Trial Outcomes & Findings for A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis (NCT NCT01620255)

NCT ID: NCT01620255

Last Updated: 2021-06-11

Results Overview

Clinical remission was defined as a Total Mayo Score of less than or equal (\<=) 2 points with no individual subscore exceeding 1 point and rectal bleed subscore of 0 or 1. The Mayo Score is a tool designed to measure disease activity for ulcerative colitis (UC). Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

357 participants

Primary outcome timeframe

Week 12

Results posted on

2021-06-11

Participant Flow

Two (2) subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead and were counted under that group. The numbers Started reflect the number of participants who received treatment.

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 centimeters (cm) apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 7.5 mg Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 22.5 mg Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 75 mg Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 225 mg Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
Overall Study STARTED	73	71	70	73	70
Overall Study Treated	73	71	70	73	70
Overall Study COMPLETED	69	65	68	70	64
Overall Study NOT COMPLETED	4	6	2	3	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 centimeters (cm) apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 7.5 mg Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 22.5 mg Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 75 mg Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 225 mg Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
Overall Study Withdrawal by Subject	4	1	1	2	4
Overall Study Participant underwent fecal transplant	0	0	1	0	0
Overall Study Non-compliance	0	1	0	0	0
Overall Study Adverse Event	0	4	0	1	1
Overall Study Withdrawn at discretion of investigator	0	0	0	0	1

Baseline Characteristics

A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=73 Participants Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 7.5 mg n=71 Participants Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 22.5 mg n=70 Participants Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 75 mg n=73 Participants Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 225 mg n=70 Participants Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	Total n=357 Participants Total of all reporting groups
Age, Continuous	38.6 years STANDARD_DEVIATION 12.7 • n=93 Participants	41.3 years STANDARD_DEVIATION 12.5 • n=4 Participants	42.1 years STANDARD_DEVIATION 14.7 • n=27 Participants	37.7 years STANDARD_DEVIATION 12.4 • n=483 Participants	41.3 years STANDARD_DEVIATION 13.2 • n=36 Participants	40.2 years STANDARD_DEVIATION 13.2 • n=10 Participants
Sex: Female, Male Female	29 Participants n=93 Participants	32 Participants n=4 Participants	25 Participants n=27 Participants	35 Participants n=483 Participants	28 Participants n=36 Participants	149 Participants n=10 Participants
Sex: Female, Male Male	44 Participants n=93 Participants	39 Participants n=4 Participants	45 Participants n=27 Participants	38 Participants n=483 Participants	42 Participants n=36 Participants	208 Participants n=10 Participants

PRIMARY outcome

Timeframe: Week 12

Population: The primary analysis population was based on a modified intent-to-treat (mITT) analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.

Outcome measures

Outcome measures
Measure	PF-00547659 22.5 mg n=72 Participants Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 75 mg n=71 Participants Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	Placebo n=73 Participants Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 7.5 mg n=71 Participants Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 225 mg n=70 Participants Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
Percentage of Participants in Clinical Remission at Week 12 Centrally read	16.7 percentage of participants Interval 9.9 to 25.4	15.5 percentage of participants Interval 9.5 to 23.6	2.7 percentage of participants Interval 0.7 to 7.6	11.3 percentage of participants Interval 5.7 to 18.8	5.7 percentage of participants Interval 2.5 to 12.5
Percentage of Participants in Clinical Remission at Week 12 Locally read	23.6 percentage of participants Interval 15.6 to 33.1	18.3 percentage of participants Interval 11.9 to 27.1	5.5 percentage of participants Interval 2.4 to 12.0	14.1 percentage of participants Interval 7.8 to 22.0	12.9 percentage of participants Interval 7.3 to 21.1

SECONDARY outcome

Timeframe: Week 12

Population: The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of participants evaluable for the specified category.

Clinical response was defined as a decrease from baseline of at least 3 points in Total Mayo Score with at least a 30 percent (%) change, accompanied by at least 1 point decrease or absolute score of 0 or 1 in rectal bleeding subscore. The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.

Outcome measures

Outcome measures
Measure	PF-00547659 22.5 mg n=72 Participants Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 75 mg n=71 Participants Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	Placebo n=73 Participants Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 7.5 mg n=71 Participants Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 225 mg n=70 Participants Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
Percentage of Participants With Clinical Response at Week 12 Centrally read (n=73,71,72,71,70)	54.2 percentage of participants Interval 44.2 to 64.2	45.1 percentage of participants Interval 35.0 to 55.3	28.8 percentage of participants Interval 20.2 to 37.8	38.0 percentage of participants Interval 28.4 to 47.6	50.0 percentage of participants Interval 39.6 to 60.4
Percentage of Participants With Clinical Response at Week 12 Locally read (n=73,70,72,70,70)	54.2 percentage of participants Interval 44.2 to 64.2	48.6 percentage of participants Interval 38.2 to 59.0	32.9 percentage of participants Interval 24.2 to 42.3	38.6 percentage of participants Interval 28.8 to 48.1	51.4 percentage of participants Interval 41.0 to 61.8

SECONDARY outcome

Timeframe: Week 12

Population: The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment.

Mucosal healing was defined as absolute Mayo subscore for endoscopy of 0 or 1. The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.

Outcome measures

Outcome measures
Measure	PF-00547659 22.5 mg n=72 Participants Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 75 mg n=71 Participants Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	Placebo n=73 Participants Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 7.5 mg n=71 Participants Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 225 mg n=70 Participants Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
Percentage of Participants With Mucosal Healing at Week 12 Centrally read	27.8 percentage of participants Interval 19.5 to 37.1	25.4 percentage of participants Interval 17.1 to 35.0	8.2 percentage of participants Interval 3.6 to 15.4	15.5 percentage of participants Interval 9.5 to 23.6	14.3 percentage of participants Interval 8.0 to 22.3
Percentage of Participants With Mucosal Healing at Week 12 Locally read	37.5 percentage of participants Interval 28.0 to 47.2	35.2 percentage of participants Interval 25.8 to 44.7	21.9 percentage of participants Interval 14.9 to 31.4	22.5 percentage of participants Interval 15.4 to 31.6	28.6 percentage of participants Interval 20.2 to 38.2

SECONDARY outcome

Timeframe: Weeks 4, 8, and 12

Population: As this endpoint was incorrectly stated in the protocol, no analyses were done and no data are presented.

An absolute Partial Mayo Score of \<=2 corresponds to remission. However, this endpoint was incorrectly stated in the protocol and instead of "absolute Partial Mayo Score \<=2", it was stated as "change from baseline in Partial Mayo Score \<=2".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 12

The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.

Outcome measures

Outcome measures
Measure	PF-00547659 22.5 mg n=72 Participants Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 75 mg n=71 Participants Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	Placebo n=73 Participants Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 7.5 mg n=71 Participants Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 225 mg n=70 Participants Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
Change From Baseline in Total Mayo Score at Week 12 Locally read change (n=67,62,70,66,64)	-3.1 units on a scale Standard Deviation 2.70 • Interval -3.866 to -2.775	-2.7 units on a scale Standard Deviation 2.92 • Interval -3.357 to -2.236	-1.7 units on a scale Standard Deviation 2.55 • Interval -2.28 to -1.171	-2.7 units on a scale Standard Deviation 3.05 • Interval -3.241 to -2.084	-3.1 units on a scale Standard Deviation 3.07 • Interval -3.583 to -2.442
Change From Baseline in Total Mayo Score at Week 12 Locally read baseline (n=73,70,72,70,70)	8.1 units on a scale Standard Deviation 1.72	8.3 units on a scale Standard Deviation 1.99	8.4 units on a scale Standard Deviation 1.72	8.8 units on a scale Standard Deviation 1.59	8.6 units on a scale Standard Deviation 1.62
Change From Baseline in Total Mayo Score at Week 12 Centrally read baseline (n=73,71,72,71,70)	8.1 units on a scale Standard Deviation 1.63	8.4 units on a scale Standard Deviation 1.94	8.4 units on a scale Standard Deviation 1.71	8.7 units on a scale Standard Deviation 1.65	8.7 units on a scale Standard Deviation 1.60
Change From Baseline in Total Mayo Score at Week 12 Centrally read change (n=67,63,69,67,63)	-2.9 units on a scale Standard Deviation 2.49 • Interval -3.57 to -2.55	-2.5 units on a scale Standard Deviation 2.74 • Interval -3.162 to -2.131	-1.5 units on a scale Standard Deviation 2.42 • Interval -2.043 to -1.014	-2.4 units on a scale Standard Deviation 2.78 • Interval -2.944 to -1.881	-2.9 units on a scale Standard Deviation 2.78 • Interval -3.337 to -2.27

SECONDARY outcome

Timeframe: Baseline; Weeks (W) 4, 8, and 12

The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, PGA, findings on flexible sigmoidoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. Changes from baseline in the subscore of less than (\<) 0, 0, and \>0 corresponded to improvement (imp), no change (NC), and worsening (wors) in that specific subscore.

Outcome measures

Outcome measures
Measure	PF-00547659 22.5 mg n=72 Participants Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 75 mg n=71 Participants Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	Placebo n=73 Participants Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 7.5 mg n=71 Participants Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 225 mg n=70 Participants Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 Imp in Stool frequency, W4 (n=67,64,71,69,65)	36.62 percentage of participants Interval -3.57 to -2.55	30.43 percentage of participants Interval -3.162 to -2.131	26.87 percentage of participants Interval -2.043 to -1.014	46.88 percentage of participants Interval -2.944 to -1.881	43.08 percentage of participants Interval -3.337 to -2.27
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 NC in Stool frequency, W4 (n=67,64,71,69,65)	60.56 percentage of participants Interval -3.866 to -2.775	63.77 percentage of participants Interval -3.357 to -2.236	59.70 percentage of participants Interval -2.28 to -1.171	42.19 percentage of participants Interval -3.241 to -2.084	52.31 percentage of participants Interval -3.583 to -2.442
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 Wors in Stool frequency, W4 (n=67,64,71,69,65)	2.82 percentage of participants	5.80 percentage of participants	13.43 percentage of participants	10.94 percentage of participants	4.62 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 Imp in Stool frequency, W8 (n=71,63,71,69,68)	43.66 percentage of participants	49.28 percentage of participants	28.17 percentage of participants	49.21 percentage of participants	51.47 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 NC in Stool frequency, W8 (n=71,63,71,69,68)	53.52 percentage of participants	46.38 percentage of participants	60.56 percentage of participants	42.86 percentage of participants	48.53 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 Wors in Stool frequency, W8 (n=71,63,71,69,68)	2.82 percentage of participants	4.35 percentage of participants	11.27 percentage of participants	7.94 percentage of participants	0 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 Imp in Stool frequency, W12 (n=67,63,71,68,64)	56.34 percentage of participants	45.59 percentage of participants	35.82 percentage of participants	49.21 percentage of participants	56.25 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 NC in Stool frequency, W12 (n=67,63,71,68,64)	38.03 percentage of participants	48.53 percentage of participants	52.24 percentage of participants	41.27 percentage of participants	37.50 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 Wors in Stool frequency, W12 (n=67,63,71,68,64)	5.63 percentage of participants	5.88 percentage of participants	11.94 percentage of participants	9.52 percentage of participants	6.25 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 Imp in Rectal Bleeding, W4 (n=67,64,71,69,65)	42.25 percentage of participants	42.03 percentage of participants	22.39 percentage of participants	48.44 percentage of participants	49.23 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 NC in Rectal Bleeding, W4 (n=67,64,71,69,65)	57.75 percentage of participants	53.62 percentage of participants	62.69 percentage of participants	42.19 percentage of participants	44.62 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 Wors in Rectal Bleeding, W4 (n=67,64,71,69,65)	0 percentage of participants	4.35 percentage of participants	14.93 percentage of participants	9.38 percentage of participants	6.15 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 Imp in Rectal Bleeding, W8 (n=71,63,71,69,68)	40.85 percentage of participants	46.38 percentage of participants	33.80 percentage of participants	50.79 percentage of participants	64.71 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 NC in Rectal Bleeding, W8 (n=71,63,71,69,68)	50.70 percentage of participants	44.93 percentage of participants	54.93 percentage of participants	36.51 percentage of participants	33.82 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 Wors in Rectal Bleeding, W8 (n=71,63,71,69,68)	8.45 percentage of participants	8.70 percentage of participants	11.27 percentage of participants	12.70 percentage of participants	1.47 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 Imp in Rectal Bleeding, W12 (n=67,63,71,68,64)	50.70 percentage of participants	47.06 percentage of participants	37.31 percentage of participants	53.97 percentage of participants	60.94 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 NC in Rectal Bleeding, W12 (n=67,63,71,68,64)	42.25 percentage of participants	45.59 percentage of participants	50.75 percentage of participants	34.92 percentage of participants	35.94 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 Wors in Rectal Bleeding, W12 (n=67,63,71,68,64)	7.04 percentage of participants	7.35 percentage of participants	11.94 percentage of participants	11.11 percentage of participants	3.13 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 Imp in PGA, W4 (n=67,64,71,69,65)	56.34 percentage of participants	56.52 percentage of participants	47.76 percentage of participants	57.81 percentage of participants	60.00 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 NC in PGA, W4 (n=67,64,71,69,65)	39.44 percentage of participants	42.03 percentage of participants	49.25 percentage of participants	34.38 percentage of participants	35.38 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 Wors in PGA, W4 (n=67,64,71,69,65)	4.23 percentage of participants	1.45 percentage of participants	2.99 percentage of participants	7.81 percentage of participants	4.62 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 Imp in PGA, W8 (n=71,63,71,69,68)	66.20 percentage of participants	62.32 percentage of participants	59.15 percentage of participants	61.90 percentage of participants	67.65 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 NC in PGA, W8 (n=71,63,71,69,68)	30.99 percentage of participants	37.68 percentage of participants	33.80 percentage of participants	30.16 percentage of participants	30.88 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 Wors in PGA, W8 (n=71,63,71,69,68)	2.82 percentage of participants	0 percentage of participants	7.04 percentage of participants	7.94 percentage of participants	1.47 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 Imp in PGA, W12 (n=67,63,71,68,64)	64.79 percentage of participants	55.88 percentage of participants	50.75 percentage of participants	61.90 percentage of participants	57.81 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 NC in PGA, W12 (n=67,63,71,68,64)	32.39 percentage of participants	39.71 percentage of participants	43.28 percentage of participants	31.75 percentage of participants	32.81 percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12 Wors in PGA, W12 (n=67,63,71,68,64)	2.82 percentage of participants	4.41 percentage of participants	5.97 percentage of participants	6.35 percentage of participants	9.38 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 12

The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, PGA, findings on flexible sigmoidoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. Changes from baseline in the subscore of \<0, 0, and \>0 corresponded to improvement (imp), no change (NC), and worsening (wors) in that specific subscore.

Outcome measures

Outcome measures
Measure	PF-00547659 22.5 mg n=72 Participants Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 75 mg n=71 Participants Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	Placebo n=73 Participants Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 7.5 mg n=71 Participants Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 225 mg n=70 Participants Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12 Imp (n=67,63,69,67,63)	47.83 percentage of participants Interval -3.57 to -2.55	47.76 percentage of participants Interval -3.162 to -2.131	25.37 percentage of participants Interval -2.043 to -1.014	28.57 percentage of participants Interval -2.944 to -1.881	39.68 percentage of participants Interval -3.337 to -2.27
Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12 NC (n=67,63,69,67,63)	49.28 percentage of participants Interval -3.866 to -2.775	46.27 percentage of participants Interval -3.357 to -2.236	61.19 percentage of participants Interval -2.28 to -1.171	60.32 percentage of participants Interval -3.241 to -2.084	57.14 percentage of participants Interval -3.583 to -2.442
Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12 Wors (n=67,63,69,67,63)	2.90 percentage of participants	5.97 percentage of participants	13.43 percentage of participants	11.11 percentage of participants	3.17 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, and 12

Fecal calprotectin was one of the pharmacodynamic (PD) biomarkers of the study.

Outcome measures

Outcome measures
Measure	PF-00547659 22.5 mg n=72 Participants Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 75 mg n=71 Participants Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	Placebo n=73 Participants Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 7.5 mg n=71 Participants Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 225 mg n=70 Participants Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12 Week 4 (n=62,57,68,67,60)	-23.50 percent change Interval -44.27 to 5.0	-46.22 percent change Interval -61.46 to -24.95	-25.62 percent change Interval -43.49 to -2.09	-40.21 percent change Interval -55.56 to -19.54	-39.27 percent change Interval -56.74 to -14.75
Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12 Week 8 (n=67,57,67,63,65)	-44.77 percent change Interval -60.49 to -22.8	-57.20 percent change Interval -69.74 to -39.45	-21.68 percent change Interval -39.62 to 1.6	-44.49 percent change Interval -60.05 to -22.88	-49.54 percent change Interval -65.08 to -27.07
Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12 Week 12 (n=61,55,64,64,59)	-58.41 percent change Interval -72.26 to -37.65	-56.72 percent change Interval -71.67 to -33.88	-22.59 percent change Interval -42.68 to 4.54	-56.34 percent change Interval -69.39 to -37.72	-64.52 percent change Interval -76.92 to -45.43

SECONDARY outcome

Timeframe: Baseline; Weeks 4, 8, and 12

hsCRP was one of the PD biomarkers of the study.

Outcome measures

Outcome measures
Measure	PF-00547659 22.5 mg n=72 Participants Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 75 mg n=71 Participants Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	Placebo n=73 Participants Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 7.5 mg n=71 Participants Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 225 mg n=70 Participants Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12 Week 12 (n=67,62,68,71,64)	-20.40 percent change Interval -38.61 to 3.22	-15.96 percent change Interval -33.12 to 5.6	14.85 percent change Interval -11.16 to 48.48	4.51 percent change Interval -18.02 to 33.25	2.31 percent change Interval -18.48 to 28.42
Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12 Week 4 (n=67,64,69,71,65)	-26.90 percent change Interval -39.41 to -11.82	-35.21 percent change Interval -49.1 to -17.55	-11.60 percent change Interval -25.69 to 5.17	-19.17 percent change Interval -34.22 to -0.67	-17.70 percent change Interval -30.08 to -3.13
Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12 Week 8 (n=71,63,69,71,68)	-31.43 percent change Interval -44.11 to -15.88	-43.15 percent change Interval -54.57 to -28.86	-2.42 percent change Interval -22.75 to 23.25	-6.00 percent change Interval -23.09 to 14.89	-22.70 percent change Interval -36.72 to -5.59

SECONDARY outcome

Timeframe: Baseline, Week 12

IBDQ: Psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with inflammatory bowel disease. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL.

Outcome measures

Outcome measures
Measure	PF-00547659 22.5 mg n=72 Participants Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 75 mg n=71 Participants Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	Placebo n=73 Participants Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 7.5 mg n=71 Participants Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 225 mg n=70 Participants Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12 Baseline (BL)(n=69,68,65,71,66)	133.4 units on a scale Standard Deviation 34.79 • Interval -3.57 to -2.55	128.0 units on a scale Standard Deviation 32.42 • Interval -3.162 to -2.131	128.0 units on a scale Standard Deviation 30.69 • Interval -2.043 to -1.014	122.1 units on a scale Standard Deviation 38.82 • Interval -2.944 to -1.881	132.3 units on a scale Standard Deviation 36.84 • Interval -3.337 to -2.27
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12 Change at W12 (n=62,55,61,64,54)	32.7 units on a scale Standard Deviation 34.10 • Interval -3.866 to -2.775	32.1 units on a scale Standard Deviation 31.70 • Interval -3.357 to -2.236	19.8 units on a scale Standard Deviation 34.08 • Interval -2.28 to -1.171	20.1 units on a scale Standard Deviation 35.24 • Interval -3.241 to -2.084	36.2 units on a scale Standard Deviation 29.45 • Interval -3.583 to -2.442

SECONDARY outcome

Timeframe: Baseline (BL), Week 12

IBDQ: Psychometrically validated PRO instrument for measuring disease-specific QOL in participants with inflammatory bowel disease. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL. There are 4 individual domains under the IBDQ: bowel function (fx)/symptoms (score range of 10-70), systemic symptoms (score range of 5-35), emotional status/fx (score range of 12-84), and social fx (score range of 5-35). As with total score, higher scores indicate better QOL in that domain.

Outcome measures

Outcome measures
Measure	PF-00547659 22.5 mg n=72 Participants Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 75 mg n=71 Participants Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	Placebo n=73 Participants Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 7.5 mg n=71 Participants Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 225 mg n=70 Participants Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 BL, bowel fx (n=69,68,65,71,66)	41.7 units on a scale Standard Deviation 10.60 • Interval -3.57 to -2.55	38.5 units on a scale Standard Deviation 9.95 • Interval -3.162 to -2.131	38.9 units on a scale Standard Deviation 9.96 • Interval -2.043 to -1.014	37.0 units on a scale Standard Deviation 12.23 • Interval -2.944 to -1.881	41.0 units on a scale Standard Deviation 11.37 • Interval -3.337 to -2.27
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 Change at W12, bowel fx (n=62,55,61,64,54)	11.3 units on a scale Standard Deviation 11.05 • Interval -3.866 to -2.775	11.8 units on a scale Standard Deviation 12.07 • Interval -3.357 to -2.236	7.4 units on a scale Standard Deviation 11.93 • Interval -2.28 to -1.171	6.9 units on a scale Standard Deviation 12.51 • Interval -3.241 to -2.084	12.8 units on a scale Standard Deviation 11.45 • Interval -3.583 to -2.442
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 BL, emotional fx (n=69,68,65,71,66)	51.2 units on a scale Standard Deviation 14.70	50.4 units on a scale Standard Deviation 13.73	50.4 units on a scale Standard Deviation 12.60	48.4 units on a scale Standard Deviation 15.39	51.3 units on a scale Standard Deviation 15.92
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 Change at W12, emotional fx (n=62,55,61,64,54)	10.8 units on a scale Standard Deviation 13.85	10.0 units on a scale Standard Deviation 12.04	5.9 units on a scale Standard Deviation 11.91	6.6 units on a scale Standard Deviation 12.22	12.0 units on a scale Standard Deviation 11.40
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 BL, systemic symptoms (SS)(n=69,68,65,71,66)	19.6 units on a scale Standard Deviation 5.98	18.4 units on a scale Standard Deviation 6.42	18.1 units on a scale Standard Deviation 5.62	18.2 units on a scale Standard Deviation 6.81	19.0 units on a scale Standard Deviation 5.97
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 Change at W12, SS (n=62,55,61,64,54)	4.7 units on a scale Standard Deviation 5.91	4.9 units on a scale Standard Deviation 5.49	3.3 units on a scale Standard Deviation 6.67	3.1 units on a scale Standard Deviation 5.95	4.8 units on a scale Standard Deviation 5.05
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 BL, social fx (n=69,68,65,71,66)	20.9 units on a scale Standard Deviation 7.37	20.7 units on a scale Standard Deviation 6.99	20.6 units on a scale Standard Deviation 7.87	18.5 units on a scale Standard Deviation 8.07	20.9 units on a scale Standard Deviation 7.73
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12 Change at W12, social fx (n=62,55,61,64,54)	5.9 units on a scale Standard Deviation 6.51	5.4 units on a scale Standard Deviation 6.90	3.3 units on a scale Standard Deviation 6.27	3.6 units on a scale Standard Deviation 7.33	6.6 units on a scale Standard Deviation 6.58

SECONDARY outcome

Timeframe: Week 12

Population: The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment.

Outcome measures

Outcome measures
Measure	PF-00547659 22.5 mg n=63 Participants Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 75 mg n=64 Participants Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	Placebo n=65 Participants Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 7.5 mg n=57 Participants Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 225 mg n=54 Participants Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
Percentage of Participants With an Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score of More Than or Equal to (>=) 170 at Week 12	55.6 percentage of participants Interval 45.0 to 66.3	46.9 percentage of participants Interval 36.1 to 57.5	36.9 percentage of participants Interval 27.4 to 47.5	36.8 percentage of participants Interval 26.9 to 47.9	48.1 percentage of participants Interval 36.3 to 59.4

SECONDARY outcome

Timeframe: Screening through to end of treatment period, up to 12 weeks

Population: All randomized participants who received at least 1 dose of study treatment.

An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Outcome measures

Outcome measures
Measure	PF-00547659 22.5 mg n=70 Participants Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 75 mg n=73 Participants Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	Placebo n=73 Participants Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 7.5 mg n=71 Participants Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 225 mg n=70 Participants Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12) With TEAEs	36 participants	43 participants	39 participants	41 participants	43 participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12) With SAEs	1 participants	3 participants	4 participants	11 participants	3 participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12) Withdrawals due to TEAEs	0 participants	3 participants	2 participants	5 participants	1 participants

SECONDARY outcome

Timeframe: Weeks 0 (baseline), 2, 4,8, 12, 16, 20, 24, 28, 32, and 36; Early Withdrawal

Population: Participants who received active treatment (PF-00547659) were included in this analysis.

Outcome measures

Outcome measures
Measure	PF-00547659 22.5 mg n=67 Participants Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 75 mg n=68 Participants Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	Placebo Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 7.5 mg n=67 Participants Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 225 mg n=62 Participants Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
Maximum Serum PF-00547659 Concentration Achieved	2062 nanograms (ng)/milliliter (mL) Standard Deviation 1395.5	6576 nanograms (ng)/milliliter (mL) Standard Deviation 2146.0	—	929.4 nanograms (ng)/milliliter (mL) Standard Deviation 1977.8	21470 nanograms (ng)/milliliter (mL) Standard Deviation 4788.4

Adverse Events

Placebo

Serious events: 4 serious events

Other events: 17 other events

Deaths: 0 deaths

PF-00547659 7.5 mg

Serious events: 11 serious events

Other events: 16 other events

Deaths: 0 deaths

PF-00547659 22.5 mg

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

PF-00547659 75 mg

Serious events: 4 serious events

Other events: 14 other events

Deaths: 0 deaths

PF-00547659 225 mg

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=73 participants at risk Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 7.5 mg n=71 participants at risk Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 22.5 mg n=70 participants at risk Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 75 mg n=73 participants at risk Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 225 mg n=70 participants at risk Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
Eye disorders Retinal artery embolism	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	1.4% 1/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Gastrointestinal disorders Abdominal pain	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	1.4% 1/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Gastrointestinal disorders Anal fistula	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	1.4% 1/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Gastrointestinal disorders Colitis ulcerative	1.4% 1/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	8.5% 6/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	2.7% 2/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Gastrointestinal disorders Constipation	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	1.4% 1/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Gastrointestinal disorders Diarrhoea	2.7% 2/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	1.4% 1/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Gastrointestinal disorders Vomiting	1.4% 1/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	1.4% 1/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Infections and infestations Anal abscess	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	1.4% 1/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Infections and infestations Appendicitis	1.4% 1/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Infections and infestations Clostridium difficile infection	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	1.4% 1/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Metabolism and nutrition disorders Dehydration	1.4% 1/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	1.4% 1/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	1.4% 1/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Nervous system disorders Epilepsy	1.4% 1/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Nervous system disorders Migraine	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	1.4% 1/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	1.4% 1/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Nervous system disorders Syncope	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	1.4% 1/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Nervous system disorders Tension headache	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	1.4% 1/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Psychiatric disorders Delirium	1.4% 1/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Renal and urinary disorders Acute kidney injury	1.4% 1/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.4% 1/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Surgical and medical procedures Colectomy total	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	1.4% 1/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.

Other adverse events

Other adverse events
Measure	Placebo n=73 participants at risk Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 7.5 mg n=71 participants at risk Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 22.5 mg n=70 participants at risk Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 75 mg n=73 participants at risk Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	PF-00547659 225 mg n=70 participants at risk Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
Blood and lymphatic system disorders Anaemia	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	2.9% 2/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	5.5% 4/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	2.9% 2/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Gastrointestinal disorders Abdominal pain	2.7% 2/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	8.5% 6/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	4.3% 3/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	2.7% 2/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	1.4% 1/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Gastrointestinal disorders Nausea	4.1% 3/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	8.5% 6/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	1.4% 1/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	1.4% 1/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	5.7% 4/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Gastrointestinal disorders Vomiting	4.1% 3/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	1.4% 1/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	5.7% 4/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	2.9% 2/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Infections and infestations Nasopharyngitis	4.1% 3/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	4.3% 3/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	6.8% 5/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	5.7% 4/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Nervous system disorders Headache	8.2% 6/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	7.0% 5/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	10.0% 7/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	5.5% 4/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	11.4% 8/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.
Respiratory, thoracic and mediastinal disorders Cough	5.5% 4/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	1.4% 1/71 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	1.4% 1/73 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.	0.00% 0/70 • Screening till Week 36 or Early Withdrawal, whichever was later. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER