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Clinical Trial Results:
A Phase 2, Randomized, Double Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of PF-06826647 in Participants With Moderate to Severe Plaque Psoriasis

Summary
EudraCT number	2018-004669-16
Trial protocol	PL
Global end of trial date	26 Nov 2020

Results information
Results version number	v1(current)
This version publication date	22 May 2021
First version publication date	22 May 2021
Other versions

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

C2501004

ISRCTN number

US NCT number

NCT03895372

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer, Inc.

Sponsor organisation address

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

Public contact

Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc. , +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc. , +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

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

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

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

Analysis stage

Final

Date of interim/final analysis

16 Apr 2021

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

26 Nov 2020

Was the trial ended prematurely?

Main objective of the trial

This study was conducted to provide data on efficacy, safety, tolerability, and pharmacokinetics of PF-06826647 in the oral treatment of moderate to severe plaque psoriasis.

Protection of trial subjects

This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of trial subjects.

Background therapy

Evidence for comparator

Actual start date of recruitment

27 Jun 2019

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 19

Country: Number of subjects enrolled

Japan: 13

Country: Number of subjects enrolled

Poland: 99

Country: Number of subjects enrolled

United States: 47

Worldwide total number of subjects

178

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)

166

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

This study included 2 treatment periods (16-week investigational treatment period and 24-week extension treatment period) followed by a 4-week follow-up. A total of 179 subjects were enrolled and 178 subjects were treated in investigational treatment period and 153 subjects completed this period and entered the extension treatment period.

Screening details

This was a Phase 2b, randomized, double blind, placebo-controlled, parallel group, and multicenter study in subjects with moderate to severe plaque psoriasis.

Period 1 title

Investigational Treatment Period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Placebo QD->PF-06826647 200 mg QD Group

Arm description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.

Arm type

Placebo

Investigational medicinal product name

Placebo oval tablet

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

6 tablets (2 × 25 mg size placebo and 4 × 100 mg size placebo) per day.

Placebo QD->PF-06826647 400 mg QD Group

Arm description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.

Arm type

Placebo

Investigational medicinal product name

Placebo oval tablet

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

6 tablets (2 × 25 mg size placebo and 4 × 100 mg size placebo) per day.

PF-06826647 50 mg QD->PF-06826647 200 mg QD Group

Arm description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.

Arm type

Experimental

Investigational medicinal product name

PF-06826647

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

2 tablets (2 × 25 mg PF-06826647) per day.

Investigational medicinal product name

Placebo oval tablet

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 tablets (4 × 100 mg size placebo) per day.

PF-06826647 50 mg QD->PF-06826647 400 mg QD Group

Arm description

This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.

Arm type

Experimental

Investigational medicinal product name

PF-06826647

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

2 tablets (2 × 25 mg PF-06826647) per day.

Investigational medicinal product name

Placebo oval tablet

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 tablets (4 × 100 mg size placebo) per day.

PF-06826647 100 mg QD->PF-06826647 200 mg QD Group

Arm description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.

Arm type

Experimental

Investigational medicinal product name

Placebo oval tablet

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

5 tablets (2 × 25 mg size placebo and 3 × 100 mg size placebo) per day.

Investigational medicinal product name

PF-06826647

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

1 tablet (1 × 100 mg PF-06826647) per day.

PF-06826647 100 mg QD->PF-06826647 400 mg QD Group

Arm description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.

Arm type

Experimental

Investigational medicinal product name

PF-06826647

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

1 tablet (1 × 100 mg PF-06826647) per day.

Investigational medicinal product name

Placebo oval tablet

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

5 tablets (2 × 25 mg size placebo and 3 × 100 mg size placebo) per day.

PF-06826647 200 mg QD->PF-06826647 200 mg QD Group

Arm description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.

Arm type

Experimental

Investigational medicinal product name

Placebo oval tablet

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 tablets (2 × 25 mg size placebo and 2 × 100 mg size placebo) per day.

Investigational medicinal product name

PF-06826647

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

2 tablet (2 × 100 mg PF-06826647) per day.

PF-06826647 400 mg QD->PF-06826647 400 mg QD Group

Arm description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.

Arm type

Experimental

Investigational medicinal product name

PF-06826647

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 tablet (4 × 100 mg PF-06826647) per day.

Investigational medicinal product name

Placebo oval tablet

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

2 tablets (2 × 25 mg size placebo) per day.

Number of subjects in period 1	Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
Started	23	22	11	11	12	11	45	43
Completed	19	19	10	9	12	9	37	38
Not completed	4	3	1	2	0	2	8	5
Consent withdrawn by subject	2	3	1	1	-	1	3	-
Adverse event, non-fatal	1	-	-	-	-	-	4	3
Unspecified	-	-	-	-	-	1	-	2
Lost to follow-up	-	-	-	-	-	-	1	-
Lack of efficacy	1	-	-	-	-	-	-	-
Protocol deviation	-	-	-	1	-	-	-	-

Period 2 title

Extension Treatment Period

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Placebo QD->PF-06826647 200 mg QD Group

Arm description

Arm type

Experimental

Investigational medicinal product name

PF-06826647

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

2 tablets (2 × 100 mg PF-06826647) per day.

Investigational medicinal product name

Placebo oval tablet

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

2 tablets (2 × 100 mg size placebo) per day.

Placebo QD->PF-06826647 400 mg QD Group

Arm description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.

Arm type

Experimental

Investigational medicinal product name

PF-06826647

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 tablets (4 × 100 mg PF-06826647) per day.

PF-06826647 50 mg QD->PF-06826647 200 mg QD Group

Arm description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.

Arm type

Experimental

Investigational medicinal product name

Placebo oval tablet

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

2 tablets (2 × 100 mg size placebo) per day.

Investigational medicinal product name

PF-06826647

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

2 tablets (2 × 100 mg PF-06826647) per day.

PF-06826647 50 mg QD->PF-06826647 400 mg QD Group

Arm description

Arm type

Experimental

Investigational medicinal product name

PF-06826647

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 tablets (4 × 100 mg PF-06826647) per day.

PF-06826647 100 mg QD->PF-06826647 200 mg QD Group

Arm description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.

Arm type

Experimental

Investigational medicinal product name

PF-06826647

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

2 tablets (2 × 100 mg PF-06826647) per day.

Investigational medicinal product name

Placebo oval tablet

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

2 tablets (2 × 100 mg size placebo) per day.

PF-06826647 100 mg QD->PF-06826647 400 mg QD Group

Arm description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.

Arm type

Experimental

Investigational medicinal product name

PF-06826647

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 tablets (4 × 100 mg PF-06826647) per day.

PF-06826647 200 mg QD->PF-06826647 200 mg QD Group

Arm description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.

Arm type

Experimental

Investigational medicinal product name

PF-06826647

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

2 tablets (2 × 100 mg PF-06826647) per day.

Investigational medicinal product name

Placebo oval tablet

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

2 tablets (2 × 100 mg size placebo) per day.

PF-06826647 400 mg QD->PF-06826647 400 mg QD Group

Arm description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.

Arm type

Experimental

Investigational medicinal product name

PF-06826647

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 tablets (4 × 100 mg PF-06826647) per day.

Number of subjects in period 2	Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
Started	19	19	10	9	12	9	37	38
Completed	16	14	10	8	9	8	33	32
Not completed	3	5	0	1	3	1	4	6
Consent withdrawn by subject	2	1	-	-	1	1	1	1
Adverse event, non-fatal	-	1	-	1	-	-	3	3
Pregnancy	-	-	-	-	1	-	-	-
Unspecified	1	3	-	-	1	-	-	2

Baseline characteristics

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Reporting group title

Placebo QD->PF-06826647 200 mg QD Group

Reporting group description

Reporting group title

Placebo QD->PF-06826647 400 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.

Reporting group title

PF-06826647 50 mg QD->PF-06826647 200 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.

Reporting group title

PF-06826647 50 mg QD->PF-06826647 400 mg QD Group

Reporting group description

Reporting group title

PF-06826647 100 mg QD->PF-06826647 200 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.

Reporting group title

PF-06826647 100 mg QD->PF-06826647 400 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.

Reporting group title

PF-06826647 200 mg QD->PF-06826647 200 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.

Reporting group title

PF-06826647 400 mg QD->PF-06826647 400 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.

Reporting group values	Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group	Total
Number of subjects	23	22	11	11	12	11	45	43	178
Age Categorical
Units: Subjects
In utero	0	0	0	0	0	0	0	0	0
Gestational age <37 weeks	0	0	0	0	0	0	0	0	0
0-27 days	0	0	0	0	0	0	0	0	0
28 days - 23 months	0	0	0	0	0	0	0	0	0
2-11 years	0	0	0	0	0	0	0	0	0
12-17 years	0	0	0	0	0	0	0	0	0
18-64 years	21	20	11	9	12	10	43	40	166
65-84 years	2	2	0	2	0	1	2	3	12
85 years and over	0	0	0	0	0	0	0	0	0
Age Continuous
Units: Years
median (full range (min-max))	46.0 (18 to 72)	45.5 (22 to 71)	43.0 (19 to 57)	49.0 (23 to 68)	43.5 (23 to 57)	42.0 (23 to 65)	44.0 (18 to 67)	45.0 (20 to 70)	-
Sex: Female, Male
Units: Subjects
Female	7	8	2	5	3	4	19	8	56
Male	16	14	9	6	9	7	26	35	122
Race/Ethnicity, Customized
Units: Subjects
White	20	19	10	11	10	11	37	40	158
Black or African American	0	1	0	0	0	0	1	1	3
Asian	3	2	1	0	2	0	6	2	16
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	1	0	1
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	1	1	1	0	1	0	1	4	9
Not Hispanic or Latino	22	21	10	11	11	11	44	39	169

End points

Top of page

Reporting group title

Placebo QD->PF-06826647 200 mg QD Group

Reporting group description

Reporting group title

Placebo QD->PF-06826647 400 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.

Reporting group title

PF-06826647 50 mg QD->PF-06826647 200 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.

Reporting group title

PF-06826647 50 mg QD->PF-06826647 400 mg QD Group

Reporting group description

Reporting group title

PF-06826647 100 mg QD->PF-06826647 200 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.

Reporting group title

PF-06826647 100 mg QD->PF-06826647 400 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.

Reporting group title

PF-06826647 200 mg QD->PF-06826647 200 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.

Reporting group title

PF-06826647 400 mg QD->PF-06826647 400 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.

Reporting group title

Placebo QD->PF-06826647 200 mg QD Group

Reporting group description

Reporting group title

Placebo QD->PF-06826647 400 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.

Reporting group title

PF-06826647 50 mg QD->PF-06826647 200 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.

Reporting group title

PF-06826647 50 mg QD->PF-06826647 400 mg QD Group

Reporting group description

Reporting group title

PF-06826647 100 mg QD->PF-06826647 200 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.

Reporting group title

PF-06826647 100 mg QD->PF-06826647 400 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.

Reporting group title

PF-06826647 200 mg QD->PF-06826647 200 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.

Reporting group title

PF-06826647 400 mg QD->PF-06826647 400 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.

Subject analysis set title

Placebo QD Group

Subject analysis set type

Per protocol

Subject analysis set description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.

Subject analysis set title

PF-06826647 50 mg QD Group

Subject analysis set type

Per protocol

Subject analysis set description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.

Subject analysis set title

PF-06826647 100 mg QD Group

Subject analysis set type

Per protocol

Subject analysis set description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.

Subject analysis set title

PF-06826647 200 mg QD Group

Subject analysis set type

Per protocol

Subject analysis set description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.

Subject analysis set title

PF-06826647 400 mg QD Group

Subject analysis set type

Per protocol

Subject analysis set description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.

Primary: Percentage of Subjects With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period

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End point title

Percentage of Subjects With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period

End point description

The PASI quantifies the severity of a subject’s psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. The analysis population included all randomized subjects who received at least 1 dose of study drug (PF-06826647 or placebo) after non-responder imputation applied (the subjects discontinued due to coronavirus disease 2019 were removed).

End point type

Primary

End point timeframe

Baseline up to Week 16

End point values	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Number of subjects analysed	42	22	21	45	41
Units: Percentage of subjects
number (confidence interval 90%)
Week 1	0 (0.00 to 6.41)	0 (0.00 to 12.60)	0 (0.00 to 12.33)	0 (0.00 to 5.97)	0 (0.00 to 6.57)
Week 2	0 (0.00 to 6.41)	0 (0.00 to 12.60)	0 (0.00 to 12.33)	2.2 (0.23 to 9.17)	0 (0.00 to 6.57)
Week 4	0 (0.00 to 6.41)	0 (0.00 to 12.60)	0 (0.00 to 12.33)	11.1 (5.50 to 21.80)	7.3 (2.72 to 17.32)
Week 6	0 (0.00 to 6.41)	4.5 (0.48 to 19.56)	4.8 (0.50 to 20.57)	20.0 (11.72 to 31.73)	26.8 (17.12 to 39.77)
Week 8	2.4 (0.25 to 9.85)	4.5 (0.48 to 19.56)	4.8 (0.50 to 20.57)	24.4 (15.47 to 35.88)	34.1 (23.04 to 46.94)
Week 12	2.4 (0.25 to 9.85)	13.6 (5.12 to 31.13)	9.5 (2.56 to 24.50)	37.8 (25.96 to 50.95)	48.8 (35.14 to 62.56)
Week 16	4.8 (1.27 to 13.53)	13.6 (5.12 to 31.13)	9.5 (2.56 to 24.50)	37.8 (25.96 to 50.95)	51.2 (37.44 to 64.86)

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 50 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2621 ^[1]

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

8.87

Confidence interval

level

90%

sides

2-sided

lower limit

-4.5

upper limit

26.26

Notes
[1] - One-sided Hochberg p-value, significant level is 0.05.

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 100 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2621 ^[2]

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

4.76

Confidence interval

level

90%

sides

2-sided

lower limit

-7.07

upper limit

21.48

Notes
[2] - One-sided Hochberg p-value, significant level is 0.05.

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 200 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0004 ^[3]

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

33.02

Confidence interval

level

90%

sides

2-sided

lower limit

18.01

upper limit

47.11

Notes
[3] - One-sided Hochberg p-value, significant level is 0.05.

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 400 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[4]

Method

Chan and Zhang method

Parameter type

Risk difference (RD)

Point estimate

46.46

Confidence interval

level

90%

sides

2-sided

lower limit

30.62

upper limit

60.56

Notes
[4] - One-sided Hochberg p-value, significant level is 0.05.

Primary: Number of Subjects With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period

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End point title

Number of Subjects With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period ^[5]

End point description

An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. A serious AE (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. An AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time. IP=investigational product; TD=temporary discontinuation. The analysis population included all subjects who received at least 1 dose of study drug (PF-06826647 or placebo) and who entered the extension treatment period.

End point type

Primary

End point timeframe

From Week 16 to Week 40

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint.

End point values	Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
Number of subjects analysed	19	18	10	9	12	9	37	38
Units: Subjects
Subjects with AEs	11	8	7	6	7	7	24	26
Subjects with SAEs	0	1	0	0	0	1	2	0
Subjects with severe AEs	2	0	0	0	1	2	2	3
Subjects discontinued from study due to AEs	0	1	0	1	1	0	3	3
IP discontinued due to AE, subjects continue	0	0	0	0	1	0	1	0
Subjects dose reduced or TD due to AEs	0	0	1	0	0	1	4	1

No statistical analyses for this end point

Primary: Number of Subjects With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period

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End point title

Number of Subjects With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period ^[6]

End point description

Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (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. An AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time. Relatedness to study drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category. IP=investigational product; TD=temporary discontinuation. The analysis population included all subjects who received at least 1 dose of study drug (PF-06826647 or placebo) and who entered the extension treatment period.

End point type

Primary

End point timeframe

From Week 16 to Week 40

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint.

End point values	Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
Number of subjects analysed	19	18	10	9	12	9	37	38
Units: Subjects
Subjects with AEs	4	3	2	3	0	1	10	5
Subjects with SAEs	0	0	0	0	0	0	2	0
Subjects with severe AEs	0	0	0	0	0	0	1	1
Subjects discontinued from study due to AEs	0	1	0	1	0	0	2	2
IP discontinued due to AE, subjects continue	0	0	0	0	0	0	0	0
Subjects dose reduced or TD due to AEs	0	0	1	0	0	0	3	0

No statistical analyses for this end point

Primary: Number of Subjects With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period

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End point title

Number of Subjects With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period ^[7]

End point description

Following hematology parameters were analyzed for laboratory examination: hemoglobin, hematocrit, erythrocytes (Ery.), reticulocytes, Ery. mean corpuscular volume, Ery. mean corpuscular hemoglobin (MCH), Ery. mean corpuscular hemoglobin concentration (MCHC), platelets, reticulocytes/erythrocytes, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes, activated partial thromboplastin time (aPTT), prothrombin time, prothrombin international (Intl.) normalized ratio, neutrophils total count, and lymphocytes total count. The analysis population included all subjects who received at least 1 dose of study drug (PF-06826647 or placebo) and had at least 1 laboratory assessment and who entered the extension treatment period. LLN=lower limit of normal; ULN=upper limit of normal.

End point type

Primary

End point timeframe

From Week 16 to Week 40

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint.

End point values	Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
Number of subjects analysed	19	18	10	9	12	9	37	38
Units: Subjects
Hemoglobin (g/dL) <0.8*LLN	0	1	0	0	0	0	1	0
Hematocrit (%) <0.8*LLN	0	1	0	0	0	0	1	0
Erythrocytes (10^6/mm^3) <0.8*LLN	2	2	0	2	1	0	1	0
Reticulocytes (10^3/mm^3) <0.5*LLN	0	1	0	1	0	0	0	0
Reticulocytes (10^3/mm^3) >1.5*ULN	0	1	0	0	0	0	0	1
Ery. Mean Corpuscular Volume (um^3) <0.9*LLN	0	0	0	0	0	0	0	0
Ery. Mean Corpuscular Volume (um^3) <1.1*ULN	1	0	1	0	0	0	1	0
Ery. MCH (pg/cell) <0.9*LLN	0	0	0	0	0	0	0	0
Ery. MCH (pg/cell) >1.1*ULN	0	0	0	0	0	0	0	0
Ery. MCHC (g/dL) <0.9*LLN	0	0	0	0	0	0	0	0
Ery. MCHC (g/dL) >1.1*ULN	0	0	0	0	0	0	0	0
Platelets (10^3/mm^3) <0.5*LLN	0	1	0	0	0	0	0	0
Platelets (10^3/mm^3) >1.75*ULN	0	0	0	0	0	0	0	0
Reticulocytes/Erythrocytes (%) <0.5*LLN	0	1	0	0	0	0	0	0
Reticulocytes/Erythrocytes (%) >1.5*ULN	0	2	0	1	0	0	1	2
Leukocytes(10^3/mm^3) <0.6*LLN	0	0	0	0	0	0	0	0
Leukocytes(10^3/mm^3) >1.5*ULN	0	0	0	0	0	0	0	0
Lymphocytes/Leukocytes (%) <0.8*LLN	0	1	0	0	0	0	0	1
Lymphocytes/Leukocytes (%) >1.2*ULN	0	5	0	0	0	0	2	5
Neutrophils/Leukocytes (%) <0.8*LLN	1	3	0	0	0	0	1	3
Neutrophils/Leukocytes (%) >1.2*ULN	0	0	0	0	0	0	0	0
Basophils (10^3/mm^3) >1.2*ULN	0	0	0	0	0	0	0	0
Basophils/Leukocytes (%) >1.2*ULN	0	0	0	0	0	0	0	0
Eosinophils (10^3/mm^3) >1.2*ULN	0	0	0	0	0	0	0	1
Eosinophils/Leukocytes (%) >1.2*ULN	0	1	0	0	0	0	0	0
Monocytes (10^3/mm^3) >1.2*ULN	0	0	0	1	0	0	0	1
Monocytes/Leukocytes (%) >1.2*ULN	2	1	1	0	0	0	0	3
aPTT (sec) >1.1*ULN	1	0	0	1	1	0	0	0
Prothrombin Time (sec) >1.1*ULN	3	0	0	1	0	0	0	0
Prothrombin Intl. Normalized Ratio >1.1*ULN	0	0	0	0	0	0	0	0
Neutrophils total count (10^3/mm^3) <0.8*LLN	1	3	1	2	2	1	7	4
Neutrophils total count (10^3/mm^3) >1.2*ULN	0	0	0	0	0	0	1	1
Lymphocytes total count (10^3/mm^3) <0.8*LLN	0	2	0	0	0	0	1	0
Lymphocytes total count (10^3/mm^3) >1.2*ULN	0	0	0	0	0	1	1	0

No statistical analyses for this end point

Primary: Number of Subjects With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period

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End point title

Number of Subjects With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period ^[8]

End point description

Following clinical chemistry parameters were analyzed for laboratory examination: bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, urea, creatinine, urate, HDL cholesterol, LDL cholesterol, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, and cholesterol. The analysis population included all subjects who received at least 1 dose of study drug (PF-06826647 or placebo) and had at least 1 laboratory assessment and who entered the extension treatment period. LLN=lower limit of normal; ULN=upper limit of normal.

End point type

Primary

End point timeframe

From Week 16 to Week 40

Notes
[8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint.

End point values	Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
Number of subjects analysed	19	18	10	9	12	9	37	38
Units: Subjects
Bilirubin (mg/dL) >1.5*ULN	0	0	0	0	0	0	1	0
Direct Bilirubin (mg/dL) >1.5*ULN	0	0	0	0	0	0	0	0
Indirect Bilirubin (mg/dL) >1.5*ULN	0	0	0	0	0	0	0	0
Aspartate Aminotransferase (U/L) > 3.0*ULN	0	1	0	0	0	1	1	2
Alanine Aminotransferase (U/L) > 3.0*ULN	0	0	0	0	0	0	2	0
Gamma Glutamyl Transferase (U/L) > 3.0*ULN	0	0	0	0	0	0	2	0
Alkaline Phosphatase (U/L) > 3.0*ULN	0	0	0	0	0	0	0	0
Protein (g/dL) <0.8*LLN	0	0	0	0	0	0	0	0
Protein (g/dL) >1.2*ULN	0	0	0	0	0	0	0	0
Albumin (g/dL) <0.8*LLN	0	0	0	0	0	0	0	0
Albumin (g/dL) >1.2*ULN	0	0	0	0	0	0	0	0
Blood Urea Nitrogen (mg/dL) >1.3*ULN	1	0	0	0	0	0	0	0
Urea (mg/dL) >1.3*ULN	0	0	0	0	0	0	0	0
Creatinine (mg/dL) >1.3*ULN	0	1	0	0	0	0	0	1
Urate (mg/dL) >1.2*ULN	0	0	0	0	0	0	0	1
HDL Cholesterol (mg/dL) <0.8*LLN	0	0	0	0	0	0	0	0
LDL Cholesterol (mg/dL) >1.2*ULN	0	0	0	0	0	0	0	0
Triglycerides (mg/dL) >1.3*ULN	0	0	0	0	0	1	0	1
Sodium (Meq/L) <0.95*LLN	0	0	0	0	0	0	0	0
Sodium (Meq/L) >1.05*ULN	0	0	0	0	0	0	0	0
Potassium (Meq/L) <0.9*LLN	0	0	0	0	0	0	0	0
Potassium (Meq/L) >1.1*ULN	1	0	0	0	0	0	0	1
Chloride (Meq/L) <0.9*LLN	0	0	0	0	0	0	0	0
Chloride (Meq/L) >1.1*ULN	0	0	0	0	0	0	0	0
Calcium (mg/dL) <0.9*LLN	0	0	0	0	0	0	0	0
Calcium (mg/dL) >1.1*ULN	0	0	0	0	0	0	0	0
Bicarbonate (Meq/L) <0.9*LLN	0	0	0	0	0	0	0	0
Bicarbonate (Meq/L) >1.1*ULN	0	0	0	0	0	0	0	0
Glucose (mg/dL) <0.6*LLN	0	0	0	0	0	0	0	0
Glucose (mg/dL) >1.5*ULN	1	0	0	0	0	0	3	2
Creatine Kinase (U/L) >2.0*ULN	2	6	2	5	2	3	5	12
Cholesterol (mg/dL) >1.3*ULN	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Primary: Number of Subjects With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period

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End point title

Number of Subjects With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period ^[9]

End point description

Following urinalysis parameters were analyzed for laboratory examination: urine pH, urine glucose, urine ketones, urine protein, urine hemoglobin, urine urobilinogen, urine bilirubin, urine nitrite, urine leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline, and urine bacteria. The analysis population included all subjects who received at least 1 dose of study drug (PF-06826647 or placebo) and had at least 1 laboratory assessment and who entered the extension treatment period. LLN=lower limit of normal; ULN=upper limit of normal.

End point type

Primary

End point timeframe

From Week 16 to Week 40

Notes
[9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint.

End point values	Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
Number of subjects analysed	19	18	10	9	12	9	37	38
Units: Subjects
Urine pH (Scalar) <4.5	0	0	0	0	0	0	0	0
Urine pH (Scalar) >8	0	0	0	0	0	0	0	0
Urine Glucose >=1	0	0	0	0	0	0	0	1
Urine Ketones (Scalar) >=1	0	0	0	0	0	0	0	0
Urine Protein >=1	1	0	0	0	0	0	1	0
Urine Hemoglobin (Scalar) >=1	0	1	1	0	0	0	0	2
Urine Urobilinogen (EU/dL) >=1	0	0	0	0	0	0	2	0
Urine Bilirubin (Scalar) >=1	0	0	0	0	0	0	0	0
Urine Nitrite (Scalar) >=1	2	0	0	0	0	0	0	0
Urine Leukocyte Esterase (Scalar) >=1	2	1	0	1	0	1	2	0
Urine Erythrocytes (Scalar) >=20	0	0	0	0	0	0	0	0
Urine Leukocytes (/HPF) >=20	1	0	0	0	0	1	0	0
Urine Hyaline Casts (/LPF) >1	0	0	0	0	0	0	0	0
Urine Bacteria (/LPF) >20	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Primary: Number of Subjects With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period

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End point title

Number of Subjects With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period ^[10]

End point description

Criteria for ECG abnormalities: maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) >=25 percent (%) for baseline value of >200 milliseconds (msec) and Pctchg>=50% for baseline value of <=200 msec for PR interval, a maximum IFB: Pctchg>=50%, maximum QTcF interval (Fridericia’s Correction) of 450 msec to <=480 msec, 480 msec to <=500 msec and a maximum change of <30change<=60 or >60 msec from baseline. The analysis population included all subjects who received at least 1 dose of study drug (PF-06826647 or placebo) and who had at least 1 ECG assessment and who entered the extension treatment period.

End point type

Primary

End point timeframe

From Week 16 to Week 40

Notes
[10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint.

End point values	Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
Number of subjects analysed	17	17	10	9	11	8	37	36
Units: Subjects
PR interval, single beat (msec) Pctchg >=25/50%	0	0	0	0	1	0	0	0
QRS duration, singe beat (msec) Pctchg >=50%	0	0	0	0	1	0	0	0
QT interval, single beat (msec) >500	0	0	1	0	0	0	0	0
450< QTcF (msec) <=480	0	0	1	0	1	0	1	0
480< QTcF (msec) <=500	0	0	0	0	1	0	0	0
30< QTcF (msec) change <=60	1	0	0	0	2	0	3	1
QTcF (msec) change >60	0	0	0	0	1	0	0	0

No statistical analyses for this end point

Primary: Number of Subjects With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period

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End point title

Number of Subjects With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period ^[11]

End point description

The vital signs were obtained with subject in the seated position, after having sat calmly for at least 5 minutes. Criteria for vital signs abnormalities: sitting diastolic blood pressure (BP) < 50 millimeter of mercury (mmHg), sitting diastolic BP change >= 20 mmHg increase, sitting diastolic BP change >= 20 mmHg decrease, sitting systolic BP < 90 mmHg, sitting systolic BP change >= 30 mmHg increase, and sitting systolic BP change >= 30 mmHg decrease. The analysis population inluded all subjects who received at least 1 dose of inverstigaional product and who entered the extension treatment period.

End point type

Primary

End point timeframe

From Week 16 to Week 40

Notes
[11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was planned for this endpoint.

End point values	Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
Number of subjects analysed	19	18	10	9	12	9	37	38
Units: Subjects
Sitting diastolic BP (mmHg) <50	0	1	0	0	0	0	0	0
Sitting diastolic BP (mmHg) change >= 20 increase	0	1	1	0	0	0	4	4
Sitting diastolic BP (mmHg) change >= 20 decrease	1	1	0	2	0	0	3	4
Sitting systolic BP (mmHg) <90	0	0	0	0	0	0	1	0
Sitting systolic BP (mmHg) change >= 30 increase	0	0	0	1	0	2	4	5
Sitting systolic BP (mmHg) change >= 30 decrease	0	2	0	0	0	0	1	1

No statistical analyses for this end point

Secondary: Percentage of Subjects With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period

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End point title

Percentage of Subjects With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period

End point description

The PASI quantifies the severity of a subject's psoriasis based on both "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. The analysis population included all randomized subjects who received at least 1 dose of study drug (PF-06826647 or placebo) after non-responder imputation applied (the subjects discontinued due to coronavirus disease 2019 were removed).

End point type

Secondary

End point timeframe

Baseline up to Week 16

End point values	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Number of subjects analysed	42	22	21	45	41
Units: Percentage of subjects
number (confidence interval 90%)
Week 1	0 (0.00 to 6.41)	0 (0.00 to 12.60)	0 (0.00 to 12.33)	2.2 (0.23 to 9.17)	0 (0.00 to 6.57)
Week 2	4.8 (1.27 to 13.53)	0 (0 to 12.60)	0 (0 to 12.33)	8.9 (3.93 to 18.01)	2.4 (0.26 to 10.10)
Week 4	7.1 (2.56 to 17.39)	4.5 (0.48 to 19.56)	0 (0 to 12.33)	24.4 (15.47 to 35.88)	31.7 (19.88 to 44.52)
Week 6	7.1 (2.56 to 17.39)	13.6 (5.12 to 31.13)	4.8 (0.50 to 20.57)	33.3 (21.80 to 46.08)	43.9 (31.18 to 57.87)
Week 8	4.8 (1.27 to 13.53)	13.6 (5.12 to 31.13)	14.3 (5.37 to 32.81)	40.0 (28.66 to 52.89)	61.0 (46.94 to 73.77)
Week 12	9.5 (4.22 to 19.38)	13.6 (5.12 to 31.13)	9.5 (2.56 to 24.50)	51.1 (38.26 to 64.12)	70.7 (57.87 to 82.16)
Week 16	14.3 (6.41 to 25.56)	18.2 (8.17 to 35.25)	9.5 (2.56 to 24.50)	46.7 (33.79 to 59.13)	73.2 (60.23 to 82.88)

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 50 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Risk difference (RD)

Point estimate

3.9

Confidence interval

level

90%

sides

2-sided

lower limit

-11.82

upper limit

23.42

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 100 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Risk difference (RD)

Point estimate

-4.76

Confidence interval

level

90%

sides

2-sided

lower limit

-18.61

upper limit

13.29

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 200 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Risk difference (RD)

Point estimate

32.38

Confidence interval

level

90%

sides

2-sided

lower limit

14.32

upper limit

47.52

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 400 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Risk difference (RD)

Point estimate

58.89

Confidence interval

level

90%

sides

2-sided

lower limit

41.01

upper limit

72.41

Secondary: Percentage of Subjects With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear" and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period

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End point title

Percentage of Subjects With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear" and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period

End point description

The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). The analysis population included all randomized subjects who received at least 1 dose of study drug (PF-06826647 or placebo) after non-responder imputation applied (the subjects discontinued due to coronavirus disease 2019 were removed).

End point type

Secondary

End point timeframe

Baseline up to Week 16

End point values	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Number of subjects analysed	42	22	21	45	41
Units: Percentage of subjects
number (confidence interval 90%)
Week 1	2.4 (0.25 to 9.85)	0 (0.00 to 12.60)	4.8 (0.50 to 20.57)	4.4 (1.19 to 12.58)	4.9 (1.30 to 13.87)
Week 2	2.4 (0.25 to 9.85)	0 (0.00 to 12.60)	4.8 (0.50 to 20.57)	11.1 (5.50 to 21.80)	7.3 (2.72 to 17.32)
Week 4	9.5 (4.22 to 19.38)	9.1 (2.44 to 23.60)	4.8 (0.50 to 20.57)	35.6 (23.73 to 48.68)	36.6 (24.57 to 50.00)
Week 6	14.3 (6.41 to 25.56)	13.6 (5.12 to 31.13)	14.3 (5.37 to 32.81)	46.7 (33.79 to 59.13)	53.7 (39.77 to 66.11)
Week 8	14.3 (6.41 to 25.56)	18.2 (8.17 to 35.25)	14.3 (5.37 to 32.81)	44.4 (31.73 to 56.75)	63.4 (50.00 to 75.43)
Week 12	14.3 (6.41 to 25.56)	18.2 (8.17 to 35.25)	19.0 (8.58 to 37.19)	46.7 (33.79 to 59.13)	78.0 (64.86 to 87.04)
Week 16	16.7 (9.06 to 27.68)	18.2 (8.17 to 35.25)	14.3 (5.37 to 32.81)	44.4 (31.73 to 56.75)	70.7 (57.87 to 82.16)

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 50 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Risk difference (RD)

Point estimate

1.52

Confidence interval

level

90%

sides

2-sided

lower limit

-14.52

upper limit

20.77

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 100 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Risk difference (RD)

Point estimate

-2.38

Confidence interval

level

90%

sides

2-sided

lower limit

-17.67

upper limit

17.01

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 200 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Risk difference (RD)

Point estimate

27.78

Confidence interval

level

90%

sides

2-sided

lower limit

8.86

upper limit

43.26

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 400 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Risk difference (RD)

Point estimate

54.07

Confidence interval

level

90%

sides

2-sided

lower limit

36.46

upper limit

68.27

Secondary: Percentage of Subjects With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear", Up to Week 16 - Investigational Treatment Period

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End point title

Percentage of Subjects With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear", Up to Week 16 - Investigational Treatment Period

End point description

The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). The analysis population included all randomized subjects who received at least 1 dose of study drug (PF-06826647 or placebo) after non-responder imputation applied (the subjects discontinued due to coronavirus disease 2019 were removed).

End point type

Secondary

End point timeframe

Baseline up to Week 16

End point values	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Number of subjects analysed	42	22	21	45	41
Units: Percentage of subjects
number (confidence interval 90%)
Week 1	2.4 (0.25 to 9.85)	0 (0.00 to 12.60)	4.8 (0.50 to 20.57)	4.4 (1.19 to 12.58)	4.9 (1.30 to 13.87)
Week 2	2.4 (0.25 to 9.85)	0 (0.00 to 12.60)	4.8 (0.50 to 20.57)	11.1 (5.50 to 21.80)	7.3 (2.72 to 17.32)
Week 4	9.5 (4.22 to 19.38)	9.1 (2.44 to 23.60)	4.8 (0.50 to 20.57)	35.6 (23.73 to 48.68)	36.6 (24.57 to 50.00)
Week 6	14.3 (6.41 to 25.56)	13.6 (5.12 to 31.13)	14.3 (5.37 to 32.81)	46.7 (33.79 to 59.13)	53.7 (39.77 to 66.11)
Week 8	14.3 (6.41 to 25.56)	18.2 (8.17 to 35.25)	14.3 (5.37 to 32.81)	44.4 (31.73 to 56.75)	63.4 (50.00 to 75.43)
Week 12	14.3 (6.41 to 25.56)	18.2 (8.17 to 35.25)	19.0 (8.58 to 37.19)	46.7 (33.79 to 59.13)	78.0 (64.86 to 87.04)
Week 16	16.7 (9.06 to 27.68)	18.2 (8.17 to 35.25)	14.3 (5.37 to 32.81)	44.4 (31.73 to 56.75)	70.7 (57.87 to 82.16)

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 50 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Risk difference (RD)

Point estimate

1.52

Confidence interval

level

90%

sides

2-sided

lower limit

-14.52

upper limit

20.77

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 100 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Risk difference (RD)

Point estimate

-2.38

Confidence interval

level

90%

sides

2-sided

lower limit

-17.67

upper limit

17.01

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 200 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Risk difference (RD)

Point estimate

27.78

Confidence interval

level

90%

sides

2-sided

lower limit

8.86

upper limit

43.26

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 400 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Risk difference (RD)

Point estimate

54.07

Confidence interval

level

90%

sides

2-sided

lower limit

36.46

upper limit

68.27

Secondary: Percentage of Subjects With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period

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End point title

Percentage of Subjects With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period

End point description

The PASI quantifies the severity of a subject's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. The analysis population included all randomized subjects who received at least 1 dose of study drug (PF-06826647 or placebo) after non-responder imputation applied (the subjects discontinued due to coronavirus disease 2019 were removed).

End point type

Secondary

End point timeframe

Baseline up to Week 16

End point values	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Number of subjects analysed	36	20	20	38	39
Units: Percentage of subjects
number (not applicable)
Week 1 (n=42, 22, 21, 44, 40)	2.4	0	4.8	11.4	5.0
Week 2 (n=42, 22, 21, 45, 41)	7.1	13.6	4.8	28.9	22.0
Week 4 (n=40, 21, 21, 44, 40)	22.5	19.0	14.3	50.0	65.0
Week 6 (n=38, 21, 20, 44, 39)	28.9	33.3	30.0	59.1	69.2
Week 8 (n=37, 20, 20, 41, 40)	32.4	35.0	25.0	70.7	75.0
Week 12 (n=36, 20, 21, 41, 40)	38.9	45.0	38.1	73.2	92.5
Week 16 (n=36, 20, 20, 38, 39)	41.7	45.0	45.0	68.4	94.9

No statistical analyses for this end point

Secondary: Percentage of Subjects With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period

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End point title

Percentage of Subjects With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period

End point description

The PASI quantifies the severity of a subject's psoriasis based on both "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 100 response was defined as at least a 100% reduction in PASI relative to Baseline. The analysis population included all randomized subjects who received at least 1 dose of study drug (PF-06826647 or placebo) after non-responder imputation applied (the subjects discontinued due to coronavirus disease 2019 were removed).

End point type

Secondary

End point timeframe

Baseline up to Week 16

End point values	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Number of subjects analysed	36	20	20	38	39
Units: Percentage of subjects
number (not applicable)
Week 1 (n=42, 22, 21, 44, 40)	0	0	0	0	0
Week 2 (n=42, 22, 21, 45, 41)	0	0	0	2.2	0
Week 4 (n=40, 21, 21, 44, 40)	0	0	0	4.5	0
Week 6 (n=38, 21, 20, 44, 39)	0	4.8	0	9.1	7.7
Week 8 (n=37, 20, 20, 41, 40)	0	5.0	0	17.1	15.0
Week 12 (n=36, 20, 21, 41, 40)	0	5.0	4.8	12.2	22.5
Week 16 (n=36, 20, 20, 38, 39)	0	15.0	5.0	15.8	20.5

No statistical analyses for this end point

Secondary: Change From Baseline in Psoriasis Area and Severity Index (PASI) scores, Up to Week 16 - Investigational Treatment Period

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End point title

Change From Baseline in Psoriasis Area and Severity Index (PASI) scores, Up to Week 16 - Investigational Treatment Period

End point description

Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90–100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. The analysis population included all randomized subjects who received at least 1 dose of study drug (PF-06826647 or placebo) after non-responder imputation applied (the subjects discontinued due to coronavirus disease 2019 were removed).

End point type

Secondary

End point timeframe

Baseline up to Week 16

End point values	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Number of subjects analysed	36	20	20	38	39
Units: Units on a scale
least squares mean (standard error)
Week 1 (n=42, 22, 21, 44, 40)	-1.18 ( 0.697 )	-2.82 ( 0.969 )	-1.96 ( 0.984 )	-4.32 ( 0.676 )	-3.00 ( 0.708 )
Week 2 (n=42, 22, 21, 45, 41)	-3.44 ( 0.959 )	-3.83 ( 1.330 )	-3.24 ( 1.356 )	-0.804 ( 0.926 )	-7.40 ( 0.970 )
Week 4 (n=40, 21, 21, 44, 40)	-5.08 ( 1.108 )	-5.16 ( 1.528 )	-4.68 ( 1.553 )	-12.25 ( 1.065 )	-12.16 ( 1.114 )
Week 6 (n=38, 21, 20, 44, 39)	-6.02 ( 1.268 )	-6.96 ( 1.737 )	-7.53 ( 1.769 )	-14.45 ( 1.212 )	-14.78 ( 1.268 )
Week 8 (n=37, 20, 20, 41, 40)	-7.43 ( 1.333 )	-7.55 ( 1.827 )	-9.29 ( 1.847 )	-15.74 ( 1.274 )	-17.12 ( 1.324 )
Week 12 (n=36, 20, 21, 41, 40)	-8.09 ( 1.364 )	-8.58 ( 1.863 )	-10.02 ( 1.861 )	-16.79 ( 1.300 )	-19.69 ( 1.340 )
Week 16 (n=36, 20, 20, 38, 39)	-7.88 ( 1.417 )	-9.34 ( 1.932 )	-11.42 ( 1.928 )	-17.68 ( 1.354 )	-20.21 ( 1.387 )

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 50 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Least Squares Mean Difference

Point estimate

-1.46

Confidence interval

level

90%

sides

2-sided

lower limit

-5.42

upper limit

2.51

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 100 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Least Squares Mean Difference

Point estimate

-3.54

Confidence interval

level

90%

sides

2-sided

lower limit

-7.5

upper limit

0.42

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 200 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Least Squares Mean Difference

Point estimate

-9.8

Confidence interval

level

90%

sides

2-sided

lower limit

-13.05

upper limit

-6.56

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 400 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Least Squares Mean Difference

Point estimate

-12.33

Confidence interval

level

90%

sides

2-sided

lower limit

-15.61

upper limit

-9.04

Secondary: Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) scores, Up to Week 16 - Investigational Treatment Period

Top of page

End point title

Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) scores, Up to Week 16 - Investigational Treatment Period

End point description

End point type

Secondary

End point timeframe

Baseline up to Week 16

End point values	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Number of subjects analysed	36	20	20	38	39
Units: Percent change
least squares mean (standard error)
Week 1 (n=42, 22, 21, 44, 40)	-5.63 ( 2.858 )	-9.42 ( 3.975 )	-8.93 ( 4.039 )	-17.41 ( 2.774 )	-12.55 ( 2.908 )
Week 2 (n=42, 22, 21, 45, 41)	-16.18 ( 3.809 )	-14.80 ( 5.283 )	-14.37 ( 5.385 )	-33.65 ( 3.677 )	-30.58 ( 3.851 )
Week 4 (n=40, 21, 21, 44, 40)	-22.66 ( 4.437 )	-20.88 ( 6.107 )	-22.70 ( 6.205 )	-51.26 ( 4.259 )	-53.81 ( 4.449 )
Week 6 (n=38, 21, 20, 44, 39)	-27.07 ( 4.833 )	-30.25 ( 6.619 )	-33.79 ( 6.739 )	-60.63 ( 4.620 )	-64.03 ( 4.828 )
Week 8 (n=37, 20, 20, 41, 40)	-31.16 ( 4.983 )	-33.27 ( 6.831 )	-39.81 ( 6.909 )	-66.51 ( 4.763 )	-72.81 ( 4.954 )
Week 12 (n=36, 20, 21, 41, 40)	-32.66 ( 5.137 )	-37.24 ( 7.010 )	-42.25 ( 6.996 )	-70.28 ( 4.886 )	-84.17 ( 5.039 )
Week 16 (n=36, 20, 20, 38, 39)	-33.29 ( 5.369 )	-41.92 ( 7.304 )	-46.31 ( 7.271 )	-74.03 ( 5.122 )	-86.33 ( 5.236 )

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 50 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Least Squares Mean Difference

Point estimate

-8.63

Confidence interval

level

90%

sides

2-sided

lower limit

-23.61

upper limit

6.35

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 100 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Least Squares Mean Difference

Point estimate

-13.02

Confidence interval

level

90%

sides

2-sided

lower limit

-27.98

upper limit

1.94

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 200 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Least Squares Mean Difference

Point estimate

-40.74

Confidence interval

level

90%

sides

2-sided

lower limit

-53.02

upper limit

-28.46

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 400 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Least Squares Mean Difference

Point estimate

-53.04

Confidence interval

level

90%

sides

2-sided

lower limit

-65.44

upper limit

-40.63

Secondary: Change From Baseline in Peak‑Pruritus Numerical Rating Scale (PP-NRS) scores, Up to Week 16 - Investigational Treatment Period

Top of page

End point title

Change From Baseline in Peak‑Pruritus Numerical Rating Scale (PP-NRS) scores, Up to Week 16 - Investigational Treatment Period

End point description

The intensity of pruritus was assessed by a PP-NRS, an 11-category numeric rating scale from 0 to 10, which was subject reported. Subjects were asked to assess their itch over the past 24 hours, anchored by the terms “no itch” (0) and “worst itch imaginable” (10) at the ends. The analysis population included all randomized subjects who received at least 1 dose of study drug (PF-06826647 or placebo) after non-responder imputation applied (the subjects discontinued due to coronavirus disease 2019 were removed).

End point type

Secondary

End point timeframe

Baseline up to Week 16

End point values	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Number of subjects analysed	33	17	18	35	36
Units: Units on a scale
least squares mean (standard error)
Study Day 2, Week 1 (n=38, 17, 19, 41, 37)	-0.60 ( 0.238 )	0.05 ( 0.355 )	-0.64 ( 0.331 )	-0.76 ( 0.229 )	-0.41 ( 0.241 )
Study Day 3, Week 1 (n=38, 17, 20, 40, 38)	-0.71 ( 0.239 )	-0.65 ( 0.354 )	-0.90 ( 0.325 )	-0.83 ( 0.230 )	-0.88 ( 0.239 )
Study Day 4, Week 1 (n=38, 17, 19, 41, 37)	-0.76 ( 0.234 )	-0.83 ( 0.348 )	-0.89 ( 0.323 )	-1.24 ( 0.224 )	-1.04 ( 0.236 )
Study Day 5, Week 1 (n=38, 16, 18, 41, 35)	-0.63 ( 0.233 )	-0.91 ( 0.348 )	-1.12 ( 0.324 )	-1.26 ( 0.223 )	-1.08 ( 0.237 )
Study Day 6, Week 1 (n=38, 17, 19, 41, 34)	-0.82 ( 0.246 )	-0.94 ( 0.362 )	-0.81 ( 0.336 )	-1.49 ( 0.235 )	-1.34 ( 0.250 )
Study Day 7, Week 1 (n=37, 17, 18, 38, 37)	-0.72 ( 0.272 )	-1.11 ( 0.399 )	-0.86 ( 0.372 )	-1.75 ( 0.261 )	-1.11 ( 0.273 )
Study Day 8, Week 1 (n=37, 16, 20, 42, 37)	-0.83 ( 0.274 )	-1.26 ( 0.403 )	-0.92 ( 0.371 )	-1.65 ( 0.261 )	-1.21 ( 0.276 )
Study Day 9, Week 1 (n=37, 17, 18, 39, 37)	-0.79 ( 0.289 )	-1.32 ( 0.425 )	-1.08 ( 0.394 )	-1.50 ( 0.278 )	-1.43 ( 0.292 )
Study Day 10, Week 1 (n=37, 16, 20, 40, 36)	-0.85 ( 0.284 )	-1.48 ( 0.420 )	-1.01 ( 0.384 )	-1.63 ( 0.272 )	-1.46 ( 0.286 )
Study Day 11, Week 1 (n=33, 15, 19, 37, 36)	-0.70 ( 0.291 )	-1.55 ( 0.429 )	-1.11 ( 0.392 )	-1.67 ( 0.278 )	-1.27 ( 0.291 )
Study Day 12, Week 2 (n=32, 16, 18, 38, 35)	-0.63 ( 0.289 )	-1.67 ( 0.424 )	-0.92 ( 0.390 )	-1.93 ( 0.275 )	-1.39 ( 0.289 )
Study Day 13, Week 2 (n=34, 16, 19, 41, 33)	-0.78 ( 0.294 )	-1.49 ( 0.433 )	-1.15 ( 0.397 )	-2.18 ( 0.280 )	-1.61 ( 0.296 )
Study Day 14, Week 2 (n=34, 17, 20, 38, 36)	-0.82 ( 0.317 )	-1.66 ( 0.464 )	-1.21 ( 0.426 )	-2.15 ( 0.302 )	-1.81 ( 0.317 )
Study Day 15, Week 2 (n=36, 16, 19, 40, 38)	-0.75 ( 0.308 )	-1.48 ( 0.454 )	-1.18 ( 0.417 )	-2.20 ( 0.294 )	-1.83 ( 0.309 )
Study Day 16, Week 2 (n=34, 16, 18, 37, 37)	-0.73 ( 0.314 )	-1.52 ( 0.462 )	-1.13 ( 0.426 )	-2.29 ( 0.301 )	-1.80 ( 0.314 )
Week 4 (n=36, 17, 20, 41, 37)	-0.54 ( 0.354 )	-1.74 ( 0.517 )	-1.64 ( 0.477 )	-2.90 ( 0.337 )	-2.57 ( 0.354 )
Week 8 (n=34, 17, 20, 37, 38)	-1.24 ( 0.391 )	-1.10 ( 0.561 )	-1.93 ( 0.517 )	-4.10 ( 0.374 )	-4.12 ( 0.381 )
Week 12 (n=34, 17, 20, 38, 37)	-0.84 ( 0.455 )	-1.66 ( 0.651 )	-2.18 ( 0.599 )	-3.92 ( 0.433 )	-4.27 ( 0.442 )
Week 16 (n=33, 17, 18, 35, 36)	-0.93 ( 0.453 )	-2.15 ( 0.645 )	-2.14 ( 0.604 )	-4.40 ( 0.435 )	-4.59 ( 0.440 )

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 50 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Least Squares Mean Difference

Point estimate

-1.22

Confidence interval

level

90%

sides

2-sided

lower limit

-2.52

upper limit

0.09

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 100 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Least Squares Mean Difference

Point estimate

-1.21

Confidence interval

level

90%

sides

2-sided

lower limit

-2.46

upper limit

0.05

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 200 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Least Squares Mean Difference

Point estimate

-3.47

Confidence interval

level

90%

sides

2-sided

lower limit

-4.51

upper limit

-2.43

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 400 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Least Squares Mean Difference

Point estimate

-3.66

Confidence interval

level

90%

sides

2-sided

lower limit

-4.71

upper limit

-2.61

Secondary: Percentage of Subjects Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, at Week 16 - Investigational Treatment Period

Top of page

End point title

Percentage of Subjects Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, at Week 16 - Investigational Treatment Period

End point description

The Psoriasis Symptom Inventory (PSI) is a self administered 8-item questionnaire that measures the severity of psoriasis symptoms over the past 24 hours and the past 7 days. The measure includes concepts of itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Subjects were asked to respond to each item using a 5-point Likert response scale: 0: not all severe, 1: mild, 2: moderate, 3: severe and 4: very severe. The analysis population included all randomized subjects who received at least 1 dose of study drug (PF-06826647 or placebo) after non-responder imputation applied (the subjects discontinued due to coronavirus disease 2019 were removed).

End point type

Secondary

End point timeframe

Baseline up to Week 16

End point values	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Number of subjects analysed	42	22	21	45	41
Units: Percentage of subjects
number (confidence interval 90%)
Study Day 2, Week 1	7.1 (2.65 to 17.39)	0 (0.00 to 12.60)	4.8 (0.50 to 20.57)	6.7 (2.47 to 16.17)	12.2 (6.05 to 23.04)
Study Day 3, Week 1	7.1 (2.65 to 17.39)	0 (0.00 to 12.60)	19.0 (8.58 to 37.19)	6.7 (2.47 to 16.17)	12.2 (6.05 to 23.04)
Study Day 4, Week 1	9.5 (4.22 to 19.38)	4.5 (0.48 to 19.56)	14.3 (5.37 to 32.81)	13.3 (5.97 to 23.73)	14.6 (6.57 to 26.23)
Study Day 5, Week 1	7.1 (2.65 to 17.39)	9.1 (2.44 to 23.60)	14.3 (5.37 to 32.81)	15.6 (8.42 to 25.96)	19.5 (10.10 to 31.18)
Study Day 6, Week 1	4.8 (1.27 to 13.53)	13.6 (5.12 to 31.13)	19.0 (8.58 to 37.19)	20.0 (11.72 to 31.73)	19.5 (10.10 to 31.18)
Study Day 7, Week 1	9.5 (4.22 to 19.38)	9.1 (2.44 to 23.60)	19.0 (8.58 to 37.19)	17.8 (9.17 to 29.70)	19.5 (10.10 to 31.18)
Study Day 8, Week 1	11.9 (5.91 to 22.74)	9.1 (2.44 to 23.60)	14.3 (5.37 to 32.81)	20.0 (11.72 to 31.73)	19.5 (10.10 to 31.18)
Study Day 9, Week 1	9.5 (4.22 to 19.38)	9.1 (2.44 to 23.60)	9.5 (2.56 to 24.50)	20.0 (11.72 to 31.73)	22.0 (12.96 to 35.14)
Study Day 10, Week 1	11.9 (5.91 to 22.74)	4.5 (0.48 to 19.56)	19.0 (8.58 to 37.19)	24.4 (15.47 to 35.88)	19.5 (10.10 to 31.18)
Study Day 11, Week 1	9.5 (4.22 to 19.38)	4.5 (0.48 to 19.56)	19.0 (8.58 to 37.19)	20.0 (11.72 to 31.73)	26.8 (17.12 to 39.77)
Study Day 12, Week 2	4.8 (1.27 to 13.53)	4.5 (0.48 to 19.56)	19.0 (8.58 to 37.19)	22.2 (12.58 to 33.79)	29.3 (17.84 to 42.13)
Study Day 13, Week 2	11.9 (5.91 to 22.74)	18.2 (8.17 to 35.25)	14.3 (5.37 to 32.81)	40.0 (28.66 to 52.89)	26.8 (17.12 to 39.77)
Study Day 14, Week 2	11.9 (5.91 to 22.74)	22.7 (11.49 to 39.52)	14.3 (5.37 to 32.81)	33.3 (21.80 to 46.08)	34.1 (23.04 to 46.94)
Study Day 15, Week 2	4.8 (1.27 to 13.53)	9.1 (2.44 to 23.60)	14.3 (5.37 to 32.81)	33.3 (21.80 to 46.08)	29.3 (17.84 to 42.13)
Study Day 16, Week 2	14.3 (6.41 to 25.56)	13.6 (5.12 to 31.13)	9.5 (2.56 to 24.50)	24.4 (15.47 to 35.88)	39.0 (26.23 to 53.06)
Week 4	14.3 (6.41 to 25.56)	13.6 (5.12 to 31.13)	28.6 (13.24 to 46.41)	44.4 (31.73 to 56.75)	43.9 (31.18 to 57.87)
Week 8	11.9 (5.91 to 22.74)	22.7 (11.49 to 39.52)	23.8 (12.06 to 41.72)	53.3 (40.87 to 66.21)	63.4 (50.00 to 75.43)
Week 12	7.1 (2.65 to 17.39)	31.8 (18.11 to 50.00)	28.6 (13.24 to 46.41)	55.6 (43.25 to 68.27)	63.4 (50.00 to 75.43)
Week 16	14.3 (6.41 to 25.56)	27.3 (12.60 to 44.36)	38.1 (20.57 to 58.28)	55.6 (43.25 to 68.27)	63.4 (50.00 to 75.43)

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 50 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Risk difference (RD)

Point estimate

12.99

Confidence interval

level

90%

sides

2-sided

lower limit

-4.52

upper limit

32.87

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 100 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Risk difference (RD)

Point estimate

23.81

Confidence interval

level

90%

sides

2-sided

lower limit

2.62

upper limit

44.64

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 200 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Risk difference (RD)

Point estimate

41.27

Confidence interval

level

90%

sides

2-sided

lower limit

23.47

upper limit

56.18

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 400 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Risk difference (RD)

Point estimate

49.13

Confidence interval

level

90%

sides

2-sided

lower limit

30.62

upper limit

63.69

Secondary: Change From Baseline in Psoriasis Symptom Inventory (PSI), Up to Week 16 - Investigational Treatment Period

Top of page

End point title

Change From Baseline in Psoriasis Symptom Inventory (PSI), Up to Week 16 - Investigational Treatment Period

End point description

End point type

Secondary

End point timeframe

Baseline up to Week 16

End point values	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Number of subjects analysed	33	17	18	35	37
Units: Units on a scale
least squares mean (standard error)
Study Day 2, Week 1 (n=38, 18, 19, 42, 37)	-1.51 ( 0.636 )	-0.89 ( 0.927 )	-1.98 ( 0.880 )	-2.54 ( 0.605 )	-1.25 ( 0.639 )
Study Day 3, Week 1 (n=38, 18, 21, 41, 38)	-2.70 ( 0.653 )	-1.95 ( 0.952 )	-3.65 ( 0.879 )	-3.45 ( 0.624 )	-2.79 ( 0.650 )
Study Day 4, Week 1 (n=38, 17, 19, 41, 37)	-2.88 ( 0.666 )	-3.05 ( 0.985 )	-3.95 ( 0.915 )	-4.61 ( 0.637 )	-4.28 ( 0.665 )
Study Day 5, Week 1 (n=38, 16, 18, 41, 35)	-2.55 ( 0.692 )	-3.18 ( 1.032 )	-3.87 ( 0.959 )	-5.40 ( 0.661 )	-3.93 ( 0.696 )
Study Day 6, Week 1 (n=38, 17, 19, 41, 35)	-3.01 ( 0.716 )	-3.98 ( 1.058 )	-3.94 ( 0.981 )	-5.43 ( 0.684 )	-4.77 ( 0.717 )
Study Day 7, Week 1 (n=37, 17, 18, 38, 38)	-3.23 ( 0.770 )	-4.34 ( 1.134 )	-4.08 ( 1.059 )	-6.42 ( 0.740 )	-4.90 ( 0.763 )
Study Day 8, Week 1 (n=37, 16, 20, 42, 38)	-3.27 ( 0.768 )	-4.38 ( 1.137 )	-4.65 ( 1.042 )	-6.23 ( 0.731 )	-5.67 ( 0.762 )
Study Day 9, Week 1 (n=37, 17, 18, 39, 38)	-3.11 ( 0.788 )	-3.95 ( 1.159 )	-4.54 ( 1.078 )	-5.71 ( 0.756 )	-5.70 ( 0.782 )
Study Day 10, Week 1 (n=37, 17, 20, 40, 37)	-3.29 ( 0.781 )	-4.24 ( 1.150 )	-4.15 ( 1.055 )	-6.22 ( 0.747 )	-6.02 ( 0.776 )
Study Day 11, Week 1 (n=33, 15, 19, 37, 37)	-2.89 ( 0.825 )	-4.72 ( 1.216 )	-4.41 ( 1.111 )	-7.06 ( 0.787 )	-6.03 ( 0.812 )
Study Day 12, Week 2 (n=32, 16, 19, 38, 36)	-3.04 ( 0.763 )	-4.54 ( 1.118 )	-4.65 ( 1.027 )	-7.10 ( 0.726 )	-6.62 ( 0.753 )
Study Day 13, Week 2 (n=34, 16, 19, 41, 34)	-2.94 ( 0.781 )	-5.61 ( 1.149 )	-4.79 ( 1.055 )	-7.94 ( 0.742 )	-7.16 ( 0.776 )
Study Day 14, Week 2 (n=34, 17, 21, 38, 37)	-3.25 ( 0.793 )	-5.84 ( 1.162 )	-5.22 ( 1.065 )	-8.12 ( 0.757 )	-7.09 ( 0.784 )
Study Day 15, Week 2 (n=36, 16, 20, 40, 39)	-2.71 ( 0.830 )	-4.98 ( 1.227 )	-5.23 ( 1.123 )	-7.84 ( 0.793 )	-7.47 ( 0.821 )
Study Day 16, Week 2 (n=34, 16, 18, 37, 38)	-3.27 ( 0.847 )	-5.03 ( 1.250 )	-4.83 ( 1.150 )	-8.12 ( 0.810 )	-7.45 ( 0.836 )
Week 4 (n=36, 17, 20, 41, 38)	-2.53 ( 0.990 )	-4.83 ( 1.449 )	-6.58 ( 1.338 )	-9.14 ( 0.943 )	-9.02 ( 0.978 )
Week 8 (n=34, 17, 20, 37, 39)	-3.45 ( 1.069 )	-4.09 ( 1.536 )	-7.30 ( 1.407 )	-11.63 ( 1.022 )	-12.19 ( 1.026 )
Week 12 (n=34, 17, 20, 38, 38)	-2.27 ( 1.208 )	-5.65 ( 1.722 )	-7.35 ( 1.572 )	-11.50 ( 1.146 )	-13.42 ( 1.145 )
Week 16 (n=33, 17, 18, 35, 37)	-1.87 ( 1.260 )	-6.07 ( 1.782 )	-8.31 ( 1.661 )	-12.38 ( 1.205 )	-12.68 ( 1.191 )

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 50 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Least Squares Mean Difference

Point estimate

-4.21

Confidence interval

level

90%

sides

2-sided

lower limit

-7.82

upper limit

-0.59

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 100 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Least Squares Mean Difference

Point estimate

-6.44

Confidence interval

level

90%

sides

2-sided

lower limit

-9.89

upper limit

-2.99

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 200 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Least Squares Mean Difference

Point estimate

-10.51

Confidence interval

level

90%

sides

2-sided

lower limit

-13.4

upper limit

-7.62

Difference from Placebo QD at Week 16

Comparison groups

Placebo QD Group v PF-06826647 400 mg QD Group

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Least Squares Mean Difference

Point estimate

-10.81

Confidence interval

level

90%

sides

2-sided

lower limit

-13.68

upper limit

-7.94

Secondary: Number of Subjects With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period

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End point title

Number of Subjects With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period

End point description

End point type

Secondary

End point timeframe

Baseline up to Week 16

End point values	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Number of subjects analysed	45	22	23	45	43
Units: Subjects
Subjects with AEs	23	13	16	28	29
Subjects with SAEs	0	1	0	1	0
Subjects with severe AEs	1	0	1	2	3
Subjects discontinued from study due to AEs	1	0	0	5	3
IP discontinued due to AE, subjects continue	0	0	0	1	0
Subjects dose reduced or TD due to AEs	1	1	2	3	3

No statistical analyses for this end point

Secondary: Number of Subjects With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period

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End point title

Number of Subjects With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period

End point description

Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (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. An AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time. Relatedness to investigational product was assessed by the investigator. Subjects with multiple occurrences of an AE within a category were counted once within the category. IP=investigational product; TD=temporary discontinuation. The analysis population included all subjects who received at least 1 dose of study drug (PF-06826647 or placebo).

End point type

Secondary

End point timeframe

Baseline up to Week 16

End point values	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Number of subjects analysed	45	22	23	45	43
Units: Subjects
Subjects with AEs	4	0	4	11	8
Subjects with SAEs	0	0	0	1	0
Subjects with severe AEs	0	0	0	2	1
Subjects discontinued from study due to AEs	0	0	0	4	3
IP discontinued due to AE, subjects continue	0	0	0	1	0
Subjects dose reduced or TD due to AEs	0	0	0	1	1

No statistical analyses for this end point

Secondary: Number of Subjects With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period

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End point title

Number of Subjects With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period

End point description

Criteria for ECG abnormalities: maximum PR interval >=300 milliseconds (msec) and maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) >=25 percent (%) for baseline value of >200 msec and Pctchg>=50% for baseline value of <=200 msec for PR interval, maximum QRS interval >=140 msec and a maximum IFB: Pctchg>=50%, maximum QTcF interval (Fridericia’s Correction) of 450 msec to <=480 msec, 480 msec to <=500 msec and a maximum change of <30change<=60 or >60 msec from baseline. The analysis population included all subjects who received at least 1 dose of study drug (PF-06826647 or placebo) and who had at least 1 ECG assessment.

End point type

Secondary

End point timeframe

Baseline up to Week 16

End point values	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Number of subjects analysed	44	22	23	44	43
Units: Subjects
PR interval, single beat (msec) >=300	1	0	0	0	0
PR interval, single beat (msec) Pctchg >=25/50%	0	0	2	1	0
QRS duration, single beat (msec) >=140	1	0	0	0	0
QRS duration, single beat (msec) Pctchg >=50%	1	0	1	0	0
450< QTcF (msec) <=480	1	0	2	2	0
480< QTcF (msec) <=500	1	0	0	0	0
30< QTcF (msec) change <=60	0	1	1	1	2
QTcF (msec) change >60	1	0	1	0	0

No statistical analyses for this end point

Secondary: Number of Subjects With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period

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End point title

Number of Subjects With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period

End point description

The vital signs were obtained with subject in the seated position, after having sat calmly for at least 5 minutes. Criteria for vital signs abnormalities: pulse rate >120 beats per minute (BPM), sitting diastolic blood pressure (BP) change >=20 millimeter of mercury (mmHg) increase, sitting diastolic BP change >=20 mmHg decrease, sitting systolic BP <90 mmHg, sitting systolic BP change >=30 mmHg increase, and sitting systolic BP change >=30 mmHg decrease. The analysis population included all subjects who received at least 1 dose of study drug (PF-06826647 or placebo).

End point type

Secondary

End point timeframe

Baseline up to Week 16.

End point values	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Number of subjects analysed	45	22	23	45	43
Units: Subjects
Pulse rate (BMP) >120	0	0	0	0	1
Sitting diastolic BP (mmHg) change >=20 increase	4	3	1	4	4
Sitting diastolic BP (mmHg) change >=20 decrease	4	2	0	2	4
Sitting systolic BP (mmHg) <90 increase	0	0	0	0	1
Sitting systolic BP (mmHg) change >=30 increase	0	1	2	2	2
Sitting systolic BP (mmHg) change >=30 decrease	4	0	1	1	2

No statistical analyses for this end point

Secondary: Number of Subjects With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period

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End point title

Number of Subjects With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period

End point description

Following hematology parameters were analyzed for laboratory examination: hemoglobin, hematocrit, erythrocytes (Ery.), reticulocytes, Ery. mean corpuscular volume, Ery. mean corpuscular hemoglobin (MCH), Ery. mean corpuscular hemoglobin concentration (MCHC), platelets, reticulocytes/erythrocytes, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes, activated partial thromboplastin time (aPTT), prothrombin time, neutrophils total count, and lymphocytes total count. The analysis population included all subjects who received at least 1 dose of study drug (PF-06826647 or placebo) and had at least 1 laboratory assessment. ULN=upper limit of normal; LLN=lower limit of normal.

End point type

Secondary

End point timeframe

Baseline up to Week 16

End point values	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Number of subjects analysed	45	22	23	45	43
Units: Subjects
Hemoglobin (g/dL) <0.8*LLN	0	0	0	2	3
Hematocrit (%) <0.8*LLN	0	0	0	2	3
Erythrocytes (10^6/mm^3) <0.8*LLN	0	0	0	1	4
Reticulocytes (10^3/mm^3) <0.5*LLN	0	0	0	0	2
Reticulocytes (10^3/mm^3) >1.5*ULN	0	0	0	0	2
Ery. Mean Corpuscular Volume (um^3) <0.9*LLN	0	0	0	0	0
Ery. Mean Corpuscular Volume (um^3) >1.1*ULN	0	0	0	0	1
Ery. MCH (pg/cell) <0.9*LLN	0	0	0	0	0
Ery. MCH (pg/cell) >1.1*ULN	0	0	0	0	0
Ery. MCHC (g/dL) <0.9*LLN	0	0	0	0	0
Ery. MCHC (g/dL) >1.1*ULN	0	0	0	0	0
Platelets (10^3/mm^3) <0.5*LLN	0	0	0	0	1
Platelets (10^3/mm^3) >1.75*ULN	0	0	0	0	0
Reticulocytes/Erythrocytes (%) <0.5*LLN	0	0	0	0	2
Reticulocytes/Erythrocytes (%) >1.5*ULN	0	0	0	1	2
Leukocytes(10^3/mm^3) <0.6*LLN	0	0	0	1	1
Leukocytes(10^3/mm^3) >1.5*ULN	0	0	0	0	0
Lymphocytes/Leukocytes (%) <0.8*LLN	0	1	0	1	3
Lymphocytes/Leukocytes (%) >1.2*ULN	0	0	0	3	4
Neutrophils/Leukocytes (%) <0.8* LLN	1	0	0	2	2
Neutrophils/Leukocytes (%) >1.2*ULN	0	0	0	0	0
Basophils (10^3/mm^3) >1.2*ULN	0	0	0	1	0
Basophils/Leukocytes (%) >1.2*ULN	2	1	1	1	1
Eosinophils (10^3/mm^3) >1.2*ULN	1	1	0	0	0
Eosinophils/Leukocytes (%) >1.2*ULN	2	1	0	0	0
Monocytes (10^3/mm^3) >1.2*ULN	1	0	1	0	0
Monocytes/Leukocytes (%) >1.2*ULN	2	0	0	1	0
aPTT (sec) >1.1*ULN	1	0	0	0	1
Prothrombin Time (sec) >1.1*ULN	1	0	0	0	3
Neutrophils total count (10^3/mm^3) <0.8*LLN	1	0	2	3	4
Neutrophils total count (10^3/mm^3) >1.2*ULN	3	1	1	2	2
Lymphocytes total count (10^3/mm^3) <0.8*LLN	0	0	0	1	1
Lymphocytes total count (10^3/mm^3) >1.2*ULN	0	0	1	1	1

No statistical analyses for this end point

Secondary: Number of Subjects With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period

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End point title

Number of Subjects With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period

End point description

Following clinical chemistry parameters were analyzed for laboratory examination: bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, urea, creatinine, urate, HDL cholesterol, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, and cholesterol. The analysis population included all subjects who received at least 1 dose of study drug (PF-06826647 or placebo) and had at least 1 laboratory assessment. ULN=upper limit of normal; LLN=lower limit of normal.

End point type

Secondary

End point timeframe

Baseline up to Week 16

End point values	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Number of subjects analysed	45	22	23	45	43
Units: Subjects
Bilirubin (mg/dL) >1.5*ULN	0	0	0	0	0
Indirect Bilirubin (mg/dL) >1.5*ULN	0	0	0	0	0
Aspartate Aminotransferase (U/L) > 3.0*ULN	1	0	1	0	0
Alanine Aminotransferase (U/L) > 3.0*ULN	1	0	0	0	0
Gamma Glutamyl Transferase (U/L) > 3.0*ULN	0	0	0	0	0
Alkaline Phosphatase (U/L) > 3.0*ULN	0	0	0	0	0
Protein (g/dL) <0.8*LLN	0	0	0	0	0
Protein (g/dL) >1.2*ULN	0	0	0	0	0
Albumin (g/dL) <0.8*LLN	0	0	0	0	0
Albumin (g/dL) >1.2*ULN	0	0	0	0	0
Blood Urea Nitrogen (mg/dL) >1.3*ULN	1	0	0	2	0
Urea (mg/dL) >1.3*ULN	0	0	0	0	0
Creatinine (mg/dL) >1.3*ULN	0	0	0	1	1
Urate (mg/dL) >1.2*ULN	0	0	0	0	0
HDL Cholesterol (mg/dL) <0.8*LLN	0	0	0	0	0
Triglycerides (mg/dL) >1.3*ULN	1	0	0	0	3
Sodium (Meq/L) <0.95*LLN	0	0	0	0	0
Sodium (Meq/L) >1.05*ULN	0	0	0	0	0
Potassium (Meq/L) <0.9*LLN	0	0	0	0	0
Potassium (Meq/L) >1.1*ULN	1	0	1	0	0
Chloride (Meq/L) <0.9*LLN	0	0	0	0	0
Chloride (Meq/L) >1.1*ULN	0	0	0	0	0
Calcium (mg/dL) <0.9*LLN	0	0	0	0	0
Calcium (mg/dL) >1.1*ULN	0	0	0	0	0
Bicarbonate (Meq/L) <0.9*LLN	0	0	1	0	0
Bicarbonate (Meq/L) >1.1*ULN	0	0	0	0	0
Glucose (mg/dL) <0.6*LLN	0	0	0	0	0
Glucose (mg/dL) >1.5*ULN	1	0	0	0	1
Creatine Kinase (U/L) >2.0*ULN	3	3	2	9	15
Cholesterol (mg/dL) >1.3*ULN	0	0	0	0	0

No statistical analyses for this end point

Secondary: Number of Subjects With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period

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End point title

Number of Subjects With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period

End point description

End point type

Secondary

End point timeframe

Baseline up to Week 16

End point values	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Number of subjects analysed	45	22	23	45	43
Units: Subjects
Urine pH (Scalar) <4.5	0	0	0	0	0
Urine pH (Scalar) >8	0	0	0	0	0
Urine Glucose >=1	0	0	0	1	1
Urine Ketones (Scalar) >=1	2	0	1	0	2
Urine Protein >=1	1	0	0	1	2
Urine Hemoglobin (Scalar) >=1	3	1	0	4	0
Urine Urobilinogen (EU/dL) >=1	1	0	0	1	2
Urine Bilirubin (Scalar) >=1	0	0	0	0	0
Urine Nitrite (Scalar) >=1	0	1	0	0	0
Urine Leukocyte Esterase (Scalar) >=1	1	2	0	1	0
Urine Erythrocytes (Scalar) >=20	1	0	0	1	0
Urine Leukocytes (/HPF) >=20	1	0	0	0	0
Urine Hyaline Casts (/LPF) >1	1	1	0	3	1
Urine Bacteria (/LPF) >20	0	0	0	0	0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280.

Adverse event reporting additional description

Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section End Points, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

23.1

Reporting group title

Placebo QD->PF-06826647 200 mg QD Group

Reporting group description

Reporting group title

Placebo QD->PF-06826647 400 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.

Reporting group title

PF-06826647 50 mg QD->PF-06826647 200 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.

Reporting group title

PF-06826647 50 mg QD->PF-06826647 400 mg QD Group

Reporting group description

Reporting group title

PF-06826647 100 mg QD->PF-06826647 200 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.

Reporting group title

PF-06826647 100 mg QD->PF-06826647 400 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.

Reporting group title

PF-06826647 200 mg QD->PF-06826647 200 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.

Reporting group title

PF-06826647 400 mg QD->PF-06826647 400 mg QD Group

Reporting group description

This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled subjects entered the investigational treatment period first and then the subjects who completed the investigational treatment period entered the extension treatment period. The subjects in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.

Serious adverse events	Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 23 (0.00%)	1 / 22 (4.55%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	1 / 11 (9.09%)	3 / 45 (6.67%)	0 / 43 (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
Investigations
Fibrin D dimer increased
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
SARS-CoV-2 test positive
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	1 / 45 (2.22%)	0 / 43 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Hypertension
subjects affected / exposed	0 / 23 (0.00%)	1 / 22 (4.55%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 45 (2.22%)	0 / 43 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Presyncope
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Chest pain
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 45 (2.22%)	0 / 43 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Hypoacusis
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Viral sepsis
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
Total subjects affected by non serious adverse events
subjects affected / exposed	14 / 23 (60.87%)	11 / 22 (50.00%)	10 / 11 (90.91%)	8 / 11 (72.73%)	9 / 12 (75.00%)	9 / 11 (81.82%)	29 / 45 (64.44%)	32 / 43 (74.42%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Vascular disorders
Hypertension
subjects affected / exposed	1 / 23 (4.35%)	1 / 22 (4.55%)	0 / 11 (0.00%)	1 / 11 (9.09%)	1 / 12 (8.33%)	0 / 11 (0.00%)	2 / 45 (4.44%)	5 / 43 (11.63%)
occurrences all number	1	1	0	1	1	0	2	5
Pregnancy, puerperium and perinatal conditions
Pregnancy
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Fatigue
subjects affected / exposed	0 / 23 (0.00%)	1 / 22 (4.55%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	2 / 45 (4.44%)	2 / 43 (4.65%)
occurrences all number	0	1	0	0	0	1	2	2
Feeling hot
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Oedema peripheral
subjects affected / exposed	0 / 23 (0.00%)	1 / 22 (4.55%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	1	1	0	0	0	0	0
Peripheral swelling
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Pyrexia
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Vessel puncture site bruise
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	1 / 45 (2.22%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	2	0	1	0
Epistaxis
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0
Nasal mucosal hypertrophy
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Nasal polyps
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0
Nasal septum deviation
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0
Psychiatric disorders
Depression
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0
Investigations
Activated partial thromboplastin time prolonged
subjects affected / exposed	1 / 23 (4.35%)	0 / 22 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	1	0	1	0	0	0	0	0
Alanine aminotransferase increased
subjects affected / exposed	1 / 23 (4.35%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	2 / 45 (4.44%)	3 / 43 (6.98%)
occurrences all number	1	0	0	0	0	0	2	3
Aspartate aminotransferase increased
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	2 / 43 (4.65%)
occurrences all number	0	0	0	0	0	2	0	2
Blood creatine phosphokinase increased
subjects affected / exposed	1 / 23 (4.35%)	1 / 22 (4.55%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	5 / 45 (11.11%)	6 / 43 (13.95%)
occurrences all number	1	1	0	0	0	1	8	13
Blood pressure diastolic increased
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Blood pressure increased
subjects affected / exposed	1 / 23 (4.35%)	0 / 22 (0.00%)	1 / 11 (9.09%)	1 / 11 (9.09%)	1 / 12 (8.33%)	2 / 11 (18.18%)	4 / 45 (8.89%)	4 / 43 (9.30%)
occurrences all number	1	0	4	1	1	3	8	4
Gamma-glutamyltransferase increased
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 45 (0.00%)	3 / 43 (6.98%)
occurrences all number	0	0	0	0	0	0	0	3
Prothrombin time prolonged
subjects affected / exposed	1 / 23 (4.35%)	0 / 22 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	1	0	1	0	0	0	0	0
SARS-CoV-2 test positive
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	2 / 45 (4.44%)	0 / 43 (0.00%)
occurrences all number	0	0	1	0	0	0	3	0
Serum ferritin increased
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Transaminases increased
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Injury, poisoning and procedural complications
Contusion
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	2 / 11 (18.18%)	1 / 45 (2.22%)	3 / 43 (6.98%)
occurrences all number	0	0	0	0	0	2	1	3
Diffuse axonal injury
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Hand fracture
subjects affected / exposed	0 / 23 (0.00%)	1 / 22 (4.55%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	1	0	0	0	1	0	0
Ligament sprain
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Road traffic accident
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Skin laceration
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	1	0	0	1	0	0
Cardiac disorders
Atrial fibrillation
subjects affected / exposed	1 / 23 (4.35%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	1	0	0	0	1	0	0	0
Nervous system disorders
Circadian rhythm sleep disorder
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Dysgeusia
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	1 / 45 (2.22%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	1	0	1	0
Headache
subjects affected / exposed	2 / 23 (8.70%)	1 / 22 (4.55%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	2 / 45 (4.44%)	6 / 43 (13.95%)
occurrences all number	2	1	2	0	0	2	2	7
Peripheral sensory neuropathy
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Sciatica
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 45 (0.00%)	1 / 43 (2.33%)
occurrences all number	0	0	1	0	0	0	0	1
Syncope
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	2 / 11 (18.18%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 45 (2.22%)	3 / 43 (6.98%)
occurrences all number	0	0	0	2	0	0	1	3
Leukocytosis
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Leukopenia
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 45 (2.22%)	0 / 43 (0.00%)
occurrences all number	0	0	1	0	0	0	1	0
Lymphadenopathy
subjects affected / exposed	2 / 23 (8.70%)	0 / 22 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	1 / 11 (9.09%)	1 / 45 (2.22%)	2 / 43 (4.65%)
occurrences all number	2	0	0	1	0	1	1	2
Lymphocytosis
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Neutropenia
subjects affected / exposed	1 / 23 (4.35%)	0 / 22 (0.00%)	1 / 11 (9.09%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 11 (0.00%)	3 / 45 (6.67%)	2 / 43 (4.65%)
occurrences all number	1	0	1	1	0	0	3	3
Ear and labyrinth disorders
Tinnitus
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0
Vertigo
subjects affected / exposed	1 / 23 (4.35%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	1	0	0	0	0	1	0	0
Vestibular disorder
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Eye disorders
Diplopia
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Strabismus
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 11 (0.00%)	2 / 45 (4.44%)	1 / 43 (2.33%)
occurrences all number	0	0	0	1	0	0	2	1
Abdominal pain upper
subjects affected / exposed	0 / 23 (0.00%)	2 / 22 (9.09%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	3 / 43 (6.98%)
occurrences all number	0	2	0	1	0	1	0	4
Constipation
subjects affected / exposed	1 / 23 (4.35%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	1	0	0	0	0	1	0	0
Diarrhoea
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	1 / 11 (9.09%)	0 / 45 (0.00%)	1 / 43 (2.33%)
occurrences all number	0	0	0	0	1	1	0	1
Dyspepsia
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	1 / 45 (2.22%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	0	2	1	0
Nausea
subjects affected / exposed	1 / 23 (4.35%)	1 / 22 (4.55%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	2 / 45 (4.44%)	1 / 43 (2.33%)
occurrences all number	2	1	0	0	1	0	2	2
Toothache
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 45 (0.00%)	1 / 43 (2.33%)
occurrences all number	0	0	0	0	1	0	0	1
Vomiting
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	2 / 43 (4.65%)
occurrences all number	0	0	0	1	0	1	0	2
Skin and subcutaneous tissue disorders
Pseudofolliculitis
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Psoriasis
subjects affected / exposed	1 / 23 (4.35%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	1	0	0	0	0	1	0	0
Endocrine disorders
Autoimmune thyroiditis
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	2 / 23 (8.70%)	1 / 22 (4.55%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	2 / 11 (18.18%)	0 / 45 (0.00%)	2 / 43 (4.65%)
occurrences all number	3	1	0	1	0	5	0	2
Back pain
subjects affected / exposed	1 / 23 (4.35%)	0 / 22 (0.00%)	1 / 11 (9.09%)	1 / 11 (9.09%)	1 / 12 (8.33%)	0 / 11 (0.00%)	1 / 45 (2.22%)	3 / 43 (6.98%)
occurrences all number	1	0	1	2	1	0	1	3
Joint swelling
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0
Limb discomfort
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Myalgia
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	1 / 43 (2.33%)
occurrences all number	0	0	0	0	0	1	0	1
Pain in extremity
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 45 (0.00%)	1 / 43 (2.33%)
occurrences all number	0	0	0	1	0	0	0	1
Psoriatic arthropathy
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	1	1	0	0	0
Infections and infestations
Bronchitis
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 11 (0.00%)	3 / 45 (6.67%)	1 / 43 (2.33%)
occurrences all number	0	0	0	1	0	0	3	1
Erythema migrans
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Folliculitis
subjects affected / exposed	2 / 23 (8.70%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 45 (2.22%)	0 / 43 (0.00%)
occurrences all number	3	0	0	0	0	0	1	0
Fungal skin infection
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Gastroenteritis
subjects affected / exposed	0 / 23 (0.00%)	1 / 22 (4.55%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	1 / 45 (2.22%)	0 / 43 (0.00%)
occurrences all number	0	1	0	0	1	0	1	0
Gastroenteritis viral
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Hordeolum
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 45 (0.00%)	0 / 43 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0
Laryngitis
subjects affected / exposed	0 / 23 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 11 (0.00%)

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Clinical trials

Clinical Trial Results: A Phase 2, Randomized, Double Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of PF-06826647 in Participants With Moderate to Severe Plaque Psoriasis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period

Primary: Percentage of Subjects With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period

Primary: Number of Subjects With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period

Primary: Number of Subjects With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period

Primary: Number of Subjects With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period

Primary: Number of Subjects With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period

Primary: Number of Subjects With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period

Primary: Number of Subjects With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period

Primary: Number of Subjects With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period

Primary: Number of Subjects With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period

Primary: Number of Subjects With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period

Primary: Number of Subjects With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period

Primary: Number of Subjects With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period

Primary: Number of Subjects With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period

Primary: Number of Subjects With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period

Primary: Number of Subjects With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period

Secondary: Percentage of Subjects With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period

Secondary: Percentage of Subjects With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period

Secondary: Percentage of Subjects With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear" and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period

Secondary: Percentage of Subjects With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear" and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period

Secondary: Percentage of Subjects With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear", Up to Week 16 - Investigational Treatment Period

Secondary: Percentage of Subjects With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear", Up to Week 16 - Investigational Treatment Period

Secondary: Percentage of Subjects With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period

Secondary: Percentage of Subjects With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period

Secondary: Percentage of Subjects With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period

Secondary: Percentage of Subjects With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period

Secondary: Change From Baseline in Psoriasis Area and Severity Index (PASI) scores, Up to Week 16 - Investigational Treatment Period

Secondary: Change From Baseline in Psoriasis Area and Severity Index (PASI) scores, Up to Week 16 - Investigational Treatment Period

Secondary: Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) scores, Up to Week 16 - Investigational Treatment Period

Secondary: Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) scores, Up to Week 16 - Investigational Treatment Period

Secondary: Change From Baseline in Peak‑Pruritus Numerical Rating Scale (PP-NRS) scores, Up to Week 16 - Investigational Treatment Period

Secondary: Change From Baseline in Peak‑Pruritus Numerical Rating Scale (PP-NRS) scores, Up to Week 16 - Investigational Treatment Period

Secondary: Percentage of Subjects Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, at Week 16 - Investigational Treatment Period

Secondary: Percentage of Subjects Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, at Week 16 - Investigational Treatment Period

Secondary: Change From Baseline in Psoriasis Symptom Inventory (PSI), Up to Week 16 - Investigational Treatment Period

Secondary: Change From Baseline in Psoriasis Symptom Inventory (PSI), Up to Week 16 - Investigational Treatment Period

Secondary: Number of Subjects With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period

Secondary: Number of Subjects With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period

Secondary: Number of Subjects With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period

Secondary: Number of Subjects With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period

Secondary: Number of Subjects With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period

Secondary: Number of Subjects With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period

Secondary: Number of Subjects With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period

Secondary: Number of Subjects With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period

Secondary: Number of Subjects With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period

Secondary: Number of Subjects With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period

Secondary: Number of Subjects With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period

Secondary: Number of Subjects With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period

Secondary: Number of Subjects With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period

Secondary: Number of Subjects With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period

Adverse events

Clinical Trial Results:
A Phase 2, Randomized, Double Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of PF-06826647 in Participants With Moderate to Severe Plaque Psoriasis