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Clinical Trial Results:
A Phase 2B, Multicenter, Randomized, Double-blind, Placebo-controlled Dose-ranging Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis

Summary
EudraCT number	2019-002698-74
Trial protocol	ES FR BG SK PL DE GB BE HU AT IT RO
Global end of trial date	25 Oct 2022

Results information
Results version number	v1(current)
This version publication date	07 Nov 2025
First version publication date	07 Nov 2025
Other versions

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

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Trial information

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Sponsor protocol code

XA45397

ISRCTN number

US NCT number

NCT04090411

WHO universal trial number (UTN)

Sponsor organisation name

F. Hoffmann-La Roche AG

Sponsor organisation address

Grenzacherstrasse 124, Basel, Switzerland, CH-4058

Public contact

F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com

Scientific contact

F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.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

25 Oct 2022

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

25 Oct 2022

Was the trial ended prematurely?

Main objective of the trial

The primary purpose of this study was to evaluate the safety and efficacy of PF-06480605 in participants with moderate to severe active ulcerative colitis (UC).

Protection of trial subjects

All study subjects were required to read and sign an Informed Consent Form (ICF).

Background therapy

Evidence for comparator

Actual start date of recruitment

19 Dec 2019

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 5

Country: Number of subjects enrolled

Belgium: 3

Country: Number of subjects enrolled

Bulgaria: 1

Country: Number of subjects enrolled

Germany: 5

Country: Number of subjects enrolled

Spain: 1

Country: Number of subjects enrolled

France: 6

Country: Number of subjects enrolled

United Kingdom: 3

Country: Number of subjects enrolled

Hungary: 10

Country: Number of subjects enrolled

India: 35

Country: Number of subjects enrolled

Italy: 23

Country: Number of subjects enrolled

Japan: 10

Country: Number of subjects enrolled

Mexico: 7

Country: Number of subjects enrolled

Poland: 32

Country: Number of subjects enrolled

Romania: 2

Country: Number of subjects enrolled

Russian Federation: 26

Country: Number of subjects enrolled

Serbia: 4

Country: Number of subjects enrolled

Slovakia: 7

Country: Number of subjects enrolled

Thailand: 3

Country: Number of subjects enrolled

Türkiye: 8

Country: Number of subjects enrolled

Ukraine: 26

Country: Number of subjects enrolled

United States: 24

Country: Number of subjects enrolled

South Africa: 4

Worldwide total number of subjects

245

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

232

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

A total of 246 participants with moderate to severe UC took part in the study at 114 investigative sites across 23 countries from 19 December 2019 to 25 October 2022. The study consisted of a 12-week induction period and a 40-week chronic therapy period.

Screening details

Participants were randomized in 2:2:2:2:2:3:1:1:1 to 1 of 9 treatment sequences to receive PF-06480605 50 milligrams (mg), 150 mg, 450 mg or a matched placebo during the induction & chronic therapy periods. 1 participant in PF-06480605 450 mg arm was enrolled but did not receive any treatment & hence was not presented in the subject disposition.

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

Induction Period: Placebo

Arm description

Participants received PF-06480605 matching placebo, as a subcutaneous (SC) injection, every 4 weeks (Q4W) up to Week 12.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

PF-06480605 matching placebo, as a SC injection, Q4W up to Week 12.

Induction Period: PF-06480605 50 mg

Arm description

Participants received PF-06480605, 50 mg, as a SC injection, Q4W up to Week 12.

Arm type

Experimental

Investigational medicinal product name

PF-06480605

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

PF-06480605, 50 mg, as a SC injection, Q4W up to Week 12.

Induction Period: PF-06480605 150 mg

Arm description

Participants received PF-06480605, 150 mg, as a SC injection, Q4W up to Week 12.

Arm type

Experimental

Investigational medicinal product name

PF-06480605

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

PF-06480605, 150 mg, as a SC injection, Q4W up to Week 12.

Induction Period: PF-06480605 450 mg

Arm description

Participants received PF-06480605, 450 mg, as a SC injection, Q4W up to Week 12.

Arm type

Experimental

Investigational medicinal product name

PF-06480605

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

PF-06480605, 450 mg, as a SC injection, Q4W up to Week 12.

Number of subjects in period 1	Induction Period: Placebo	Induction Period: PF-06480605 50 mg	Induction Period: PF-06480605 150 mg	Induction Period: PF-06480605 450 mg
Started	45	47	62	91
Completed	40	46	58	84
Not completed	5	1	4	7
Consent withdrawn by subject	2	-	1	4
Physician decision	-	-	1	-
Adverse Event	3	1	1	1
Lack of efficacy	-	-	1	1
Protocol deviation	-	-	-	1

Period 2 title

Chronic Period

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Placebo (Induction) to PF-06480605 (Chronic) 50 mg

Arm description

Participants who received placebo and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Arm type

Experimental

Investigational medicinal product name

PF-06480605

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52.

Placebo (Induction) to PF-06480605 (Chronic) 150 mg

Arm description

Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Arm type

Experimental

Investigational medicinal product name

PF-06480605

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52.

Placebo (Induction) to PF-06480605 (Chronic) 450 mg

Arm description

Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Arm type

Experimental

Investigational medicinal product name

PF-06480605

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52.

PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg

Arm description

Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Arm type

Experimental

Investigational medicinal product name

PF-06480605

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52.

PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg

Arm description

Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Arm type

Experimental

Investigational medicinal product name

PF-06480605

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52.

PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg

Arm description

Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Arm type

Experimental

Investigational medicinal product name

PF-06480605

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52.

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg

Arm description

Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Arm type

Experimental

Investigational medicinal product name

PF-06480605

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52.

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg

Arm description

Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Arm type

Experimental

Investigational medicinal product name

PF-06480605

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52.

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg

Arm description

Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Arm type

Experimental

Investigational medicinal product name

PF-06480605

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52.

Number of subjects in period 2 ^[1]	Placebo (Induction) to PF-06480605 (Chronic) 50 mg	Placebo (Induction) to PF-06480605 (Chronic) 150 mg	Placebo (Induction) to PF-06480605 (Chronic) 450 mg	PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Started	12	14	14	46	27	30	26	26	29
Completed	11	12	12	34	22	25	18	20	24
Not completed	1	2	2	12	5	5	8	6	5
Relocation	-	-	-	1	-	-	-	-	-
Physician decision	1	-	-	1	-	-	-	1	1
Consent withdrawn by subject	-	1	1	3	3	3	1	3	-
Adverse Event	-	1	-	3	-	-	5	1	1
Lack of efficacy	-	-	1	4	2	2	2	1	2
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: All participants who completed the induction period did not enter CTP.

Baseline characteristics

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Reporting group title

Induction Period: Placebo

Reporting group description

Participants received PF-06480605 matching placebo, as a subcutaneous (SC) injection, every 4 weeks (Q4W) up to Week 12.

Reporting group title

Induction Period: PF-06480605 50 mg

Reporting group description

Participants received PF-06480605, 50 mg, as a SC injection, Q4W up to Week 12.

Reporting group title

Induction Period: PF-06480605 150 mg

Reporting group description

Participants received PF-06480605, 150 mg, as a SC injection, Q4W up to Week 12.

Reporting group title

Induction Period: PF-06480605 450 mg

Reporting group description

Participants received PF-06480605, 450 mg, as a SC injection, Q4W up to Week 12.

Reporting group values	Induction Period: Placebo	Induction Period: PF-06480605 50 mg	Induction Period: PF-06480605 150 mg	Induction Period: PF-06480605 450 mg	Total
Number of subjects	45	47	62	91	245
Age categorical
Units: Subjects
Age Continuous
Units: years
arithmetic mean (standard deviation)	39.9 ( 12.90 )	37.8 ( 13.91 )	42.2 ( 13.02 )	41.6 ( 13.79 )	-
Sex: Female, Male
Units: participants
Female	21	19	23	36	99
Male	24	28	39	55	146
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	1	2	0	2	5
Asian	13	9	9	18	49
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	1	0	0	0	1
White	30	35	49	70	184
More than one race	0	0	0	0	0
Unknown or Not Reported	0	1	4	1	6
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	2	3	2	3	10
Not Hispanic or Latino	42	43	55	86	226
Unknown or Not Reported	1	1	5	2	9

End points

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Reporting group title

Induction Period: Placebo

Reporting group description

Participants received PF-06480605 matching placebo, as a subcutaneous (SC) injection, every 4 weeks (Q4W) up to Week 12.

Reporting group title

Induction Period: PF-06480605 50 mg

Reporting group description

Participants received PF-06480605, 50 mg, as a SC injection, Q4W up to Week 12.

Reporting group title

Induction Period: PF-06480605 150 mg

Reporting group description

Participants received PF-06480605, 150 mg, as a SC injection, Q4W up to Week 12.

Reporting group title

Induction Period: PF-06480605 450 mg

Reporting group description

Participants received PF-06480605, 450 mg, as a SC injection, Q4W up to Week 12.

Reporting group title

Placebo (Induction) to PF-06480605 (Chronic) 50 mg

Reporting group description

Participants who received placebo and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Reporting group title

Placebo (Induction) to PF-06480605 (Chronic) 150 mg

Reporting group description

Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Reporting group title

Placebo (Induction) to PF-06480605 (Chronic) 450 mg

Reporting group description

Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Reporting group title

PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg

Reporting group description

Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Reporting group title

PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg

Reporting group description

Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Reporting group title

PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg

Reporting group description

Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Reporting group title

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg

Reporting group description

Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Reporting group title

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg

Reporting group description

Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Reporting group title

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg

Reporting group description

Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Primary: Induction Period: Percentage of Participants Who Achieved Clinical Remission at Week 14

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End point title

Induction Period: Percentage of Participants Who Achieved Clinical Remission at Week 14

End point description

Clinical remission was defined as total Mayo Score ≤2, with no individual subscore >1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 – 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and physician's global assessment (PGA) subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number. Evaluable population ITT included all participants randomly assigned to investigational product (IP) and who took at least one dose of IP in induction period. Participants were analyzed according to the product they received. Number analyzed is the number of participants with data available for analysis.

End point type

Primary

End point timeframe

At Week 14

End point values	Induction Period: Placebo	Induction Period: PF-06480605 50 mg	Induction Period: PF-06480605 150 mg	Induction Period: PF-06480605 450 mg
Number of subjects analysed	43	47	60	88
Units: percentage of participants
number (confidence interval 90%)	11.6 (5.77 to 22.88)	25.5 (15.44 to 37.19)	23.3 (14.98 to 33.98)	23.9 (16.58 to 32.06)

Placebo vs PF-06480605 50 mg

Comparison groups

Induction Period: Placebo v Induction Period: PF-06480605 50 mg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0545 ^[1]

Method

Chan and Zhang Method

Parameter type

Risk difference (RD)

Point estimate

13.9

Confidence interval

level

90%

sides

2-sided

lower limit

-0.2

upper limit

27.65

Notes
[1] - One-sided P-value

Placebo vs PF-06480605 450 mg

Comparison groups

Induction Period: Placebo v Induction Period: PF-06480605 450 mg

Number of subjects included in analysis

131

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0642 ^[2]

Method

Chan and Zhang Method

Parameter type

Risk difference (RD)

Point estimate

12.24

Confidence interval

level

90%

sides

2-sided

lower limit

-0.64

upper limit

22.91

Notes
[2] - One-sided P-value

Placebo vs PF-06480605 150 mg

Comparison groups

Induction Period: Placebo v Induction Period: PF-06480605 150 mg

Number of subjects included in analysis

103

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0823 ^[3]

Method

Chan and Zhang Method

Parameter type

Risk difference (RD)

Point estimate

11.71

Confidence interval

level

90%

sides

2-sided

lower limit

-1.7

upper limit

24.09

Notes
[3] - One-sided P-value

Primary: Induction Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

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End point title

Induction Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) ^[4]

End point description

TEAEs was defined as all events that started on or after the first dosing day and time, but before the last dose plus the lag time. An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Safety analysis population included all participants who received at least one dose of IP during the induction period. Participants were analyzed according to the product they received. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.

End point type

Primary

End point timeframe

From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.)

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 formal statistical analysis was planned for this study.

End point values	Induction Period: Placebo	Induction Period: PF-06480605 50 mg	Induction Period: PF-06480605 150 mg	Induction Period: PF-06480605 450 mg
Number of subjects analysed	45	47	62	91
Units: participants	25	16	29	49

No statistical analyses for this end point

Primary: Induction Period: Number of Participants With Serious Adverse Events (SAEs)

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End point title

Induction Period: Number of Participants With Serious Adverse Events (SAEs) ^[5]

End point description

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Safety analysis population included all participants who received at least one dose of IP during the induction period. Participants were analyzed according to the product they received. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.

End point type

Primary

End point timeframe

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 formal statistical analysis was planned for this study.

End point values	Induction Period: Placebo	Induction Period: PF-06480605 50 mg	Induction Period: PF-06480605 150 mg	Induction Period: PF-06480605 450 mg
Number of subjects analysed	45	47	62	91
Units: participants	4	3	1	4

No statistical analyses for this end point

Primary: Induction Period: Number of Participants With AEs or SAEs Leading to Discontinuation

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End point title

Induction Period: Number of Participants With AEs or SAEs Leading to Discontinuation ^[6]

End point description

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal lab finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Participants who had an AE/SAE that led to study discontinuation have been reported here. Safety Population: All participants who took >=1 dose of IP during induction. Participants were analyzed according to the product they received. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.

End point type

Primary

End point timeframe

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 formal statistical analysis was planned for this study.

End point values	Induction Period: Placebo	Induction Period: PF-06480605 50 mg	Induction Period: PF-06480605 150 mg	Induction Period: PF-06480605 450 mg
Number of subjects analysed	45	47	62	91
Units: participants	0	0	0	0

No statistical analyses for this end point

Primary: Chronic Period: Number of Participants With TEAEs

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End point title

Chronic Period: Number of Participants With TEAEs ^[7]

End point description

TEAEs was defined as all events that started on or after the first dosing day and time, but before the last dose plus the lag time. An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Evaluable population modified intent-to-treat (mITT) included all participants randomly assigned to IP who took at least one dose of IP in CPT. Participants were analyzed according to the treatment sequence they were randomized. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.

End point type

Primary

End point timeframe

From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.)

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 formal statistical analysis was planned for this study.

End point values	Placebo (Induction) to PF-06480605 (Chronic) 50 mg	Placebo (Induction) to PF-06480605 (Chronic) 150 mg	Placebo (Induction) to PF-06480605 (Chronic) 450 mg	PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Number of subjects analysed	12	14	14	46	27	30	26	26	29
Units: participants	5	9	9	30	16	15	18	18	20

No statistical analyses for this end point

Primary: Chronic Period: Number of Participants With SAEs

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End point title

Chronic Period: Number of Participants With SAEs ^[8]

End point description

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Evaluable population mITT included all participants randomly assigned to IP who took at least one dose of IP in CPT. Participants were analyzed according to the treatment sequence they were randomized. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.

End point type

Primary

End point timeframe

From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.)

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

End point values	Placebo (Induction) to PF-06480605 (Chronic) 50 mg	Placebo (Induction) to PF-06480605 (Chronic) 150 mg	Placebo (Induction) to PF-06480605 (Chronic) 450 mg	PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Number of subjects analysed	12	14	14	46	27	30	26	26	29
Units: participants	0	0	0	5	1	0	2	1	4

No statistical analyses for this end point

Primary: Chronic Period: Number of Participants With AEs or SAEs Leading to Discontinuation

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End point title

Chronic Period: Number of Participants With AEs or SAEs Leading to Discontinuation ^[9]

End point description

An AE is any untoward medical occurrence in a study participant, temporally associated with study intervention use, regardless of causality. It is any unfavorable/unintended sign (e.g., abnormal lab finding), symptom, or disease (new/exacerbated) temporally associated with study intervention. An SAE is any untoward medical occurrence that, at any dose, results in: death; is life-threatening; requires inpatient hospitalization/prolongation; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Evaluable mITT Population: All randomized participants who took >=1 dose of IP in the chronic period, analyzed per randomized treatment sequence. AE/SAE-related study discontinuations are reported here. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.

End point type

Primary

End point timeframe

From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.)

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

End point values	Placebo (Induction) to PF-06480605 (Chronic) 50 mg	Placebo (Induction) to PF-06480605 (Chronic) 150 mg	Placebo (Induction) to PF-06480605 (Chronic) 450 mg	PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Number of subjects analysed	12	14	14	46	27	30	26	26	29
Units: participants	0	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Induction and Chronic Periods: Percentage of Participants Who Achieved Remission as per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1)

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End point title

Induction and Chronic Periods: Percentage of Participants Who Achieved Remission as per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1)

End point description

Modified remission 1 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), stool frequency subscore = 0 (normal number of stools per day), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 – 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number. Evaluable ITT and mITT populations included all participants randomly assigned to IP and who took at least one dose of IP in induction and chronic, respectively. Number analyzed is the number of participants with data available for analysis.

End point type

Secondary

End point timeframe

Induction Period: At Week 14; Chronic Period: At Week 56

Induction Period: Placebo

Placebo (Induction) to PF-06480605 (Chronic) 50 mg

Induction Period: PF-06480605 50 mg

Placebo (Induction) to PF-06480605 (Chronic) 150 mg

Induction Period: PF-06480605 150 mg

Placebo (Induction) to PF-06480605 (Chronic) 450 mg

Induction Period: PF-06480605 450 mg

PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg

PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg

PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg

Number of subjects analysed

Units: percentage of participants

number (confidence interval 90%)

7.0 (2.59 to 16.96)

16.7 (4.52 to 39.84)

14.9 (8.05 to 25.12)

23.1 (8.80 to 46.97)

13.3 (6.81 to 21.83)

21.4 (8.15 to 46.00)

14.8 (9.50 to 21.77)

16.7 (9.06 to 27.68)

22.2 (10.15 to 38.16)

23.1 (10.56 to 39.84)

16.0 (7.17 to 30.73)

20.8 (10.50 to 36.99)

17.9 (8.95 to 33.31)

Placebo vs PF-06480605 50 mg

Comparison groups

Induction Period: Placebo v Induction Period: PF-06480605 50 mg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1398 ^[10]

Method

Chan and Zhang Method

Parameter type

Risk difference (RD)

Point estimate

7.92

Confidence interval

level

90%

sides

2-sided

lower limit

-3.62

upper limit

20.04

Notes
[10] - One-sided P-value

Placebo vs PF-06480605 150 mg

Comparison groups

Induction Period: Placebo v Induction Period: PF-06480605 150 mg

Number of subjects included in analysis

103

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2038 ^[11]

Method

Chan and Zhang Method

Parameter type

Risk difference (RD)

Point estimate

6.36

Confidence interval

level

90%

sides

2-sided

lower limit

-4.88

upper limit

17.06

Notes
[11] - One-sided P-value

Placebo vs PF-06480605 450 mg

Comparison groups

Induction Period: Placebo v Induction Period: PF-06480605 450 mg

Number of subjects included in analysis

131

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1498 ^[12]

Method

Chan and Zhang Method

Parameter type

Risk difference (RD)

Point estimate

7.8

Confidence interval

level

90%

sides

2-sided

lower limit

-3.7

upper limit

17.06

Notes
[12] - One-sided P-value

Secondary: Induction and Chronic Periods: Percentage of Participants Who Achieved Remission as per FDA Definition 2 (Modified Remission 2)

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End point title

Induction and Chronic Periods: Percentage of Participants Who Achieved Remission as per FDA Definition 2 (Modified Remission 2)

End point description

Modified remission 2 was defined as an endoscopic subscore = 0 (normal/inactive disease) or 1 (mild disease), >=1 point decrease from baseline to achieve a stool frequency subscore = 0 (normal number of stools per day) or 1 (1 or 2 more stools than normal), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 – 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. The four assessments were rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number. Evaluable ITT and mITT populations=all participants randomly assigned to IP and who took at least one dose of IP in induction and chronic, respectively. Number analyzed=number of participants with data available for analysis.

End point type

Secondary

End point timeframe

Induction Period: At Week 14; Chronic Period: At Week 56

Induction Period: Placebo

Placebo (Induction) to PF-06480605 (Chronic) 50 mg

Induction Period: PF-06480605 50 mg

Placebo (Induction) to PF-06480605 (Chronic) 150 mg

Induction Period: PF-06480605 150 mg

Placebo (Induction) to PF-06480605 (Chronic) 450 mg

Induction Period: PF-06480605 450 mg

PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg

PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg

PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg

Number of subjects analysed

Units: percentage of participants

number (confidence interval 90%)

11.6 (5.77 to 22.88)

50.0 (27.13 to 72.87)

29.8 (19.94 to 42.34)

30.8 (14.16 to 54.45)

35.0 (25.14 to 45.24)

35.7 (16.30 to 59.44)

31.8 (23.65 to 40.77)

31.0 (19.38 to 43.33)

33.3 (20.38 to 50.00)

38.5 (23.32 to 56.43)

28.0 (15.76 to 45.61)

33.3 (17.80 to 52.14)

35.7 (20.85 to 52.70)

Placebo vs PF-06480605 50 mg

Comparison groups

Induction Period: Placebo v Induction Period: PF-06480605 50 mg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0189 ^[13]

Method

Chan and Zhang Method

Parameter type

Risk difference (RD)

Point estimate

18.16

Confidence interval

level

90%

sides

2-sided

lower limit

3.25

upper limit

32.23

Notes
[13] - One-sided P-value

Placebo vs PF-06480605 450 mg

Comparison groups

Induction Period: Placebo v Induction Period: PF-06480605 450 mg

Number of subjects included in analysis

131

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0117 ^[14]

Method

Chan and Zhang Method

Parameter type

Risk difference (RD)

Point estimate

20.19

Confidence interval

level

90%

sides

2-sided

lower limit

3.22

upper limit

31.31

Notes
[14] - One-sided P-value

Placebo vs PF-06480605 150 mg

Comparison groups

Induction Period: Placebo v Induction Period: PF-06480605 150 mg

Number of subjects included in analysis

103

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0045 ^[15]

Method

Chan and Zhang Method

Parameter type

Risk difference (RD)

Point estimate

23.37

Confidence interval

level

90%

sides

2-sided

lower limit

6.24

upper limit

36.28

Notes
[15] - One-sided P-value

Secondary: Induction and Chronic Periods: Percentage of Participants Who Achieved Endoscopic Improvement

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End point title

Induction and Chronic Periods: Percentage of Participants Who Achieved Endoscopic Improvement

End point description

Endoscopic improvement was defined as an endoscopic subscore of 0 (Normal or inactive disease) or 1 (Mild disease [erythema, decreased vascular pattern, mild friability]) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 – 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Percentages have been rounded off to the nearest whole number. Evaluable ITT and mITT populations included all participants randomly assigned to IP and who took at least one dose of IP in induction and chronic, respectively. Number analyzed is the number of participants with data available for analysis.

End point type

Secondary

End point timeframe

Induction Period: At Week 14; Chronic Period: At Week 56

Induction Period: Placebo

Placebo (Induction) to PF-06480605 (Chronic) 50 mg

Induction Period: PF-06480605 50 mg

Placebo (Induction) to PF-06480605 (Chronic) 150 mg

Induction Period: PF-06480605 150 mg

Placebo (Induction) to PF-06480605 (Chronic) 450 mg

Induction Period: PF-06480605 450 mg

PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg

PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg

PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg

Number of subjects analysed

Units: percentage of participants

number (confidence interval 90%)

18.6 (9.61 to 30.24)

66.7 (39.84 to 84.58)

40.4 (28.33 to 53.46)

38.5 (17.28 to 62.14)

38.3 (27.81 to 48.61)

42.9 (22.38 to 64.51)

40.9 (32.06 to 50.00)

38.1 (25.56 to 51.95)

37.0 (22.12 to 54.66)

39.3 (23.83 to 56.49)

36.0 (21.43 to 54.39)

37.5 (22.08 to 55.27)

50.0 (33.31 to 66.69)

Placebo vs PF-06480605 50 mg

Comparison groups

Induction Period: Placebo v Induction Period: PF-06480605 50 mg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0146 ^[16]

Method

Chan and Zhang Method

Parameter type

Risk difference (RD)

Point estimate

21.82

Confidence interval

level

90%

sides

2-sided

lower limit

4.14

upper limit

37.3

Notes
[16] - One-sided P-value

Placebo vs PF-06480605 450 mg

Comparison groups

Induction Period: Placebo v Induction Period: PF-06480605 450 mg

Number of subjects included in analysis

131

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0094 ^[17]

Method

Chan and Zhang Method

Parameter type

Risk difference (RD)

Point estimate

22.3

Confidence interval

level

90%

sides

2-sided

lower limit

3.22

upper limit

34.95

Notes
[17] - One-sided P-value

Placebo vs PF-06480605 150 mg

Comparison groups

Induction Period: Placebo v Induction Period: PF-06480605 150 mg

Number of subjects included in analysis

103

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0167 ^[18]

Method

Chan and Zhang Method

Parameter type

Risk difference (RD)

Point estimate

19.73

Confidence interval

level

90%

sides

2-sided

lower limit

2.76

upper limit

34.05

Notes
[18] - One-sided P-value

Secondary: Induction and Chronic Periods: Percentage of Participants Who Achieved Endoscopic Remission

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End point title

Induction and Chronic Periods: Percentage of Participants Who Achieved Endoscopic Remission

End point description

Endoscopic remission was defined as an endoscopic subscore of 0 (Normal or inactive disease) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 – 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Percentages have been rounded off to the nearest whole number. Evaluable ITT and mITT populations included all participants randomly assigned to IP and who took at least one dose of IP in induction and chronic, respectively. Number analyzed is the number of participants with data available for analysis.

End point type

Secondary

End point timeframe

Induction Period: At Week 14; Chronic Period: At Week 56

Induction Period: Placebo

Placebo (Induction) to PF-06480605 (Chronic) 50 mg

Induction Period: PF-06480605 50 mg

Placebo (Induction) to PF-06480605 (Chronic) 150 mg

Induction Period: PF-06480605 150 mg

Placebo (Induction) to PF-06480605 (Chronic) 450 mg

Induction Period: PF-06480605 450 mg

PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg

PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg

PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg

Number of subjects analysed

Units: percentage of participants

number (confidence interval 90%)

7.0 (2.59 to 16.96)

16.7 (4.52 to 39.84)

19.1 (11.18 to 30.27)

23.1 (8.80 to 46.97)

10.0 (4.45 to 18.01)

28.6 (13.09 to 54.00)

10.2 (5.72 to 16.58)

11.9 (5.91 to 22.74)

7.4 (1.99 to 20.38)

7.1 (1.92 to 20.10)

16.0 (7.17 to 30.73)

8.3 (2.24 to 22.08)

21.4 (9.77 to 36.62)

Placebo vs PF-06480605 50 mg

Comparison groups

Induction Period: Placebo v Induction Period: PF-06480605 50 mg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0489 ^[19]

Method

Chan and Zhang Method

Parameter type

Risk difference (RD)

Point estimate

12.17

Confidence interval

level

90%

sides

2-sided

lower limit

0.05

upper limit

25.25

Notes
[19] - One-sided P-value

Placebo vs PF-06480605 150 mg

Comparison groups

Induction Period: Placebo v Induction Period: PF-06480605 150 mg

Number of subjects included in analysis

103

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3396 ^[20]

Method

Chan and Zhang Method

Parameter type

Risk difference (RD)

Point estimate

3.02

Confidence interval

level

90%

sides

2-sided

lower limit

-7.66

upper limit

12.88

Notes
[20] - One-sided P-value

Placebo vs PF-06480605 450 mg

Comparison groups

Induction Period: Placebo v Induction Period: PF-06480605 450 mg

Number of subjects included in analysis

131

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3995 ^[21]

Method

Chan and Zhang Method

Parameter type

Risk difference (RD)

Point estimate

3.25

Confidence interval

level

90%

sides

2-sided

lower limit

-7.42

upper limit

11.58

Notes
[21] - One-sided P-value

Secondary: Induction and Chronic Periods: Trough Concentration (Ctrough) of PF-06480605

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End point title

Induction and Chronic Periods: Trough Concentration (Ctrough) of PF-06480605 ^[22]

End point description

Pharmacokinetic (PK) population included all participants randomly assigned to IP and received at least one dose of PF-06480605 for whom at least one concentration value was reported. Number analyzed is the number of participants with data available for analysis. n = number of participants with data available for analysis at the specified timepoint. 9999 = The mean and standard deviation (SD) was not estimable as samples were below the limit of quantification (BLQ). 99999 = No participants were analyzed at the specified timepoint.

End point type

Secondary

End point timeframe

Induction Period: 30 mins postdose (PD) on Day 1, Weeks (W) 4, 8, 12 and 14; Chronic Period: 30 mins PD on Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48; End of Treatment (EOT) (W52) and Follow-up Visits (FUV) 1 (W56), 2 (W60) and 3 (W64)

Notes
[22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Participants who received at least one dose of PF-06480605 are included here.

End point values	Placebo (Induction) to PF-06480605 (Chronic) 50 mg	Induction Period: PF-06480605 50 mg	Placebo (Induction) to PF-06480605 (Chronic) 150 mg	Induction Period: PF-06480605 150 mg	Placebo (Induction) to PF-06480605 (Chronic) 450 mg	Induction Period: PF-06480605 450 mg	PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Number of subjects analysed	12	45	14	59	13	86	43	26	28	24	26	29
Units: nanograms per milliliter (ng/mL)
arithmetic mean (standard deviation)
PD-D1 (n=41,59,86,0,0,0,0,0,0,0,0,0)	99999 ( 99999 )	9999 ( 9999 )	99999 ( 99999 )	1.227 ( 6.7722 )	99999 ( 99999 )	1.279 ( 10.209 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
PD-W4 (n=45,58,85,0,0,0,0,0,0,0,0,0)	99999 ( 99999 )	2251 ( 1122.5 )	99999 ( 99999 )	6568 ( 3043.4 )	99999 ( 99999 )	19660 ( 8637.7 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
PD-W8 (n=45,59,84,0,0,0,0,0,0,0,0,0)	99999 ( 99999 )	2232 ( 1858.5 )	99999 ( 99999 )	8381 ( 4769.8 )	99999 ( 99999 )	25160 ( 12194 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
PD-W12 (n=45,55,82,0,0,0,0,0,0,0,0,0)	99999 ( 99999 )	2181 ( 2080.3 )	99999 ( 99999 )	8914 ( 5425.9 )	99999 ( 99999 )	30900 ( 15724 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
PD-W14 (n=33,40,55,0,0,0,0,0,0,0,0,0)	99999 ( 99999 )	4198 ( 3252.9 )	99999 ( 99999 )	17110 ( 9380.6 )	99999 ( 99999 )	49480 ( 18086 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
PD-W16 (n=0,0,0,11,13,13,42,24,28,24,25,29)	9999 ( 9999 )	99999 ( 99999 )	240.4 ( 862.23 )	99999 ( 99999 )	6.123 ( 22.077 )	99999 ( 99999 )	1969 ( 1932.7 )	9613 ( 6568.8 )	12450 ( 7605.4 )	39180 ( 19045 )	36320 ( 18215 )	32450 ( 17064 )
PD-W20 (n=0,0,0,12,13,13,43,26,28,21,26,29)	2924 ( 1706.7 )	99999 ( 99999 )	6680 ( 4188.0 )	99999 ( 99999 )	25030 ( 9240.1 )	99999 ( 99999 )	2516 ( 2279.8 )	5476 ( 4062.3 )	11500 ( 6289.0 )	19540 ( 10180 )	18200 ( 12244 )	34980 ( 17895 )
PD-W24 (n=0,0,0,12,13,12,39,22,27,24,25,26)	2897 ( 1494.1 )	99999 ( 99999 )	10990 ( 8884.5 )	99999 ( 99999 )	29820 ( 15940 )	99999 ( 99999 )	2956 ( 3018.7 )	4811 ( 3089.1 )	11090 ( 6765.1 )	10040 ( 6001.7 )	16890 ( 13735 )	35110 ( 16669 )
PD-W28 (n=0,0,0,11,14,12,39,24,28,20,24,25)	2915 ( 2739.1 )	99999 ( 99999 )	7587 ( 4748.7 )	99999 ( 99999 )	38270 ( 12846 )	99999 ( 99999 )	2613 ( 2763.5 )	3391 ( 2267.9 )	9840 ( 6630.1 )	5894 ( 3973.7 )	12920 ( 8418.9 )	35080 ( 14331 )
PD-W32 (n=0,0,0,11,14,12,38,23,25,21,24,23)	2672 ( 2275.6 )	99999 ( 99999 )	10520 ( 8027.4 )	99999 ( 99999 )	38950 ( 21386 )	99999 ( 99999 )	2330 ( 2253.4 )	3608 ( 3088.1 )	11790 ( 5931.7 )	5465 ( 3299.1 )	12060 ( 8871.1 )	36720 ( 16880 )
PD-W36 (n=0,0,0,11,14,12,36,21,23,20,22,22)	3478 ( 2422.7 )	99999 ( 99999 )	9279 ( 8345.1 )	99999 ( 99999 )	36520 ( 20234 )	99999 ( 99999 )	2802 ( 2573.3 )	3417 ( 2301.7 )	11680 ( 6728.9 )	4610 ( 2651.5 )	12360 ( 7217.1 )	33660 ( 14185 )
PD-W40 (n=0,0,0,11,12,12,36,21,24,18,22,24)	2793 ( 1893.0 )	99999 ( 99999 )	9246 ( 6289.2 )	99999 ( 99999 )	41770 ( 18436 )	99999 ( 99999 )	2820 ( 2590.1 )	3374 ( 2922.0 )	12050 ( 7678.1 )	3900 ( 2874.5 )	11830 ( 7571.4 )	33660 ( 11189 )
PD-W44 (n=0,0,0,10,12,12,33,21,23,17,21,21)	3314 ( 2152.2 )	99999 ( 99999 )	9346 ( 5199.5 )	99999 ( 99999 )	45770 ( 20693 )	99999 ( 99999 )	2867 ( 2655.4 )	3385 ( 3540.7 )	12190 ( 6504.8 )	3708 ( 2471.4 )	13060 ( 8745.9 )	36450 ( 12884 )
PD-W48 (n=0,0,0,9,10,11,33,20,23,15,20,22)	2921 ( 2084.1 )	99999 ( 99999 )	10750 ( 8216.0 )	99999 ( 99999 )	46150 ( 19825 )	99999 ( 99999 )	3159 ( 2810.1 )	3876 ( 3276.1 )	13230 ( 7740.3 )	4494 ( 3860.2 )	13700 ( 10253 )	38310 ( 13146 )
EOT (W52) (n=0,0,0,10,9,12,28,21,19,17,19,24)	3532 ( 2447.9 )	99999 ( 99999 )	10510 ( 10337 )	99999 ( 99999 )	49880 ( 21069 )	99999 ( 99999 )	2848 ( 3037.0 )	3156 ( 2337.1 )	14580 ( 7988.8 )	4215 ( 3708.6 )	13930 ( 8673.4 )	40710 ( 15146 )
FUV1 (W56) (n=0,0,0,9,8,9,27,15,14,14,18,21)	4152 ( 3804.3 )	99999 ( 99999 )	9755 ( 6903.0 )	99999 ( 99999 )	43710 ( 26683 )	99999 ( 99999 )	3246 ( 2965.2 )	3124 ( 2443.2 )	12870 ( 7884.4 )	4036 ( 3398.6 )	13410 ( 9499.7 )	43290 ( 17036 )
FUV2 (W60) (n=0,0,0,9,11,8,30,18,19,13,16,20)	1550 ( 1580.2 )	99999 ( 99999 )	3797 ( 4065.6 )	99999 ( 99999 )	19390 ( 13334 )	99999 ( 99999 )	1092 ( 1232.9 )	1025 ( 858.32 )	4806 ( 2827.2 )	1285 ( 1436.1 )	5266 ( 5457.1 )	13930 ( 9036.0 )
FUV3 (W64) (n=0,0,0,8,11,8,29,17,19,17,17,17)	1099 ( 2081.3 )	99999 ( 99999 )	1332 ( 2390.4 )	99999 ( 99999 )	7976 ( 5279.5 )	99999 ( 99999 )	766.1 ( 2372.9 )	257.3 ( 318.70 )	2011 ( 1752.1 )	825.8 ( 1883.2 )	1840 ( 2045.6 )	7136 ( 5642.6 )

No statistical analyses for this end point

Secondary: Induction Period: Change From Baseline in Fecal Calprotectin

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End point title

Induction Period: Change From Baseline in Fecal Calprotectin

End point description

Biomarker analysis population included all participants randomly assigned to IP and who took at least one dose of PF-06480605 and in whom at least one measurement of biomarker of interest was reported. Number analyzed is the number of participants with data available for analysis. n = number of participants with data available for analysis at the specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, and 12

End point values	Induction Period: Placebo	Induction Period: PF-06480605 50 mg	Induction Period: PF-06480605 150 mg	Induction Period: PF-06480605 450 mg
Number of subjects analysed	37	41	55	82
Units: micrograms per gram (µg/g)
arithmetic mean (standard deviation)
Baseline (n=37,41,55,82)	10.62 ( 2.145 )	9.99 ( 2.105 )	10.78 ( 2.120 )	10.23 ( 1.618 )
Change at Week 4 (n=35,36,49,79)	-0.32 ( 2.294 )	-0.38 ( 1.973 )	-1.24 ( 2.429 )	-0.86 ( 2.618 )
Change at Week 8 (n=34,40,43,75)	-0.77 ( 2.601 )	-1.28 ( 2.620 )	-1.84 ( 2.779 )	-1.69 ( 2.991 )
Change at Week 12 (n=34,35,44,74)	-0.62 ( 3.208 )	-1.36 ( 2.837 )	-2.43 ( 2.859 )	-1.44 ( 3.003 )

No statistical analyses for this end point

Secondary: Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)

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End point title

Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)

End point description

Biomarker analysis population included all participants randomly assigned to IP and who took at least one dose of PF-06480605 and in whom at least one measurement of biomarker of interest was reported. n = number of participants with data available for analysis at the specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, and 12

End point values	Induction Period: Placebo	Induction Period: PF-06480605 50 mg	Induction Period: PF-06480605 150 mg	Induction Period: PF-06480605 450 mg
Number of subjects analysed	40	47	62	91
Units: milligrams per deciliter (mg/dL)
arithmetic mean (standard deviation)
Baseline (n=40,47,62,91)	1.76 ( 2.135 )	1.47 ( 1.990 )	1.41 ( 1.799 )	1.82 ( 1.924 )
Change at Week 4 (n=40,46,61,89)	-0.49 ( 1.503 )	-0.48 ( 1.669 )	-0.75 ( 1.762 )	-1.08 ( 1.577 )
Change at Week 8 (n=39,47,58,86)	-0.49 ( 1.929 )	-0.45 ( 1.896 )	-0.94 ( 2.120 )	-1.09 ( 1.697 )
Change at Week 12 (n=38,43,54,82)	-0.96 ( 2.305 )	-0.71 ( 1.764 )	-1.25 ( 1.748 )	-1.06 ( 1.834 )

No statistical analyses for this end point

Secondary: Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A)

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End point title

Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A)

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, and 12

End point values	Induction Period: Placebo	Induction Period: PF-06480605 50 mg	Induction Period: PF-06480605 150 mg	Induction Period: PF-06480605 450 mg
Number of subjects analysed	39	42	58	88
Units: picograms per milliliter (pg/mL)
arithmetic mean (standard deviation)
Baseline (n=39,42,58,88)	6.86 ( 0.441 )	6.74 ( 0.499 )	6.77 ( 0.534 )	6.83 ( 0.558 )
Change at Week 4 (n=39,40,56,86)	0.01 ( 0.347 )	3.45 ( 1.097 )	3.85 ( 1.294 )	4.91 ( 0.834 )
Change at Week 8 (n=39,42,55,83)	-0.05 ( 0.549 )	3.14 ( 1.340 )	3.80 ( 1.486 )	4.88 ( 1.294 )
Change at Week 12 (n=36,40,53,81)	-0.02 ( 0.371 )	2.86 ( 1.666 )	3.72 ( 1.530 )	4.71 ( 1.908 )

No statistical analyses for this end point

Secondary: Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605

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End point title

Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 ^[23]

End point description

Samples were considered to be positive for ADA against PF-06480605 if the titer was ≥ 60, and an ADA sample was considered to be negative if the titer was < 60. Samples were considered to be positive for NAb against PF-06480605 if the titer was ≥ 5, and an NAb sample was considered to be negative if the titer was < 5. Immunogenicity analysis population included all participants randomly assigned to IP and who took at least one dose of PF-06480605 and in whom at least one post-treatment ADA determination was reported. Number analyzed is the number of participants with data available for analysis. n = number of participants with data available for analysis at the specified timepoint. 9999 = No participants were analyzed at the specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 14

Notes
[23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Participants who received at least one dose of PF-06480605 in the induction period only are included here.

End point values	Induction Period: PF-06480605 50 mg	Induction Period: PF-06480605 150 mg	Induction Period: PF-06480605 450 mg
Number of subjects analysed	45	59	88
Units: participants
ADA at Baseline (n=41,59,88)	0	1	2
NAb at Baseline (n=0,2,2)	9999	0	0
ADA at Week 4 (n=45,58,86)	29	16	24
NAb at Week 4 (n=33,27,35)	1	0	0
ADA at Week 8 (n=45,58,84)	39	34	34
NAb at Week 8 (n=44,41,41)	10	4	1
ADA at Week 12 (n=44,56,82)	41	36	36
NAb at Week 12 (n=42,40,46)	12	7	3
ADA at Week 14 (n=45,54,83)	41	35	33
NAb at Week 14 (n=42,39,38)	14	7	3

No statistical analyses for this end point

Secondary: Chronic Period: Percentage of Participants Who Achieved Clinical Remission

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End point title

Chronic Period: Percentage of Participants Who Achieved Clinical Remission

End point description

Clinical remission was defined as total Mayo Score ≤2, with no individual subscore >1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 – 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number. Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Number analyzed is the number of participants with data available for analysis.

End point type

Secondary

End point timeframe

At Week 56

End point values	Placebo (Induction) to PF-06480605 (Chronic) 50 mg	Placebo (Induction) to PF-06480605 (Chronic) 150 mg	Placebo (Induction) to PF-06480605 (Chronic) 450 mg	PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Number of subjects analysed	12	13	14	42	27	26	25	24	28
Units: percentage of participants
number (confidence interval 90%)	33.3 (15.42 to 60.16)	38.5 (17.28 to 62.14)	35.7 (16.30 to 59.44)	31.0 (19.38 to 43.33)	29.6 (15.68 to 45.34)	34.6 (20.86 to 52.62)	24.0 (11.01 to 41.68)	25.0 (11.49 to 42.28)	39.3 (23.83 to 56.49)

No statistical analyses for this end point

Secondary: Chronic Period: Percentage of Participants Who Achieved Sustained Clinical Remission

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End point title

Chronic Period: Percentage of Participants Who Achieved Sustained Clinical Remission

End point description

Clinical remission was defined as total Mayo Score ≤2, with no individual subscore >1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 – 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number. Evaluable mITT population. Number analyzed is the number of participants with data available for analysis. Participants were assessed at Week 56 if they achieved remission at Week 14. No participants in the Placebo (Induction) to PF-06480605 50 mg (Chronic) met the remission criteria at Week 14. Hence, this arm has been excluded.

End point type

Secondary

End point timeframe

At Weeks 14 and 56

End point values	Placebo (Induction) to PF-06480605 (Chronic) 150 mg	Placebo (Induction) to PF-06480605 (Chronic) 450 mg	PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Number of subjects analysed	1	4	12	6	8	7	6	7
Units: percentage of participants
number (confidence interval 90%)	0 (0 to 0)	25.0 (2.60 to 67.95)	50.0 (27.13 to 72.87)	50.0 (20.09 to 79.91)	62.5 (28.92 to 85.31)	28.6 (7.88 to 65.87)	50.0 (20.09 to 79.91)	85.7 (50.00 to 98.51)

No statistical analyses for this end point

Secondary: Chronic Period: Percentage of Participants Who Achieved Sustained Remission as per FDA Definition 1 (Modified Remission 1)

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End point title

Chronic Period: Percentage of Participants Who Achieved Sustained Remission as per FDA Definition 1 (Modified Remission 1)

End point description

Modified remission 1 =endoscopic subscore = 0 (normal/inactive disease) /1 (mild disease), stool frequency subscore = 0 (normal number of stools per day), & rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was used to measure disease activity for UC. Score range= 0-12 & was a composite of 4 following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, & PGA subscore. The 4 assessments were rated with a score from 0-3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission = who achieved clinical remission at both Weeks 14 & 56. Percentages have been rounded off. Evaluable mITT population. Number analyzed =number of participants with data available for analysis. No participants in Placebo (Induction) to PF-06480605 50 mg (Chronic) & Placebo (Induction) to PF-06480605 150 mg (Chronic) met remission criteria at Week 14. Hence, these arms have been excluded.

End point type

Secondary

End point timeframe

At Weeks 14 and 56

End point values	Placebo (Induction) to PF-06480605 (Chronic) 450 mg	PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Number of subjects analysed	3	7	5	3	4	3	5
Units: percentage of participants
number (confidence interval 90%)	33.3 (3.45 to 80.42)	28.6 (7.88 to 65.87)	40.0 (11.22 to 75.34)	66.7 (19.58 to 96.55)	25.0 (2.60 to 67.95)	0 (0 to 53.58)	80.0 (37.93 to 97.91)

No statistical analyses for this end point

Secondary: Chronic Period: Percentage of Participants Who Achieved Sustained Remission as per FDA Definition 2 (Modified Remission 2)

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End point title

Chronic Period: Percentage of Participants Who Achieved Sustained Remission as per FDA Definition 2 (Modified Remission 2)

End point description

Modified remission 2 = an endoscopic subscore = 0 (normal/inactive disease) or 1 (mild disease), ≥1 point decrease from baseline to achieve a stool frequency subscore = 0 (normal number of stools per day) or 1(1 or 2 more stools than normal), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 – 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number. Evaluable mITT population. Number analyzed is the number of participants with data available for analysis.

End point type

Secondary

End point timeframe

At Weeks 14 and 56

End point values	Placebo (Induction) to PF-06480605 (Chronic) 50 mg	Placebo (Induction) to PF-06480605 (Chronic) 150 mg	Placebo (Induction) to PF-06480605 (Chronic) 450 mg	PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Number of subjects analysed	1	1	3	14	10	11	9	10	8
Units: percentage of participants
number (confidence interval 90%)	0 (0.00 to 90.00)	0 (0.00 to 90.00)	33.3 (3.45 to 80.42)	42.9 (22.38 to 64.51)	70.0 (39.34 to 88.42)	54.5 (30.24 to 80.04)	33.3 (12.95 to 61.04)	60.0 (34.08 to 81.24)	75.0 (41.82 to 93.14)

No statistical analyses for this end point

Secondary: Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Improvement

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End point title

Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Improvement

End point description

Endoscopic improvement was defined as an endoscopic subscore of 0 (Normal or inactive disease) or 1 (Mild disease [erythema, decreased vascular pattern, mild friability]) at both Week 14 and Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 – 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Participants with sustained endoscopic improvement were defined as those who achieved improvement at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number. Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Number analyzed is the number of participants with data available for analysis.

End point type

Secondary

End point timeframe

At Weeks 14 and 56

End point values	Placebo (Induction) to PF-06480605 (Chronic) 50 mg	Placebo (Induction) to PF-06480605 (Chronic) 150 mg	Placebo (Induction) to PF-06480605 (Chronic) 450 mg	PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Number of subjects analysed	2	2	4	19	10	13	13	11	10
Units: percentage of participants
number (confidence interval 90%)	50.0 (5.13 to 94.87)	0 (0.00 to 68.38)	25.0 (2.60 to 67.95)	47.4 (27.39 to 66.28)	80.0 (50.00 to 94.55)	61.5 (37.86 to 82.72)	46.2 (24.55 to 71.30)	63.6 (34.98 to 83.08)	80.0 (50.00 to 94.55)

No statistical analyses for this end point

Secondary: Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Remission

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End point title

Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Remission

End point description

Endoscopic remission was defined as an endoscopic subscore of 0 (Normal or inactive disease) at both Week 14 & Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0-12 & was a composite of the 4 following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, & PGA subscore. Each of the 4 assessments was rated with a score from 0-3. Higher scores indicate more severe disease activity. Participants with sustained endoscopic remission were defined as those who achieved endoscopic remission at both Weeks 14 & 56. Percentages have been rounded off to the nearest whole number. Evaluable mITT population. Number analyzed is the number of participants with data available for analysis. Participants were assessed at Week 56 if they achieved remission at Week 14. No participants in Placebo (Induction) to PF-06480605 50 mg (Chronic) met remission criteria at Week 14. Hence, this arm has been excluded.

End point type

Secondary

End point timeframe

At Weeks 14 and 56

End point values	Placebo (Induction) to PF-06480605 (Chronic) 150 mg	Placebo (Induction) to PF-06480605 (Chronic) 450 mg	PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Number of subjects analysed	2	1	9	2	4	3	2	3
Units: percentage of participants
number (confidence interval 90%)	0 (0 to 68.38)	0 (0 to 90.00)	22.2 (6.08 to 51.52)	50.0 (5.13 to 94.87)	25.0 (2.60 to 67.95)	66.7 (19.58 to 96.55)	50.0 (5.13 to 94.87)	66.7 (19.58 to 96.55)

No statistical analyses for this end point

Secondary: Chronic Period: Change From Week 16 in Fecal Calprotectin

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End point title

Chronic Period: Change From Week 16 in Fecal Calprotectin

End point description

Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Number analyzed is the number of participants with data available for analysis. n = number of participants with data available for analysis at the specified time point.

End point type

Secondary

End point timeframe

Week 16 (baseline), Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, and 64

End point values	Placebo (Induction) to PF-06480605 (Chronic) 50 mg	Placebo (Induction) to PF-06480605 (Chronic) 150 mg	Placebo (Induction) to PF-06480605 (Chronic) 450 mg	PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Number of subjects analysed	12	11	12	43	23	27	22	24	29
Units: μg/g
arithmetic mean (standard deviation)
Week 16 (n=12,11,12,43,23,27,22,24,29)	10.22 ( 1.414 )	9.28 ( 2.578 )	9.77 ( 2.347 )	8.86 ( 2.728 )	9.03 ( 2.765 )	7.72 ( 2.642 )	9.34 ( 2.500 )	8.39 ( 2.368 )	9.21 ( 2.438 )
Change at Week 20 (n=12,10,12,39,23,27,21,23,29)	-0.40 ( 1.174 )	-1.46 ( 2.251 )	-1.32 ( 1.956 )	-0.31 ( 2.114 )	0.26 ( 2.247 )	0.43 ( 1.403 )	-0.32 ( 1.740 )	0.18 ( 2.569 )	-0.46 ( 1.435 )
Change at Week 24 (n=12,10,12,41,21,26,19,24,28)	-0.71 ( 1.302 )	-0.84 ( 1.718 )	-1.47 ( 3.331 )	0.24 ( 2.242 )	-0.15 ( 2.433 )	0.36 ( 2.638 )	-0.16 ( 1.874 )	-0.30 ( 1.619 )	0.10 ( 1.892 )
Change at Week 28 (n=12,11,11,37,21,24,20,22,23)	-1.55 ( 1.984 )	-1.17 ( 3.018 )	-1.48 ( 1.817 )	-0.16 ( 2.928 )	-0.15 ( 2.409 )	0.03 ( 1.996 )	-0.32 ( 2.440 )	-0.16 ( 1.716 )	-0.53 ( 2.136 )
Change at Week 32 (n=10,11,11,36,21,20,19,21,24)	-0.91 ( 2.497 )	-1.36 ( 3.553 )	-2.47 ( 3.044 )	0.21 ( 2.321 )	-0.32 ( 2.516 )	0.31 ( 2.453 )	-0.13 ( 2.192 )	0.17 ( 2.102 )	-0.08 ( 1.491 )
Change at Week 36 (n=11,10,11,32,19,21,17,22,21)	-0.68 ( 2.353 )	-1.83 ( 2.542 )	-2.36 ( 4.202 )	-0.37 ( 2.465 )	-0.21 ( 2.584 )	0.50 ( 2.152 )	-0.67 ( 1.889 )	-0.36 ( 2.362 )	-0.32 ( 1.724 )
Change at Week 40 (n=11,10,11,34,17,21,15,19,24)	-1.62 ( 1.814 )	0.22 ( 3.962 )	-2.59 ( 2.493 )	0.17 ( 2.604 )	0.02 ( 1.779 )	0.35 ( 2.179 )	0.01 ( 2.696 )	-0.42 ( 1.672 )	-0.62 ( 2.434 )
Change at Week 44 (n=11,9,11,32,19,20,14,18,22)	-0.68 ( 2.015 )	-1.48 ( 2.693 )	-1.81 ( 2.705 )	-0.09 ( 2.023 )	-0.98 ( 2.089 )	0.02 ( 2.568 )	0.21 ( 2.377 )	-0.97 ( 1.890 )	-0.69 ( 1.737 )
Change at Week 48 (n=11,10,11,31,19,20,14,19,24)	-0.85 ( 1.843 )	-1.01 ( 3.642 )	-2.56 ( 3.178 )	0.60 ( 2.255 )	-0.78 ( 2.542 )	0.09 ( 3.320 )	0.03 ( 3.027 )	-0.54 ( 2.248 )	-0.47 ( 2.150 )
Change at Week 52 (n=11,10,11,32,17,19,13,15,23)	-1.39 ( 1.922 )	-0.39 ( 3.222 )	-2.84 ( 2.668 )	-0.02 ( 2.327 )	-0.12 ( 1.386 )	0.09 ( 2.558 )	-0.20 ( 3.294 )	-0.61 ( 2.259 )	-0.75 ( 2.355 )
Change at Week 60 (n=10,7,9,28,16,15,11,14,20)	-1.31 ( 2.119 )	-0.09 ( 1.780 )	-1.96 ( 3.041 )	0.36 ( 3.169 )	-0.60 ( 1.840 )	0.17 ( 2.939 )	1.61 ( 1.426 )	-0.91 ( 2.915 )	-0.95 ( 2.131 )
Change at Week 64 (n=10,8,9,27,16,16,12,15,20)	-0.54 ( 2.208 )	-1.48 ( 2.426 )	-0.86 ( 2.562 )	0.58 ( 2.705 )	0.29 ( 1.834 )	0.10 ( 3.982 )	0.85 ( 3.321 )	-1.18 ( 4.080 )	-0.82 ( 2.007 )

No statistical analyses for this end point

Secondary: Chronic Period: Change From Week 14 in hsCRP

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End point title

Chronic Period: Change From Week 14 in hsCRP

End point description

End point type

Secondary

End point timeframe

Week 14 (baseline), Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64

End point values	Placebo (Induction) to PF-06480605 (Chronic) 50 mg	Placebo (Induction) to PF-06480605 (Chronic) 150 mg	Placebo (Induction) to PF-06480605 (Chronic) 450 mg	PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Number of subjects analysed	12	14	14	46	26	30	26	26	29
Units: mg/dL
arithmetic mean (standard deviation)
Week 14 (n=12,14,14,46,26,30,26,26,29)	1.22 ( 1.667 )	2.49 ( 2.149 )	0.43 ( 2.484 )	0.72 ( 2.322 )	0.26 ( 1.898 )	0.11 ( 1.724 )	0.49 ( 2.152 )	0.56 ( 1.843 )	1.55 ( 1.376 )
Change at Week 16 (n=12,12,13,45,25,30,25,25,29)	-0.17 ( 0.745 )	-0.32 ( 1.057 )	-0.05 ( 1.622 )	0.12 ( 0.895 )	0.28 ( 1.218 )	0.04 ( 1.074 )	-0.18 ( 1.247 )	-0.21 ( 1.390 )	-0.12 ( 1.283 )
Change at Week 20 (n=12,14,14,42,25,29,25,25,29)	-0.41 ( 1.420 )	-1.06 ( 1.370 )	-0.48 ( 2.403 )	0.34 ( 1.390 )	0.32 ( 1.449 )	0.48 ( 1.736 )	-0.22 ( 1.141 )	0.68 ( 2.359 )	-0.19 ( 1.362 )
Change at Week 24 (n=12,14,14,42,23,28,24,26,27)	-0.76 ( 1.232 )	-1.52 ( 1.440 )	-1.01 ( 2.445 )	0.28 ( 1.328 )	0.23 ( 1.063 )	0.06 ( 0.882 )	-0.20 ( 1.391 )	-0.13 ( 1.372 )	-0.16 ( 1.387 )
Changw at Week 28 (n=11,13,12,39,22,28,22,24,26)	-1.01 ( 1.398 )	-1.12 ( 1.917 )	-0.36 ( 1.665 )	0.31 ( 1.362 )	0.29 ( 1.156 )	0.26 ( 1.050 )	-0.28 ( 1.546 )	-0.25 ( 1.347 )	-0.23 ( 1.044 )
Change at Week 32 (n=11,14,13,40,24,25,23,24,24)	-0.32 ( 1.893 )	-0.79 ( 1.535 )	-0.85 ( 2.253 )	0.30 ( 1.720 )	0.32 ( 1.565 )	0.72 ( 1.347 )	-0.56 ( 1.572 )	0.28 ( 1.474 )	-0.29 ( 1.347 )
Change at Week 36 (n=11,14,13,36,22,25,21,24,22)	-1.04 ( 2.335 )	-1.29 ( 1.786 )	-0.67 ( 2.760 )	0.07 ( 1.430 )	0.29 ( 1.490 )	0.28 ( 1.179 )	-0.43 ( 1.507 )	0.36 ( 2.013 )	-0.24 ( 1.614 )
Change at Week 40 (n=11,13,12,33,20,25,19,23,23)	-0.50 ( 1.893 )	-1.09 ( 1.827 )	-1.56 ( 2.351 )	0.17 ( 1.596 )	0.16 ( 1.432 )	0.31 ( 1.206 )	-0.35 ( 1.645 )	0.19 ( 1.252 )	-0.66 ( 1.154 )
Change at Week 44 (n=11,12,12,34,21,22,18,22,22)	-0.11 ( 1.709 )	-1.31 ( 1.707 )	-1.28 ( 2.448 )	-0.06 ( 1.589 )	-0.15 ( 1.612 )	0.66 ( 1.083 )	0.05 ( 1.513 )	0.20 ( 1.457 )	-0.75 ( 1.272 )
Change at Week 48 (n=10,12,12,33,21,23,18,21,23)	-0.59 ( 1.596 )	-1.29 ( 1.700 )	-1.23 ( 2.619 )	0.28 ( 1.749 )	0.31 ( 1.314 )	0.21 ( 1.213 )	0.07 ( 0.985 )	0.07 ( 1.674 )	-0.53 ( 1.254 )
Change at Week 52 (n=11,12,12,33,21,23,19,20,22)	-0.01 ( 2.228 )	-1.05 ( 1.726 )	-1.59 ( 2.195 )	0.10 ( 1.248 )	0.09 ( 1.299 )	-0.13 ( 0.985 )	0.43 ( 1.144 )	-0.02 ( 1.760 )	-0.63 ( 1.221 )
Change at Week 56 (n=10,10,10,29,19,21,16,19,22)	-0.28 ( 1.346 )	-0.92 ( 1.776 )	-0.57 ( 1.766 )	0.25 ( 1.525 )	0.17 ( 1.998 )	0.21 ( 1.129 )	0.65 ( 0.994 )	0.31 ( 1.801 )	-0.34 ( 1.463 )
Change at Week 60 (n=9,11,10,30,20,20,16,17,21)	-0.50 ( 2.114 )	-0.93 ( 1.857 )	-0.63 ( 2.397 )	0.40 ( 1.804 )	1.21 ( 1.844 )	0.51 ( 0.992 )	0.14 ( 1.395 )	-0.55 ( 1.390 )	-0.91 ( 1.643 )
Change at Week 64 (n=10,11,10,28,21,22,17,17,17)	0.35 ( 1.750 )	-0.97 ( 2.090 )	-1.12 ( 2.366 )	0.28 ( 1.633 )	0.33 ( 1.848 )	0.22 ( 1.699 )	0.52 ( 1.659 )	-0.06 ( 2.231 )	-0.64 ( 1.802 )

No statistical analyses for this end point

Secondary: Chronic Period: Change From Week 14 in Serum sTL1A

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End point title

Chronic Period: Change From Week 14 in Serum sTL1A

End point description

Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Number analyzed is the number of participants with data available for analysis. n=number of participants with data available for analysis at the specified time point.

End point type

Secondary

End point timeframe

Week 14 (baseline), Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64

End point values	Placebo (Induction) to PF-06480605 (Chronic) 50 mg	Placebo (Induction) to PF-06480605 (Chronic) 150 mg	Placebo (Induction) to PF-06480605 (Chronic) 450 mg	PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Number of subjects analysed	12	13	14	46	25	29	25	26	29
Units: pg/mL
arithmetic mean (standard deviation)
Week 14 (n=12,13,14,46,25,29,25,26,29)	6.84 ( 0.443 )	7.21 ( 1.254 )	6.67 ( 0.463 )	9.78 ( 1.421 )	10.71 ( 1.543 )	10.61 ( 1.488 )	11.30 ( 2.495 )	11.34 ( 1.752 )	11.83 ( 0.726 )
Change at Week 16 (n=11,12,13,44,23,27,25,25,29)	-0.13 ( 0.576 )	0.29 ( 0.328 )	0.12 ( 0.330 )	-0.03 ( 0.431 )	-0.16 ( 0.302 )	0.03 ( 0.494 )	0.00 ( 0.987 )	-0.26 ( 0.510 )	-0.35 ( 0.435 )
Change at Week 20 (n=12,13,13,44,25,27,23,26,29)	3.97 ( 0.722 )	3.43 ( 1.840 )	5.42 ( 0.954 )	-0.03 ( 0.675 )	-0.36 ( 0.645 )	-0.01 ( 0.762 )	-0.22 ( 1.086 )	-0.74 ( 0.638 )	-0.61 ( 0.780 )
Change at Week 24(n=12,12,13,41,21,26,23,25,27)	2.85 ( 1.141 )	3.84 ( 1.872 )	5.65 ( 0.909 )	-0.02 ( 0.999 )	-0.59 ( 0.912 )	-0.41 ( 1.518 )	-0.60 ( 1.133 )	-0.90 ( 0.831 )	-0.70 ( 1.047 )
Change at Week 28 (n=12,13,12,39,23,27,22,24,26)	2.96 ( 1.033 )	3.78 ( 1.759 )	5.88 ( 0.731 )	-0.16 ( 1.032 )	-0.69 ( 1.036 )	-0.33 ( 1.531 )	-0.78 ( 1.384 )	-0.87 ( 1.017 )	-0.65 ( 1.047 )
Change at Week 32 (n=11,13,13,40,22,25,22,24,24)	3.18 ( 1.346 )	3.65 ( 1.749 )	5.87 ( 0.588 )	-0.10 ( 1.158 )	-0.73 ( 1.092 )	-0.07 ( 0.857 )	-1.08 ( 1.337 )	-0.93 ( 0.935 )	-0.67 ( 0.914 )
Change at Week 36(n=10,13,13,36,22,24,20,22,23)	3.35 ( 1.185 )	3.53 ( 1.811 )	5.77 ( 0.745 )	0.06 ( 1.285 )	-0.80 ( 1.036 )	0.01 ( 0.743 )	-1.28 ( 1.630 )	-0.81 ( 0.992 )	-0.60 ( 0.812 )
Change at Week 40(n=11,12,12,35,20,25,18,23,24)	3.45 ( 0.990 )	3.17 ( 1.909 )	5.66 ( 0.926 )	0.04 ( 1.243 )	-0.95 ( 1.188 )	-0.01 ( 0.919 )	-1.32 ( 1.739 )	-0.75 ( 1.017 )	-0.67 ( 0.891 )
Change at Week 44(n=11,11,12,36,21,24,18,22,24)	3.41 ( 1.068 )	3.09 ( 1.640 )	5.58 ( 1.106 )	-0.01 ( 1.289 )	-0.83 ( 1.282 )	-0.11 ( 0.634 )	-1.35 ( 1.812 )	-0.60 ( 0.958 )	-0.59 ( 0.873 )
Change at Week 48 (n=11,11,12,34,21,24,17,21,23)	3.36 ( 1.108 )	2.83 ( 1.601 )	5.73 ( 1.029 )	0.03 ( 1.138 )	-0.79 ( 1.198 )	0.14 ( 0.779 )	-1.25 ( 1.554 )	-0.54 ( 1.145 )	-0.47 ( 0.853 )
Change at Week 52 (n=11,11,12,33,21,23,18,20,25)	3.59 ( 1.128 )	2.83 ( 1.875 )	5.74 ( 1.224 )	0.06 ( 1.119 )	-0.65 ( 1.090 )	0.26 ( 0.675 )	-1.49 ( 1.711 )	-0.54 ( 1.031 )	-0.55 ( 1.134 )
Change at Week 56 (n=10,11,10,30,18,22,16,19,23)	3.72 ( 1.114 )	2.71 ( 1.999 )	5.69 ( 1.173 )	0.31 ( 1.155 )	-0.57 ( 1.191 )	0.26 ( 0.976 )	-1.36 ( 1.870 )	-0.29 ( 0.990 )	-0.33 ( 0.919 )
Change at Week 60 (n=9,10,10,32,20,20,15,16,22)	2.95 ( 1.646 )	2.87 ( 1.505 )	5.37 ( 1.556 )	-0.08 ( 1.557 )	-0.60 ( 1.303 )	-0.13 ( 0.924 )	-1.55 ( 1.985 )	-0.70 ( 1.583 )	-0.64 ( 0.929 )
Change at Week 64 (n=10,10,9,29,21,21,15,18,21)	3.15 ( 1.775 )	2.88 ( 1.730 )	4.83 ( 1.860 )	-0.28 ( 1.391 )	-0.68 ( 1.200 )	-0.19 ( 0.823 )	-1.45 ( 2.361 )	-0.97 ( 1.697 )	-0.75 ( 1.062 )

No statistical analyses for this end point

Secondary: Change From Baseline in Fecal Calprotectin Through the End of Study

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End point title

Change From Baseline in Fecal Calprotectin Through the End of Study

End point description

Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Number analyzed is the number of participants with data available for analysis. n= number of participants with data available for analysis at the specified time point. As pre-specified in the statistical analysis plan (SAP), data is presented using the treatment sequence in the chronic period.

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, and 64

End point values	Placebo (Induction) to PF-06480605 (Chronic) 50 mg	Placebo (Induction) to PF-06480605 (Chronic) 150 mg	Placebo (Induction) to PF-06480605 (Chronic) 450 mg	PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Number of subjects analysed	12	11	14	40	27	26	23	21	28
Units: μg/g
arithmetic mean (standard deviation)
Baseline(n=12,11,14,40,24,26,23,21,28)	10.43 ( 1.530 )	11.06 ( 1.450 )	10.44 ( 2.984 )	9.91 ( 2.069 )	11.12 ( 1.472 )	10.38 ( 2.683 )	10.41 ( 1.218 )	9.95 ( 2.225 )	10.23 ( 1.446 )
Change at Week 4(n=12,11,12,36,22,23,22,20,28)	0.41 ( 2.745 )	-0.21 ( 0.925 )	-1.15 ( 2.572 )	-0.38 ( 1.973 )	-1.56 ( 1.722 )	-1.03 ( 3.037 )	-1.28 ( 3.038 )	-0.80 ( 2.727 )	-0.69 ( 2.513 )
Change at Week 8(n=10,10,14,39,20,21,22,20,28)	-0.36 ( 1.169 )	-0.56 ( 1.601 )	-1.21 ( 3.752 )	-1.27 ( 2.652 )	-2.03 ( 2.251 )	-1.69 ( 3.357 )	-2.29 ( 3.142 )	-1.76 ( 3.108 )	-1.27 ( 2.874 )
Change at Week 12(n=11,9,14,35,18,24,21,21,28)	0.46 ( 2.788 )	-0.84 ( 2.026 )	-1.32 ( 4.008 )	-1.36 ( 2.837 )	-2.62 ( 2.563 )	-2.42 ( 3.174 )	-1.21 ( 3.159 )	-1.75 ( 3.477 )	-1.31 ( 2.634 )
Change at Week 16(n=12,10,12,37,21,25,21,20,28)	-0.21 ( 1.742 )	-1.73 ( 2.941 )	-0.67 ( 3.908 )	-1.48 ( 3.378 )	-2.30 ( 2.662 )	-2.55 ( 2.883 )	-0.87 ( 3.039 )	-1.26 ( 3.043 )	-1.08 ( 2.368 )
Change at Week 20(n=12,10,14,39,23,25,22,19,28)	-0.61 ( 2.247 )	-2.48 ( 2.935 )	-2.35 ( 3.701 )	-1.71 ( 3.104 )	-1.87 ( 2.328 )	-2.10 ( 2.824 )	-1.61 ( 3.685 )	-1.70 ( 3.353 )	-1.55 ( 2.490 )
Change at Week 24(n=12,10,14,38,22,24,19,21,27)	-0.92 ( 2.115 )	-1.68 ( 2.505 )	-2.52 ( 3.263 )	-1.00 ( 3.050 )	-2.31 ( 2.910 )	-2.29 ( 3.768 )	-1.25 ( 2.899 )	-1.52 ( 3.478 )	-0.95 ( 2.877 )
Change at Week 28(n=12,11,12,32,21,22,21,18,22)	-1.76 ( 2.456 )	-3.08 ( 3.021 )	-2.70 ( 2.246 )	-1.31 ( 3.225 )	-2.46 ( 2.750 )	-2.85 ( 3.782 )	-1.60 ( 3.431 )	-1.58 ( 3.213 )	-1.61 ( 2.428 )
Change at Week 32(n=10,11,12,35,27,20,20,17,24)	-1.43 ( 2.920 )	-2.45 ( 2.916 )	-2.87 ( 2.951 )	-1.19 ( 3.384 )	-2.62 ( 2.906 )	-2.61 ( 3.609 )	-1.56 ( 3.253 )	-1.48 ( 3.014 )	-1.31 ( 2.032 )
Change at Week 36(n=11,10,12,30,21,21,17,18,20)	-1.05 ( 2.958 )	-3.14 ( 2.233 )	-3.11 ( 3.401 )	-1.80 ( 3.019 )	-2.39 ( 2.680 )	-2.31 ( 3.468 )	-2.11 ( 3.406 )	-2.08 ( 3.070 )	-2.05 ( 2.502 )
Change at Week40(n=11,9,12,31,19,20,15,17,23)	-1.99 ( 2.555 )	-1.30 ( 2.745 )	-3.02 ( 2.912 )	-1.35 ( 3.354 )	-2.17 ( 2.130 )	-2.24 ( 3.311 )	-1.58 ( 3.128 )	-1.73 ( 3.158 )	-1.87 ( 2.751 )
Change at Week 44(n=11,8,12,31,21,20,14,15,21)	-1.05 ( 2.653 )	-1.87 ( 2.871 )	-2.35 ( 2.768 )	-1.60 ( 3.435 )	-2.93 ( 2.999 )	-2.96 ( 3.311 )	-1.09 ( 3.077 )	-2.41 ( 3.338 )	-2.08 ( 2.932 )
Change at Week 48(n=11,9,12,29,21,19,14,16,23)	-1.22 ( 2.640 )	-1.95 ( 3.001 )	-2.87 ( 4.006 )	-0.78 ( 2.906 )	-2.81 ( 2.789 )	-2.89 ( 3.346 )	-1.74 ( 3.257 )	-1.46 ( 3.800 )	-1.75 ( 2.562 )
Change at Week 52(n=11,9,12,30,20,17,13,12,22)	-1.76 ( 2.420 )	-1.53 ( 2.796 )	-3.27 ( 2.568 )	-1.36 ( 3.019 )	-2.20 ( 2.564 )	-2.50 ( 3.129 )	-1.90 ( 3.306 )	-2.20 ( 2.991 )	-2.07 ( 2.400 )
Change at Week 60(n=10,7,10,26,19,15,11,11,19)	-1.89 ( 2.781 )	-1.00 ( 1.778 )	-1.63 ( 3.097 )	-1.20 ( 3.371 )	-2.59 ( 2.491 )	-2.63 ( 3.885 )	-1.17 ( 2.198 )	-2.39 ( 3.217 )	-2.07 ( 2.843 )
Change at Week 64(n=10,7,10,26,19,16,12,13,19)	-1.19 ( 2.692 )	-2.56 ( 2.525 )	-0.43 ( 3.261 )	-1.16 ( 2.744 )	-2.05 ( 2.327 )	-2.40 ( 4.271 )	-1.46 ( 2.729 )	-2.03 ( 4.805 )	-2.38 ( 2.247 )

No statistical analyses for this end point

Secondary: Change From Baseline in hsCRP Through the End of Study

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End point title

Change From Baseline in hsCRP Through the End of Study

End point description

Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Number analyzed is the number of participants with data available for analysis. n= number of participants with data available for analysis at the specified time point. As pre-specified in the SAP, data is presented using the treatment sequence in the chronic period

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64

End point values	Placebo (Induction) to PF-06480605 (Chronic) 50 mg	Placebo (Induction) to PF-06480605 (Chronic) 150 mg	Placebo (Induction) to PF-06480605 (Chronic) 450 mg	PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Number of subjects analysed	12	14	14	46	27	30	26	26	29
Units: mg/dL
arithmetic mean (standard deviation)
Baseline (n=12,14,14,46,27,30,26,26,29)	2.08 ( 2.625 )	2.41 ( 1.630 )	0.86 ( 1.942 )	1.42 ( 1.989 )	1.35 ( 1.638 )	1.22 ( 1.865 )	1.23 ( 1.687 )	1.91 ( 1.948 )	2.53 ( 1.803 )
Change at Week 4 (n=12,14,14,45,27,29,26,25,29)	-1.02 ( 1.888 )	0.18 ( 1.323 )	-0.70 ( 1.108 )	-0.43 ( 1.660 )	-0.85 ( 1.585 )	-0.73 ( 1.967 )	-1.10 ( 1.645 )	-1.40 ( 1.382 )	-0.97 ( 1.656 )
Change at Week 8 (n=12,13,14,46,26,29,26,25,29)	-0.58 ( 2.105 )	-0.22 ( 1.859 )	-0.67 ( 1.957 )	-0.47 ( 1.912 )	-0.85 ( 2.109 )	-1.14 ( 2.198 )	-0.97 ( 1.980 )	-1.48 ( 1.391 )	-1.02 ( 1.695 )
Change at Week 12 (n=11,13,14,42,22,29,25,25,28)	-1.22 ( 2.248 )	-0.60 ( 2.635 )	-1.09 ( 2.151 )	-0.66 ( 1.749 )	-1.45 ( 1.768 )	-1.18 ( 1.814 )	-0.93 ( 2.133 )	-1.50 ( 1.646 )	-0.95 ( 1.646 )
Change at Week 14 (n=12,14,14,46,26,30,26,26,29)	-0.86 ( 2.162 )	0.08 ( 2.194 )	-0.43 ( 2.529 )	-0.71 ( 2.026 )	-1.05 ( 2.045 )	-1.10 ( 2.086 )	-0.74 ( 1.750 )	-1.35 ( 1.720 )	-0.98 ( 1.603 )
Change at Week 16 (n=12,12,13,45,26,30,25,25,29)	-1.03 ( 2.061 )	-0.19 ( 2.184 )	-0.72 ( 2.025 )	-0.56 ( 2.112 )	-0.61 ( 1.931 )	-1.06 ( 2.098 )	-0.98 ( 2.030 )	-1.50 ( 1.432 )	-1.09 ( 1.783 )
Change at Week 20 (n=12,14,14,42,26,29,25,25,29)	-1.27 ( 1.253 )	-0.98 ( 2.164 )	-0.91 ( 2.855 )	-0.44 ( 2.106 )	-0.83 ( 2.158 )	-0.52 ( 2.399 )	-0.98 ( 1.957 )	-0.61 ( 2.365 )	-1.16 ( 1.718 )
Change at Week 24 (n=12,14,14,42,24,28,24,26,27)	-1.62 ( 1.786 )	-1.43 ( 1.914 )	-1.44 ( 1.935 )	-0.53 ( 2.056 )	-0.80 ( 1.811 )	-0.97 ( 1.911 )	-1.03 ( 1.963 )	-1.48 ( 1.517 )	-1.14 ( 1.639 )
Change at Week 28 (n=11,13,12,39,23,28,22,24,26)	-1.39 ( 1.585 )	-1.00 ( 2.277 )	-0.84 ( 2.000 )	-0.61 ( 2.078 )	-0.73 ( 2.143 )	-0.76 ( 1.867 )	-0.87 ( 2.125 )	-1.60 ( 1.558 )	-1.18 ( 1.844 )
Change at Week 32 (n=11,14,13,40,25,25,23,24,24)	-1.23 ( 1.930 )	-0.71 ( 1.585 )	-1.36 ( 1.937 )	-0.58 ( 1.887 )	-0.79 ( 2.136 )	-0.57 ( 2.027 )	-1.35 ( 1.743 )	-1.15 ( 1.853 )	-1.31 ( 1.988 )
Change at Week 36 (n=11,14,13,36,23,25,21,24,22)	-1.94 ( 2.158 )	-1.21 ( 1.951 )	-1.18 ( 1.032 )	-0.89 ( 2.009 )	-1.03 ( 2.015 )	-0.95 ( 1.900 )	-1.21 ( 2.006 )	-1.07 ( 1.441 )	-1.18 ( 1.915 )
Change at Week40 (n=11,13,12,33,21,25,19,23,23)	-1.40 ( 2.470 )	-1.03 ( 2.294 )	-1.92 ( 1.184 )	-0.74 ( 2.371 )	-1.37 ( 2.262 )	-0.84 ( 2.009 )	-1.06 ( 1.992 )	-1.19 ( 1.390 )	-1.60 ( 1.802 )
Change at Week 44 (n=11,12,12,34,22,22,18,22,22)	-1.01 ( 2.243 )	-1.07 ( 2.041 )	-1.64 ( 1.592 )	-0.99 ( 2.154 )	-1.47 ( 1.876 )	-0.37 ( 2.008 )	-0.71 ( 1.841 )	-1.03 ( 1.411 )	-1.69 ( 1.423 )
Change at Week 48 (n=10,12,12,33,22,23,18,21,23)	-0.97 ( 1.965 )	-1.06 ( 2.213 )	-1.59 ( 1.530 )	-0.77 ( 2.377 )	-1.07 ( 1.671 )	-0.78 ( 2.213 )	-0.84 ( 1.802 )	-1.12 ( 1.478 )	-1.47 ( 1.670 )
Change at Week 52 (n=11,12,12,33,21,23,19,20,22)	-0.92 ( 3.093 )	-0.82 ( 1.873 )	-1.94 ( 1.744 )	-0.94 ( 1.993 )	-1.29 ( 1.756 )	-1.13 ( 1.951 )	-0.52 ( 1.730 )	-1.22 ( 1.456 )	-1.54 ( 1.863 )
Change at Week 56 (n=10,10,10,29,20,21,16,19,22)	-1.18 ( 2.111 )	-0.96 ( 2.381 )	-1.11 ( 1.681 )	-0.70 ( 2.227 )	-1.12 ( 2.293 )	-0.71 ( 2.434 )	-0.05 ( 1.966 )	-0.82 ( 1.648 )	-1.32 ( 2.070 )
Change at Week 60 (n=9,11,10,30,20,20,16,17,21)	-1.19 ( 1.259 )	-0.52 ( 2.427 )	-1.17 ( 2.435 )	-0.64 ( 2.236 )	-0.34 ( 2.332 )	-0.82 ( 2.135 )	-0.88 ( 2.060 )	-1.71 ( 1.670 )	-1.91 ( 2.213 )
Change at Week 64 (n=10,11,10,28,21,22,17,17,17)	-0.85 ( 1.481 )	-1.03 ( 1.776 )	-1.66 ( 1.908 )	-0.77 ( 2.162 )	-1.05 ( 1.950 )	-1.22 ( 1.981 )	-0.44 ( 1.778 )	-1.07 ( 1.870 )	-1.69 ( 2.336 )

No statistical analyses for this end point

Secondary: Change From Baseline in Serum sTL1A Through the End of Study

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End point title

Change From Baseline in Serum sTL1A Through the End of Study

End point description

Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in chronic period. Number analyzed is the number of participants with data available for analysis. n= number of participants with data available for analysis at the specified time point. As pre-specified in the SAP, data is presented using the treatment sequence in the chronic period.

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64

End point values	Placebo (Induction) to PF-06480605 (Chronic) 50 mg	Placebo (Induction) to PF-06480605 (Chronic) 150 mg	Placebo (Induction) to PF-06480605 (Chronic) 450 mg	PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Number of subjects analysed	12	14	13	41	26	27	24	25	29
Units: pg/mL
arithmetic mean (standard deviation)
Baseline (n=12,14,13,41,26,27,24,25,29)	6.76 ( 0.524 )	6.93 ( 0.300 )	6.89 ( 0.499 )	6.73 ( 0.503 )	6.77 ( 0.520 )	6.69 ( 0.520 )	6.83 ( 0.706 )	6.65 ( 0.467 )	6.83 ( 0.428 )
Change at Week 4 (n=12,14,13,39,25,27,24,24,29)	0.09 ( 0.458 )	-0.01 ( 0.349 )	-0.02 ( 0.221 )	3.50 ( 1.051 )	3.73 ( 1.445 )	3.97 ( 1.218 )	4.88 ( 0.987 )	5.29 ( 0.829 )	4.65 ( 0.686 )
Change at Week 8 (n=12,14,13,41,25,27,24,24,29)	-0.10 ( 0.908 )	0.02 ( 0.329 )	-0.10 ( 0.267 )	3.18 ( 1.331 )	3.98 ( 1.561 )	3.76 ( 1.443 )	4.87 ( 1.691 )	4.98 ( 1.434 )	4.74 ( 0.891 )
Change at Week 12 (n=11,12,13,39,23,27,23,25,29)	0.14 ( 0.383 )	-0.01 ( 0.329 )	-0.17 ( 0.365 )	2.93 ( 1.629 )	3.84 ( 1.613 )	3.75 ( 1.471 )	4.34 ( 2.700 )	4.59 ( 1.840 )	5.03 ( 1.221 )
Change at Week 14 (n=12,13,13,41,25,27,23,25,29)	0.08 ( 0.474 )	0.28 ( 1.209 )	-0.23 ( 0.329 )	2.97 ( 1.598 )	3.95 ( 1.664 )	3.97 ( 1.419 )	4.37 ( 2.724 )	4.68 ( 1.872 )	5.00 ( 0.902 )
Change at Week 16 (n=11,12,13,39,24,26,23,25,29)	-0.05 ( 0.708 )	0.56 ( 1.384 )	-0.11 ( 0.305 )	2.99 ( 1.697 )	3.55 ( 1.849 )	3.96 ( 1.406 )	4.40 ( 2.472 )	4.42 ( 2.181 )	4.66 ( 1.069 )
Change at Week 20 (n=12,14,13,39,26,27,22,25,29)	4.05 ( 0.978 )	3.75 ( 1.543 )	5.19 ( 0.861 )	3.01 ( 1.710 )	3.46 ( 1.678 )	3.96 ( 1.338 )	4.12 ( 2.459 )	3.92 ( 2.248 )	4.40 ( 1.365 )
Change at Week 24 (n=12,13,13,37,22,25,22,24,27)	2.94 ( 1.140 )	4.17 ( 1.415 )	5.41 ( 0.771 )	2.86 ( 1.881 )	3.57 ( 1.608 )	3.60 ( 2.046 )	3.74 ( 2.346 )	3.69 ( 2.117 )	4.33 ( 1.483 )
Change at Week 28 (n=12,13,11,36,24,25,21,23,26)	3.04 ( 1.182 )	4.06 ( 1.536 )	5.67 ( 0.742 )	2.87 ( 1.992 )	3.20 ( 1.715 )	3.61 ( 2.155 )	3.55 ( 2.220 )	3.68 ( 2.141 )	4.42 ( 1.548 )
Change at Week 32 (n=11,14,12,36,23,23,21,23,24)	3.29 ( 1.500 )	3.99 ( 1.497 )	5.62 ( 0.620 )	2.82 ( 1.903 )	3.09 ( 1.760 )	3.92 ( 1.535 )	3.23 ( 2.089 )	3.67 ( 2.044 )	4.39 ( 1.452 )
Change at Week 36 (n=10,14,12,33,23,22,20,21,23)	3.47 ( 1.247 )	3.90 ( 1.564 )	5.55 ( 0.842 )	2.96 ( 1.813 )	3.25 ( 1.637 )	3.99 ( 1.460 )	3.12 ( 1.854 )	3.83 ( 2.020 )	4.58 ( 1.209 )
Change at Week 40 (n=11,13,11,32,21,23,18,22,24)	3.56 ( 1.130 )	3.65 ( 1.865 )	5.44 ( 0.951 )	3.04 ( 1.839 )	3.02 ( 1.644 )	4.07 ( 1.582 )	2.95 ( 1.914 )	3.84 ( 2.007 )	4.42 ( 1.450 )
Change at Week 44 (n=11,12,11,33,22,22,18,21,24)	3.53 ( 1.172 )	3.67 ( 1.671 )	5.34 ( 1.093 )	2.98 ( 1.762 )	2.97 ( 1.769 )	3.89 ( 1.421 )	2.90 ( 1.893 )	4.05 ( 1.823 )	4.57 ( 1.276 )
Change at Week 48 (n=11,12,11,32,22,22,17,20,23)	3.47 ( 1.156 )	3.42 ( 1.682 )	5.46 ( 1.019 )	2.99 ( 1.684 )	3.01 ( 1.695 )	4.25 ( 1.438 )	3.28 ( 1.789 )	4.11 ( 1.802 )	4.61 ( 1.428 )
Change at Week 52 (n=11,12,11,31,22,21,18,19,25)	3.70 ( 1.262 )	3.43 ( 1.928 )	5.43 ( 1.211 )	2.94 ( 1.668 )	3.16 ( 1.573 )	4.26 ( 1.325 )	3.10 ( 1.725 )	4.00 ( 2.021 )	4.53 ( 1.565 )
Change at Week 56 (n=10,12,9,28,19,21,16,18,23)	3.83 ( 1.308 )	3.31 ( 1.961 )	5.35 ( 1.132 )	3.08 ( 1.445 )	3.00 ( 1.719 )	4.24 ( 1.510 )	3.10 ( 1.605 )	4.49 ( 1.553 )	4.74 ( 1.405 )
Change at Week 60 (n=9,11,9,30,20,19,15,15,22)	3.08 ( 1.718 )	3.51 ( 1.742 )	5.07 ( 1.553 )	2.98 ( 1.710 )	3.31 ( 1.714 )	3.70 ( 1.401 )	3.26 ( 1.672 )	3.72 ( 1.928 )	4.42 ( 1.254 )
Change at Week 64 (n=10,11,8,27,21,20,15,17,21)	3.31 ( 1.611 )	3.48 ( 1.919 )	4.50 ( 1.900 )	2.64 ( 2.059 )	3.30 ( 1.657 )	3.75 ( 1.383 )	2.85 ( 2.115 )	3.69 ( 2.218 )	4.39 ( 1.118 )

No statistical analyses for this end point

Secondary: Chronic Period: Number of Participants With ADA and NAbs to PF-06480605

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End point title

Chronic Period: Number of Participants With ADA and NAbs to PF-06480605

End point description

Samples were considered to be positive for ADA against PF-06480605 if the titer was >= 60, and an ADA sample was considered to be negative if the titer was < 60. Samples were considered to be positive for NAb against PF-06480605 if the titer was >= 5, and an NAb sample was considered to be negative if the titer was < 5. Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Number analyzed is the number of participants with data available for analysis. n= number of participants with data available for analysis at the specified timepoints. 9999 = No participants were analyzed at the specified timepoint.

End point type

Secondary

End point timeframe

Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64

End point values	Placebo (Induction) to PF-06480605 (Chronic) 50 mg	Placebo (Induction) to PF-06480605 (Chronic) 150 mg	Placebo (Induction) to PF-06480605 (Chronic) 450 mg	PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Number of subjects analysed	12	14	14	43	26	28	25	26	29
Units: participants
ADA at Week 16 (n=11,13,14,42,24,28,25,25,29)	0	0	0	38	18	24	10	17	15
NAb at Week 16 (n=0,0,0,39,18,24,11,18,18)	9999	9999	9999	16	7	3	1	3	1
ADA at Week 20 (n=12,13,13,43,26,28,22,26,29)	9	9	4	39	20	23	14	18	16
NAb at Week 20 (n=10,9,5,40,21,24,15,20,16)	0	0	0	12	7	4	0	5	1
ADA at Week 24 (n=12,13,11,40,23,28,24,25,26)	10	9	6	36	21	22	20	18	16
NAb at Week 24 (n=11,10,7,38,23,22,22,19,18)	1	2	0	11	4	2	1	4	0
ADA at Week 28 (n=11,14,12,38,24,27,20,24,25)	11	12	5	35	22	24	18	19	15
NAb at Week 28 (n=11,13,6,37,22,25,18,19,16)	4	3	0	13	5	4	1	4	0
ADA at Week 32 (n=11,14,13,37,23,25,21,24,24)	11	14	6	34	21	23	18	19	18
NAb at Week 32 (n=11,14,7,35,22,24,20,19,18)	4	3	0	10	4	1	0	3	1
ADA at Week 36 (n=11,14,12,35,20,22,20,22,23)	11	14	6	33	17	20	19	19	16
NAb at Week 36 (n=11,14,7,33,17,20,19,20,18)	3	3	1	10	2	3	0	5	0
ADA at Week 40 (n=11,11,12,35,21,24,18,21,24)	11	11	5	34	19	22	17	18	18
NAb at Week 40 (n=11,11,5,34,19,22,17,20,18)	3	1	1	8	3	2	0	2	0
ADA at Week 44 (n=10,12,12,35,21,24,18,20,24)	10	12	6	30	18	20	18	16	15
NAb at Week 44 (n=10,12,6,31,19,22,18,18,16)	3	1	1	7	4	3	0	1	0
ADA at Week 48 (n=11,12,11,34,22,24,18,20,22)	11	12	5	29	19	20	18	17	14
NAb at Week 48 (n=11,12,5,30,18,20,17,18,16)	2	1	1	7	3	3	0	1	1
ADA at Week 52 (n=11,12,12,32,22,23,18,20,23)	11	11	5	28	19	17	16	17	13
NAb at Week 52 (n=11,11,5,30,19,20,16,17,15)	2	2	1	8	5	2	1	1	0
ADA at Week 56 (n=10,12,10,30,19,22,17,19,23)	10	11	4	28	16	21	16	15	13
NAb at Week 56 (n=10,11,4,29,18,21,16,14,13)	2	1	1	6	5	2	0	2	0
ADA at Week 60 (n=9,12,10,32,20,21,14,17,22)	9	11	6	27	18	19	13	16	16
NAb at Week 60 (n=9,12,7,28,18,19,14,16,17)	2	0	2	5	3	3	0	3	0
ADA at Week 64 (n=10,11,10,29,21,20,17,16,20)	10	11	10	28	18	20	17	16	17
NAb at Week 64 (n=10,11,10,29,19,20,17,16,17)	0	1	1	7	4	2	1	3	0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Induction Period: Study treatment initiation to the first chronic dose or safety follow-up end, whichever is first. (~16 wks + 12 wk safety FU). Chronic Period: First chronic dose to safety follow-up end. (~40 wks + 12 wk safety FU).

Adverse event reporting additional description

Safety Population: All participants who took >=1 dose of IP during induction. Evaluable mITT Population: All randomized participants who took >=dose of IP in the chronic period. Induction: data may differ from publications using Week 14 as the AE reporting end. Chronic: data may differ from publications using Week 56 as the AE reporting end.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

25.1

Reporting group title

Induction Period: PF-06480605 50 mg

Reporting group description

Participants received PF-06480605, 50 mg, as a SC injection, Q4W up to Week 12.

Reporting group title

Induction Period: Placebo

Reporting group description

Participants received PF-06480605 matching placebo, as a SC injection, Q4W up to Week 12.

Reporting group title

Placebo (Induction) to PF-06480605 (Chronic) 50 mg

Reporting group description

Participants who received placebo and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Reporting group title

Placebo (Induction) to PF-06480605 (Chronic) 150 mg

Reporting group description

Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Reporting group title

Induction Period: PF-06480605 450 mg

Reporting group description

Participants received PF-06480605, 450 mg, as a SC injection, Q4W up to Week 12.

Reporting group title

Induction Period: PF-06480605 150 mg

Reporting group description

Participants received PF-06480605, 150 mg, as a SC injection, Q4W up to Week 12.

Reporting group title

Placebo (Induction) to PF-06480605 (Chronic) 450mg

Reporting group description

Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Reporting group title

PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg

Reporting group description

Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Reporting group title

PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg

Reporting group description

Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Reporting group title

PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg

Reporting group description

Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Reporting group title

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg

Reporting group description

Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Reporting group title

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg

Reporting group description

Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Reporting group title

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg

Reporting group description

Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.

Induction Period: PF-06480605 50 mg

Induction Period: Placebo

Placebo (Induction) to PF-06480605 (Chronic) 50 mg

Placebo (Induction) to PF-06480605 (Chronic) 150 mg

Induction Period: PF-06480605 450 mg

Induction Period: PF-06480605 150 mg

Placebo (Induction) to PF-06480605 (Chronic) 450mg

PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg

PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg

PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg

PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg

Total subjects affected by serious adverse events

subjects affected / exposed

3 / 47 (6.38%)

4 / 45 (8.89%)

0 / 12 (0.00%)

0 / 14 (0.00%)

4 / 91 (4.40%)

1 / 62 (1.61%)

0 / 14 (0.00%)

5 / 46 (10.87%)

1 / 27 (3.70%)

0 / 30 (0.00%)

2 / 26 (7.69%)

1 / 26 (3.85%)

4 / 29 (13.79%)

number of deaths (all causes)

number of deaths resulting from adverse events

Investigations

SARS-CoV-2 test positive

subjects affected / exposed

0 / 47 (0.00%)

1 / 45 (2.22%)

0 / 12 (0.00%)

0 / 14 (0.00%)

0 / 91 (0.00%)

0 / 62 (0.00%)

0 / 14 (0.00%)

0 / 46 (0.00%)

0 / 27 (0.00%)

0 / 30 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neoplasm of appendix

subjects affected / exposed

0 / 47 (0.00%)

0 / 45 (0.00%)

0 / 12 (0.00%)

0 / 14 (0.00%)

1 / 91 (1.10%)

0 / 62 (0.00%)

0 / 14 (0.00%)

0 / 46 (0.00%)

0 / 27 (0.00%)

0 / 30 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

Tibia fracture

subjects affected / exposed

0 / 47 (0.00%)

0 / 45 (0.00%)

0 / 12 (0.00%)

0 / 14 (0.00%)

0 / 91 (0.00%)

0 / 62 (0.00%)

0 / 14 (0.00%)

1 / 46 (2.17%)

0 / 27 (0.00%)

0 / 30 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vascular disorders

Embolism

subjects affected / exposed

0 / 47 (0.00%)

0 / 45 (0.00%)

0 / 12 (0.00%)

0 / 14 (0.00%)

1 / 91 (1.10%)

0 / 62 (0.00%)

0 / 14 (0.00%)

0 / 46 (0.00%)

0 / 27 (0.00%)

0 / 30 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Coronary artery stenosis

subjects affected / exposed

0 / 47 (0.00%)

0 / 45 (0.00%)

0 / 12 (0.00%)

0 / 14 (0.00%)

0 / 91 (0.00%)

0 / 62 (0.00%)

0 / 14 (0.00%)

0 / 46 (0.00%)

0 / 27 (0.00%)

0 / 30 (0.00%)

0 / 26 (0.00%)

1 / 29 (3.45%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Surgical and medical procedures

Haemorrhoid operation

subjects affected / exposed

0 / 47 (0.00%)

0 / 45 (0.00%)

0 / 12 (0.00%)

0 / 14 (0.00%)

0 / 91 (0.00%)

0 / 62 (0.00%)

0 / 14 (0.00%)

0 / 46 (0.00%)

0 / 27 (0.00%)

0 / 30 (0.00%)

0 / 26 (0.00%)

1 / 26 (3.85%)

0 / 29 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pregnancy, puerperium and perinatal conditions

Abortion spontaneous complete

subjects affected / exposed

0 / 47 (0.00%)

0 / 45 (0.00%)

0 / 12 (0.00%)

0 / 14 (0.00%)

0 / 91 (0.00%)

0 / 62 (0.00%)

0 / 14 (0.00%)

0 / 46 (0.00%)

1 / 27 (3.70%)

0 / 30 (0.00%)

0 / 26 (0.00%)

0 / 29 (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 / 47 (0.00%)

0 / 45 (0.00%)

0 / 12 (0.00%)

0 / 14 (0.00%)

0 / 91 (0.00%)

0 / 62 (0.00%)

0 / 14 (0.00%)

0 / 46 (0.00%)

0 / 27 (0.00%)

0 / 30 (0.00%)

0 / 26 (0.00%)

1 / 29 (3.45%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Hypereosinophilic syndrome

subjects affected / exposed

0 / 47 (0.00%)

1 / 45 (2.22%)

0 / 12 (0.00%)

0 / 14 (0.00%)

0 / 91 (0.00%)

0 / 62 (0.00%)

0 / 14 (0.00%)

0 / 46 (0.00%)

0 / 27 (0.00%)

0 / 30 (0.00%)

0 / 26 (0.00%)

0 / 29 (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

Drug ineffective

subjects affected / exposed

0 / 47 (0.00%)

0 / 45 (0.00%)

0 / 12 (0.00%)

0 / 14 (0.00%)

0 / 91 (0.00%)

0 / 62 (0.00%)

0 / 14 (0.00%)

1 / 46 (2.17%)

0 / 27 (0.00%)

0 / 30 (0.00%)

0 / 26 (0.00%)

0 / 29 (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

1 / 47 (2.13%)

1 / 45 (2.22%)

0 / 12 (0.00%)

0 / 14 (0.00%)

1 / 91 (1.10%)

1 / 62 (1.61%)

0 / 14 (0.00%)

1 / 46 (2.17%)

0 / 27 (0.00%)

0 / 30 (0.00%)

1 / 26 (3.85%)

0 / 26 (0.00%)

0 / 29 (0.00%)

occurrences causally related to treatment / all

0 / 1

1 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Duodenal ulcer haemorrhage

subjects affected / exposed

0 / 47 (0.00%)

0 / 45 (0.00%)

0 / 12 (0.00%)

0 / 14 (0.00%)

0 / 91 (0.00%)

0 / 62 (0.00%)

0 / 14 (0.00%)

1 / 46 (2.17%)

0 / 27 (0.00%)

0 / 30 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Intestinal perforation

subjects affected / exposed

0 / 47 (0.00%)

0 / 45 (0.00%)

0 / 12 (0.00%)

0 / 14 (0.00%)

0 / 91 (0.00%)

0 / 62 (0.00%)

0 / 14 (0.00%)

0 / 46 (0.00%)

0 / 27 (0.00%)

0 / 30 (0.00%)

0 / 26 (0.00%)

1 / 29 (3.45%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Lower gastrointestinal haemorrhage

subjects affected / exposed

0 / 47 (0.00%)

0 / 45 (0.00%)

0 / 12 (0.00%)

0 / 14 (0.00%)

0 / 91 (0.00%)

0 / 62 (0.00%)

0 / 14 (0.00%)

0 / 46 (0.00%)

0 / 27 (0.00%)

0 / 30 (0.00%)

0 / 26 (0.00%)

1 / 29 (3.45%)

occurrences causally related to treatment / all

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Vomiting

subjects affected / exposed

0 / 47 (0.00%)

1 / 45 (2.22%)

0 / 12 (0.00%)

0 / 14 (0.00%)

0 / 91 (0.00%)

0 / 62 (0.00%)

0 / 14 (0.00%)

0 / 46 (0.00%)

0 / 27 (0.00%)

0 / 30 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatobiliary disorders

Cholecystitis

subjects affected / exposed

1 / 47 (2.13%)

0 / 45 (0.00%)

0 / 12 (0.00%)

0 / 14 (0.00%)

0 / 91 (0.00%)

0 / 62 (0.00%)

0 / 14 (0.00%)

1 / 46 (2.17%)

0 / 27 (0.00%)

0 / 30 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

COVID-19 pneumonia

subjects affected / exposed

1 / 47 (2.13%)

0 / 45 (0.00%)

0 / 12 (0.00%)

0 / 14 (0.00%)

0 / 91 (0.00%)

0 / 62 (0.00%)

0 / 14 (0.00%)

0 / 46 (0.00%)

0 / 27 (0.00%)

0 / 30 (0.00%)

1 / 26 (3.85%)

0 / 26 (0.00%)

0 / 29 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cytomegalovirus infection

subjects affected / exposed

0 / 47 (0.00%)

0 / 45 (0.00%)

0 / 12 (0.00%)

0 / 14 (0.00%)

1 / 91 (1.10%)

0 / 62 (0.00%)

0 / 14 (0.00%)

0 / 46 (0.00%)

0 / 27 (0.00%)

0 / 30 (0.00%)

0 / 26 (0.00%)

0 / 29 (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	Induction Period: PF-06480605 50 mg	Induction Period: Placebo	Placebo (Induction) to PF-06480605 (Chronic) 50 mg	Placebo (Induction) to PF-06480605 (Chronic) 150 mg	Induction Period: PF-06480605 450 mg	Induction Period: PF-06480605 150 mg	Placebo (Induction) to PF-06480605 (Chronic) 450mg	PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg	PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Total subjects affected by non serious adverse events
subjects affected / exposed	11 / 47 (23.40%)	16 / 45 (35.56%)	5 / 12 (41.67%)	9 / 14 (64.29%)	34 / 91 (37.36%)	20 / 62 (32.26%)	9 / 14 (64.29%)	24 / 46 (52.17%)	15 / 27 (55.56%)	12 / 30 (40.00%)	14 / 26 (53.85%)	15 / 26 (57.69%)	14 / 29 (48.28%)
Investigations
Blood creatine phosphokinase increased
subjects affected / exposed	1 / 47 (2.13%)	2 / 45 (4.44%)	0 / 12 (0.00%)	0 / 14 (0.00%)	1 / 91 (1.10%)	1 / 62 (1.61%)	0 / 14 (0.00%)	3 / 46 (6.52%)	0 / 27 (0.00%)	0 / 30 (0.00%)	1 / 26 (3.85%)	1 / 26 (3.85%)	3 / 29 (10.34%)
occurrences all number	1	2	0	0	1	1	0	3	0	0	1	1	3
Blood pressure increased
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	1 / 14 (7.14%)	0 / 91 (0.00%)	0 / 62 (0.00%)	0 / 14 (0.00%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	0	0	3	0	0	0	0	0	0	0	0	0
SARS-CoV-2 antibody test positive
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 91 (0.00%)	1 / 62 (1.61%)	0 / 14 (0.00%)	1 / 46 (2.17%)	0 / 27 (0.00%)	1 / 30 (3.33%)	1 / 26 (3.85%)	2 / 26 (7.69%)	0 / 29 (0.00%)
occurrences all number	0	0	0	0	0	1	0	1	0	1	1	2	0
Electrocardiogram QT prolonged
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	1 / 12 (8.33%)	0 / 14 (0.00%)	0 / 91 (0.00%)	0 / 62 (0.00%)	0 / 14 (0.00%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	1 / 26 (3.85%)	0 / 29 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	1	0
SARS-CoV-2 test positive
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	1 / 12 (8.33%)	2 / 14 (14.29%)	1 / 91 (1.10%)	2 / 62 (3.23%)	2 / 14 (14.29%)	1 / 46 (2.17%)	5 / 27 (18.52%)	3 / 30 (10.00%)	4 / 26 (15.38%)	3 / 26 (11.54%)	2 / 29 (6.90%)
occurrences all number	0	0	1	2	1	2	2	1	5	3	4	3	2
Injury, poisoning and procedural complications
Arthropod bite
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	1 / 14 (7.14%)	0 / 91 (0.00%)	0 / 62 (0.00%)	0 / 14 (0.00%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0
Skin abrasion
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 91 (0.00%)	0 / 62 (0.00%)	1 / 14 (7.14%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0	0	0	0
Thermal burn
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	1 / 12 (8.33%)	0 / 14 (0.00%)	0 / 91 (0.00%)	0 / 62 (0.00%)	0 / 14 (0.00%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	1 / 26 (3.85%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	1	0	0
Cardiac disorders
Tachycardia
subjects affected / exposed	0 / 47 (0.00%)	1 / 45 (2.22%)	1 / 12 (8.33%)	0 / 14 (0.00%)	0 / 91 (0.00%)	0 / 62 (0.00%)	0 / 14 (0.00%)	0 / 46 (0.00%)	1 / 27 (3.70%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	1	1	0	0	0	0	0	1	0	0	0	0
Nervous system disorders
Dizziness
subjects affected / exposed	1 / 47 (2.13%)	0 / 45 (0.00%)	1 / 12 (8.33%)	0 / 14 (0.00%)	3 / 91 (3.30%)	1 / 62 (1.61%)	0 / 14 (0.00%)	2 / 46 (4.35%)	2 / 27 (7.41%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	3	0	1	0	3	1	0	7	3	0	0	0	0
Headache
subjects affected / exposed	2 / 47 (4.26%)	1 / 45 (2.22%)	1 / 12 (8.33%)	1 / 14 (7.14%)	9 / 91 (9.89%)	2 / 62 (3.23%)	1 / 14 (7.14%)	3 / 46 (6.52%)	2 / 27 (7.41%)	0 / 30 (0.00%)	2 / 26 (7.69%)	2 / 26 (7.69%)	1 / 29 (3.45%)
occurrences all number	2	1	1	1	13	2	1	3	2	0	3	3	1
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	2 / 47 (4.26%)	4 / 45 (8.89%)	1 / 12 (8.33%)	2 / 14 (14.29%)	2 / 91 (2.20%)	5 / 62 (8.06%)	0 / 14 (0.00%)	4 / 46 (8.70%)	1 / 27 (3.70%)	0 / 30 (0.00%)	3 / 26 (11.54%)	3 / 26 (11.54%)	2 / 29 (6.90%)
occurrences all number	2	4	1	2	2	5	0	4	1	0	3	3	2
Iron deficiency anaemia
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	1 / 14 (7.14%)	2 / 91 (2.20%)	0 / 62 (0.00%)	0 / 14 (0.00%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	1 / 29 (3.45%)
occurrences all number	0	0	0	1	2	0	0	0	0	0	0	0	1
General disorders and administration site conditions
Fatigue
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	5 / 91 (5.49%)	1 / 62 (1.61%)	1 / 14 (7.14%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	1 / 29 (3.45%)
occurrences all number	0	0	0	0	6	1	1	0	0	0	0	0	1
Oedema
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	1 / 14 (7.14%)	0 / 91 (0.00%)	0 / 62 (0.00%)	0 / 14 (0.00%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0
Injection site reaction
subjects affected / exposed	1 / 47 (2.13%)	1 / 45 (2.22%)	0 / 12 (0.00%)	0 / 14 (0.00%)	2 / 91 (2.20%)	3 / 62 (4.84%)	1 / 14 (7.14%)	1 / 46 (2.17%)	3 / 27 (11.11%)	0 / 30 (0.00%)	1 / 26 (3.85%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	2	1	0	0	2	4	3	5	3	0	1	0	0
Pain
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 91 (0.00%)	0 / 62 (0.00%)	0 / 14 (0.00%)	0 / 46 (0.00%)	2 / 27 (7.41%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0	0	0
Pyrexia
subjects affected / exposed	0 / 47 (0.00%)	1 / 45 (2.22%)	2 / 12 (16.67%)	1 / 14 (7.14%)	5 / 91 (5.49%)	1 / 62 (1.61%)	1 / 14 (7.14%)	2 / 46 (4.35%)	2 / 27 (7.41%)	2 / 30 (6.67%)	3 / 26 (11.54%)	0 / 26 (0.00%)	1 / 29 (3.45%)
occurrences all number	0	1	2	1	9	1	1	4	2	2	4	0	1
Peripheral swelling
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 91 (0.00%)	0 / 62 (0.00%)	1 / 14 (7.14%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	4 / 91 (4.40%)	1 / 62 (1.61%)	1 / 14 (7.14%)	2 / 46 (4.35%)	0 / 27 (0.00%)	1 / 30 (3.33%)	1 / 26 (3.85%)	1 / 26 (3.85%)	0 / 29 (0.00%)
occurrences all number	0	0	0	0	4	1	1	3	0	1	1	1	0
Angular cheilitis
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	1 / 12 (8.33%)	0 / 14 (0.00%)	0 / 91 (0.00%)	0 / 62 (0.00%)	0 / 14 (0.00%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0
Colitis ulcerative
subjects affected / exposed	2 / 47 (4.26%)	0 / 45 (0.00%)	0 / 12 (0.00%)	1 / 14 (7.14%)	3 / 91 (3.30%)	1 / 62 (1.61%)	0 / 14 (0.00%)	8 / 46 (17.39%)	4 / 27 (14.81%)	2 / 30 (6.67%)	6 / 26 (23.08%)	3 / 26 (11.54%)	1 / 29 (3.45%)
occurrences all number	2	0	0	1	3	1	0	8	4	2	6	3	2
Diarrhoea
subjects affected / exposed	2 / 47 (4.26%)	0 / 45 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 91 (0.00%)	1 / 62 (1.61%)	1 / 14 (7.14%)	1 / 46 (2.17%)	1 / 27 (3.70%)	0 / 30 (0.00%)	1 / 26 (3.85%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	2	0	0	0	0	1	1	1	1	0	2	0	0
Gastritis
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	1 / 12 (8.33%)	0 / 14 (0.00%)	0 / 91 (0.00%)	0 / 62 (0.00%)	1 / 14 (7.14%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	0	1	0	0	0	1	0	0	0	0	0	0
Nausea
subjects affected / exposed	3 / 47 (6.38%)	1 / 45 (2.22%)	0 / 12 (0.00%)	0 / 14 (0.00%)	2 / 91 (2.20%)	2 / 62 (3.23%)	1 / 14 (7.14%)	1 / 46 (2.17%)	2 / 27 (7.41%)	3 / 30 (10.00%)	2 / 26 (7.69%)	1 / 26 (3.85%)	0 / 29 (0.00%)
occurrences all number	3	1	0	0	2	2	1	4	2	3	2	1	0
Stomatitis
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	1 / 14 (7.14%)	0 / 91 (0.00%)	0 / 62 (0.00%)	0 / 14 (0.00%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0
Vomiting
subjects affected / exposed	1 / 47 (2.13%)	1 / 45 (2.22%)	0 / 12 (0.00%)	1 / 14 (7.14%)	0 / 91 (0.00%)	0 / 62 (0.00%)	0 / 14 (0.00%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	1 / 26 (3.85%)	1 / 29 (3.45%)
occurrences all number	1	1	0	1	0	0	0	0	0	0	0	1	1
Umbilical hernia
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	1 / 14 (7.14%)	0 / 91 (0.00%)	0 / 62 (0.00%)	0 / 14 (0.00%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0
Proctitis
subjects affected / exposed	0 / 47 (0.00%)	1 / 45 (2.22%)	0 / 12 (0.00%)	1 / 14 (7.14%)	0 / 91 (0.00%)	0 / 62 (0.00%)	0 / 14 (0.00%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	1	0	1	0	0	0	0	0	0	0	0	0
Toothache
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 91 (0.00%)	0 / 62 (0.00%)	0 / 14 (0.00%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	2 / 26 (7.69%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	2	0	0
Reproductive system and breast disorders
Adnexa uteri pain
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 91 (0.00%)	0 / 62 (0.00%)	1 / 14 (7.14%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	1 / 14 (7.14%)	1 / 91 (1.10%)	0 / 62 (0.00%)	0 / 14 (0.00%)	0 / 46 (0.00%)	0 / 27 (0.00%)	1 / 30 (3.33%)	1 / 26 (3.85%)	0 / 26 (0.00%)	1 / 29 (3.45%)
occurrences all number	0	0	0	1	1	0	0	0	0	1	1	0	1
Epistaxis
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 91 (0.00%)	0 / 62 (0.00%)	1 / 14 (7.14%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0
Oropharyngeal pain
subjects affected / exposed	0 / 47 (0.00%)	1 / 45 (2.22%)	1 / 12 (8.33%)	0 / 14 (0.00%)	2 / 91 (2.20%)	0 / 62 (0.00%)	1 / 14 (7.14%)	0 / 46 (0.00%)	0 / 27 (0.00%)	3 / 30 (10.00%)	0 / 26 (0.00%)	1 / 26 (3.85%)	0 / 29 (0.00%)
occurrences all number	0	1	1	0	3	0	1	0	0	3	0	1	0
Skin and subcutaneous tissue disorders
Alopecia
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	1 / 14 (7.14%)	1 / 91 (1.10%)	0 / 62 (0.00%)	1 / 14 (7.14%)	0 / 46 (0.00%)	1 / 27 (3.70%)	0 / 30 (0.00%)	0 / 26 (0.00%)	1 / 26 (3.85%)	1 / 29 (3.45%)
occurrences all number	0	0	0	1	1	0	1	0	1	0	0	1	1
Dermatitis atopic
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	1 / 14 (7.14%)	0 / 91 (0.00%)	0 / 62 (0.00%)	0 / 14 (0.00%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0
Hand dermatitis
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 91 (0.00%)	0 / 62 (0.00%)	1 / 14 (7.14%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0
Dry skin
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	1 / 91 (1.10%)	0 / 62 (0.00%)	0 / 14 (0.00%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	2 / 29 (6.90%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	2
Rash
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	2 / 91 (2.20%)	0 / 62 (0.00%)	0 / 14 (0.00%)	1 / 46 (2.17%)	0 / 27 (0.00%)	0 / 30 (0.00%)	2 / 26 (7.69%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	0	0	0	4	0	0	2	0	0	2	0	0
Acne
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	1 / 12 (8.33%)	0 / 14 (0.00%)	1 / 91 (1.10%)	0 / 62 (0.00%)	0 / 14 (0.00%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	0	1	0	1	0	0	0	0	0	0	0	0
Dermatitis psoriasiform
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	1 / 14 (7.14%)	0 / 91 (0.00%)	0 / 62 (0.00%)	0 / 14 (0.00%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	1 / 91 (1.10%)	0 / 62 (0.00%)	0 / 14 (0.00%)	1 / 46 (2.17%)	0 / 27 (0.00%)	0 / 30 (0.00%)	2 / 26 (7.69%)	1 / 26 (3.85%)	0 / 29 (0.00%)
occurrences all number	0	0	0	0	1	0	0	1	0	0	2	1	0
Arthralgia
subjects affected / exposed	0 / 47 (0.00%)	1 / 45 (2.22%)	1 / 12 (8.33%)	0 / 14 (0.00%)	4 / 91 (4.40%)	0 / 62 (0.00%)	0 / 14 (0.00%)	0 / 46 (0.00%)	1 / 27 (3.70%)	1 / 30 (3.33%)	2 / 26 (7.69%)	1 / 26 (3.85%)	1 / 29 (3.45%)
occurrences all number	0	1	1	0	5	0	0	0	1	1	3	1	1
Coccydynia
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	1 / 14 (7.14%)	0 / 91 (0.00%)	0 / 62 (0.00%)	0 / 14 (0.00%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0
Neck pain
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 91 (0.00%)	0 / 62 (0.00%)	1 / 14 (7.14%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0
Infections and infestations
COVID-19
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 91 (0.00%)	1 / 62 (1.61%)	1 / 14 (7.14%)	2 / 46 (4.35%)	0 / 27 (0.00%)	1 / 30 (3.33%)	1 / 26 (3.85%)	1 / 26 (3.85%)	2 / 29 (6.90%)
occurrences all number	0	0	0	0	0	1	1	2	0	1	1	1	2
Chorioretinitis
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 91 (0.00%)	0 / 62 (0.00%)	1 / 14 (7.14%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0
Nasopharyngitis
subjects affected / exposed	1 / 47 (2.13%)	2 / 45 (4.44%)	0 / 12 (0.00%)	0 / 14 (0.00%)	2 / 91 (2.20%)	1 / 62 (1.61%)	1 / 14 (7.14%)	3 / 46 (6.52%)	1 / 27 (3.70%)	2 / 30 (6.67%)	0 / 26 (0.00%)	1 / 26 (3.85%)	2 / 29 (6.90%)
occurrences all number	1	2	0	0	2	1	1	3	3	3	0	1	2
Pharyngitis
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	1 / 12 (8.33%)	0 / 14 (0.00%)	0 / 91 (0.00%)	0 / 62 (0.00%)	0 / 14 (0.00%)	1 / 46 (2.17%)	1 / 27 (3.70%)	0 / 30 (0.00%)	1 / 26 (3.85%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	0	0	1	0	0	0	0	1	1	0	1	0	0
Sinusitis
subjects affected / exposed	1 / 47 (2.13%)	0 / 45 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 91 (0.00%)	1 / 62 (1.61%)	1 / 14 (7.14%)	0 / 46 (0.00%)	0 / 27 (0.00%)	1 / 30 (3.33%)	0 / 26 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	1	0	0	0	0	1	1	0	0	1	0	0	0
Urinary tract infection
subjects affected / exposed	3 / 47 (6.38%)	0 / 45 (0.00%)	1 / 12 (8.33%)	0 / 14 (0.00%)	2 / 91 (2.20%)	0 / 62 (0.00%)	0 / 14 (0.00%)	1 / 46 (2.17%)	2 / 27 (7.41%)	0 / 30 (0.00%)	2 / 26 (7.69%)	0 / 26 (0.00%)	0 / 29 (0.00%)
occurrences all number	3	0	1	0	2	0	0	1	2	0	3	0	0
Upper respiratory tract infection
subjects affected / exposed	0 / 47 (0.00%)	0 / 45 (0.00%)	0 / 12 (0.00%)	0 / 14 (0.00%)	0 / 91 (0.00%)	2 / 62 (3.23%)	0 / 14 (0.00%)	0 / 46 (0.00%)	0 / 27 (0.00%)	0 / 30 (0.00%)	1 / 26 (3.85%)	2 / 26 (7.69%)	2 / 29 (6.90%)
occurrences all number	0	0	0	0	0	2	0	0	0	0	1	3	3

More information

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Were there any global substantial amendments to the protocol? Yes

01 Sep 2020

1. Estimands regarding primary induction and chronic therapy period, related to what is considered a non-responder regarding early treatment discontinuation were clarified. Estimands section updated to reflect and clarify how a participants who discontinues study treatment prior to week 12 will be allocated regarding responder and non-responder. 2. Various changes were implemented in the Schedule of Activities. 3. Inclusion criterion weight, body mass index (BMI) was removed as the investigational drug was not dosed based on weight. 4. Time period for collecting AE and SAE information: Protocol wording states, “through and including Visit 20; this was corrected to Visit 18. 5. Mayo Scoring system for assessment of ulcerative colitis was updated: the modified endoscopic scoring system was used in this study. Friability was removed from endoscopic subscore of 1 and placed into the endoscopic subscore 2.

15 Mar 2022

1. Modified estimands to permit exclusion of participants with missed visits due to COVID–19 from analysis. 2. Chronic Therapy Period secondary endpoint change from baseline for fecal calprotectin, hsCRP, and sTL1A biomarkers in order to better understand the full trajectory over time was added. 3. Tertiary endpoint for the Inflammatory Bowel Disease Questionnaire (IBDQ) to assess the impact of drug on a clinically meaningful threshold and more details around histopathology endpoints was added. 4. Language was modified to clarify participants who withdraw from the treatment period should be followed for 3 study visits (one being the Early Withdrawal Visit) for a total of 12 weeks from the last dose of IP. 4. Analysis methods were modified to align with similar analysis of binary endpoints, and to allow comparison with historical data from other studies and publications with similar endpoints on treatment effect-Return stool diary data collection tool from Early Withdrawal visit due to administrative error was removed 6. Evaluable Population was updated to include ITT and mITT in order to distinguish between Induction and Chronic Period, and clarification was provided for Biomarker Analysis Population and clarified biomarker analysis population.

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, Multicenter, Randomized, Double-blind, Placebo-controlled Dose-ranging Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of PF-06480605 in Adult Participants 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: Percentage of Participants Who Achieved Clinical Remission at Week 14

Primary: Induction Period: Percentage of Participants Who Achieved Clinical Remission at Week 14

Primary: Induction Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Primary: Induction Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Primary: Induction Period: Number of Participants With Serious Adverse Events (SAEs)

Primary: Induction Period: Number of Participants With Serious Adverse Events (SAEs)

Primary: Induction Period: Number of Participants With AEs or SAEs Leading to Discontinuation

Primary: Induction Period: Number of Participants With AEs or SAEs Leading to Discontinuation

Primary: Chronic Period: Number of Participants With TEAEs

Primary: Chronic Period: Number of Participants With TEAEs

Primary: Chronic Period: Number of Participants With SAEs

Primary: Chronic Period: Number of Participants With SAEs

Primary: Chronic Period: Number of Participants With AEs or SAEs Leading to Discontinuation

Primary: Chronic Period: Number of Participants With AEs or SAEs Leading to Discontinuation

Secondary: Induction and Chronic Periods: Percentage of Participants Who Achieved Remission as per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1)

Secondary: Induction and Chronic Periods: Percentage of Participants Who Achieved Remission as per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1)

Secondary: Induction and Chronic Periods: Percentage of Participants Who Achieved Remission as per FDA Definition 2 (Modified Remission 2)

Secondary: Induction and Chronic Periods: Percentage of Participants Who Achieved Remission as per FDA Definition 2 (Modified Remission 2)

Secondary: Induction and Chronic Periods: Percentage of Participants Who Achieved Endoscopic Improvement

Secondary: Induction and Chronic Periods: Percentage of Participants Who Achieved Endoscopic Improvement

Secondary: Induction and Chronic Periods: Percentage of Participants Who Achieved Endoscopic Remission

Secondary: Induction and Chronic Periods: Percentage of Participants Who Achieved Endoscopic Remission

Secondary: Induction and Chronic Periods: Trough Concentration (Ctrough) of PF-06480605

Secondary: Induction and Chronic Periods: Trough Concentration (Ctrough) of PF-06480605

Secondary: Induction Period: Change From Baseline in Fecal Calprotectin

Secondary: Induction Period: Change From Baseline in Fecal Calprotectin

Secondary: Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)

Secondary: Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)

Secondary: Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A)

Secondary: Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A)

Secondary: Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605

Secondary: Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605

Secondary: Chronic Period: Percentage of Participants Who Achieved Clinical Remission

Secondary: Chronic Period: Percentage of Participants Who Achieved Clinical Remission

Secondary: Chronic Period: Percentage of Participants Who Achieved Sustained Clinical Remission

Secondary: Chronic Period: Percentage of Participants Who Achieved Sustained Clinical Remission

Secondary: Chronic Period: Percentage of Participants Who Achieved Sustained Remission as per FDA Definition 1 (Modified Remission 1)

Secondary: Chronic Period: Percentage of Participants Who Achieved Sustained Remission as per FDA Definition 1 (Modified Remission 1)

Secondary: Chronic Period: Percentage of Participants Who Achieved Sustained Remission as per FDA Definition 2 (Modified Remission 2)

Secondary: Chronic Period: Percentage of Participants Who Achieved Sustained Remission as per FDA Definition 2 (Modified Remission 2)

Secondary: Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Improvement

Secondary: Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Improvement

Secondary: Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Remission

Secondary: Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Remission

Secondary: Chronic Period: Change From Week 16 in Fecal Calprotectin

Secondary: Chronic Period: Change From Week 16 in Fecal Calprotectin

Secondary: Chronic Period: Change From Week 14 in hsCRP

Secondary: Chronic Period: Change From Week 14 in hsCRP

Secondary: Chronic Period: Change From Week 14 in Serum sTL1A

Secondary: Chronic Period: Change From Week 14 in Serum sTL1A

Secondary: Change From Baseline in Fecal Calprotectin Through the End of Study

Secondary: Change From Baseline in Fecal Calprotectin Through the End of Study

Secondary: Change From Baseline in hsCRP Through the End of Study

Secondary: Change From Baseline in hsCRP Through the End of Study

Secondary: Change From Baseline in Serum sTL1A Through the End of Study

Secondary: Change From Baseline in Serum sTL1A Through the End of Study

Secondary: Chronic Period: Number of Participants With ADA and NAbs to PF-06480605

Secondary: Chronic Period: Number of Participants With ADA and NAbs to PF-06480605

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 2B, Multicenter, Randomized, Double-blind, Placebo-controlled Dose-ranging Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis