-0.51 ± 2.509	-0.17 ± 1.966	-0.02 ± 2.072	-0.10 ± 1.582	0.22 ± 1.323	0.14 ± 1.323	-0.03 ± 1.039	0.33 ± 1.695
Mon/Leukocytes:CAW6(n=29,27,31,32,31,24,32,33)	0.06 ± 2.488	0.33 ± 2.257	-0.00 ± 1.813	-0.24 ± 1.217	-0.12 ± 1.030	0.13 ± 0.807	-0.02 ± 1.324	-0.16 ± 1.516
Mon/Leuk:CAW visit(n=30,29,30,32,30,31,32,30)	0.06 ± 2.105	-0.22 ± 1.304	0.50 ± 1.463	-0.07 ± 1.226	0.13 ± 1.205	0.26 ± 1.543	0.15 ± 1.599	-0.04 ± 1.047

No statistical analyses for this end point

Secondary: Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

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End point title

Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	34	35	33	34	34	33	35	34
Units: 10^12*cells per litre
arithmetic mean (standard deviation)
Erythrocytes: CAW1(n=34,35,32,34,34,33,35,34)	0.03 ± 0.261	-0.07 ± 0.232	-0.12 ± 0.264	-0.04 ± 0.252	-0.08 ± 0.254	-0.08 ± 0.298	-0.08 ± 0.192	-0.09 ± 0.240
Erythrocytes:CAW2(n=34,33,32,34,32,30,33,31)	-0.05 ± 0.234	-0.03 ± 0.212	-0.18 ± 0.251	-0.10 ± 0.208	-0.07 ± 0.242	-0.10 ± 0.366	-0.06 ± 0.229	-0.11 ± 0.232
Erythrocytes:CAW4(n=28,27,33,31,32,25,30,30)	-0.01 ± 0.216	-0.05 ± 0.221	-0.16 ± 0.251	-0.10 ± 0.233	0.01 ± 0.275	-0.12 ± 0.271	-0.08 ± 0.248	-0.06 ± 0.219
Erythrocytes:CAW6(n=29,27,31,32,31,24,32,33)	-0.04 ± 0.247	-0.01 ± 0.180	-0.17 ± 0.265	-0.04 ± 0.238	-0.02 ± 0.262	-0.10 ± 0.256	-0.07 ± 0.303	-0.08 ± 0.239
Erythrocytes:CAW visit(n=30,29,30,32,30,31,32,30)	0.03 ± 0.220	0.02 ± 0.244	-0.15 ± 0.266	-0.03 ± 0.254	0.04 ± 0.300	-0.08 ± 0.280	-0.03 ± 0.308	-0.05 ± 0.262
Reticulocytes:CAW1(n=31,31,29,29,27,28,31,27)	0.0 ± 0.02	0.0 ± 0.02	-0.0 ± 0.02	0.0 ± 0.02	0.0 ± 0.02	0.0 ± 0.01	0.0 ± 0.02	-0.0 ± 0.02
Reticulocytes:CAW2(n=31,30,29,29,25,26,29,24)	-0.0 ± 0.02	0.0 ± 0.02	0.0 ± 0.02	-0.0 ± 0.02	0.0 ± 0.02	-0.0 ± 0.02	0.0 ± 0.02	-0.0 ± 0.02
Reticulocytes:CAW4(n=25,24,30,27,25,23,26,23)	0.0 ± 0.03	-0.0 ± 0.02	-0.0 ± 0.02	0.0 ± 0.02	0.0 ± 0.02	-0.0 ± 0.01	-0.0 ± 0.02	0.0 ± 0.02
Reticulocytes:CAW6(n=26,25,28,28,24,22,28,26)	-0.0 ± 0.02	0.0 ± 0.02	0.0 ± 0.02	-0.0 ± 0.02	0.0 ± 0.02	-0.0 ± 0.01	-0.0 ± 0.02	0.0 ± 0.02
Reticulocytes:CAFvisit(n=27,25,27,27,23,27,27,23)	-0.0 ± 0.02	-0.0 ± 0.02	0.0 ± 0.02	-0.0 ± 0.02	-0.0 ± 0.01	-0.0 ± 0.02	-0.0 ± 0.02	0.0 ± 0.02

No statistical analyses for this end point

Secondary: Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

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End point title

Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	34	35	33	34	34	33	35	34
Units: 10^9 *cells per litre
arithmetic mean (standard deviation)
Platelets:CAW1(n=34,25,32,34,34,33,35,34)	0.9 ± 60.03	6.8 ± 34.08	-3.3 ± 32.39	1.0 ± 25.76	8.5 ± 41.61	6.6 ± 33.40	-2.1 ± 31.94	12.6 ± 44.08
Platelets:CAW2(n=34,33,32,34,32,30,33,31)	-4.9 ± 58.16	7.1 ± 43.34	-8.1 ± 41.92	-0.1 ± 32.45	5.0 ± 31.39	-4.9 ± 31.84	7.5 ± 37.94	14.8 ± 50.99
Platelets:CAW4(n=28,27,33,31,32,25,30,30)	10.5 ± 36.42	10.1 ± 37.55	-2.4 ± 37.68	-0.3 ± 36.27	-5.9 ± 37.47	4.4 ± 37.79	0.7 ± 36.51	11.0 ± 46.26
Platelets:CAW6(n=29,27,31,32,31,24,32,33)	4.9 ± 35.17	-3.3 ± 32.76	-6.6 ± 41.66	-2.3 ± 32.70	-5.2 ± 38.53	0.2 ± 37.28	-1.8 ± 37.05	8.6 ± 47.85
Platelets:CAFvisit(n=29,29,30,32,30,31,32,30)	1.3 ± 30.48	16.3 ± 37.13	-8.5 ± 30.15	0.1 ± 32.36	10.2 ± 47.30	-5.2 ± 40.70	5.8 ± 48.55	2.5 ± 58.75
Leukocytes:CAW1(n=34,35,32,34,34,33,35,34)	0.027 ± 1.8740	0.395 ± 1.0940	-0.051 ± 1.2403	0.407 ± 1.2225	0.259 ± 1.1290	0.068 ± 1.2929	0.238 ± 1.4993	-0.025 ± 2.3529
Leukocytes:CAW2(n=34,33,32,34,32,30,33,31)	-0.206 ± 1.8886	0.459 ± 1.5567	-0.288 ± 1.6842	-0.094 ± 1.2877	-0.116 ± 1.0364	-0.007 ± 1.2637	0.422 ± 1.8986	-0.006 ± 2.3428
Leukocytes:CAW4(n=28,27,33,31,32,25,30,30)	-0.203 ± 1.7390	0.729 ± 1.3199	0.189 ± 1.3534	0.085 ± 1.3541	-0.074 ± 1.0641	0.398 ± 1.5999	0.168 ± 1.0902	0.041 ± 2.1647
Leukocytes:CAW6(n=29,27,31,32,31,24,32,33)	0.160 ± 1.7059	0.066 ± 1.0672	-0.505 ± 1.6474	0.237 ± 1.4501	-0.244 ± 1.2763	-0.269 ± 1.0761	-0.048 ± 1.3823	-0.347 ± 2.1442
Leukocytes:CAFvisit(n=30,29,30,32,30,31,32,30)	-0.066 ± 1.5744	0.479 ± 1.0939	-0.048 ± 2.0206	0.329 ± 1.3938	0.123 ± 0.8496	-0.117 ± 1.4856	0.210 ± 1.7456	-0.404 ± 2.4817
Lymphocytes:CAW1(n=34,35,32,34,34,33,35,34)	-0.008 ± 0.5539	0.124 ± 0.3659	0.107 ± 0.3130	0.081 ± 0.3839	0.186 ± 0.3840	0.051 ± 0.3557	0.089 ± 0.4320	0.223 ± 0.3849
Lymphocytes:CAW2(n=34,33,32,34,32,30,33,31)	-0.061 ± 0.5558	0.145 ± 0.3735	0.010 ± 0.4115	0.044 ± 0.4225	0.012 ± 0.4251	-0.003 ± 0.3165	0.070 ± 0.4603	0.169 ± 0.5319
Lymphocytes:CAW4(n=28,27,33,31,32,25,30,30)	0.107 ± 0.4302	0.229 ± 0.3998	0.135 ± 0.4400	0.012 ± 0.4596	0.139 ± 0.3977	0.039 ± 0.4169	0.127 ± 0.2630	0.176 ± 0.6274
Lymphocytes:CAW6(n=29,27,31,32,31,24,32,33)	0.033 ± 0.3375	0.016 ± 0.3437	-0.079 ± 0.4826	0.104 ± 0.4337	0.068 ± 0.3168	-0.033 ± 0.3092	0.027 ± 0.2455	0.079 ± 0.3846
LymphocytesCAFvisit(n=30,29,30,32,30,31,32,30)	0.134 ± 0.3256	0.194 ± 0.3533	0.065 ± 0.6042	-0.022 ± 0.4419	0.130 ± 0.4277	-0.035 ± 0.4054	0.050 ± 0.4699	0.195 ± 0.4663
Neutrophils:CAW1(n=34,35,32,34,34,33,35,34)	0.027 ± 1.6137	0.205 ± 0.9185	-0.177 ± 1.0805	0.319 ± 1.0276	0.069 ± 1.0706	0.017 ± 1.1291	0.030 ± 1.3015	-0.251 ± 2.2421
Neutrophils:CAW2(n=34,33,32,34,32,30,33,31)	-0.119 ± 1.5672	0.293 ± 1.5459	-0.261 ± 1.3969	-0.136 ± 1.0669	-0.109 ± 0.9653	-0.015 ± 1.1305	0.288 ± 1.7822	-0.190 ± 2.0749
Neutrophils:CAW4(n=28,27,33,31,32,25,30,30)	-0.304 ± 1.6117	0.441 ± 1.2814	0.036 ± 1.1595	0.096 ± 1.3199	-0.190 ± 1.0404	0.338 ± 1.3577	-0.005 ± 0.9958	-0.158 ± 2.0005
Neutrophils:CAW6(n=29,27,31,32,31,24,32,33)	0.112 ± 1.6282	-0.001 ± 0.8996	-0.362 ± 1.3154	0.112 ± 1.2240	-0.250 ± 1.1720	-0.228 ± 0.9681	-0.064 ± 1.2422	-0.376 ± 2.1125
Neutrophils:CAFvisit(n=30,29,30,32,30,31,32,30)	-0.229 ± 1.3379	0.261 ± 0.8874	-0.114 ± 1.4545	0.343 ± 1.3049	-0.020 ± 0.7731	-0.093 ± 1.2340	0.088 ± 1.4614	-0.562 ± 2.3227
Basophils:CAW1(n=34,35,32,34,34,33,35,34)	-0.006 ± 0.0319	0.004 ± 0.0445	-0.007 ± 0.0349	0.010 ± 0.0258	0.003 ± 0.0361	0.001 ± 0.0191	0.002 ± 0.0299	0.002 ± 0.0343
Basophils:CAW2(n=34,33,32,34,32,30,33,31)	-0.002 ± 0.0179	0.004 ± 0.0261	-0.009 ± 0.0276	0.001 ± 0.0197	-0.005 ± 0.0394	0.003 ± 0.0244	-0.003 ± 0.0433	-0.012 ± 0.0428
Basophils:CAW4(n=28,27,33,31,32,25,30,30)	-0.006 ± 0.0328	0.011 ± 0.0404	-0.002 ± 0.0300	0.001 ± 0.0256	-0.007 ± 0.0495	-0.001 ± 0.0255	-0.001 ± 0.0337	-0.004 ± 0.0323
Basophils:CAW6(n=29,27,31,32,31,24,32,33)	-0.005 ± 0.0186	0.009 ± 0.0489	-0.012 ± 0.0313	0.008 ± 0.0344	-0.015 ± 0.0415	-0.004 ± 0.0188	-0.009 ± 0.0373	-0.015 ± 0.0383
Basophils:CAFvisit(n=30,29,30,32,30,31,32,30)	-0.004 ± 0.0265	-0.003 ± 0.0259	-0.007 ± 0.0321	0.007 ± 0.0407	-0.015 ± 0.0426	-0.005 ± 0.0269	0.001 ± 0.0295	-0.019 ± 0.0361
Eosinophils:CAW1(n=34,35,32,34,34,33,35,34)	0.007 ± 0.0964	0.036 ± 0.0963	-0.004 ± 0.1092	-0.011 ± 0.0930	-0.014 ± 0.1216	-0.008 ± 0.1148	0.068 ± 0.0959	-0.006 ± 0.1165
Eosinophils:CAW2(n=34,33,32,34,32,30,33,31)	-0.019 ± 0.1087	-0.000 ± 0.0734	-0.023 ± 0.0809	0.009 ± 0.0980	-0.029 ± 0.0915	-0.006 ± 0.0621	0.022 ± 0.0762	0.005 ± 0.1256
Eosinophils:CAW4(n=28,27,33,31,32,25,30,30)	0.032 ± 0.1813	0.018 ± 0.1120	0.008 ± 0.1325	-0.019 ± 0.1102	-0.032 ± 0.1040	-0.012 ± 0.0832	0.042 ± 0.1076	-0.012 ± 0.1499
Eosinophils:CAW6(n=29,27,31,32,31,24,32,33)	0.002 ± 0.0935	0.029 ± 0.1090	-0.025 ± 0.1351	0.018 ± 0.1387	-0.027 ± 0.1125	-0.007 ± 0.1025	-0.001 ± 0.0812	-0.022 ± 0.1415
Eosinophils:CAFvisit(n=30,29,30,32,30,31,32,30)	0.022 ± 0.1461	0.006 ± 0.0931	-0.023 ± 0.1196	-0.004 ± 0.1810	0.008 ± 0.1270	-0.008 ± 0.2483	0.048 ± 0.1520	-0.011 ± 0.1945
Monocytes:CAW1(n=34,35,32,34,34,33,35,34)	0.006 ± 0.1796	0.030 ± 0.0855	0.030 ± 0.0987	0.009 ± 0.0879	0.019 ± 0.1055	0.006 ± 0.0877	0.051 ± 0.1244	0.011 ± 0.1195
Monocytes:CAW2(n=34,33,32,34,32,30,33,31)	-0.006 ± 0.1509	0.016 ± 0.1343	-0.003 ± 0.0724	-0.014 ± 0.1055	0.017 ± 0.0865	0.013 ± 0.0983	0.049 ± 0.1471	0.025 ± 0.1496
Monocytes:CAW4(n=28,27,33,31,32,25,30,30)	-0.035 ± 0.1904	0.030 ± 0.1212	0.013 ± 0.1234	-0.003 ± 0.1092	0.009 ± 0.0986	0.035 ± 0.0978	0.007 ± 0.1008	0.038 ± 0.1331
Monocytes:CAW6(n=29,27,31,32,31,24,32,33)	0.017 ± 0.1777	0.017 ± 0.1069	-0.025 ± 0.1191	-0.005 ± 0.1021	-0.019 ± 0.0726	0.004 ± 0.0847	0.003 ± 0.1097	-0.012 ± 0.1200
Monocytes:CAF visit(n=30,29,30,32,30,31,32,30)	0.011 ± 0.1806	0.021 ± 0.0824	0.030 ± 0.1467	0.005 ± 0.0887	0.021 ± 0.0739	0.018 ± 0.1047	0.029 ± 0.1788	-0.006 ± 0.1282

No statistical analyses for this end point

Secondary: Change From Baseline in Lipids Profile Values at Week 6

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End point title

Change From Baseline in Lipids Profile Values at Week 6

End point description

Lipid parameters that were assessed: high density lipoprotein (HDL) cholesterol, triglycerides, cholesterol, low density lipoprotein (LDL) cholesterol. Safety analysis set included all subjects who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, “Number of Subjects Analysed” signifies subjects evaluable for this end point and “n” signifies subjects evaluable for the each specified rows.

End point type

Secondary

End point timeframe

Baseline, Week 6

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	28	27	31	32	29	24	30	32
Units: Microgram per decilitre
arithmetic mean (standard deviation)
HDL cholesterol	-2.8 ± 6.65	0.1 ± 5.34	-1.3 ± 7.74	2.7 ± 8.33	1.9 ± 11.18	0.0 ± 6.76	1.2 ± 4.12	0.3 ± 8.56
Triglycerides(n=28,27,31,31,29,24,30,32)	3.3 ± 38.84	-4.2 ± 59.30	-6.5 ± 37.30	1.8 ± 60.74	-18.9 ± 56.78	-8.1 ± 50.41	-7.0 ± 58.36	-4.4 ± 55.66
Cholesterol	-3.5 ± 16.39	-5.6 ± 27.59	-12.8 ± 20.53	6.8 ± 24.09	-10.4 ± 30.79	-0.2 ± 18.70	5.3 ± 30.58	-0.9 ± 19.86
LDL Cholesterol	-3.4 ± 14.45	-6.3 ± 25.28	-12.1 ± 16.44	2.1 ± 20.13	-11.0 ± 29.06	-0.8 ± 14.48	4.4 ± 23.55	-1.1 ± 16.29

No statistical analyses for this end point

Secondary: Change From Baseline in Ratio of LDL Cholesterol to HDL Cholesterol Lipids Profile at Week 6

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End point title

Change From Baseline in Ratio of LDL Cholesterol to HDL Cholesterol Lipids Profile at Week 6

End point description

Mean change in total cholesterol/HDL cholesterol ratio was assessed and reported. Safety analysis set included all subjects who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, “Number of Subjects Analysed” signifies subjects evaluable for this end point.

End point type

Secondary

End point timeframe

Baseline, Week 6

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	28	27	31	32	29	24	30	32
Units: Ratio
arithmetic mean (standard deviation)	0.0 ± 0.31	-0.1 ± 0.48	-0.2 ± 0.40	-0.0 ± 0.32	-0.3 ± 0.77	-0.0 ± 0.35	0.0 ± 0.46	-0.0 ± 0.42

No statistical analyses for this end point

Secondary: Change From Baseline in Electrocardiogram (ECG) Parameter- Heart Rate at Weeks 2 and 6

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End point title

Change From Baseline in Electrocardiogram (ECG) Parameter- Heart Rate at Weeks 2 and 6

End point description

Safety analysis set included all subjects who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, “n” signifies subjects evaluable for the each specified time point.

End point type

Secondary

End point timeframe

Baseline, Weeks 2 and 6

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	37	37	36	37	36	36	36	37
Units: Beats per minute
arithmetic mean (standard deviation)
Baseline	66.8 ± 11.45	66.9 ± 9.33	68.4 ± 14.66	64.9 ± 9.05	64.9 ± 12.26	66.9 ± 12.03	68.2 ± 12.11	68.1 ± 12.48
Change at week 2 (n=33,31,33,33,31,26,34,32)	0.7 ± 10.05	-0.5 ± 8.03	-1.8 ± 11.53	-0.6 ± 7.88	1.9 ± 8.01	2.2 ± 8.76	1.7 ± 9.13	1.7 ± 12.52
Change at week 6(n=28,27,33,32,30,24,31,33)	0.3 ± 6.19	-1.1 ± 7.65	-1.7 ± 9.06	0.8 ± 8.53	-0.3 ± 8.46	-0.8 ± 8.23	0.5 ± 8.76	-0.4 ± 12.06

No statistical analyses for this end point

Secondary: Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6

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End point title

Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 2 and 6

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	37	37	36	37	36	36	36	37
Units: Milliseconds
arithmetic mean (standard deviation)
PR interval: baseline	161.9 ± 23.30	160.2 ± 24.01	161.4 ± 27.59	162.5 ± 22.04	160.7 ± 24.20	156.4 ± 22.65	157.9 ± 23.55	157.8 ± 23.15
PR interval:CAW2(n=33,31,33,33,31,26,34,32)	0.8 ± 14.41	-0.9 ± 15.92	0.7 ± 18.54	0.3 ± 10.13	1.1 ± 14.42	6.0 ± 14.79	1.2 ± 16.06	2.1 ± 7.98
PR interval:CAW 6(n=28,27,33,32,30,24,31,33)	-0.9 ± 10.16	-0.1 ± 13.81	2.8 ± 19.66	2.9 ± 13.63	3.5 ± 21.88	4.0 ± 14.56	6.5 ± 19.15	5.7 ± 16.11
QRS interval: baseline	92.5 ± 9.36	91.5 ± 9.71	91.1 ± 9.29	93.0 ± 11.13	93.1 ± 8.69	92.2 ± 13.00	92.4 ± 13.30	91.5 ± 11.68
QRS intervalCAW2(n=33,31,33,33,31,26,34,32)	-1.4 ± 8.02	-0.4 ± 5.34	-1.3 ± 3.46	-0.8 ± 5.64	0.1 ± 4.79	1.5 ± 9.29	0.2 ± 8.07	1.0 ± 5.63
QRS interval:CAW6(n=28,27,33,32,30,24,31,33)	-1.9 ± 6.55	1.4 ± 5.62	-0.5 ± 4.76	-0.9 ± 4.04	-1.3 ± 4.00	0.9 ± 6.37	0.6 ± 5.49	0.7 ± 5.67
QTCF interval: baseline	407.7 ± 17.78	397.9 ± 15.98	403.8 ± 22.43	408.5 ± 18.42	401.0 ± 16.29	403.0 ± 16.65	397.7 ± 17.05	405.0 ± 20.38
QTCF interval:CAW 2(n=33,31,33,33,31,26,34,32)	-5.7 ± 11.86	-1.5 ± 13.70	-3.9 ± 15.60	2.6 ± 16.20	-0.6 ± 12.75	1.4 ± 15.56	2.4 ± 10.32	-4.6 ± 15.43
QTCF interval:CAW6(n=28,27,33,32,30,24,31,33)	-4.1 ± 14.61	-0.5 ± 14.93	-1.9 ± 14.37	0.3 ± 17.19	-1.4 ± 14.93	4.6 ± 14.27	2.0 ± 11.94	-0.2 ± 9.67
QT interval: baseline	395.2 ± 31.53	385.3 ± 23.64	388.8 ± 33.66	401.0 ± 25.23	392.0 ± 27.36	390.9 ± 24.87	383.8 ± 30.79	390.6 ± 32.43
QT interval:CAW 2(n=33,31,33,33,31,26,34,32)	-5.9 ± 23.16	-1.3 ± 17.73	-1.1 ± 19.31	3.5 ± 21.06	-4.5 ± 15.75	1.2 ± 24.03	-2.3 ± 18.69	-4.6 ± 25.76
QT interval:CAW6(n=28,27,33,32,30,24,31,33)	-4.9 ± 19.54	1.3 ± 18.11	0.9 ± 16.11	-4.1 ± 23.42	-0.9 ± 20.12	7.8 ± 24.11	-1.4 ± 20.47	4.0 ± 27.74

No statistical analyses for this end point

Secondary: Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6

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End point title

Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6

End point description

Blood pressure included supine and sitting systolic and diastolic BP. Safety analysis set included all subjects who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, “n” signifies subjects evaluable for the each specified time point.

End point type

Secondary

End point timeframe

Baseline, Weeks 2 and 6

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	25	26	29	22	23	26	23	25
Units: Millimeters of mercury
arithmetic mean (standard deviation)
Supine systolic BP: Baseline	123.3 ± 12.01	123.2 ± 12.35	123.0 ± 13.89	119.7 ± 9.08	122.6 ± 12.76	123.1 ± 12.40	117.1 ± 14.07	118.9 ± 12.43
Supine SBP:CAW2(n=21,20,25,18,20,18,21,22)	0.3 ± 11.55	-1.4 ± 9.61	0.5 ± 14.73	2.3 ± 6.99	-0.3 ± 10.25	-0.3 ± 8.02	3.5 ± 13.65	2.9 ± 8.48
Supine SBP:CAW 6(n=16,15,24,17,19,18,21,22)	-0.2 ± 12.98	1.1 ± 10.06	2.0 ± 14.05	0.2 ± 9.13	-3.4 ± 11.02	-1.4 ± 10.49	2.1 ± 12.41	0.6 ± 10.31
Sitting SBP: Baseline(n=15,17,17,19,19,16,18,15)	117.7 ± 13.05	120.8 ± 10.26	120.2 ± 12.43	116.9 ± 17.76	124.6 ± 11.25	119.4 ± 12.96	122.9 ± 15.25	125.6 ± 12.21
Sitting SBP: CAW2(n=12,11,8,15,11,7,11,10)	1.3 ± 12.12	-1.9 ± 11.86	-3.9 ± 14.54	1.3 ± 13.59	-2.4 ± 11.76	-3.1 ± 10.46	1.1 ± 9.81	4.4 ± 11.68
Sitting SBP: CAW6(n=12,10,9,15,10,5,10,11)	0.6 ± 12.24	-7.5 ± 8.67	-9.4 ± 8.95	1.0 ± 14.63	-8.4 ± 10.81	-0.6 ± 14.40	-3.6 ± 8.37	-1.5 ± 5.80
Supine DBP: Baseline	77.7 ± 9.28	75.2 ± 8.79	78.8 ± 8.39	74.5 ± 8.26	75.9 ± 8.78	77.5 ± 8.71	74.4 ± 8.20	73.7 ± 8.59
Supine DBP: CAW2(n=21,20,25,18,20,18,21,22)	0.5 ± 7.51	0.6 ± 6.47	-0.4 ± 8.50	1.6 ± 10.33	1.2 ± 8.32	-2.8 ± 6.69	1.6 ± 8.89	1.4 ± 7.74
Supine DBP: CAW 6(n=16,15,24,17,19,18,21,22)	-2.5 ± 7.69	1.5 ± 7.61	-0.7 ± 8.32	0.5 ± 7.96	-0.9 ± 10.65	-1.6 ± 6.22	1.9 ± 9.72	0.5 ± 6.32
Sitting DBP: Baseline	76.5 ± 9.28	80.1 ± 6.76	77.8 ± 10.02	69.6 ± 11.48	80.9 ± 8.21	75.1 ± 5.77	77.1 ± 12.00	80.3 ± 7.83
Sitting DBP: CAW2(n=12, 11, 8, 15, 11, 7, 11, 10)	-1.6 ± 8.49	0.7 ± 7.93	0.0 ± 9.44	1.6 ± 12.00	-2.9 ± 10.77	1.7 ± 8.20	4.5 ± 5.80	-1.2 ± 6.49
Sitting DBP: CAW 6(n=12, 10, 9, 15, 10, 5, 10, 11)	0.8 ± 9.90	0.0 ± 5.79	-1.6 ± 11.97	1.1 ± 15.61	-5.3 ± 9.27	-2.8 ± 12.60	-0.3 ± 7.89	0.4 ± 8.41

No statistical analyses for this end point

Secondary: Change From Baseline in Vital Signs- Pulse Rate at Weeks 2 and 6

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End point title

Change From Baseline in Vital Signs- Pulse Rate at Weeks 2 and 6

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 2 and 6

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	37	37	36	37	36	36	36	37
Units: Beats per minute
arithmetic mean (standard deviation)
Baseline	69.6 ± 12.58	69.5 ± 9.82	72.9 ± 14.30	67.9 ± 9.31	68.8 ± 11.76	69.4 ± 11.15	70.1 ± 11.18	68.2 ± 9.59
Change at week 2(n=33,31,33,33,31,26,33,32)	0.5 ± 10.41	0.2 ± 8.11	-2.5 ± 9.66	1.1 ± 9.13	0.5 ± 6.54	3.7 ± 9.47	2.8 ± 8.28	4.1 ± 9.16
Change at week 6(n=28,27,33,32,30,24,31,33)	2.1 ± 10.59	0.3 ± 8.04	-1.4 ± 11.90	0.9 ± 9.71	1.8 ± 8.73	4.1 ± 6.76	0.5 ± 9.12	1.8 ± 8.64

No statistical analyses for this end point

Secondary: Change From Baseline in Vital Signs- Temperature at Weeks 2 and 6

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End point title

Change From Baseline in Vital Signs- Temperature at Weeks 2 and 6

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 2 and 6

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	37	37	36	37	36	36	36	37
Units: Degree Celsius
arithmetic mean (standard deviation)
Baseline	36.5 ± 0.33	36.5 ± 0.43	36.6 ± 0.44	36.6 ± 0.33	36.5 ± 0.37	36.5 ± 0.29	36.6 ± 0.41	36.6 ± 0.29
Change at week 2(n=33,31,33,33,31,26,33,32)	-0.1 ± 0.41	-0.1 ± 0.30	0.0 ± 0.38	-0.0 ± 0.43	0.1 ± 0.35	-0.0 ± 0.34	0.0 ± 0.38	0.0 ± 0.41
Change at week 6(n=28,27,33,32,30,24,31,33)	-0.0 ± 0.40	-0.0 ± 0.29	0.0 ± 0.38	0.1 ± 0.32	0.0 ± 0.29	0.1 ± 0.50	0.0 ± 0.37	-0.0 ± 0.46

No statistical analyses for this end point

Secondary: Number of Subjects With Each Severity Grade in Local Tolerability Assessments

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End point title

Number of Subjects With Each Severity Grade in Local Tolerability Assessments

End point description

Local tolerability skin assessments were performed by investigator and graded based on severity from grade 0 to 4 as: grade 0=none (no evidence of local intolerance); grade 1=mild (minimal erythema and/or oedema, 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 (erythema, oedema glazing with fissures, few vesicles or papules consider removing topical agent [if still in place]) and grade 4= very severe (strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent [if still in place]). Higher grades indicated worsening of condition. Only those categories in which at least 1 subject had data were reported. Safety analysis set included all subjects who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, “N” signifies number of subjects evaluable for this end point.

End point type

Secondary

End point timeframe

Day 1 and any day on of Week 1, 2, 4, 6: pre dose (before application of IP) and post dose (after application of IP); Follow up visit (28 days after last dose of study drug = maximum up to Day 71) and Early termination (anytime within week 11)

End point values	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Number of subjects analysed	35	36	31	33	36	35	34	36
Units: Subjects
Day 1: tolerability before: none	35	35	31	33	36	35	34	36
Day 1: tolerability before: mild	0	0	1	3	0	1	2	0
Day 1: tolerability before: moderate	2	2	4	1	0	0	0	1
Day 1: tolerability after: none	33	36	30	33	35	34	32	33
Day 1: tolerability after: mild	1	0	1	2	0	0	2	2
Day 1: tolerability after: moderate	1	1	3	1	0	1	0	0
Week 1: tolerability before: none	31	28	28	30	30	30	33	33
Week 1: tolerability before: mild	1	2	3	3	3	1	1	1
Week 1: tolerability before: moderate	2	0	3	0	0	0	0	0
Week 1: tolerability after: none	28	29	29	30	28	27	32	31
Week 1: tolerability after: mild	2	2	2	3	2	3	1	1
Week 1: tolerability after: moderate	2	0	2	0	0	1	0	0
Week 2: tolerability before: none	29	28	26	30	30	23	31	33
Week 2: tolerability before: mild	3	2	2	2	1	1	1	0
Week 2: tolerability before: moderate	1	0	3	1	0	0	1	0
Week 2: tolerability after: none	28	26	29	31	29	23	32	30
Week 2: tolerability after: mild	1	3	2	1	1	2	0	1
Week 2: tolerability after: moderate	1	0	1	1	0	0	1	0
Week 4: tolerability before: none	27	26	30	30	30	24	31	31
Week 4: tolerability before: mild	0	2	2	2	0	0	1	1
Week 4: tolerability before: moderate	1	0	1	0	1	1	0	0
Week 4: tolerability after: none	24	26	30	30	29	24	31	30
Week 4: tolerability after: mild	1	2	2	1	0	0	1	0
Week 4: tolerability after: moderate	1	0	0	0	1	1	0	0
Week 6: tolerability before: none	26	25	29	30	30	21	30	32
Week 6: tolerability before: mild	1	1	2	1	0	1	0	1
Week 6: tolerability after: none	25	24	28	29	29	22	30	30
Week 6: tolerability after: mild	0	1	3	0	0	0	0	0
Early termination: tolerability: none	6	5	3	2	2	9	2	1
Early termination: tolerability: mild	0	2	0	0	0	0	0	1
Early termination:tolerability: moderate	2	0	0	0	0	1	0	0
Early termination:tolerability: severe	1	1	0	1	1	0	0	0
Follow Up: tolerability: none	22	26	25	25	28	25	26	28
Follow Up: tolerability: mild	1	0	2	0	0	1	1	1
Follow Up: tolerability: moderate	1	0	1	4	1	1	0	0
Follow Up: tolerability: severe	0	0	1	0	0	0	0	0

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

23.0

Reporting group title

Vehicle Cream Once Daily (QD)

Reporting group description

Subjects or caregivers of subjects, topically applied vehicle cream on all eligible atopic dermatitis (AD) areas (of subjects) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Subjects were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 0.1% Cream QD

Reporting group description

Reporting group title

PF-06700841 0.3% Cream QD

Reporting group description

Reporting group title

PF-06700841 1.0% Cream QD

Reporting group description

Reporting group title

PF-06700841 3.0% Cream QD

Reporting group description

Reporting group title

Vehicle Cream Twice Daily (BID)

Reporting group description

Reporting group title

PF-06700841 0.3% Cream BID

Reporting group description

Subjects or caregivers of subjects, topically applied PF-06700841 0.3% cream on all eligible AD areas (of subjects) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Subjects were followed up for 4 weeks after last dose.

Reporting group title

PF-06700841 1.0% Cream BID

Reporting group description

Subjects or caregivers of subjects, topically applied PF-06700841 1.0% cream on all eligible AD areas (of subjects) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Subjects were followed up for 4 weeks after last dose.

Serious adverse events	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
number of deaths (all causes)	0	0	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0	0	0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Vehicle Cream Once Daily (QD)	PF-06700841 0.1% Cream QD	PF-06700841 0.3% Cream QD	PF-06700841 1.0% Cream QD	PF-06700841 3.0% Cream QD	Vehicle Cream Twice Daily (BID)	PF-06700841 0.3% Cream BID	PF-06700841 1.0% Cream BID
Total subjects affected by non serious adverse events
subjects affected / exposed	18 / 37 (48.65%)	17 / 37 (45.95%)	11 / 36 (30.56%)	12 / 37 (32.43%)	10 / 36 (27.78%)	17 / 36 (47.22%)	9 / 36 (25.00%)	14 / 37 (37.84%)
Vascular disorders
Haematoma
subjects affected / exposed	1 / 37 (2.70%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Pregnancy, puerperium and perinatal conditions
Pregnancy
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
General disorders and administration site conditions
Application site erythema
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	2 / 36 (5.56%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	2	0	1
Application site pruritus
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	3 / 36 (8.33%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	3	0	0
Administration site warmth
subjects affected / exposed	1 / 37 (2.70%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Application site acne
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	0	0	1
Application site pain
subjects affected / exposed	1 / 37 (2.70%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	1 / 36 (2.78%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences all number	1	0	0	0	1	1	0	1
Chills
subjects affected / exposed	0 / 37 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Injection site pain
subjects affected / exposed	1 / 37 (2.70%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Oedema peripheral
subjects affected / exposed	1 / 37 (2.70%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Pain
subjects affected / exposed	1 / 37 (2.70%)	0 / 37 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	1	0	0	0	0	0
Pyrexia
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	1	1	0	0
Vessel puncture site haematoma
subjects affected / exposed	0 / 37 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Immune system disorders
Allergy to arthropod sting
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Cockroach allergy
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Mite allergy
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Allergy to animal
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Reproductive system and breast disorders
Menstruation irregular
subjects affected / exposed	0 / 37 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Metrorrhagia
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	2 / 36 (5.56%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences all number	0	0	2	0	0	1	1	0
Oropharyngeal pain
subjects affected / exposed	1 / 37 (2.70%)	2 / 37 (5.41%)	1 / 36 (2.78%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	2	1	0	0	0	0	0
Increased viscosity of bronchial secretion
subjects affected / exposed	0 / 37 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Psychiatric disorders
Insomnia
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	1	0	0	0	0	1
Aspartate aminotransferase increased
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	0	0	1
Blood bilirubin increased
subjects affected / exposed	1 / 37 (2.70%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Blood creatine phosphokinase increased
subjects affected / exposed	0 / 37 (0.00%)	1 / 37 (2.70%)	1 / 36 (2.78%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	1	0	0	1	0	0
Blood glucose increased
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0
Electrocardiogram T wave inversion
subjects affected / exposed	0 / 37 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Glomerular filtration rate decreased
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Lipids abnormal
subjects affected / exposed	0 / 37 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Neutrophil count decreased
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0
Pregnancy test positive
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Injury, poisoning and procedural complications
Limb injury
subjects affected / exposed	1 / 37 (2.70%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0
Tooth fracture
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	0	0	1
Nervous system disorders
Burning sensation
subjects affected / exposed	0 / 37 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	1	0	0	0	0
Headache
subjects affected / exposed	1 / 37 (2.70%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0
Eye disorders
Swelling of eyelid
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Ulcerative keratitis
subjects affected / exposed	1 / 37 (2.70%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Gastrointestinal disorders
Dyspepsia
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	0	0	1
Nausea
subjects affected / exposed	1 / 37 (2.70%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	1	0	0	0
Skin and subcutaneous tissue disorders
Dermatitis atopic
subjects affected / exposed	3 / 37 (8.11%)	3 / 37 (8.11%)	1 / 36 (2.78%)	0 / 37 (0.00%)	1 / 36 (2.78%)	3 / 36 (8.33%)	0 / 36 (0.00%)	2 / 37 (5.41%)
occurrences all number	3	3	1	0	1	3	0	2
Pruritus
subjects affected / exposed	2 / 37 (5.41%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	3	1	0	0	0	0	0	0
Acne
subjects affected / exposed	0 / 37 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Dermatitis contact
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)	1 / 36 (2.78%)	1 / 36 (2.78%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	1	1	1	0	1
Dry skin
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Eczema
subjects affected / exposed	1 / 37 (2.70%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	1	0	0
Erythema
subjects affected / exposed	1 / 37 (2.70%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	1 / 37 (2.70%)
occurrences all number	1	1	0	0	0	0	1	1
Granuloma annulare
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	0	0	1
Hyperhidrosis
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Photosensitivity reaction
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Skin discolouration
subjects affected / exposed	1 / 37 (2.70%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Skin irritation
subjects affected / exposed	1 / 37 (2.70%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	1	1	0
Solar urticaria
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Renal and urinary disorders
Dysuria
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Musculoskeletal pain
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Neck pain
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Infections and infestations
Influenza
subjects affected / exposed	0 / 37 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	2 / 37 (5.41%)	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	2	1	0	0	0
Nasopharyngitis
subjects affected / exposed	1 / 37 (2.70%)	2 / 37 (5.41%)	2 / 36 (5.56%)	3 / 37 (8.11%)	4 / 36 (11.11%)	2 / 36 (5.56%)	2 / 36 (5.56%)	2 / 37 (5.41%)
occurrences all number	1	2	2	3	4	3	2	2
Urinary tract infection
subjects affected / exposed	1 / 37 (2.70%)	0 / 37 (0.00%)	2 / 36 (5.56%)	2 / 37 (5.41%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	2	0	2	2	0	0	0	0
Bacterial allergy
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Bronchitis
subjects affected / exposed	1 / 37 (2.70%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Conjunctivitis
subjects affected / exposed	1 / 37 (2.70%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Cystitis
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Eczema infected
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Folliculitis
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	2	0	1
Furuncle
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Gastroenteritis
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0
Gastroenteritis viral
subjects affected / exposed	0 / 37 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Gingivitis
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0
Herpes simplex
subjects affected / exposed	0 / 37 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0	1	0
Kaposi's varicelliform eruption
subjects affected / exposed	0 / 37 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Laryngitis
subjects affected / exposed	1 / 37 (2.70%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Oral herpes
subjects affected / exposed	1 / 37 (2.70%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	1	0	1	0
Pharyngitis
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0
Rhinitis
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	0	0	1
Skin infection
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Staphylococcal skin infection
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Tonsillitis
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	0	0	1
Upper respiratory tract infection
subjects affected / exposed	0 / 37 (0.00%)	1 / 37 (2.70%)	1 / 36 (2.78%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	1	1	1	0	0	0	1
Vaginal infection
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Viral infection
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	0	0	1
Viral pharyngitis
subjects affected / exposed	1 / 37 (2.70%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Viral rhinitis
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0
Viral upper respiratory tract infection
subjects affected / exposed	0 / 37 (0.00%)	0 / 37 (0.00%)	1 / 36 (2.78%)	1 / 37 (2.70%)	0 / 36 (0.00%)	1 / 36 (2.78%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	1	1	0	1	0	0

More information

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Were there any global substantial amendments to the protocol? No

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

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Clinical trials

Clinical Trial Results: A Phase 2b, Randomized, Double Blind, Vehicle Controlled, Parallel Group, Dose Ranging Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Cream Applied Once or Twice Daily for 6 Weeks in Participants With Mild or Moderate Atopic Dermatitis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation

Primary: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation

Secondary: Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Score Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( >=2) Points at Week 6: Non-responder Imputation

Secondary: Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Score Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( >=2) Points at Week 6: Non-responder Imputation

Secondary: Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation

Secondary: Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation

Secondary: Percentage of Subjects Achieving >=2 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation

Secondary: Percentage of Subjects Achieving >=2 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation

Secondary: Percentage of Subjects Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4, 6 and Follow-up Visit: Non-responder Imputation

Secondary: Percentage of Subjects Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4, 6 and Follow-up Visit: Non-responder Imputation

Secondary: Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit

Secondary: Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit

Secondary: Percentage of Subjects Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation

Secondary: Percentage of Subjects Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation

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

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

Secondary: Number of Subjects With Pre-defined Criteria For Vital Sign

Secondary: Number of Subjects With Pre-defined Criteria For Vital Sign

Secondary: Number of Subjects With Laboratory Abnormalities

Secondary: Number of Subjects With Laboratory Abnormalities

Secondary: Number of Subjects With Clinically Significant Change in Electrocardiogram (ECG) Findings

Secondary: Number of Subjects With Clinically Significant Change in Electrocardiogram (ECG) Findings

Secondary: Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

Secondary: Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

Secondary: Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

Secondary: Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

Secondary: Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

Secondary: Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

Secondary: Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

Secondary: Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

Secondary: Change From Baseline in Hematology- Hemoglobin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

Secondary: Change From Baseline in Hematology- Hemoglobin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

Secondary: Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

Secondary: Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

Secondary: Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

Secondary: Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

Secondary: Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

Secondary: Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit

Secondary: Change From Baseline in Lipids Profile Values at Week 6

Secondary: Change From Baseline in Lipids Profile Values at Week 6

Secondary: Change From Baseline in Ratio of LDL Cholesterol to HDL Cholesterol Lipids Profile at Week 6

Secondary: Change From Baseline in Ratio of LDL Cholesterol to HDL Cholesterol Lipids Profile at Week 6

Secondary: Change From Baseline in Electrocardiogram (ECG) Parameter- Heart Rate at Weeks 2 and 6

Secondary: Change From Baseline in Electrocardiogram (ECG) Parameter- Heart Rate at Weeks 2 and 6

Secondary: Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6

Secondary: Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6

Secondary: Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6

Secondary: Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6

Secondary: Change From Baseline in Vital Signs- Pulse Rate at Weeks 2 and 6

Secondary: Change From Baseline in Vital Signs- Pulse Rate at Weeks 2 and 6

Secondary: Change From Baseline in Vital Signs- Temperature at Weeks 2 and 6

Secondary: Change From Baseline in Vital Signs- Temperature at Weeks 2 and 6

Secondary: Number of Subjects With Each Severity Grade in Local Tolerability Assessments

Secondary: Number of Subjects With Each Severity Grade in Local Tolerability Assessments

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 2b, Randomized, Double Blind, Vehicle Controlled, Parallel Group, Dose Ranging Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Cream Applied Once or Twice Daily for 6 Weeks in Participants With Mild or Moderate Atopic Dermatitis