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Clinical Trial Results:
A Phase 2b, Double‑Blind, Randomized, Placebo‑Controlled, Parallel Group, Dose Ranging Study of Oral PF‑06651600 and PF‑06700841 as Induction and Chronic Therapy in Subjects With Moderate to Severe Ulcerative Colitis

Summary
EudraCT number	2016-003708-29
Trial protocol	SK LT DK DE AT PL HU ES NL BG IT
Global end of trial date	10 May 2021

Results information
Results version number	v2(current)
This version publication date	27 Jul 2022
First version publication date	25 May 2022
Other versions	v1
Version creation reason

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

B7981005

ISRCTN number

US NCT number

NCT02958865

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

10 May 2021

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

10 May 2021

Was the trial ended prematurely?

Main objective of the trial

This multicenter, multiple arm, dose ranging, placebo controlled (in the induction period only) study was to evaluate the efficacy (based on total Mayo score), safety, tolerability, PK, and PD of multiple doses of PF-06651600 (20, 70, and 200 mg doses) and PF-06700841 (10, 30, and 60 mg doses) during an 8-week induction period, followed by a chronic dosing period at doses of 50 mg and 30 mg of PF-06651600 and PF-06700841, respectively, for 24 weeks.

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

03 Feb 2017

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Bulgaria: 8

Country: Number of subjects enrolled

Czechia: 5

Country: Number of subjects enrolled

Denmark: 12

Country: Number of subjects enrolled

Georgia: 2

Country: Number of subjects enrolled

Germany: 23

Country: Number of subjects enrolled

Hungary: 20

Country: Number of subjects enrolled

Israel: 3

Country: Number of subjects enrolled

Italy: 29

Country: Number of subjects enrolled

Korea, Republic of: 8

Country: Number of subjects enrolled

Poland: 77

Country: Number of subjects enrolled

Romania: 1

Country: Number of subjects enrolled

Russian Federation: 31

Country: Number of subjects enrolled

Serbia: 8

Country: Number of subjects enrolled

Slovakia: 6

Country: Number of subjects enrolled

Spain: 10

Country: Number of subjects enrolled

Turkey: 18

Country: Number of subjects enrolled

Ukraine: 23

Country: Number of subjects enrolled

United States: 33

Worldwide total number of subjects

317

EEA total number of subjects

191

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)

304

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The study consisted of a screening period of up to 6 weeks, an 8 week double blind induction period, an additional 24 week open label active chronic dosing period followed by a 4 week follow up period after the last dose of investigational product for a total of 36 weeks.

Screening details

A total of 319 subjects were randomized and 317 subjects were treated.

Period 1 title

Induction 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 (Induction: 0 to 8 weeks)

Arm description

The placebo was administered orally once daily (QD) from Day 1 to Week 8.

Arm type

Placebo

Investigational medicinal product name

Matching placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received Placebo QD from Day 1 to Week 8.

PF-06651600 20 mg (Induction)

Arm description

PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.

Arm type

Experimental

Investigational medicinal product name

PF-06651600

Investigational medicinal product code

Other name

Ritlecitinib

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received PF-06651600 20 mg QD from Day 1 to Week 8.

PF-06651600 70 mg (Induction)

Arm description

PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.

Arm type

Experimental

Investigational medicinal product name

PF-06651600

Investigational medicinal product code

Other name

Ritlecitinib

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received PF-06651600 70 mg QD from Day 1 to Week 8.

PF-06651600 200 mg (Induction)

Arm description

PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.

Arm type

Experimental

Investigational medicinal product name

PF-06651600

Investigational medicinal product code

Other name

Ritlecitinib

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received PF-06651600 200 mg QD from Day 1 to Week 8.

PF-06700841 10 mg (Induction)

Arm description

PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Brepocitinib

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received PF-06700841 10 mg QD from Day 1 to Week 8.

PF-06700841 30 mg (Induction)

Arm description

PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Brepocitinib

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received PF-06700841 30 mg QD from Day 1 to Week 8.

PF-06700841 60 mg (Induction)

Arm description

PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Brepocitinib

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received PF-06700841 60 mg QD from Day 1 to Week 8.

Number of subjects in period 1	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)
Started	25	51	49	50	48	47	47
Completed	21	44	43	41	45	43	44
Not completed	4	7	6	9	3	4	3
Consent withdrawn by subject	2	-	3	1	1	1	1
Physician decision	1	1	-	-	-	-	-
Adverse event, non-fatal	-	2	-	3	-	1	-
ADVERSE EVENT, serious non-fatal	-	2	-	2	1	1	1
No longer meets eligibility criteria	-	-	-	1	-	-	1
Death	-	1	-	-	-	-	-
other	-	-	1	2	-	1	-
Lost to follow-up	-	-	-	-	1	-	-
Lack of efficacy	1	1	1	-	-	-	-
Protocol deviation	-	-	1	-	-	-	-

Period 2 title

Chronic Period

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

PF-06651600 200 mg -> PF-06651600 50 mg

Arm description

PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.

Arm type

Experimental

Investigational medicinal product name

PF-06651600

Investigational medicinal product code

Other name

Ritlecitinib

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received PF-06651600 50 mg QD from Week 9 to Week 32.

PF-06651600 70 mg -> PF-06651600 50 mg

Arm description

PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.

Arm type

Experimental

Investigational medicinal product name

PF-06651600

Investigational medicinal product code

Other name

Ritlecitinib

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received PF-06651600 50 mg QD from Week 9 to Week 32.

PF-06651600 20 mg -> PF-06651600 50 mg

Arm description

PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.

Arm type

Experimental

Investigational medicinal product name

PF-06651600

Investigational medicinal product code

Other name

Ritlecitinib

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received PF-06651600 50 mg QD from Week 9 to Week 32.

Placebo -> PF-06651600 50 mg

Arm description

The placebo was administered orally QD from Day 1 to Week 8 and PF-06651600 was administered at 50 mg QD from Week 9 to Week 32.

Arm type

Placebo

Investigational medicinal product name

PF-06651600

Investigational medicinal product code

Other name

Ritlecitinib

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received PF-06651600 50 mg QD from Week 9 to Week 32.

PF-06700841 60 mg -> PF-06700841 30 mg

Arm description

PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Brepocitinib

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received PF-06700841 30 mg QD from Week 9 to Week 32.

PF-06700841 30 mg -> PF-06700841 30 mg

Arm description

PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Brepocitinib

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received PF-06700841 30 mg QD from Week 9 to Week 32.

PF-06700841 10 mg -> PF-06700841 30 mg

Arm description

PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.

Arm type

Experimental

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Brepocitinib

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received PF-06700841 30 mg QD from Week 9 to Week 32.

Placebo -> PF-06700841 30 mg

Arm description

The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.

Arm type

Placebo

Investigational medicinal product name

PF-06700841

Investigational medicinal product code

Other name

Brepocitinib

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received PF-06700841 30 mg QD from Week 9 to Week 32.

Pooling Placebo During Chronic

Arm description

The placebo was administered orally QD from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received Placebo QD from Week 9 to Week 32.

Number of subjects in period 2 ^[1]	PF-06651600 200 mg -> PF-06651600 50 mg	PF-06651600 70 mg -> PF-06651600 50 mg	PF-06651600 20 mg -> PF-06651600 50 mg	Placebo -> PF-06651600 50 mg	PF-06700841 60 mg -> PF-06700841 30 mg	PF-06700841 30 mg -> PF-06700841 30 mg	PF-06700841 10 mg -> PF-06700841 30 mg	Placebo -> PF-06700841 30 mg	Pooling Placebo During Chronic
Started	35	36	39	10	38	37	39	9	37
Completed	33	33	33	10	31	26	31	5	20
Not completed	2	3	6	0	7	11	8	4	17
Consent withdrawn by subject	-	-	-	-	1	6	3	3	2
ADVERSE EVENT, serious non-fatal	1	1	1	-	1	3	-	-	-
Adverse event, non-fatal	-	-	1	-	-	1	1	1	5
No longer meets eligibility criteria	-	-	1	-	-	-	-	-	-
Pregnancy	-	-	1	-	-	-	-	-	1
Non-compliance with study drug	-	-	-	-	-	-	1	-	-
other	1	-	1	-	-	1	-	-	1
Lack of efficacy	-	2	1	-	5	-	2	-	8
Protocol deviation	-	-	-	-	-	-	1	-	-

Notes
[1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: One subject who was re-randomized but not treated during chronic period was not included.

Baseline characteristics

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Reporting group title

Placebo (Induction: 0 to 8 weeks)

Reporting group description

The placebo was administered orally once daily (QD) from Day 1 to Week 8.

Reporting group title

PF-06651600 20 mg (Induction)

Reporting group description

PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.

Reporting group title

PF-06651600 70 mg (Induction)

Reporting group description

PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.

Reporting group title

PF-06651600 200 mg (Induction)

Reporting group description

PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.

Reporting group title

PF-06700841 10 mg (Induction)

Reporting group description

PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.

Reporting group title

PF-06700841 30 mg (Induction)

Reporting group description

PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.

Reporting group title

PF-06700841 60 mg (Induction)

Reporting group description

PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.

Reporting group values	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)	Total
Number of subjects	25	51	49	50	48	47	47	317
Age Categorical
Units: Subjects
In utero	0	0	0	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0	0	0	0
Children (2-11 years)	0	0	0	0	0	0	0	0
Adolescents (12-17 years)	0	0	0	0	0	0	0	0
Adults (18-64 years)	23	47	48	46	47	47	46	304
From 65-84 years	2	4	1	4	1	0	1	13
85 years and over	0	0	0	0	0	0	0	0
Age Continuous
Units: years
arithmetic mean (standard deviation)	42.8 ( 15.45 )	41.3 ( 14.03 )	40.2 ( 13.31 )	37.3 ( 15.67 )	40.8 ( 13.04 )	40.9 ( 13.03 )	40.3 ( 12.80 )	-
Gender Categorical
Units: Subjects
Male	14	34	24	32	30	23	25	182
Female	11	17	25	18	18	24	22	135
Race
Units: Subjects
White	22	46	46	48	44	44	45	295
Black or African American	1	1	2	1	0	0	1	6
Asian	1	3	1	0	3	3	0	11
Other	1	1	0	1	1	0	1	5
Ethnicity
Units: Subjects
Hispanic or Latino	0	2	0	0	0	2	2	6
Not Hispanic or Latino	25	49	49	50	48	45	45	311

End points

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Reporting group title

Placebo (Induction: 0 to 8 weeks)

Reporting group description

The placebo was administered orally once daily (QD) from Day 1 to Week 8.

Reporting group title

PF-06651600 20 mg (Induction)

Reporting group description

PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.

Reporting group title

PF-06651600 70 mg (Induction)

Reporting group description

PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.

Reporting group title

PF-06651600 200 mg (Induction)

Reporting group description

PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.

Reporting group title

PF-06700841 10 mg (Induction)

Reporting group description

PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.

Reporting group title

PF-06700841 30 mg (Induction)

Reporting group description

PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.

Reporting group title

PF-06700841 60 mg (Induction)

Reporting group description

PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.

Reporting group title

PF-06651600 200 mg -> PF-06651600 50 mg

Reporting group description

PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.

Reporting group title

PF-06651600 70 mg -> PF-06651600 50 mg

Reporting group description

PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.

Reporting group title

PF-06651600 20 mg -> PF-06651600 50 mg

Reporting group description

PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.

Reporting group title

Placebo -> PF-06651600 50 mg

Reporting group description

The placebo was administered orally QD from Day 1 to Week 8 and PF-06651600 was administered at 50 mg QD from Week 9 to Week 32.

Reporting group title

PF-06700841 60 mg -> PF-06700841 30 mg

Reporting group description

PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.

Reporting group title

PF-06700841 30 mg -> PF-06700841 30 mg

Reporting group description

PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.

Reporting group title

PF-06700841 10 mg -> PF-06700841 30 mg

Reporting group description

PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.

Reporting group title

Placebo -> PF-06700841 30 mg

Reporting group description

The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.

Reporting group title

Pooling Placebo During Chronic

Reporting group description

The placebo was administered orally QD from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.

Subject analysis set title

mITT Analysis Set: Placebo -> PF-06651600 50 mg

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

The placebo was administered orally from Day 1 to Week 8 and PF-06651600 at 50 mg QD from Week 9 to Week 32.

Subject analysis set title

mITT Analysis Set: PF-06651600 20 mg -> PF-06651600 50 mg

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.

Subject analysis set title

mITT Analysis Set: PF-06651600 70 mg -> PF-06651600 50 mg

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.

Subject analysis set title

mITT Analysis Set: PF-06651600 200 mg -> PF-06651600 50 mg

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 9 and at 50 mg QD from Week 9 to Week 32.

Subject analysis set title

mITT Analysis Set: Placebo -> PF-06700841 30 mg

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.

Subject analysis set title

mITT Analysis Set: PF-06700841 10 mg -> PF-06700841 30 mg

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.

Subject analysis set title

mITT Analysis Set: PF-06700841 30 mg -> PF-06700841 30 mg

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.

Subject analysis set title

mITT Analysis Set: PF-06700841 60 mg -> PF-06700841 30 mg

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.

Primary: Induction Period: Total Mayo Score at Week 8

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End point title

Induction Period: Total Mayo Score at Week 8

End point description

The Mayo score ranges from 0 to 12, with higher scores indicating more severe disease. The intent-to-treat (ITT) analysis set was used to analyze this endpoint, defined as all randomized subjects who received at least 1 dose of investigational product or placebo.

End point type

Primary

End point timeframe

Week 8

End point values	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)
Number of subjects analysed	25	51	49	50	48	47	47
Units: Unit on a scale
least squares mean (confidence interval 90%)	7.88 (6.95 to 8.81)	5.85 (5.18 to 6.51)	4.00 (3.33 to 4.67)	3.27 (2.58 to 3.96)	6.08 (5.43 to 6.74)	5.60 (4.93 to 6.27)	4.67 (4.01 to 5.33)

Placebo, PF-06651600 20 mg

Comparison groups

Placebo (Induction: 0 to 8 weeks) v PF-06651600 20 mg (Induction)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0017

Method

Constrained Longitudinal Data Analysis

Parameter type

Mean difference (final values)

Point estimate

-2.03

Confidence interval

level

90%

sides

2-sided

lower limit

-3.17

upper limit

-0.89

Variability estimate

Standard error of the mean

Dispersion value

0.69

Placebo, PF-06651600 70 mg

Comparison groups

Placebo (Induction: 0 to 8 weeks) v PF-06651600 70 mg (Induction)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Constrained Longitudinal Data Analysis

Parameter type

Mean difference (final values)

Point estimate

-3.88

Confidence interval

level

90%

sides

2-sided

lower limit

-5.01

upper limit

-2.74

Variability estimate

Standard error of the mean

Dispersion value

0.69

Placebo, PF-06651600 200 mg

Comparison groups

Placebo (Induction: 0 to 8 weeks) v PF-06651600 200 mg (Induction)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Constrained Longitudinal Data Analysis

Parameter type

Mean difference (final values)

Point estimate

-4.61

Confidence interval

level

90%

sides

2-sided

lower limit

-5.76

upper limit

-3.46

Variability estimate

Standard error of the mean

Dispersion value

0.7

Placebo, PF-06700841 10 mg

Comparison groups

Placebo (Induction: 0 to 8 weeks) v PF-06700841 10 mg (Induction)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0045

Method

Constrained Longitudinal Data Analysis

Parameter type

Mean difference (final values)

Point estimate

-1.79

Confidence interval

level

90%

sides

2-sided

lower limit

-2.92

upper limit

-0.67

Variability estimate

Standard error of the mean

Dispersion value

0.68

Placebo, PF-06700841 30 mg

Comparison groups

Placebo (Induction: 0 to 8 weeks) v PF-06700841 30 mg (Induction)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0005

Method

Constrained Longitudinal Data Analysis

Parameter type

Mean difference (final values)

Point estimate

-2.28

Confidence interval

level

90%

sides

2-sided

lower limit

-3.41

upper limit

-1.14

Variability estimate

Standard error of the mean

Dispersion value

0.69

Placebo, PF-06700841 60 mg

Comparison groups

Placebo (Induction: 0 to 8 weeks) v PF-06700841 60 mg (Induction)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Constrained Longitudinal Data Analysis

Parameter type

Mean difference (final values)

Point estimate

-3.21

Confidence interval

level

90%

sides

2-sided

lower limit

-4.34

upper limit

-2.08

Variability estimate

Standard error of the mean

Dispersion value

0.69

Primary: Chronic Period: Number of subjects with Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and with withdrawals due to adverse events

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End point title

Chronic Period: Number of subjects with Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and with withdrawals due to adverse events ^[1]

End point description

An AE is any untoward medical occurrence in a study subjects administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that: results in death; is life threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect; or that is considered to be an important medical event that may jeopardize the subject or may require intervention to prevent one of the other AE outcomes. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of the study medication. All AEs in the table below were treatment-emergent AEs. All subjects who received at least one dose of the randomized study treatment.

End point type

Primary

End point timeframe

Baseline of Chronic period (Week 8) to Week 36

Notes
[1] - 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	PF-06651600 200 mg -> PF-06651600 50 mg	PF-06651600 70 mg -> PF-06651600 50 mg	PF-06651600 20 mg -> PF-06651600 50 mg	Placebo -> PF-06651600 50 mg	PF-06700841 60 mg -> PF-06700841 30 mg	PF-06700841 30 mg -> PF-06700841 30 mg	PF-06700841 10 mg -> PF-06700841 30 mg	Placebo -> PF-06700841 30 mg	Pooling Placebo During Chronic
Number of subjects analysed	35	36	39	10	38	37	39	9	37
Units: Subjects
subjects with AEs	18	27	18	8	21	23	26	4	18
Subjects with SAEs	3	1	1	0	2	4	2	0	0
Subjects with severe adverse events	2	1	3	0	3	4	4	1	4
Subjects discontinued from study due to AEs	1	1	3	1	1	4	1	1	6

No statistical analyses for this end point

Primary: Chronic Period: Number of subjects with Laboratory Abnormalities without regard to baseline values - Hematology

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End point title

Chronic Period: Number of subjects with Laboratory Abnormalities without regard to baseline values - Hematology ^[2]

End point description

Following parameters were analyzed for laboratory examination: hemoglobin, hematocrit, erythrocytes, reticulocytes, ery. Mean Corpuscular Volume, platelets, Reticulocytes/Erythrocytes, Leukocytes, Lymphocytes,Neutrophils, Basophils, Eosinophils,Monocytes, Activated Partial Thromboplastin Time, Prothrombin Time,Prothrombin Intl. Normalized Ratio.The analysis population included all enrolled participants who received at least one dose of study medication.

End point type

Primary

End point timeframe

Baseline of Chronic period (Week 8) to Week 36

Notes
[2] - 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	PF-06651600 200 mg -> PF-06651600 50 mg	PF-06651600 70 mg -> PF-06651600 50 mg	PF-06651600 20 mg -> PF-06651600 50 mg	Placebo -> PF-06651600 50 mg	PF-06700841 60 mg -> PF-06700841 30 mg	PF-06700841 30 mg -> PF-06700841 30 mg	PF-06700841 10 mg -> PF-06700841 30 mg	Placebo -> PF-06700841 30 mg	Pooling Placebo During Chronic
Number of subjects analysed	35	35	39	10	38	37	39	9	37
Units: Subjects
Hemoglobin(g/dL)<0.8x LLN	2	2	1	1	3	3	6	2	3
Hematocrit(%)<0.8x LLN	0	2	1	0	1	1	1	1	2
Erythrocytes(10^6/mm^3)<0.8x LLN	0	1	1	0	1	0	1	1	1
Reticulocytes (ABSOLUTE) (10^3/mm^3)<0.5x LLN	0	0	0	0	0	0	0	0	0
Reticulocytes (ABSOLUTE) (10^3/mm^3)>1.5x ULN	0	0	1	0	0	0	0	0	0
Ery. Mean Corpuscular Volume (10^-15L)<0.9x LLN	0	0	1	0	0	1	0	0	0
Ery. Mean Corpuscular Volume (10^-15L)>1.1x ULN	0	0	0	0	0	0	0	0	0
Platelets (10^3/mm^3)<0.5xLLN	0	0	0	0	0	0	0	0	0
Platelets (10^3/mm^3)>1.75xULN	0	0	0	0	3	1	2	0	2
Reticulocytes/Erythrocytes (%)<0.5xLLN	0	0	0	0	0	0	0	0	0
Reticulocytes/Erythrocytes (%)>1.5xULN	1	1	2	0	1	1	0	0	1
Leukocytes (10^3/mm^3)<0.6xLLN	0	0	0	0	0	0	0	0	0
Leukocytes (10^3/mm^3)>1.5xULN	0	0	1	1	1	1	1	1	1
Lymphocytes (ABSOLUTE) (10^3/mm^3)<0.8xLLN	7	6	6	1	0	0	3	0	3
Lymphocytes (ABSOLUTE) (10^3/mm^3)>1.2xULN	0	0	0	0	0	0	0	1	0
Neutrophils (ABSOLUTE) (10^3/mm^3)<0.8xLLN	1	2	0	0	3	1	2	1	1
Neutrophils (ABSOLUTE) (10^3/mm^3)>1.2xULN	3	8	11	1	8	6	6	3	6
Basophils (ABSOLUTE)(10^3/mm^3)>1.2xULN	0	0	0	0	2	1	0	0	1
Eosinophils (ABSOLUTE) (10^3/mm^3)>1.2xULN	0	0	0	0	2	1	0	0	2
Monocytes (ABSOLUTE) (10^3/mm^3)>1.2xULN	0	0	0	0	2	2	0	0	0
ActivatedPartialThromboplastinTime (sec)>1.1xULN	0	3	1	0	2	0	0	0	0
Prothrombin Time (sec)>1.1xULN	2	3	2	0	2	2	0	0	0
Prothrombin Intl. Normalized Ratio>1.1xULN	2	3	2	0	2	1	0	0	0

No statistical analyses for this end point

Primary: Chronic Period: Number of subjects with Laboratory Abnormalities without regard to basline values - Clinical Chemistry

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End point title

Chronic Period: Number of subjects with Laboratory Abnormalities without regard to basline values - Clinical Chemistry ^[3]

End point description

Following parameters were analyzed for laboratory examination: Bilirubin, Direct Bilirubin,Indirect Bilirubin, Aspartate Aminotransferase, Alanine Aminotransferase, Gamma Glutamyl Transferase, Alkaline Phosphatase, Protein,Albumin,Urea Nitrogen, Creatinine,Urate, HDL Cholesterol, LDL Cholesterol, Triglycerides, Sodium,Potassium, Chloride,Calcium, Glucose,Hemoglobin A1C, Creatine Kinase,Cholesterol. The analysis population included all enrolled participants who received at least one dose of study medication.

End point type

Primary

End point timeframe

Baseline of Chronic period (Week 8) to Week 36

Notes
[3] - 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	PF-06651600 200 mg -> PF-06651600 50 mg	PF-06651600 70 mg -> PF-06651600 50 mg	PF-06651600 20 mg -> PF-06651600 50 mg	Placebo -> PF-06651600 50 mg	PF-06700841 60 mg -> PF-06700841 30 mg	PF-06700841 30 mg -> PF-06700841 30 mg	PF-06700841 10 mg -> PF-06700841 30 mg	Placebo -> PF-06700841 30 mg	Pooling Placebo During Chronic
Number of subjects analysed	35	35	39	10	38	37	39	9	37
Units: Subjects
Bilirubin (mg/dL)>1.5x ULN	1	0	1	0	1	0	1	0	1
Direct Bilirubin (mg/dL)>1.5x ULN	0	0	0	0	0	0	0	0	0
Indirect Bilirubin (mg/dL)>1.5x ULN	0	0	0	0	0	0	0	0	0
Aspartate Aminotransferase (U/L)>3.0x ULN	0	0	2	0	0	0	0	0	0
Alanine Aminotransferase (U/L)>3.0x ULN	1	0	1	0	0	0	2	0	0
Gamma Glutamyl Transferase (U/L)>3.0x ULN	0	0	0	0	0	0	0	0	0
Alkaline Phosphatase (U/L)>3.0x ULN	0	0	1	0	0	0	0	0	0
Protein (g/dL)<0.8x LLN	0	0	0	0	0	0	0	0	0
Protein (g/dL)>1.2x ULN	0	0	0	0	0	0	0	0	0
Albumin (g/dL)<0.8x LLN	0	0	0	0	0	0	0	0	0
Albumin (g/dL)>1.2x ULN	0	0	0	0	0	0	0	0	0
Urea Nitrogen (mg/dL)>1.3x ULN	0	1	0	0	0	0	0	0	0
Creatinine (mg/dL)>1.3x ULN	0	1	0	0	0	1	1	0	0
Urate (mg/dL)>1.2x ULN	0	2	0	0	0	1	1	0	0
HDL Cholesterol (mg/dL)<0.8x LLN	1	0	0	0	0	0	1	0	0
LDL Cholesterol (mg/dL)>1.2x ULN	1	1	0	0	1	0	2	1	0
Triglycerides (mg/dL)>1.3x ULN	3	2	1	0	2	2	1	0	1
Sodium (Meq/L)<0.95x LLN	0	0	0	0	0	0	0	0	0
Sodium (Meq/L)>1.05x ULN	0	0	0	0	0	0	0	0	0
Potassium (Meq/L)<0.9x LLN	0	0	0	0	0	1	0	0	0
Potassium (Meq/L)>1.1x ULN	1	0	0	0	2	0	0	0	0
Chloride (Meq/L)<0.9x LLN	0	0	0	0	0	0	0	0	0
Chloride (Meq/L)>1.1x ULN	0	0	0	0	0	0	0	0	0
Calcium (mg/dL)<0.9x LLN	0	0	0	0	0	1	0	0	0
Calcium (mg/dL)>1.1x ULN	0	0	0	0	0	0	0	0	0
Glucose (mg/dL)<0.6x LLN	0	0	0	0	0	0	0	0	0
Glucose (mg/dL)>1.5x ULN	1	3	3	0	1	2	0	0	0
Hemoglobin A1C (%)>1.3x ULN	0	0	0	0	0	0	0	0	0
Creatine Kinase (U/L)>2.0x ULN	1	3	2	1	3	10	2	0	1
Cholesterol (mg/dl)>1.3x ULN	0	1	0	0	0	0	1	0	0

No statistical analyses for this end point

Primary: Chronic Period: Number of subjects with Laboratory Abnormalities without regard to basline values - Urinalysis

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End point title

Chronic Period: Number of subjects with Laboratory Abnormalities without regard to basline values - Urinalysis ^[4]

End point description

Following parameters were analyzed for laboratory examination: pH,URINE Glucose,Ketones,URINE Protein,URINE Hemoglobin,Nitrite,Leukocyte Esterase,URINE Erythrocytes,URINE Leukocytes, Hyaline Casts,WBC Casts,Bacteria. The analysis population included all enrolled participants who received at least one dose of study medication.

End point type

Primary

End point timeframe

Baseline of Chronic period (Week 8) to Week 36

Notes
[4] - 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	PF-06651600 200 mg -> PF-06651600 50 mg	PF-06651600 70 mg -> PF-06651600 50 mg	PF-06651600 20 mg -> PF-06651600 50 mg	Placebo -> PF-06651600 50 mg	PF-06700841 60 mg -> PF-06700841 30 mg	PF-06700841 30 mg -> PF-06700841 30 mg	PF-06700841 10 mg -> PF-06700841 30 mg	Placebo -> PF-06700841 30 mg	Pooling Placebo During Chronic
Number of subjects analysed	35	36	39	10	38	37	39	9	37
Units: Subjects
pH (scalar)<4.5	0	0	0	0	0	0	0	0	0
pH (scalar)>8	0	0	0	0	0	0	0	0	0
URINE Glucose (No Unit)>=1	1	2	1	1	1	1	0	0	1
Ketones (No Unit)>=1	4	3	8	2	4	1	3	0	2
URINE Protein (No Unit)>=1	0	1	3	0	1	0	2	0	1
URINE Hemoglobin (No Unit)>=1	7	4	5	1	7	9	9	0	9
Nitrite (No Unit)>=1	2	2	0	2	1	1	1	0	1
Leukocyte Esterase (No Unit)>=1	8	13	11	1	14	7	8	1	9
URINE Erythrocytes (/HPF)>=20	1	1	4	1	2	3	5	0	1
URINE Leukocytes (/HPF)>=20	0	2	3	1	3	1	1	0	4
Hyaline Casts (/LPF)>1	5	0	6	2	4	1	2	1	2
WBC Casts (/LPF)>1	0	0	0	0	0	0	0	0	1
Bacteria (No Unit)>20	0	0	0	0	0	0	1	0	0

No statistical analyses for this end point

Primary: Chronic Period: Number of subjects with abnormal electrocardiogram findings

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End point title

Chronic Period: Number of subjects with abnormal electrocardiogram findings ^[5]

End point description

The analysis population included all enrolled participants who received at least one dose of study medication. The criteria of test abnormality is defined as one of the following conditions was met: 1)Associated with accompanying symptoms; 2)Test result requires additional diagnostic testing or medical/surgical intervention; 3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy; 4)Test result is considered to be an AE by the investigator or sponsor.

End point type

Primary

End point timeframe

Baseline of Chronic period (Week 8) to Week 36

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	PF-06651600 200 mg -> PF-06651600 50 mg	PF-06651600 70 mg -> PF-06651600 50 mg	PF-06651600 20 mg -> PF-06651600 50 mg	Placebo -> PF-06651600 50 mg	PF-06700841 60 mg -> PF-06700841 30 mg	PF-06700841 30 mg -> PF-06700841 30 mg	PF-06700841 10 mg -> PF-06700841 30 mg	Placebo -> PF-06700841 30 mg	Pooling Placebo During Chronic
Number of subjects analysed	33	34	37	10	32	30	36	9	33
Units: Subjects
NORMAL	30	28	35	9	31	28	32	7	29
ABNORMAL, NOT CLINICALLY SIGNIFICANT	3	6	2	1	1	2	4	2	4
ABNORMAL, CLINICALLY SIGNIFICANT	0	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Primary: Chronic Period: Number of subjects with vital signs abonormalities

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End point title

Chronic Period: Number of subjects with vital signs abonormalities ^[6]

End point description

The criteria of test are indicated below. The analysis population are the subjects evaluated against the criteria during the chronic period.

End point type

Primary

End point timeframe

Baseline of Chronic period (Week 8) to Week 36

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	PF-06651600 200 mg -> PF-06651600 50 mg	PF-06651600 70 mg -> PF-06651600 50 mg	PF-06651600 20 mg -> PF-06651600 50 mg	Placebo -> PF-06651600 50 mg	PF-06700841 60 mg -> PF-06700841 30 mg	PF-06700841 30 mg -> PF-06700841 30 mg	PF-06700841 10 mg -> PF-06700841 30 mg	Placebo -> PF-06700841 30 mg	Pooling Placebo During Chronic
Number of subjects analysed	35	35	39	10	38	37	39	9	37
Units: Subjects
SITTING SYSTOLIC BLOOD PRESSURE Value <90mmHg	0	0	1	0	0	0	1	0	1
SITTING SYSTOLIC BP Chg>=30mmHg increase	0	3	4	0	3	2	3	0	3
SITTING SYSTOLIC BP Chg >= 30mmHg decrease	0	0	0	0	1	1	0	0	1
SITTING DIASTOLIC BP Value <50 mmHg	0	0	0	0	0	0	0	0	0
SITTING DIASTOLIC BP Chg >= 20mmHg increase	0	1	6	1	4	2	1	1	1
SITTING DIASTOLIC BP Chg >= 20mmHg decrease	2	4	5	0	2	3	1	0	2
SITTING PULSE RATE Value <40 bpm	0	0	0	0	0	0	0	0	0
SITTING PULSE RATE Value >120 bpm	0	0	1	0	0	0	0	0	0

No statistical analyses for this end point

Primary: Chronic Period: Number of subjects with Serious Infection

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End point title

Chronic Period: Number of subjects with Serious Infection ^[7]

End point description

Serious infections are treated infections that: Require parenteral antimicrobial therapy and present with positive pre-treatment culture; and either Require hospitalization for treatment; or Meet other criteria that require the infection to be classified as a SAE. The analysis population included all enrolled participants who received at least one dose of study medication.

End point type

Primary

End point timeframe

Baseline of Chronic period (Week 8) to Week 36

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	PF-06651600 200 mg -> PF-06651600 50 mg	PF-06651600 70 mg -> PF-06651600 50 mg	PF-06651600 20 mg -> PF-06651600 50 mg	Placebo -> PF-06651600 50 mg	PF-06700841 60 mg -> PF-06700841 30 mg	PF-06700841 30 mg -> PF-06700841 30 mg	PF-06700841 10 mg -> PF-06700841 30 mg	Placebo -> PF-06700841 30 mg	Pooling Placebo During Chronic
Number of subjects analysed	35	36	39	10	38	37	39	9	37
Units: Subjects
COVID 19 pneumonia	0	0	0	0	0	0	1	0	0
viral infection	0	0	0	0	1	0	0	0	0

No statistical analyses for this end point

Secondary: Induction Period: Percentage of subjects achieving remission based on total Mayo score

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End point title

Induction Period: Percentage of subjects achieving remission based on total Mayo score

End point description

Remission excludes friability and is based on total Mayo score of less than/equal to 2 with no individual subscore greater than 1 and a rectal bleeding subscore of 0 at Week 8. The ITT analysis set was used to analyze this endpoint, defined as all randomized subjects who received at least 1 dose of investigational product or placebo.

End point type

Secondary

End point timeframe

Week 8

End point values	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)
Number of subjects analysed	25	51	49	50	48	47	47
Units: Percentage of subjects
number (confidence interval 90%)	0 (0.0 to 11.0)	9.8 (4.8 to 19.1)	28.6 (19.0 to 40.4)	34.0 (24.0 to 45.4)	8.3 (3.7 to 16.8)	23.4 (14.8 to 34.5)	23.4 (14.8 to 34.5)

No statistical analyses for this end point

Secondary: Induction Period: Percentage of subjects achieving improvement in endoscopic appearance at Week 8

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End point title

Induction Period: Percentage of subjects achieving improvement in endoscopic appearance at Week 8

End point description

Improvement of endoscopic appearance is defined as a Mayo endoscopic subscore of less than/equal to 1. The ITT analysis set was used to analyze this endpoint, defined as all randomized subjects who received at least 1 dose of investigational product or placebo.

End point type

Secondary

End point timeframe

Week 8

End point values	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)
Number of subjects analysed	25	51	49	50	48	47	47
Units: Percengate of subjects
number (confidence interval 90%)	0 (0.0 to 11.0)	21.6 (13.5 to 33.1)	34.7 (24.4 to 46.4)	42.0 (30.3 to 54.6)	20.8 (11.8 to 31.5)	31.9 (20.8 to 44.4)	29.8 (19.9 to 42.3)

No statistical analyses for this end point

Secondary: Induction Period: Percentage of subjects achieving clinical response at Week 8

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End point title

Induction Period: Percentage of subjects achieving clinical response at Week 8

End point description

Clinical response is defined as a decrease from baseline in total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1. The ITT analysis set was used to analyze this endpoint, defined as all randomized subjects who received at least 1 dose of investigational product or placebo.

End point type

Secondary

End point timeframe

Week 8

End point values	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)
Number of subjects analysed	25	51	49	50	48	47	47
Units: Percentage of subjects
number (confidence interval 90%)	24.0 (11.0 to 41.7)	41.2 (29.9 to 53.6)	69.4 (57.6 to 80.1)	68.0 (56.6 to 78.8)	41.7 (29.6 to 54.5)	53.2 (40.3 to 65.5)	61.7 (48.7 to 72.9)

No statistical analyses for this end point

Secondary: Induction Period: Percentage of subjects in endoscopic remission at Week 8

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End point title

Induction Period: Percentage of subjects in endoscopic remission at Week 8

End point description

Endoscopic remission is defined as an endoscopic subscore of 0. The ITT analysis set was used to analyze this endpoint, defined as all randomized subjects who received at least 1 dose of investigational product or placebo.

End point type

Secondary

End point timeframe

Week 8

End point values	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)
Number of subjects analysed	25	51	49	50	48	47	47
Units: Percentage of subjects
number (confidence interval 90%)	0 (0.0 to 11.0)	3.9 (1.0 to 11.0)	8.2 (3.6 to 16.5)	12.0 (5.4 to 21.2)	2.1 (0.2 to 8.6)	17.0 (8.8 to 28.3)	8.5 (3.8 to 17.2)

No statistical analyses for this end point

Secondary: Induction Period: Percentage of subjects in symptomatic remission at Week 8

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End point title

Induction Period: Percentage of subjects in symptomatic remission at Week 8

End point description

Symptomatic remission is defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and both rectal bleeding and stool frequency subscores of 0. The ITT analysis set was used to analyze this endpoint, defined as all randomized subjects who received at least 1 dose of investigational product or placebo.

End point type

Secondary

End point timeframe

Week 8

End point values	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)
Number of subjects analysed	25	51	49	50	48	47	47
Units: Percentage of subjects
number (confidence interval 90%)	0 (0.0 to 11.0)	7.8 (3.5 to 15.9)	16.3 (8.4 to 27.1)	26.0 (16.2 to 37.6)	6.3 (2.3 to 15.1)	14.9 (8.0 to 25.1)	14.9 (8.0 to 25.1)

No statistical analyses for this end point

Secondary: Induction Period: Percentage of subjects achieving deep remission at Week 8

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End point title

Induction Period: Percentage of subjects achieving deep remission at Week 8

End point description

Deep remission is defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a 0 on both endoscopic and rectal bleeding subscores. The ITT analysis set was used to analyze this endpoint, defined as all randomized subjects who received at least 1 dose of investigational product or placebo.

End point type

Secondary

End point timeframe

Week 8

End point values	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)
Number of subjects analysed	25	51	49	50	48	47	47
Units: Percentage of subjects
number (confidence interval 90%)	0 (0.0 to 11.0)	3.9 (1.0 to 11.0)	8.2 (3.6 to 16.5)	12.0 (5.4 to 21.2)	0 (0.0 to 5.6)	14.9 (8.0 to 25.1)	6.4 (2.4 to 15.4)

No statistical analyses for this end point

Secondary: Induction Period: Partial Mayo Scores and changes from baseline at Weeks 2,4,and 8

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End point title

Induction Period: Partial Mayo Scores and changes from baseline at Weeks 2,4,and 8

End point description

A partial Mayo Score (Mayo Score without endoscopic subscore) ranges from 0 to 9, with higher scores indicating more severe disease. Baseline value is defined as the last non-missing measurement collected prior to the first administration of study drug at Day 1. ITT analysis set was defined as all randomized subjects who received at least 1 dose of investigational product or placebo. The subjects in the ITT analysis set who had partial Mayo score at each specified time point was used to analyze this endpoint.

End point type

Secondary

End point timeframe

Weeks 2,4,and 8

End point values	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)
Number of subjects analysed	25	51	49	50	48	47	47
Units: Unit on a scale
least squares mean (standard error)
Week 2	-0.66 ( 0.37 )	-1.65 ( 0.26 )	-2.56 ( 0.26 )	-3.19 ( 0.27 )	-1.60 ( 0.27 )	-1.64 ( 0.27 )	-2.45 ( 0.27 )
Week 4	-1.64 ( 0.42 )	-2.24 ( 0.29 )	-3.29 ( 0.30 )	-4.24 ( 0.31 )	-2.31 ( 0.30 )	-2.06 ( 0.30 )	-2.95 ( 0.30 )
Week 8	-1.15 ( 0.43 )	-2.54 ( 0.30 )	-4.06 ( 0.30 )	-4.69 ( 0.32 )	-2.51 ( 0.30 )	-2.71 ( 0.31 )	-3.47 ( 0.31 )

No statistical analyses for this end point

Secondary: Induction Period: Change from baseline in total Mayo score

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End point title

Induction Period: Change from baseline in total Mayo score

End point description

Total Mayo Score ranges from 0 to 12, with higher scores indicating more severe disease. Baseline value is defined as the last non-missing measurement collected prior to the first administration of study drug at Day 1. The ITT analysis set was used to analyze this endpoint, defined as all randomized subjects who received at least 1 dose of investigational product or placebo.

End point type

Secondary

End point timeframe

Week 8

End point values	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)
Number of subjects analysed	25	51	49	50	48	47	47
Units: Units on a scale
least squares mean (confidence interval 90%)	-1.14 (-2.06 to -0.22)	-3.17 (-3.83 to -2.51)	-5.02 (-5.68 to -4.36)	-5.74 (-6.43 to -5.06)	-2.93 (-3.58 to -2.29)	-3.42 (-4.08 to -2.76)	-4.35 (-5.00 to -3.69)

No statistical analyses for this end point

Secondary: Induction Period: Changes from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Weeks 4 and 8

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End point title

Induction Period: Changes from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Weeks 4 and 8

End point description

IBDQ is a psychometrically validated PRO instrument for measuring the disease-specific quality of life in subjects with IBD, including UC. A score of at least 170 corresponds to clinical remission and an increase of at least 16 points is considered to indicate a clinically meaningful improvement.

End point type

Secondary

End point timeframe

Weeks 4 and 8

End point values	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)
Number of subjects analysed	25	51	49	50	48	47	47
Units: Units on a scale
least squares mean (confidence interval 90%)
Week 4	30.30 (19.56 to 41.05)	33.71 (26.12 to 41.30)	51.12 (43.52 to 58.72)	57.01 (49.12 to 64.90)	28.45 (20.73 to 36.17)	37.94 (30.16 to 45.72)	49.79 (41.99 to 57.60)
Week 8	24.23 (12.02 to 36.45)	37.91 (29.41 to 46.42)	59.20 (50.56 to 67.83)	62.17 (53.14 to 71.20)	36.6 (27.87 to 45.33)	48.81 (40.01 to 57.61)	56.39 (47.60 to 65.18)

No statistical analyses for this end point

Secondary: Indution Period: Percentage of subjects with IBDQ total score greater than/equal to 170 at Weeks 4 and 8

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End point title

Indution Period: Percentage of subjects with IBDQ total score greater than/equal to 170 at Weeks 4 and 8

End point description

End point type

Secondary

End point timeframe

Weeks 4 and 8

End point values	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)
Number of subjects analysed	25	51	49	50	48	47	47
Units: Percentage of subjects
number (confidence interval 90%)
Week 4	24.0 (11.0 to 41.7)	21.6 (13.5 to 33.1)	40.8 (28.9 to 53.6)	46.0 (34.2 to 58.5)	27.1 (16.8 to 39.4)	27.7 (17.2 to 40.3)	38.3 (27.1 to 51.3)
Week 8	20.0 (10.1 to 36.2)	29.4 (19.1 to 40.6)	57.1 (44.4 to 69.2)	44.0 (33.0 to 56.6)	31.3 (20.4 to 43.4)	40.4 (28.3 to 53.5)	51.1 (38.9 to 62.8)

No statistical analyses for this end point

Secondary: Induction Period: Percentage of subjects with greater than/equal to 16 point increase in IBDQ total score from baseline at Weeks 4 and 8

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End point title

Induction Period: Percentage of subjects with greater than/equal to 16 point increase in IBDQ total score from baseline at Weeks 4 and 8

End point description

End point type

Secondary

End point timeframe

Weeks 4 and 8

End point values	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)
Number of subjects analysed	25	51	49	50	48	47	47
Units: Percentage of subjects
number (confidence interval 90%)
Week 4	48.0 (30.7 to 64.0)	60.8 (48.4 to 72.3)	83.7 (72.9 to 91.6)	80.0 (69.7 to 88.7)	64.6 (52.5 to 75.3)	78.7 (67.8 to 88.0)	72.3 (59.7 to 82.8)
Week 8	56.0 (38.9 to 73.0)	54.9 (42.5 to 66.9)	79.6 (69.2 to 88.5)	70.0 (58.5 to 80.5)	62.5 (50.0 to 73.6)	80.9 (69.7 to 88.8)	78.7 (67.8 to 88.0)

No statistical analyses for this end point

Secondary: Indction Period: Percentage of subjects with improvement in IBDQ bowel symptom domain at Weeks 4 and 8

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End point title

Indction Period: Percentage of subjects with improvement in IBDQ bowel symptom domain at Weeks 4 and 8

End point description

Improvement is defined as an increase of at least 1.2 points from baseline in average score among IBDQ bowel symptom domain (items 1, 5, 9, 13, 17, 20, 22, 24, 26, 29).

End point type

Secondary

End point timeframe

Weeks 4 and 8

End point values	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)
Number of subjects analysed	25	51	49	50	48	47	47
Units: Percentage of subjects
number (confidence interval 90%)
Week 4	20.0 (10.1 to 36.2)	51.0 (38.7 to 63.2)	65.3 (53.6 to 75.6)	64.0 (52.6 to 75.1)	37.5 (26.4 to 50.0)	53.2 (40.3 to 65.5)	57.4 (44.4 to 69.7)
Week 8	24.0 (11.0 to 41.7)	47.1 (35.0 to 59.4)	69.4 (57.6 to 80.1)	62.0 (50.0 to 73.5)	50.0 (37.6 to 62.4)	63.8 (51.3 to 74.9)	66.0 (53.5 to 77.3)

No statistical analyses for this end point

Secondary: Induction Period: Changes from baseline in Short Form 36 version 2 (SF-36 v2) at Weeks 4 and 8

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End point title

Induction Period: Changes from baseline in Short Form 36 version 2 (SF-36 v2) at Weeks 4 and 8

End point description

The SF-36 version 2 (Acute version) is a 36-item generic health status measure. It measures 8 general health concepts or domains: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH). These 8 domains can also be summarized as physical and mental component scores. The summary component scores, Physical Component Summary (PCS) and Mental Component Summary (MCS), are based on a normalized sum of the 8 scale scores PF, RP, BP, GH, VT, SF, RE, and MH . All domains and summary components are scored such that a higher score indicates a higher functioning or health level. The minimum and maximum scores of the PCS Score are 6.1 and 79.7, respectively. The minimum and maximum scores of the MCS Score are -3.8 and 78.7, respectively.

End point type

Secondary

End point timeframe

Weeks 4 and 8

End point values	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)
Number of subjects analysed	25	51	49	50	48	47	47
Units: Units on a scale
least squares mean (confidence interval 90%)
PCS at Week 4	4.69 (2.59 to 6.80)	5.90 (4.41 to 7.39)	6.36 (4.88 to 7.85)	9.21 (7.67 to 10.76)	5.67 (4.16 to 7.19)	5.85 (4.31 to 7.38)	6.40 (4.87 to 7.93)
MCS at Week 4	7.83 (4.59 to 11.06)	4.95 (2.67 to 7.23)	7.79 (5.50 to 10.07)	8.81 (6.43 to 11.18)	2.44 (0.13 to 4.74)	7.46 (5.11 to 9.82)	9.28 (6.93 to 11.62)
PCS at Week 8	5.37 (2.96 to 7.77)	5.85 (4.19 to 7.52)	8.66 (6.97 to 10.35)	10.86 (9.08 to 12.64)	6.29 (4.57 to 8.02)	8.21 (6.47 to 9.95)	8.55 (6.83 to 10.27)
MCS at Week 8	4.24 (0.69 to 7.78)	5.18 (2.72 to 7.64)	9.72 (7.22 to 12.22)	9.41 (6.79 to 12.03)	5.22 (2.70 to 7.75)	8.04 (5.48 to 10.61)	10.01 (7.47 to 12.55)

No statistical analyses for this end point

Secondary: Induction Period: Changes from baseline in EuroQoL-5 Dimensions at Weeks 4 and 8

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End point title

Induction Period: Changes from baseline in EuroQoL-5 Dimensions at Weeks 4 and 8

End point description

For EQ-5D 3L, participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. For utility score, participants rated their current health state on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total score range of 0.05 to 1.00; higher scores indicating a better health state. The EQ-5D VAS records the respondent’s self rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).

End point type

Secondary

End point timeframe

Weeks 4 and 8

End point values	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)
Number of subjects analysed	25	51	49	50	48	47	47
Units: Units on a scale
least squares mean (confidence interval 90%)
EQ5D01-Index Value at week 4	0.11 (0.06 to 0.16)	0.07 (0.04 to 0.11)	0.12 (0.09 to 0.15)	0.13 (0.10 to 0.17)	0.07 (0.03 to 0.10)	0.11 (0.08 to 0.14)	0.12 (0.09 to 0.15)
EQ5D01-Index Value at Week 8	0.08 (0.03 to 0.13)	0.08 (0.05 to 0.12)	0.15 (0.11 to 0.18)	0.15 (0.12 to 0.19)	0.09 (0.05 to 0.13)	0.13 (0.10 to 0.17)	0.14 (0.11 to 0.18)
EQ5D01-EQ VAS Score at Week 4	8.41 (2.18 to 14.63)	13.6 (9.20 to 18.00)	16.35 (11.96 to 20.74)	17.45 (12.88 to 22.02)	10.48 (6.04 to 14.92)	12.24 (7.72 to 16.77)	14.44 (9.90 to 18.97)
EQ5D01-EQ VAS Score at Week 8	13.17 (6.48 to 19.85)	13.11 (8.48 to 17.74)	18.88 (14.17 to 23.60)	22.54 (17.60 to 27.49)	10.35 (5.58 to 15.12)	17.11 (12.28 to 21.94)	20.01 (15.21 to 24.81)

No statistical analyses for this end point

Secondary: Induction Period: Number of subjects with Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and with withdrawals due to adverse events (All-Causalities)

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End point title

Induction Period: Number of subjects with Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and with withdrawals due to adverse events (All-Causalities)

End point description

End point type

Secondary

End point timeframe

Baseline, Week 8

End point values	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)
Number of subjects analysed	25	51	49	50	48	47	47
Units: Subjects
Subjects with AEs	13	23	21	21	19	26	23
Subjects with SAEs	0	3	0	3	1	3	1
Subjects with severe AEs	0	2	0	1	0	1	1
Subjects discontinued from study due to AEs	0	5	0	5	1	2	1

No statistical analyses for this end point

Secondary: Induction Period: Number of subjects with Laboratory Abnormalities without regard to baseline values - Hematology

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End point title

Induction Period: Number of subjects with Laboratory Abnormalities without regard to baseline values - Hematology

End point description

Following parameters were analyzed for laboratory examination: hemoglobin,hematocrit, erythrocytes, reticulocytes, ery. Mean Corpuscular Volume, platelets, Reticulocytes/Erythrocytes, Leukocytes, Lymphocytes,Neutrophils, Basophils, Eosinophils,Monocytes, Activated Partial Thromboplastin Time, Prothrombin Time,Prothrombin Intl. Normalized Ratio.The ITT analysis set was used to analyze this endpoint, defined as all randomized subjects who received at least 1 dose of investigational product or placebo.

End point type

Secondary

End point timeframe

Baseline, Week 8

End point values	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)
Number of subjects analysed	25	51	49	50	48	47	47
Units: Subjects
Hemoglobin (g/dL)<0.8x LLN	3	2	5	9	4	4	5
Hematocrit (%)<0.8x LLN	2	0	3	4	1	1	0
Erythrocytes (10^6/mm^3)<0.8x LLN	0	0	4	3	1	1	2
Reticulocytes (ABSOLUTE) (10^3/mm^3)<0.5x LLN	0	0	0	0	0	0	0
Reticulocytes (ABSOLUTE) (10^3/mm^3)>1.5x ULN	1	1	2	2	0	0	0
Ery. Mean Corpuscular Volume (10^-15L)<0.9x LLN	0	0	0	0	0	0	0
Ery. Mean Corpuscular Volume (10^-15L)>1.1x ULN	0	0	0	0	0	0	0
Platelets (10^3/mm^3)<0.5x LLN	0	0	0	0	0	0	0
Platelets (10^3/mm^3)>1.75x ULN	1	0	0	0	2	2	5
Reticulocytes/Erythrocytes (%)<0.5x LLN	0	0	0	0	0	0	0
Reticulocytes/Erythrocytes (%)>1.5x ULN	1	2	3	3	0	0	2
Leukocytes (10^3/mm^3)<0.6x LLN	0	0	0	0	1	0	0
Leukocytes (10^3/mm^3)>1.5x ULN	0	3	0	3	2	2	1
Lymphocytes (ABSOLUTE) (10^3/mm^3)<0.8x LLN	3	2	4	11	2	1	2
Lymphocytes (ABSOLUTE) (10^3/mm^3)>1.2x ULN	0	1	0	0	1	1	1
Neutrophils (ABSOLUTE) (10^3/mm^3)<0.8x LLN	1	0	0	0	2	3	2
Neutrophils (ABSOLUTE) (10^3/mm^3)>1.2x ULN	7	13	7	9	7	7	11
Basophils (ABSOLUTE) (10^3/mm^3)>1.2x ULN	0	0	1	0	1	1	0
Eosinophils (ABSOLUTE) (10^3/mm^3)>1.2x ULN	2	3	1	1	1	3	2
Monocytes (ABSOLUTE) (10^3/mm^3)>1.2x ULN	2	2	0	2	1	1	2
Activated Partial Thromboplastin Time>1.1x ULN	1	0	1	0	0	0	0
Prothrombin Time (sec)>1.1x ULN	1	2	1	1	0	0	0
Prothrombin Intl. Normalized Ratio>1.1x ULN	1	2	1	1	0	0	0

No statistical analyses for this end point

Secondary: Induction Period: Number of subjects with Laboratory Abnormalities without regard to baseline values - Clinical Chemistry

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End point title

Induction Period: Number of subjects with Laboratory Abnormalities without regard to baseline values - Clinical Chemistry

End point description

End point type

Secondary

End point timeframe

Baseline through Week 8

End point values	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)
Number of subjects analysed	25	51	48	50	48	47	47
Units: Subjects
Bilirubin (mg/dL)>1.5x ULN	0	1	0	1	2	2	1
Direct Bilirubin (mg/dL)>1.5x ULN	0	0	0	0	0	0	0
Indirect Bilirubin (mg/dL)>1.5x ULN	0	0	0	0	0	0	0
Aspartate Aminotransferase (U/L)>3.0x ULN	0	0	0	0	0	0	0
Alanine Aminotransferase (U/L)>3.0x ULN	0	0	0	0	2	0	0
Gamma Glutamyl Transferase (U/L)>3.0x ULN	0	0	0	0	0	0	0
Alkaline Phosphatase (U/L)>3.0x ULN	0	1	0	0	0	0	0
Protein (g/dL)<0.8x LLN	0	0	0	0	0	0	0
Protein (g/dL)>1.2x ULN	0	0	0	0	0	0	0
Albumin (g/dL)<0.8x LLN	0	0	0	0	0	0	0
Albumin (g/dL)>1.2x ULN	0	0	0	0	0	0	0
Urea Nitrogen (mg/dL)>1.3x ULN	0	0	0	0	0	0	0
Creatinine (mg/dL)>1.3x ULN	0	0	0	0	0	1	0
Urate (mg/dL)>1.2x ULN	0	0	1	0	0	0	0
HDL Cholesterol (mg/dL)<0.8x LLN	0	0	0	0	0	0	0
LDL Cholesterol (mg/dL)>1.2x ULN	0	0	1	0	0	0	1
Triglycerides (mg/dL)>1.3x ULN	1	1	1	3	1	2	5
Sodium (Meq/L)<0.95x LLN	0	0	0	0	0	0	0
Sodium (Meq/L)>1.05xULN	0	0	0	0	0	0	0
Potassium (Meq/L)<0.9x LLN	0	0	0	0	0	0	0
Potassium (Meq/L)>1.1x ULN	0	0	1	0	0	0	0
Chloride (Meq/L)<0.9x LLN	0	0	0	0	0	0	0
Chloride (Meq/L)>1.1x ULN	0	0	0	0	0	0	0
Calcium (mg/dL)<0.9x LLN	0	0	0	0	0	0	0
Calcium (mg/dL)>1.1x ULN	0	0	0	0	0	0	0
Glucose (mg/dL)<0.6x LLN	0	0	0	0	0	0	0
Glucose (mg/dL)>1.5x ULN	0	1	2	1	1	0	2
Hemoglobin A1C (%)>1.3x ULN	0	0	0	0	0	0	0
Creatine Kinase (U/L)>2.0x ULN	2	0	2	3	2	3	6
Cholesterol (mg/dl)>1.3x ULN	0	0	1	0	0	1	0

No statistical analyses for this end point

Secondary: Induction Period: Number of subjects with Laboratory Abnormalities without regard to baseline values - Urinalysis

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End point title

Induction Period: Number of subjects with Laboratory Abnormalities without regard to baseline values - Urinalysis

End point description

End point type

Secondary

End point timeframe

Baseline through Week 8

End point values	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)
Number of subjects analysed	25	49	48	50	48	47	47
Units: Subjects
pH (scalar)<4.5	0	0	0	0	0	0	0
pH (scalar)>8	0	0	0	0	0	0	0
URINE Glucose (No Unit)>=1	0	1	4	1	0	1	1
Ketones (No Unit)>=1	1	4	1	1	7	4	4
URINE Protein (No Unit)>=1	0	2	0	1	1	2	0
URINE Hemoglobin (No Unit)>=1	2	4	4	4	5	8	4
Nitrite (No Unit)>=1	1	1	2	1	2	0	1
Leukocyte Esterase (No Unit)>=1	3	11	4	10	7	8	14
URINE Erythrocytes (/HPF)>=20	0	0	1	1	0	0	0
URINE Leukocytes (/HPF)>=20	1	2	1	4	3	1	3
Granular Casts (/LPF)>1	1	0	0	1	0	0	0
Hyaline Casts (/LPF)>1	3	2	2	4	4	2	1
WBC Casts (/LPF)>1	0	0	1	0	0	0	0
Bacteria (No Unit)>20	0	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Induction Period: Number of subjects with abnormal electrocardiogram findings

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End point title

Induction Period: Number of subjects with abnormal electrocardiogram findings

End point description

The analysis population included all enrolled participants who received at least one dose of study medication.

End point type

Secondary

End point timeframe

Baseline through Week 8

End point values	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)
Number of subjects analysed	20	42	42	40	44	42	43
Units: Subjects
NORMAL	18	35	34	35	39	37	40
ABNORMAL, NOT CLINICALLY SIGNIFICANT	2	7	8	4	5	4	3
ABNORMAL, CLINICALLY SIGNIFICANT	0	0	0	1	0	0	0
NOT EVALUABLE	0	0	0	0	0	1	0

No statistical analyses for this end point

Secondary: Induction Period: Number of subjects with vital signs abonormalities

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End point title

Induction Period: Number of subjects with vital signs abonormalities

End point description

The criteria of test are indicated below. The analysis population are the subjects evaluated against the criteria during the induction period.

End point type

Secondary

End point timeframe

Baseline through Week 8

End point values	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)
Number of subjects analysed	25	48	48	49	47	46	45
Units: Subjects
SITTING SYSTOLIC BLOOD PRESSURE Value <90mmHg	0	1	1	0	3	0	0
SITTING SYSTOLIC BP Chg >= 30mmHg increase	0	1	3	0	0	0	3
SITTING SYSTOLIC BP Chg >= 30mmHg decrease	0	1	0	0	0	1	0
SITTING DIASTOLIC BP Value <50 mmHg	0	0	1	0	0	0	0
SITTING DIASTOLIC BP Chg >= 20mmHg increase	0	2	3	0	2	1	5
SITTING DIASTOLIC BP Chg >= 20mmHg decrease	0	4	4	2	2	1	2
SITTING PULSE RATE Value <40 bpm	0	0	0	0	0	0	0
SITTING PULSE RATE Value >120 bpm	0	1	0	0	0	0	0

No statistical analyses for this end point

Secondary: Induction Period: Number of subjects with Serious Infection

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End point title

Induction Period: Number of subjects with Serious Infection

End point description

End point type

Secondary

End point timeframe

Baseline through Week 8

End point values	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)
Number of subjects analysed	25	51	49	50	48	47	47
Units: Subjects
Listeria encephalitis	0	0	0	1	0	0	0
Pneumonia	0	1	0	0	0	0	0
Viral infection	0	1	0	0	0	0	0

No statistical analyses for this end point

Secondary: Chronic Period: Total Mayo Score at Week 32

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End point title

Chronic Period: Total Mayo Score at Week 32

End point description

The Mayo score ranges from 0 to 12, with higher scores indicating more severe disease. The mITT analysis set was used to analyze this endpoint, defined as all randomized subjects who received at least 1 dose of investigational product or placebo.

End point type

Secondary

End point timeframe

Week 32

End point values	PF-06651600 200 mg -> PF-06651600 50 mg	PF-06651600 70 mg -> PF-06651600 50 mg	PF-06651600 20 mg -> PF-06651600 50 mg	Placebo -> PF-06651600 50 mg	PF-06700841 60 mg -> PF-06700841 30 mg	PF-06700841 30 mg -> PF-06700841 30 mg	PF-06700841 10 mg -> PF-06700841 30 mg	Placebo -> PF-06700841 30 mg
Number of subjects analysed	35	36	39	10	38	37	39	9
Units: Unit on a scale
least squares mean (confidence interval 90%)	2.89 (2.18 to 3.60)	3.46 (2.77 to 4.16)	3.47 (2.75 to 4.19)	4.13 (2.82 to 5.44)	3.86 (2.98 to 4.75)	3.63 (2.67 to 4.59)	3.81 (2.94 to 4.68)	4.62 (2.62 to 6.61)

No statistical analyses for this end point

Secondary: Chronic Period: Percentage of subjects achieving remission based on total Mayo score at Week 32

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End point title

Chronic Period: Percentage of subjects achieving remission based on total Mayo score at Week 32

End point description

Remission excludes friability and is based on total Mayo score of less than/equal to 2 with no individual subscore greater than 1 and a rectal bleeding subscore of 0 at week 32.The mITT analysis set was used to analyze this endpoint, defined as all randomized subjects who received at least 1 dose of investigational product or placebo.

End point type

Secondary

End point timeframe

Week 32

End point values	mITT Analysis Set: Placebo -> PF-06651600 50 mg	mITT Analysis Set: PF-06651600 20 mg -> PF-06651600 50 mg	mITT Analysis Set: PF-06651600 70 mg -> PF-06651600 50 mg	mITT Analysis Set: PF-06651600 200 mg -> PF-06651600 50 mg	mITT Analysis Set: Placebo -> PF-06700841 30 mg	mITT Analysis Set: PF-06700841 10 mg -> PF-06700841 30 mg	mITT Analysis Set: PF-06700841 30 mg -> PF-06700841 30 mg	mITT Analysis Set: PF-06700841 60 mg -> PF-06700841 30 mg
Number of subjects analysed	12	46	42	44	11	42	41	41
Units: Percentage of subjects
number (confidence interval 90%)	16.7 (4.5 to 39.8)	23.9 (15.1 to 35.0)	28.6 (17.4 to 41.0)	34.1 (22.3 to 46.5)	18.2 (4.9 to 43.6)	21.4 (12.6 to 34.2)	26.8 (17.1 to 39.8)	26.8 (17.1 to 39.8)

No statistical analyses for this end point

Secondary: Chronic Period: Percentage of subjects achieving improvement in endoscopic appearance at Week 32

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End point title

Chronic Period: Percentage of subjects achieving improvement in endoscopic appearance at Week 32

End point description

Improvement of endoscopic appearance is defined as a Mayo endoscopic subscore of less than/equal to 1.The mITT analysis set was used to analyze this endpoint, defined as all randomized subjects who received at least 1 dose of investigational product or placebo.

End point type

Secondary

End point timeframe

Week 32

End point values	mITT Analysis Set: Placebo -> PF-06651600 50 mg	mITT Analysis Set: PF-06651600 20 mg -> PF-06651600 50 mg	mITT Analysis Set: PF-06651600 70 mg -> PF-06651600 50 mg	mITT Analysis Set: PF-06651600 200 mg -> PF-06651600 50 mg	mITT Analysis Set: Placebo -> PF-06700841 30 mg	mITT Analysis Set: PF-06700841 10 mg -> PF-06700841 30 mg	mITT Analysis Set: PF-06700841 30 mg -> PF-06700841 30 mg	mITT Analysis Set: PF-06700841 60 mg -> PF-06700841 30 mg
Number of subjects analysed	12	46	42	44	11	42	41	41
Units: Percentage of subjects
number (confidence interval 90%)	33.3 (15.4 to 60.2)	26.1 (15.8 to 37.7)	40.5 (27.7 to 54.3)	34.1 (22.3 to 46.5)	18.2 (4.9 to 43.6)	31.0 (19.4 to 43.3)	34.1 (23.0 to 46.9)	36.6 (24.6 to 50.0)

No statistical analyses for this end point

Other pre-specified: Chronic Period: Change from baseline in total Mayo score

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End point title

Chronic Period: Change from baseline in total Mayo score

End point description

Total Mayo Score ranges from 0 to 12, with higher scores indicating more severe disease. Baseline value is defined as the last non-missing measurement collected prior to the first administration of study drug at Day 1. The mITT analysis set was used to analyze this endpoint, defined as all randomized subjects who received at least 1 dose of investigational product or placebo.

End point type

Other pre-specified

End point timeframe

Week 32

End point values	PF-06651600 200 mg -> PF-06651600 50 mg	PF-06651600 70 mg -> PF-06651600 50 mg	PF-06651600 20 mg -> PF-06651600 50 mg	Placebo -> PF-06651600 50 mg	PF-06700841 60 mg -> PF-06700841 30 mg	PF-06700841 30 mg -> PF-06700841 30 mg	PF-06700841 10 mg -> PF-06700841 30 mg	Placebo -> PF-06700841 30 mg
Number of subjects analysed	35	36	39	10	38	37	39	9
Units: Units on a scale
least squares mean (confidence interval 90%)	-6.12 (-6.83 to -5.41)	-5.55 (-6.24 to -4.85)	-5.54 (-6.26 to -4.82)	-4.88 (-6.19 to -3.57)	-5.21 (-6.09 to -4.32)	-5.44 (-6.39 to -4.48)	-5.26 (-6.12 to -4.39)	-4.45 (-6.45 to -2.45)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From the time the subject took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

24.0

Reporting group title

Placebo (Induction: 0 to 8 weeks)

Reporting group description

The placebo was administered orally once daily (QD) from Day 1 to Week 8.

Reporting group title

PF-06651600 20 mg (Induction)

Reporting group description

PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.

Reporting group title

PF-06651600 70 mg (Induction)

Reporting group description

PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.

Reporting group title

PF-06651600 200 mg (Induction)

Reporting group description

PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.

Reporting group title

PF-06700841 10 mg (Induction)

Reporting group description

PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.

Reporting group title

PF-06700841 30 mg (Induction)

Reporting group description

PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.

Reporting group title

PF-06700841 60 mg (Induction)

Reporting group description

PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.

Reporting group title

PF-06651600 200 mg -> PF-06651600 50 mg

Reporting group description

PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.

Reporting group title

Placebo -> PF-06651600 50 mg

Reporting group description

The placebo was administered orally QD from Day 1 to Week 8 and PF-06651600 was administered at 50 mg QD from Week 9 to Week 32.

Reporting group title

PF-06651600 20 mg -> PF-06651600 50 mg

Reporting group description

PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.

Reporting group title

PF-06651600 70 mg -> PF-06651600 50 mg

Reporting group description

PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.

Reporting group title

PF-06700841 60 mg -> PF-06700841 30 mg

Reporting group description

PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.

Reporting group title

Placebo -> PF-06700841 30 mg

Reporting group description

The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.

Reporting group title

PF-06700841 10 mg -> PF-06700841 30 mg

Reporting group description

PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.

Reporting group title

PF-06700841 30 mg -> PF-06700841 30 mg

Reporting group description

PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.

Reporting group title

Pooling Placebo During Chronic

Reporting group description

The placebo was administered orally QD from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.

Placebo (Induction: 0 to 8 weeks)

PF-06651600 20 mg (Induction)

PF-06651600 70 mg (Induction)

PF-06651600 200 mg (Induction)

PF-06700841 10 mg (Induction)

PF-06700841 30 mg (Induction)

PF-06700841 60 mg (Induction)

PF-06651600 200 mg -> PF-06651600 50 mg

Placebo -> PF-06651600 50 mg

PF-06651600 20 mg -> PF-06651600 50 mg

PF-06651600 70 mg -> PF-06651600 50 mg

PF-06700841 60 mg -> PF-06700841 30 mg

Placebo -> PF-06700841 30 mg

PF-06700841 10 mg -> PF-06700841 30 mg

PF-06700841 30 mg -> PF-06700841 30 mg

Pooling Placebo During Chronic

Total subjects affected by serious adverse events

subjects affected / exposed

0 / 25 (0.00%)

3 / 51 (5.88%)

0 / 49 (0.00%)

3 / 50 (6.00%)

1 / 48 (2.08%)

3 / 47 (6.38%)

1 / 47 (2.13%)

3 / 35 (8.57%)

0 / 10 (0.00%)

1 / 39 (2.56%)

1 / 36 (2.78%)

2 / 38 (5.26%)

0 / 9 (0.00%)

2 / 39 (5.13%)

4 / 37 (10.81%)

0 / 37 (0.00%)

number of deaths (all causes)

number of deaths resulting from adverse events

Injury, poisoning and procedural complications

Ankle injury

Additional description: Ankle fracture

subjects affected / exposed

0 / 25 (0.00%)

0 / 51 (0.00%)

0 / 49 (0.00%)

0 / 50 (0.00%)

0 / 48 (0.00%)

0 / 47 (0.00%)

1 / 35 (2.86%)

0 / 10 (0.00%)

0 / 39 (0.00%)

0 / 36 (0.00%)

0 / 38 (0.00%)

0 / 9 (0.00%)

0 / 39 (0.00%)

0 / 37 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Fracture bone

Additional description: Femur fracture

subjects affected / exposed

0 / 25 (0.00%)

0 / 51 (0.00%)

0 / 49 (0.00%)

0 / 50 (0.00%)

0 / 48 (0.00%)

0 / 47 (0.00%)

1 / 35 (2.86%)

0 / 10 (0.00%)

0 / 39 (0.00%)

0 / 36 (0.00%)

0 / 38 (0.00%)

0 / 9 (0.00%)

0 / 39 (0.00%)

0 / 37 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vascular disorders

Peripheral vasoconstriction, necrosis and vascular insufficiency

Additional description: Peripheral artery thrombosis

subjects affected / exposed

0 / 25 (0.00%)

0 / 51 (0.00%)

0 / 49 (0.00%)

0 / 50 (0.00%)

0 / 48 (0.00%)

1 / 47 (2.13%)

0 / 47 (0.00%)

0 / 35 (0.00%)

0 / 10 (0.00%)

0 / 39 (0.00%)

0 / 36 (0.00%)

0 / 38 (0.00%)

0 / 9 (0.00%)

0 / 39 (0.00%)

0 / 37 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Myocardial infarction

subjects affected / exposed

0 / 25 (0.00%)

1 / 51 (1.96%)

0 / 49 (0.00%)

0 / 50 (0.00%)

0 / 48 (0.00%)

0 / 47 (0.00%)

0 / 35 (0.00%)

0 / 10 (0.00%)

0 / 39 (0.00%)

0 / 36 (0.00%)

0 / 38 (0.00%)

0 / 9 (0.00%)

0 / 39 (0.00%)

0 / 37 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

1 / 1

0 / 0

Myocardial ischemia

subjects affected / exposed

0 / 25 (0.00%)

0 / 51 (0.00%)

0 / 49 (0.00%)

0 / 50 (0.00%)

0 / 48 (0.00%)

0 / 47 (0.00%)

0 / 35 (0.00%)

0 / 10 (0.00%)

0 / 39 (0.00%)

0 / 36 (0.00%)

0 / 38 (0.00%)

0 / 9 (0.00%)

0 / 39 (0.00%)

1 / 37 (2.70%)

0 / 37 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Surgical and medical procedures

Haemorrhoid

Additional description: Haemorrhoid operation

subjects affected / exposed

0 / 25 (0.00%)

0 / 51 (0.00%)

0 / 49 (0.00%)

0 / 50 (0.00%)

0 / 48 (0.00%)

1 / 47 (2.13%)

0 / 47 (0.00%)

0 / 35 (0.00%)

0 / 10 (0.00%)

0 / 39 (0.00%)

0 / 36 (0.00%)

0 / 38 (0.00%)

0 / 9 (0.00%)

0 / 39 (0.00%)

0 / 37 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Blood and lymphatic system disorders

Anaemia

subjects affected / exposed

0 / 25 (0.00%)

0 / 51 (0.00%)

0 / 49 (0.00%)

0 / 50 (0.00%)

0 / 48 (0.00%)

0 / 47 (0.00%)

1 / 47 (2.13%)

0 / 35 (0.00%)

0 / 10 (0.00%)

0 / 39 (0.00%)

0 / 36 (0.00%)

0 / 38 (0.00%)

0 / 9 (0.00%)

0 / 39 (0.00%)

0 / 37 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

General disorders and administration site conditions

Pyrexia

subjects affected / exposed

0 / 25 (0.00%)

0 / 51 (0.00%)

0 / 49 (0.00%)

0 / 50 (0.00%)

0 / 48 (0.00%)

1 / 47 (2.13%)

0 / 47 (0.00%)

0 / 35 (0.00%)

0 / 10 (0.00%)

0 / 39 (0.00%)

0 / 36 (0.00%)

0 / 38 (0.00%)

0 / 9 (0.00%)

0 / 39 (0.00%)

0 / 37 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Colitis ulcerative

subjects affected / exposed

0 / 25 (0.00%)

1 / 51 (1.96%)

0 / 49 (0.00%)

1 / 50 (2.00%)

1 / 48 (2.08%)

0 / 47 (0.00%)

0 / 35 (0.00%)

0 / 10 (0.00%)

1 / 39 (2.56%)

1 / 36 (2.78%)

1 / 38 (2.63%)

0 / 9 (0.00%)

1 / 39 (2.56%)

2 / 37 (5.41%)

0 / 37 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

1 / 1

0 / 1

1 / 1

0 / 0

0 / 1

1 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Large intestine perforation

subjects affected / exposed

0 / 25 (0.00%)

0 / 51 (0.00%)

0 / 49 (0.00%)

0 / 50 (0.00%)

0 / 48 (0.00%)

0 / 47 (0.00%)

0 / 35 (0.00%)

0 / 10 (0.00%)

0 / 39 (0.00%)

0 / 36 (0.00%)

0 / 38 (0.00%)

0 / 9 (0.00%)

0 / 39 (0.00%)

1 / 37 (2.70%)

0 / 37 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory, thoracic and mediastinal disorders

Interstitial lung fibrosis

subjects affected / exposed

0 / 25 (0.00%)

0 / 51 (0.00%)

0 / 49 (0.00%)

1 / 50 (2.00%)

0 / 48 (0.00%)

0 / 47 (0.00%)

0 / 35 (0.00%)

0 / 10 (0.00%)

0 / 39 (0.00%)

0 / 36 (0.00%)

0 / 38 (0.00%)

0 / 9 (0.00%)

0 / 39 (0.00%)

0 / 37 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Skin and subcutaneous tissue disorders

Urticaria generalised

subjects affected / exposed

0 / 25 (0.00%)

0 / 51 (0.00%)

0 / 49 (0.00%)

0 / 50 (0.00%)

0 / 48 (0.00%)

0 / 47 (0.00%)

1 / 35 (2.86%)

0 / 10 (0.00%)

0 / 39 (0.00%)

0 / 36 (0.00%)

0 / 38 (0.00%)

0 / 9 (0.00%)

0 / 39 (0.00%)

0 / 37 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal and urinary disorders

Kidney dysfunction

Additional description: Acute kidney injury

subjects affected / exposed

0 / 25 (0.00%)

0 / 51 (0.00%)

0 / 49 (0.00%)

0 / 50 (0.00%)

0 / 48 (0.00%)

0 / 47 (0.00%)

0 / 35 (0.00%)

0 / 10 (0.00%)

0 / 39 (0.00%)

0 / 36 (0.00%)

1 / 38 (2.63%)

0 / 9 (0.00%)

0 / 39 (0.00%)

0 / 37 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

Listeria encephalitis

subjects affected / exposed

0 / 25 (0.00%)

0 / 51 (0.00%)

0 / 49 (0.00%)

1 / 50 (2.00%)

0 / 48 (0.00%)

0 / 47 (0.00%)

0 / 35 (0.00%)

0 / 10 (0.00%)

0 / 39 (0.00%)

0 / 36 (0.00%)

0 / 38 (0.00%)

0 / 9 (0.00%)

0 / 39 (0.00%)

0 / 37 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia

subjects affected / exposed

0 / 25 (0.00%)

1 / 51 (1.96%)

0 / 49 (0.00%)

0 / 50 (0.00%)

0 / 48 (0.00%)

0 / 47 (0.00%)

0 / 35 (0.00%)

0 / 10 (0.00%)

0 / 39 (0.00%)

0 / 36 (0.00%)

0 / 38 (0.00%)

0 / 9 (0.00%)

0 / 39 (0.00%)

0 / 37 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Viral DNA test positive

Additional description: Viral infection

subjects affected / exposed

0 / 25 (0.00%)

1 / 51 (1.96%)

0 / 49 (0.00%)

0 / 50 (0.00%)

0 / 48 (0.00%)

0 / 47 (0.00%)

0 / 35 (0.00%)

0 / 10 (0.00%)

0 / 39 (0.00%)

0 / 36 (0.00%)

1 / 38 (2.63%)

0 / 9 (0.00%)

0 / 39 (0.00%)

0 / 37 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia viral

Additional description: COVID-19

subjects affected / exposed

0 / 25 (0.00%)

0 / 51 (0.00%)

0 / 49 (0.00%)

0 / 50 (0.00%)

0 / 48 (0.00%)

0 / 47 (0.00%)

0 / 35 (0.00%)

0 / 10 (0.00%)

0 / 39 (0.00%)

0 / 36 (0.00%)

0 / 38 (0.00%)

0 / 9 (0.00%)

1 / 39 (2.56%)

0 / 37 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolism and nutrition disorders

Dehydration

subjects affected / exposed

0 / 25 (0.00%)

0 / 51 (0.00%)

0 / 49 (0.00%)

0 / 50 (0.00%)

0 / 48 (0.00%)

0 / 47 (0.00%)

0 / 35 (0.00%)

0 / 10 (0.00%)

0 / 39 (0.00%)

0 / 36 (0.00%)

1 / 38 (2.63%)

0 / 9 (0.00%)

0 / 39 (0.00%)

0 / 37 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

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

Non-serious adverse events	Placebo (Induction: 0 to 8 weeks)	PF-06651600 20 mg (Induction)	PF-06651600 70 mg (Induction)	PF-06651600 200 mg (Induction)	PF-06700841 10 mg (Induction)	PF-06700841 30 mg (Induction)	PF-06700841 60 mg (Induction)	PF-06651600 200 mg -> PF-06651600 50 mg	Placebo -> PF-06651600 50 mg	PF-06651600 20 mg -> PF-06651600 50 mg	PF-06651600 70 mg -> PF-06651600 50 mg	PF-06700841 60 mg -> PF-06700841 30 mg	Placebo -> PF-06700841 30 mg	PF-06700841 10 mg -> PF-06700841 30 mg	PF-06700841 30 mg -> PF-06700841 30 mg	Pooling Placebo During Chronic
Total subjects affected by non serious adverse events
subjects affected / exposed	4 / 25 (16.00%)	8 / 51 (15.69%)	6 / 49 (12.24%)	5 / 50 (10.00%)	2 / 48 (4.17%)	11 / 47 (23.40%)	9 / 47 (19.15%)	9 / 35 (25.71%)	8 / 10 (80.00%)	11 / 39 (28.21%)	21 / 36 (58.33%)	15 / 38 (39.47%)	4 / 9 (44.44%)	20 / 39 (51.28%)	15 / 37 (40.54%)	15 / 37 (40.54%)
Vascular disorders
Hypertension
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	2 / 10 (20.00%)	0 / 39 (0.00%)	4 / 36 (11.11%)	0 / 38 (0.00%)	0 / 9 (0.00%)	2 / 39 (5.13%)	1 / 37 (2.70%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	4	0	0	2	1	0
General disorders and administration site conditions
Feeling hot
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	1 / 10 (10.00%)	0 / 39 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 9 (0.00%)	0 / 39 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0
Feeling bad
Additional description: Influenza like illness
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	0 / 10 (0.00%)	0 / 39 (0.00%)	2 / 36 (5.56%)	0 / 38 (0.00%)	0 / 9 (0.00%)	0 / 39 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0
Oedema peripheral
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	1 / 10 (10.00%)	0 / 39 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 9 (0.00%)	0 / 39 (0.00%)	1 / 37 (2.70%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0	0	0	0	1	0
Pyrexia
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	1 / 35 (2.86%)	1 / 10 (10.00%)	1 / 39 (2.56%)	2 / 36 (5.56%)	1 / 38 (2.63%)	1 / 9 (11.11%)	2 / 39 (5.13%)	0 / 37 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	0	0	1	1	1	2	1	1	2	0	1
Swelling face
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	1 / 35 (2.86%)	1 / 10 (10.00%)	0 / 39 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 9 (0.00%)	0 / 39 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	0 / 10 (0.00%)	0 / 39 (0.00%)	0 / 36 (0.00%)	2 / 38 (5.26%)	0 / 9 (0.00%)	0 / 39 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0
Rhinorrhoea
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	0 / 10 (0.00%)	0 / 39 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	1 / 9 (11.11%)	0 / 39 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Psychiatric disorders
Anxiety
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	0 / 10 (0.00%)	0 / 39 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	1 / 9 (11.11%)	0 / 39 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0
Irritable mood
Additional description: Irritability
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	0 / 10 (0.00%)	0 / 39 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	1 / 9 (11.11%)	0 / 39 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Investigations
Blood creatine phosphokinase increased
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	0 / 10 (0.00%)	1 / 39 (2.56%)	1 / 36 (2.78%)	1 / 38 (2.63%)	0 / 9 (0.00%)	3 / 39 (7.69%)	3 / 37 (8.11%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	1	1	0	4	3	0
Blood urine present
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	0 / 10 (0.00%)	0 / 39 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 9 (0.00%)	2 / 39 (5.13%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0
Urine protein, quantitative
Additional description: Protein urine present
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	0 / 10 (0.00%)	0 / 39 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 9 (0.00%)	2 / 39 (5.13%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0
Nervous system disorders
Headache
subjects affected / exposed	2 / 25 (8.00%)	3 / 51 (5.88%)	3 / 49 (6.12%)	0 / 50 (0.00%)	1 / 48 (2.08%)	4 / 47 (8.51%)	0 / 47 (0.00%)	0 / 35 (0.00%)	2 / 10 (20.00%)	0 / 39 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 9 (0.00%)	2 / 39 (5.13%)	1 / 37 (2.70%)	1 / 37 (2.70%)
occurrences all number	3	3	6	0	1	4	0	0	7	0	0	1	0	2	1	1
Sciatca
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	0 / 10 (0.00%)	0 / 39 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	1 / 9 (11.11%)	0 / 39 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	1 / 25 (4.00%)	1 / 51 (1.96%)	2 / 49 (4.08%)	4 / 50 (8.00%)	1 / 48 (2.08%)	1 / 47 (2.13%)	4 / 47 (8.51%)	1 / 35 (2.86%)	1 / 10 (10.00%)	0 / 39 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	1 / 9 (11.11%)	2 / 39 (5.13%)	0 / 37 (0.00%)	2 / 37 (5.41%)
occurrences all number	1	1	2	4	1	1	4	1	1	0	0	1	1	2	0	2
Ear and labyrinth disorders
Hearing loss unilateral
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	2 / 10 (20.00%)	1 / 39 (2.56%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 9 (0.00%)	0 / 39 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	2	0	0	0	0	0	0
Eye disorders
Visual field tests abnormal
Additional description: Visual impairment
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	1 / 10 (10.00%)	0 / 39 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 9 (0.00%)	0 / 39 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	2 / 25 (8.00%)	1 / 51 (1.96%)	1 / 49 (2.04%)	0 / 50 (0.00%)	0 / 48 (0.00%)	2 / 47 (4.26%)	2 / 47 (4.26%)	0 / 35 (0.00%)	0 / 10 (0.00%)	1 / 39 (2.56%)	1 / 36 (2.78%)	1 / 38 (2.63%)	0 / 9 (0.00%)	2 / 39 (5.13%)	1 / 37 (2.70%)	1 / 37 (2.70%)
occurrences all number	2	1	1	0	0	2	2	0	0	1	1	1	0	2	2	1
Anal exam abnormal
Additional description: Anal fissure
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	0 / 10 (0.00%)	0 / 39 (0.00%)	2 / 36 (5.56%)	0 / 38 (0.00%)	0 / 9 (0.00%)	0 / 39 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0
Ulcerative colitis
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	4 / 35 (11.43%)	3 / 10 (30.00%)	4 / 39 (10.26%)	5 / 36 (13.89%)	2 / 38 (5.26%)	1 / 9 (11.11%)	6 / 39 (15.38%)	2 / 37 (5.41%)	8 / 37 (21.62%)
occurrences all number	0	0	0	0	0	0	0	5	3	4	6	2	1	6	2	8
Diarrhoea
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	1 / 35 (2.86%)	2 / 10 (20.00%)	0 / 39 (0.00%)	2 / 36 (5.56%)	1 / 38 (2.63%)	0 / 9 (0.00%)	0 / 39 (0.00%)	2 / 37 (5.41%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	2	0	3	1	0	0	2	0
Nausea
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	0 / 10 (0.00%)	0 / 39 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 9 (0.00%)	0 / 39 (0.00%)	2 / 37 (5.41%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	2	0
Flatulence
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	0 / 10 (0.00%)	2 / 39 (5.13%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 9 (0.00%)	0 / 39 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	1	0	0	0	0	0
Dyspepsia
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	1 / 10 (10.00%)	0 / 39 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 9 (0.00%)	1 / 39 (2.56%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	2	0	0	1	0	0
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	1 / 35 (2.86%)	1 / 10 (10.00%)	0 / 39 (0.00%)	0 / 36 (0.00%)	2 / 38 (5.26%)	0 / 9 (0.00%)	1 / 39 (2.56%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	1	0	0	2	0	1	0	0
Alopecia
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	1 / 35 (2.86%)	1 / 10 (10.00%)	1 / 39 (2.56%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 9 (0.00%)	0 / 39 (0.00%)	1 / 37 (2.70%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	1	1	1	0	0	0	1	0
Dermatitis atopic
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	1 / 10 (10.00%)	0 / 39 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 9 (0.00%)	0 / 39 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Rash
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	1 / 35 (2.86%)	1 / 10 (10.00%)	1 / 39 (2.56%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 9 (0.00%)	0 / 39 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	1	1	0	0	0	0	0	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 25 (0.00%)	2 / 51 (3.92%)	1 / 49 (2.04%)	0 / 50 (0.00%)	1 / 48 (2.08%)	3 / 47 (6.38%)	1 / 47 (2.13%)	2 / 35 (5.71%)	1 / 10 (10.00%)	0 / 39 (0.00%)	1 / 36 (2.78%)	2 / 38 (5.26%)	0 / 9 (0.00%)	4 / 39 (10.26%)	1 / 37 (2.70%)	1 / 37 (2.70%)
occurrences all number	0	2	1	0	1	3	1	3	1	0	1	2	0	5	1	1
Arthritis
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	1 / 10 (10.00%)	0 / 39 (0.00%)	1 / 36 (2.78%)	0 / 38 (0.00%)	0 / 9 (0.00%)	0 / 39 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0
Contracture of palmar fascia
Additional description: Dupuytren's contracture
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	1 / 10 (10.00%)	0 / 39 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 9 (0.00%)	0 / 39 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Osteoarthritis
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	2 / 10 (20.00%)	0 / 39 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 9 (0.00%)	1 / 39 (2.56%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0	0	0	1	0	0
Pain
Additional description: Pain in extremity
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	1 / 10 (10.00%)	0 / 39 (0.00%)	1 / 36 (2.78%)	1 / 38 (2.63%)	0 / 9 (0.00%)	0 / 39 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	1	1	0	0	0	0
Infections and infestations
Nasopharyngitis
subjects affected / exposed	0 / 25 (0.00%)	2 / 51 (3.92%)	0 / 49 (0.00%)	1 / 50 (2.00%)	0 / 48 (0.00%)	5 / 47 (10.64%)	3 / 47 (6.38%)	1 / 35 (2.86%)	0 / 10 (0.00%)	0 / 39 (0.00%)	1 / 36 (2.78%)	4 / 38 (10.53%)	1 / 9 (11.11%)	2 / 39 (5.13%)	5 / 37 (13.51%)	4 / 37 (10.81%)
occurrences all number	0	2	0	1	0	5	3	1	0	0	1	5	2	3	7	5
COVID-19
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	0 / 10 (0.00%)	2 / 39 (5.13%)	1 / 36 (2.78%)	1 / 38 (2.63%)	0 / 9 (0.00%)	2 / 39 (5.13%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	1	1	0	2	0	0
Conjunctivitis
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	1 / 10 (10.00%)	0 / 39 (0.00%)	0 / 36 (0.00%)	1 / 38 (2.63%)	0 / 9 (0.00%)	0 / 39 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0
Herpes zoster
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	0 / 10 (0.00%)	0 / 39 (0.00%)	3 / 36 (8.33%)	0 / 38 (0.00%)	0 / 9 (0.00%)	1 / 39 (2.56%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	3	0	0	1	0	0
Influenza
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	0 / 10 (0.00%)	2 / 39 (5.13%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 9 (0.00%)	0 / 39 (0.00%)	1 / 37 (2.70%)	1 / 37 (2.70%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0	0	0	0	1	1
Urinary tract infection
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	1 / 10 (10.00%)	0 / 39 (0.00%)	0 / 36 (0.00%)	2 / 38 (5.26%)	0 / 9 (0.00%)	1 / 39 (2.56%)	0 / 37 (0.00%)	2 / 37 (5.41%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	2	0	1	0	2
Metabolism and nutrition disorders
Hypermatraemia
subjects affected / exposed	0 / 25 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 50 (0.00%)	0 / 48 (0.00%)	0 / 47 (0.00%)	0 / 47 (0.00%)	0 / 35 (0.00%)	1 / 10 (10.00%)	0 / 39 (0.00%)	0 / 36 (0.00%)	0 / 38 (0.00%)	0 / 9 (0.00%)	0 / 39 (0.00%)	0 / 37 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

27 Oct 2016

In the Schedule of Activities, Section 6 Study Procedures, and Section 7.2.12 Audiogram, added audiogram assessments at regular intervals. In the Schedule of Activities and Section 6 Study Procedures, added Serum Cystatin C (and eGFR) at all time points. In the Schedule of Activities, Section 6.5 Guidelines for Monitoring and Discontinuations, Section 7.2.2 Creatinine and Cystatin C, and Section 8.4.3 Potential Cases of Decreased eGFR, removed statement that a creatinine increase above the ULN will trigger a reflex test for serum cystatin-C in order to facilitate both serum cystatin-C based, and serum creatinine based eGFR calculation. Section 7.2.2 Creatinine and Cystatin C, clarified that creatinine elevations above the ULN will be followed until resolution or baseline. In the Schedule of Activities and Section 6 Study Procedures, added that the screening urinalysis will include a spot urine albumin/creatinine ratio. In the Schedule of Activities, Section 5.3, Subject Compliance, Section 5.5, Administration, and Section 6, Study Procedures, removed reference to subject dosing diary. In the Schedule of Activities, Section 2, Study Objectives and Endpoints, Section 6 Study Procedures, and Section 7.3.5 Ulcerative Colitis Endoscopic Index of Severity, added UCEIS evaluation at same time points as Mayo score. Changes were made in Section 4.1, 4.2 to provide updates in inclusion and exclusion criterion. Section 5.8.1, Oral Corticosteroids, removed requirement for subject to record oral corticosteroids on a daily diary. Section 6.5, Guidelines for Monitoring and Discontinuations, added that treatment with investigational product will be discontinued and subject withdrawn from the study if there is an AST or ALT elevation ≥3 times the upper limit of normal with an INR >1.5.

14 Mar 2017

Changes were made in Section 4.1, 4.2 to provide updates in inclusion and exclusion criterion. Section 5.2, Breaking the Blind is revised to state that discussion with a member of the study team in advance of unblinding is not required. Section 5.8.3, Prohibited Medications revised to prohibit any live (attenuated) vaccines from 30 days prior to baseline and through the end of study (Week 36). Section 5.8.4, Vaccinations is added. Section 6.5, Guidelines for Monitoring and Discontinuations revised to state that an absolute neutrophil count <1.0x 109/L (<1000/mm3) or platelet count <75x 109/L (<75,000/mm3) or lymphocyte count <500/mm3 (<0.5x109/L) must be repeated as soon as feasible and within 3 days. Section 6.5, Guidelines for Monitoring and Discontinuations, added criteria to state that subjects who are inadequately responding to investigational product in the opinion of the investigator should be withdrawn from the study.Section 7.2.13, Electrocardiogram revised to include a statement defining QTc prolongations. Section 9.5, Interim Analysis is revised to incorporate futility stopping guidelines and remove reference to re-estimation of sample size.

05 Apr 2017

Changes were made in Section 1.2.1 to provide clarification for Non-Clinical Pharmacokinetics and Metabolism of PF-06651600. Changes were made in Section 4.1 and 4.2 to provide clarification and update for inclusion and exclusion criterion. Section 5.5, Administration, revised to note that for study visit days (ie, baseline, Weeks 2, 4, 8, 12, 16, 20, and 24), to highlight that on visits where dosing is at the clinic, subjects are to take the dose at the clinic and from their current blister card or bottle. Section 6.1, Screening, Section 6.2.1, Baseline/(Week 0, Day 1), Section 7.3.1, Endoscopy and Schedule of Activities footnote w, revised to clarify that the stool frequency, rectal bleeding and centrally read endoscopy subscores from the screening endoscopy and the PGA obtained at baseline are used to determine eligibility. Section 7.4.6, Stool Samples for Microbiome Analysis revised to indicate sequencing of DNA present in the stool will be performed to better understand disease activity and response to therapy. During this process some human DNA may be inadvertently sequenced, but will not be used for the final microbiome analysis. Appendix 8, France Appendix added to capture operational items not included in the mandatory contract format for France (ie, French “Contrat Unique”). Administrative changes and sentence revisions made throughout the document.

06 Mar 2018

Changes were made in Sction 4.2 Exclusion Crierion to provide clarification, consistency within protocol and remove redundancy. Section 7.2.12 Audiogram Testing: Clarification was provided that results of the audiogram test must be available by the time of the following clinic visit. Gene expression analysis was moved from Section 7.6.1 to Section 7.4.7 of the protocol.Several additional minor editorial changes were made to protocol language for the purposes of improving clarity and readability and for maintaining consistency throughout the document.

16 Aug 2018

Changes were made in Background and rationale to align with Investigator Brochure. In Protocol Summary, Schedule of Activities (SoA), Section 1 Introduction, Section 2 Study Objectives and Endpoints, Section 3 Study Design, Section 6 Study Procedures, and Section 9 Data Analysis/Statistical Methods, placebo treatment has been removed from the chronic dosing period. Various changes were made to SoA footnote to provide clarification of specific examinations.

17 Sep 2020

Changes were made in protocol summary,Schedule of Activities, Section 6.1, Section 7 and Section 7.3.6 To provide guidance on study conduct during public emergencies including COVID-19.Schedule of Activities Footnote “d” and Section 7.2.11 updated to clarify that breast and external genitalia examination as a part of physical exam is optional, but skin examination should include a visual examination of the breast and external genitalia to assess rashes. Changes were made in Section 1.3, 1.4, 4.3.1 to align with Investigator Brochure.Section 2: Objectives and Endpoints listed separately for the Induction and Chronic dosing periods. Safety Endpoints for Induction and Chronic dosing periods updated to include laboratory abnormalites, vital signs and 12-lead ECG.Section 4.1 Inclusion criteria #6, Section 5.8.2 and Appendix 1: Updated to reference Steroid conversion table in Appendix 9.Section 4.2: Exclusion criterion #14 updated to exclude re-testing of a positive IGRA test even though protocol states that all screening labs with abnormal results may be repeated within the screening window to confirm abnormal results.Section 5.4.2: Updated to include reference to Appendix 10 on alternative measures during public emergencies.Section 6.5 (Guidelines for Monitoring and Discontinuations): Added Lymphocytes <800/mm3; <0.8 x 109/L and CK >3x ULN as additional labs to monitor.Section 7.2.6 updated to allow central lab to replace QuantiFERON®-TB Gold test (QFT-G), QuantiFERON®-TB Gold In-Tube test (QFT-GIT) and T-SPOT® TB test with other acceptable QFT tests.Section 7.2.12 updated to indicate that audiogram results maybe reviewed by an external audiologist.Section 7.3.1: updated to indicate that a Colonoscopy should not be performed at the Early Termination (ET) visit if the previous colonoscopy was less than 8 weeks prior to this.

18 Nov 2020

Changes were made in protocol summary, Sections 1.3.2, 1.4.1, 1.4.2, 2.1- 2.2, 3.1, 4.2, 6.5, 7.3.3, 7.3.4, 9.1,9.2.1 and 9.2.3 with the rational of clarity and to correct grammatical errors and typographical errors, to align with the updated Investigator Brochure, and regulatory request.

Were there any global interruptions to the trial? No

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

None reported

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Clinical trials

Clinical Trial Results: A Phase 2b, Double‑Blind, Randomized, Placebo‑Controlled, Parallel Group, Dose Ranging Study of Oral PF‑06651600 and PF‑06700841 as Induction and Chronic Therapy in Subjects With Moderate to Severe Ulcerative Colitis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Induction Period: Total Mayo Score at Week 8

Primary: Induction Period: Total Mayo Score at Week 8

Primary: Chronic Period: Number of subjects with Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and with withdrawals due to adverse events

Primary: Chronic Period: Number of subjects with Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and with withdrawals due to adverse events

Primary: Chronic Period: Number of subjects with Laboratory Abnormalities without regard to baseline values - Hematology

Primary: Chronic Period: Number of subjects with Laboratory Abnormalities without regard to baseline values - Hematology

Primary: Chronic Period: Number of subjects with Laboratory Abnormalities without regard to basline values - Clinical Chemistry

Primary: Chronic Period: Number of subjects with Laboratory Abnormalities without regard to basline values - Clinical Chemistry

Primary: Chronic Period: Number of subjects with Laboratory Abnormalities without regard to basline values - Urinalysis

Primary: Chronic Period: Number of subjects with Laboratory Abnormalities without regard to basline values - Urinalysis

Primary: Chronic Period: Number of subjects with abnormal electrocardiogram findings

Primary: Chronic Period: Number of subjects with abnormal electrocardiogram findings

Primary: Chronic Period: Number of subjects with vital signs abonormalities

Primary: Chronic Period: Number of subjects with vital signs abonormalities

Primary: Chronic Period: Number of subjects with Serious Infection

Primary: Chronic Period: Number of subjects with Serious Infection

Secondary: Induction Period: Percentage of subjects achieving remission based on total Mayo score

Secondary: Induction Period: Percentage of subjects achieving remission based on total Mayo score

Secondary: Induction Period: Percentage of subjects achieving improvement in endoscopic appearance at Week 8

Secondary: Induction Period: Percentage of subjects achieving improvement in endoscopic appearance at Week 8

Secondary: Induction Period: Percentage of subjects achieving clinical response at Week 8

Secondary: Induction Period: Percentage of subjects achieving clinical response at Week 8

Secondary: Induction Period: Percentage of subjects in endoscopic remission at Week 8

Secondary: Induction Period: Percentage of subjects in endoscopic remission at Week 8

Secondary: Induction Period: Percentage of subjects in symptomatic remission at Week 8

Secondary: Induction Period: Percentage of subjects in symptomatic remission at Week 8

Secondary: Induction Period: Percentage of subjects achieving deep remission at Week 8

Secondary: Induction Period: Percentage of subjects achieving deep remission at Week 8

Secondary: Induction Period: Partial Mayo Scores and changes from baseline at Weeks 2,4,and 8

Secondary: Induction Period: Partial Mayo Scores and changes from baseline at Weeks 2,4,and 8

Secondary: Induction Period: Change from baseline in total Mayo score

Secondary: Induction Period: Change from baseline in total Mayo score

Secondary: Induction Period: Changes from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Weeks 4 and 8

Secondary: Induction Period: Changes from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Weeks 4 and 8

Secondary: Indution Period: Percentage of subjects with IBDQ total score greater than/equal to 170 at Weeks 4 and 8

Secondary: Indution Period: Percentage of subjects with IBDQ total score greater than/equal to 170 at Weeks 4 and 8

Secondary: Induction Period: Percentage of subjects with greater than/equal to 16 point increase in IBDQ total score from baseline at Weeks 4 and 8

Secondary: Induction Period: Percentage of subjects with greater than/equal to 16 point increase in IBDQ total score from baseline at Weeks 4 and 8

Secondary: Indction Period: Percentage of subjects with improvement in IBDQ bowel symptom domain at Weeks 4 and 8

Secondary: Indction Period: Percentage of subjects with improvement in IBDQ bowel symptom domain at Weeks 4 and 8

Secondary: Induction Period: Changes from baseline in Short Form 36 version 2 (SF-36 v2) at Weeks 4 and 8

Secondary: Induction Period: Changes from baseline in Short Form 36 version 2 (SF-36 v2) at Weeks 4 and 8

Secondary: Induction Period: Changes from baseline in EuroQoL-5 Dimensions at Weeks 4 and 8

Secondary: Induction Period: Changes from baseline in EuroQoL-5 Dimensions at Weeks 4 and 8

Secondary: Induction Period: Number of subjects with Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and with withdrawals due to adverse events (All-Causalities)

Secondary: Induction Period: Number of subjects with Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and with withdrawals due to adverse events (All-Causalities)

Secondary: Induction Period: Number of subjects with Laboratory Abnormalities without regard to baseline values - Hematology

Secondary: Induction Period: Number of subjects with Laboratory Abnormalities without regard to baseline values - Hematology

Secondary: Induction Period: Number of subjects with Laboratory Abnormalities without regard to baseline values - Clinical Chemistry

Secondary: Induction Period: Number of subjects with Laboratory Abnormalities without regard to baseline values - Clinical Chemistry

Secondary: Induction Period: Number of subjects with Laboratory Abnormalities without regard to baseline values - Urinalysis

Secondary: Induction Period: Number of subjects with Laboratory Abnormalities without regard to baseline values - Urinalysis

Secondary: Induction Period: Number of subjects with abnormal electrocardiogram findings

Secondary: Induction Period: Number of subjects with abnormal electrocardiogram findings

Secondary: Induction Period: Number of subjects with vital signs abonormalities

Secondary: Induction Period: Number of subjects with vital signs abonormalities

Secondary: Induction Period: Number of subjects with Serious Infection

Secondary: Induction Period: Number of subjects with Serious Infection

Secondary: Chronic Period: Total Mayo Score at Week 32

Secondary: Chronic Period: Total Mayo Score at Week 32

Secondary: Chronic Period: Percentage of subjects achieving remission based on total Mayo score at Week 32

Secondary: Chronic Period: Percentage of subjects achieving remission based on total Mayo score at Week 32

Secondary: Chronic Period: Percentage of subjects achieving improvement in endoscopic appearance at Week 32

Secondary: Chronic Period: Percentage of subjects achieving improvement in endoscopic appearance at Week 32

Other pre-specified: Chronic Period: Change from baseline in total Mayo score

Other pre-specified: Chronic Period: Change from baseline in total Mayo score

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Clinical Trial Results:
A Phase 2b, Double‑Blind, Randomized, Placebo‑Controlled, Parallel Group, Dose Ranging Study of Oral PF‑06651600 and PF‑06700841 as Induction and Chronic Therapy in Subjects With Moderate to Severe Ulcerative Colitis