Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01284062
• Collaborator: (none)
• Enrollment: 84
• Locations: 76
• Arms: 4
• Duration (Months): 25
• Patients Per Site: 1.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This study represents the first investigation of anrukinzumab in patients with active ulcerative colitis (UC) and will evaluate proof of mechanism by changes in the mechanism based biomarker (YKL 40) and pharmacodynamic biomarkers (fecal calprotectin, lactoferrin and hs-CRP). It will provide further assessment of the safety, tolerability, and pharmacokinetics (PK) by administration of multiple intravenous (IV) doses of anrukinzumab.

Condition or Disease	Intervention/Treatment	Phase
Colitis, Ulcerative	Biological: Anrukinzumab; Biological: Anrukinzumab; Biological: Anrukinzumab; Other: placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 2a, Randomized, Double-blind, Sponsor Unblinded, Placebo-controlled, Multiple Dose Study To Evaluate The Pharmacodynamics, Pharmacokinetics And Safety Of Anrukinzumab In Subjects With Active Ulcerative Colitis
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 200 mg PF-05230917, Anrukinzumab active dose level	Biological: Anrukinzumab; 200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12; Other Names: PF-05230917
Experimental: Arm 2 400 mg PF-05230917, Anrukinzumab active dose level	Biological: Anrukinzumab; 200 mg sterile liquid vial, dose level 400 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12; Other Names: PF-05230917
Experimental: Arm 3 600 mg PF-05230917, Anrukinzumab active dose level	Biological: Anrukinzumab; 200 mg sterile liquid vial, dose level 600 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12 Note: dosing in the 600 mg arm will be delayed until the safety of the 200 mg and 400 mg arms has been reviewed.; Other Names: PF-05230917
Placebo Comparator: Arm 4 Matching placebo - administered at matching dose level 200 mg, 400 mg or 600 mg.	Other: placebo; 200 mg liquid sterile vial, administered at matching dose level 200 mg, 400 mg or 600 mg intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12

Outcome Measures

Primary Outcome Measures

1. Fold Change From Baseline in Fecal Calprotectin at Week 14 [Baseline, Week 14]

   The fold change from baseline in fecal calprotectin at Week 14, is the ratio of the measurement of fecal calprotectin at Week 14 to baseline measurement; this was calculated as the change from baseline in natural log transformed fecal calprotectin at Week 14.

Secondary Outcome Measures

1. Maximum Observed Plasma Concentration (Cmax) for Anrukinzumab [Pre-dose to end of the dosing interval after Day 1, Week 12]

   Maximum concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).

2. Minimum Observed Plasma Trough Concentration (Cmin) for Anrukinzumab [Pre-dose to end of the dosing interval after Day 1, Week 12]

   Lowest concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).

3. Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Anrukinzumab [Pre-dose, within 1 hour post-end of infusion on Day 1; Day 2, 4, 7, pre-dose on Week 2]

   Area under the plasma concentration curve from time zero to end of dosing interval (2 weeks) was reported.

4. Plasma Decay Half-Life (t1/2) for Anrukinzumab [Within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32]

   Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

5. Systemic Clearance (CL) for Anrukinzumab [Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32]

   CL is a quantitative measure of the rate at which a drug substance is removed from the body.

6. Volume of Distribution (Vz) for Anrukinzumab [Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32]

   Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.

7. Fold Change From Baseline in Fecal Calprotectin at Week 2, 4, 8 and 12 [Baseline, Week 2, 4, 8, 12]

   The fold change from baseline in fecal calprotectin at post-baseline visit, is the ratio of the measurement of fecal calprotectin at post-baseline visit to baseline measurement; this was calculated as the change from baseline in natural log transformed fecal calprotectin at post-baseline visit.

8. Total Interleukin-13 (IL-13) Level [Baseline, Day 2, 4, 7, Week 2, 4, 8, 12, 14, 16, 20, 24, 28, 32]

9. Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to Week 32]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. Treatment-emergent are events between first dose of study drug and up to Week 32 that were absent before treatment or that worsened relative to pretreatment state. All causality AEs included SAEs as well as non-serious AEs, without regard to relationship to the study drug, which occurred during the trial.

10. Number of Participants Who Discontinued From the Study Due to Adverse Events [Baseline up to Week 32]

11. Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody [Day 1, Week 4, 8, 12, 14, 16, 20, 24, 28, 32]

    Neutralizing antibody was not analyzed as no participant had positive ADA samples.

12. Number of Participants With Change From Baseline in Endoscopic Subscore at Week 14 [Baseline, Week 14]

    Mayo score is used to measure the disease activity of ulcerative colitis. Endoscopy or flexible sigmoidoscopy is a sub score of Mayo score. The score for endoscopic subscore ranges from 0 to 3, where higher score indicates more severe disease activity. Participant's score for endoscopy or flexible sigmoidoscopy at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.

Other Outcome Measures

1. Clinical Response Rate at Week 14 [Week 14]

   Clinical response rate is defined as percentage of participants with at least 3 point decrease from baseline in total Mayo score with at least 30% change along with 1 point decrease from baseline or absolute score of 0 or 1 in rectal bleeding. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy [endoscopy] and physician's global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.

2. Clinical Remission Rate at Week 14 [Week 14]

   Clinical remission rate is defined as percentage of participants with a total Mayo score less than or equal to 2, with no individual subscore greater than 1 at post baseline visit. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy and physician's global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.

3. Change From Baseline in Total Mayo Score at Week 14 [Baseline, Week 14]

   The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy [endoscopy] and physician's global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.

4. Number of Participants With Change From Baseline in Stool Frequency at Week 14 [Baseline, Week 14]

   Stool frequency is a sub score of Mayo score used to measure the disease activity of ulcerative colitis. The score for stool frequency ranges from 0 to 3, where higher score indicates more severe disease activity. Participant's score for stool frequency at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.

5. Number of Participants With Change From Baseline in Rectal Bleeding at Week 14 [Baseline, Week 14]

   Mayo score is used to measure the disease activity of ulcerative colitis. Rectal bleeding is a sub score of Mayo score. The score for rectal bleeding ranges from 0 to 3, where higher score indicates more severe disease activity. Participant's score for rectal bleeding at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or Female, Age >=18 and <=65 years

• Active ulcerative colitis (UC) beyond the rectum based upon Mayo Score

• women of childbearing potential with highly effective method of contraception

Exclusion Criteria:

• Indeterminate disease status, Crohn's disease, ischemic colitis, positive HIV, positive or history of tuberculosis infection, active enteric infections, transplant organ recipient, concomitant steroids, immunosuppressives or anti-TNFs.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Kirkland Clinic	Birmingham	Alabama	United States	35233
2	UAB Hospital	Birmingham	Alabama	United States	35233
3	UAB Hospital Department of Pharmacy	Birmingham	Alabama	United States	35249
4	Administrative Offices	Birmingham	Alabama	United States	35294
5	UAB ACIP	Birmingham	Alabama	United States	35294
6	Arizona Surgical Center	Phoenix	Arizona	United States	85006
7	Dedicated Phase I, Inc.	Phoenix	Arizona	United States	85013
8	AGMG Endoscopy Center	Anaheim	California	United States	92801
9	Anaheim Clinical Trials, LLC	Anaheim	California	United States	92801
10	West Coast Radiology Center	Santa Ana	California	United States	92705
11	Endoscopy Center of Connecticut, LLC	Hamden	Connecticut	United States	06518
12	Gastroenterology Center of Connecticut, PC	Hamden	Connecticut	United States	06518
13	Medical Research Center of Connecticut, LLC	Hamden	Connecticut	United States	06518
14	International Clinical Research - US, LLC	Sanford	Florida	United States	32771
15	Gastrointestinal Specialists of Georgia, PC	Marietta	Georgia	United States	30060
16	GI Diagnostics	Marietta	Georgia	United States	30067
17	Gastrointestinal Associates, PA	Jackson	Mississippi	United States	39202
18	Gastrointestional Associates, PA	Jackson	Mississippi	United States	39202
19	St. Dominic Hospital	Jackson	Mississippi	United States	39216
20	Digestive Health Specialists, PA	Tupelo	Mississippi	United States	38801
21	North Mississippi Medical Center	Tupelo	Mississippi	United States	38801
22	Premier Medical Group of the Hudson Valley	Poughkeepsie	New York	United States	12601
23	Piedmont Gastroenterology Specialists	Winston-Salem	North Carolina	United States	27103
24	PMG Research of Winston-Salem	Winston-Salem	North Carolina	United States	27103
25	University Hospitals Case Medical Center - Division of Gastroenterology and Liver Disease	Cleveland	Ohio	United States	44106
26	Wheeler and Stuckey, Inc.	Oklahoma City	Oklahoma	United States	73103
27	Oklahoma Foundation for Digestive Research	Oklahoma City	Oklahoma	United States	73104
28	OU Physicians Building	Oklahoma City	Oklahoma	United States	73104
29	Memphis Gastroenterology Group, PC	Germantown	Tennessee	United States	38138
30	The West Clinic	Memphis	Tennessee	United States	38120
31	Centennial Medical Center Physicians Park	Nashville	Tennessee	United States	37203
32	Centennial Medical Center Tower Medical Imaging	Nashville	Tennessee	United States	37203
33	Columbia Medical Group - The First Clinic Inc.	Nashville	Tennessee	United States	37203
34	Radiology Alliance	Nashville	Tennessee	United States	37203
35	Professional Quality Research, Inc.	Austin	Texas	United States	78705
36	Austin Endoscopy Center	Austin	Texas	United States	78757
37	Austin Gastroenterology, PA	Austin	Texas	United States	78757
38	Texas Center for Drug Development, Inc.	Houston	Texas	United States	77081
39	Austin Gastroenterology, PA	Round Rocks	Texas	United States	78681
40	Cardiology Clinic of San Antonio	San Antonio	Texas	United States	78229
41	Gastroenterology Research of San Antonio	San Antonio	Texas	United States	78229
42	San Antonio Endoscopy Center	San Antonio	Texas	United States	78229
43	CNS Pharmacy	Murray	Utah	United States	84123
44	RGL Medical Services	Salt Lake City	Utah	United States	84084
45	Alpine Medical Group	Salt Lake City	Utah	United States	84102
46	Wasatch Clinical Research	Salt Lake City	Utah	United States	84107
47	Wasatch Endoscopy Center	Salt Lake City	Utah	United States	84124
48	University of Utah Hospital	Salt Lake City	Utah	United States	84132
49	Krankenhaus der Elisabethinen Linz GmbH	Linz		Austria	4020
50	Landesklinikum St. Poelten	St. Poelten		Austria	3100
51	AKH Wien Universitaetsklinik fuer Innere Medizin III	Wien		Austria	1090
52	MBAL Ruse / MHAT Ruse, Terapevtichno, gastroenterologichno i hematologichno otdelenie	Ruse		Bulgaria	7002
53	MBAL Voennomeditsinska Akademia / MMA HAT, Klinika po gastroenterologia i hepatologia	Sofia		Bulgaria	1606
54	DKTs Sveta Anna, Gastroenterologichen cabinet	Sofia		Bulgaria	1750
55	Heritage Medical Research Clinic - University of Calgary	Calgary	Alberta	Canada	T2N 4Z6
56	Vancouver Coastal Health - Vancouver General Hospital	Vancouver	British Columbia	Canada	V5Z 1M9
57	Vancouver General Hospital - The Gordon and Leslie Diamond Centre	Vancouver	British Columbia	Canada	V5Z 1M9
58	The Religious Hospitallers of St. Joseph of the Hotel Dieu of Kingston	Kingston	Ontario	Canada	K7L 5G2
59	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5
60	CHU Hopital Nord	Amiens Cedex 01		France	80054
61	Hopital Beaujon	Clichy		France	92110
62	CHU Hotel-Dieu	Nantes CEDEX 1		France	44093
63	Charite - Campus Berlin Mitte	Berlin		Germany	10117
64	Universitaetsklinikum Heidelberg	Heidelberg		Germany	69120
65	Universitaetsklinikum Schleswig-Holstein, Campus Kiel	Kiel		Germany	24105
66	Gastroenterologische Gemeinschaftspraxis Minden	Minden		Germany	32423
67	Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszati-Gasztroenterologiai Osztaly	Budapest		Hungary	1125
68	Pannonia Maganorvosi Centrum Kft.	Budapest		Hungary	1136
69	Clinfan Kft.	Szekszard		Hungary	7100
70	VU Medisch Centrum	Amsterdam		Netherlands	1081 HV
71	Academic Medical Center - University of Amsterdam, Dept. of Gastroenterology	Amsterdam		Netherlands	1105 AZ
72	Academisch Ziekenhuis Maastricht	Maastricht		Netherlands	6229 HX
73	Centralny Szpital Kliniczny MSWiA, Klinika Chorob Wewnetrznych i Gastroenterologii	Warszawa		Poland	02-507
74	Sectia Clinica Medicina Interna II	Bucuresti		Romania	010816
75	Hospital Clinic I Provincial de Barcelona	Barcelona		Spain	08036
76	Hospital General Universitario Gregorio Marañon	Madrid		Spain	28007

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01284062
• Other Study ID Numbers: B2421003; IMA-638 Anti-IL13 mAb; 2010-023762-49
• First Posted: Jan 26, 2011
• Last Update Posted: Nov 18, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by Pfizer: Active Ulcerative Colitis; Phase 2A; Double-blind; Randomized; PK/PD Biomarker Study
• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Ulcer

Study Results

Participant Flow

Arm/Group Title	Placebo	Anrukinzumab 200 mg	Anrukinzumab 400 mg	Anrukinzumab 600 mg
Arm/Group Description	Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Period Title: Overall Study
STARTED	21	21	21	21
COMPLETED	10	13	15	7
NOT COMPLETED	11	8	6	14

Baseline Characteristics

Arm/Group Title	Placebo	Anrukinzumab 200 mg	Anrukinzumab 400 mg	Anrukinzumab 600 mg	Total
Arm/Group Description	Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Total of all reporting groups
Overall Participants	21	21	21	21	84
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.6 (14.5)	37.5 (10.4)	46.3 (12.9)	37.0 (11.5)	39.4 (12.8)
Sex: Female, Male (Count of Participants)
Female	8 38.1%	10 47.6%	7 33.3%	10 47.6%	35 41.7%
Male	13 61.9%	11 52.4%	14 66.7%	11 52.4%	49 58.3%

Outcome Measures

1. Primary Outcome

Title	Fold Change From Baseline in Fecal Calprotectin at Week 14
Description	The fold change from baseline in fecal calprotectin at Week 14, is the ratio of the measurement of fecal calprotectin at Week 14 to baseline measurement; this was calculated as the change from baseline in natural log transformed fecal calprotectin at Week 14.
Time Frame	Baseline, Week 14

Outcome Measure Data

Analysis Population Description

Modified Intent to Treat (mITT: all randomized participants who received greater than or equal to [>=] 1 dose study drug); Data as Observed (DAO: all mITT participants with all data needed for calculation of specified endpoint). "Number of Participants Analyzed" signifies participants in the mITT DAO population for specified endpoint.

Arm/Group Title	Placebo	Anrukinzumab 200 mg	Anrukinzumab 400 mg	Anrukinzumab 600 mg
Arm/Group Description	Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Measure Participants	7	14	15	13
Least Squares Mean (95% Confidence Interval) [fold change]	0.41	0.29	0.79	1.24

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least squares (LS) mean
	Estimated Value	0.41
	Confidence Interval	(2-Sided) 80%; 0.225 to 0.766
	Parameter Dispersion	Type: Value:
	Estimation Comments	LS mean and confidence interval (CI) were based on back log-transformation of those from the analysis of covariance (ANCOVA) model.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 200 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS mean
	Estimated Value	0.29
	Confidence Interval	(2-Sided) 80%; 0.187 to 0.446
	Parameter Dispersion	Type: Value:
	Estimation Comments	LS mean and CI were based on back log-transformation of those from the ANCOVA model.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 400 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS mean
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 80%; 0.517 to 1.203
	Parameter Dispersion	Type: Value:
	Estimation Comments	LS mean and CI were based on back log-transformation of those from the ANCOVA model.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 600 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS mean
	Estimated Value	1.24
	Confidence Interval	(2-Sided) 80%; 0.794 to 1.949
	Parameter Dispersion	Type: Value:
	Estimation Comments	LS mean and CI were based on back log-transformation of those from the ANCOVA model.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 200 mg
	Comments	P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5320
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean ratio
	Estimated Value	0.70
	Confidence Interval	(2-Sided) 80%; 0.329 to 1.472
	Parameter Dispersion	Type: Value:
	Estimation Comments	LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 400 mg
	Comments	P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2700
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean ratio
	Estimated Value	1.90
	Confidence Interval	(2-Sided) 80%; 0.900 to 4.013
	Parameter Dispersion	Type: Value:
	Estimation Comments	LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 600 mg
	Comments	P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0666
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean ratio
	Estimated Value	3.00
	Confidence Interval	(2-Sided) 80%; 1.403 to 6.409
	Parameter Dispersion	Type: Value:
	Estimation Comments	LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.

2. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) for Anrukinzumab
Description	Maximum concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).
Time Frame	Pre-dose to end of the dosing interval after Day 1, Week 12

Outcome Measure Data

Analysis Population Description

All participants with evaluable pharmacokinetic (PK) results were included in PK population. PK samples with time deviation greater than (>) 20 percent (%) from nominal time were excluded from statistical summary and PK analysis. "Number of participants analyzed" = participants in PK population; "n" = evaluable participants at specified time point.

Arm/Group Title	Anrukinzumab 200 mg	Anrukinzumab 400 mg	Anrukinzumab 600 mg
Arm/Group Description	Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Measure Participants	20	20	21
Day 1 (n=19, 20, 20)	54480 (15027)	101200 (36239)	182200 (64817)
Week 12 (n=15, 16, 13)	68270 (34360)	121400 (43461)	197600 (80647)

3. Secondary Outcome

Title	Minimum Observed Plasma Trough Concentration (Cmin) for Anrukinzumab
Description	Lowest concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).
Time Frame	Pre-dose to end of the dosing interval after Day 1, Week 12

Outcome Measure Data

Analysis Population Description

All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. "Number of participants analyzed" signifies participants in PK population; "n" signifies evaluable participants at specified time point.

Arm/Group Title	Anrukinzumab 200 mg	Anrukinzumab 400 mg	Anrukinzumab 600 mg
Arm/Group Description	Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Measure Participants	20	20	21
Day 1 (n=19, 20, 20)	0.0000 (0.00000)	42.45 (165.38)	51.19 (201.57)
Week 12 (n=15, 16, 13)	13310 (8314.0)	22350 (14281)	31120 (16821)

4. Secondary Outcome

Title	Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Anrukinzumab
Description	Area under the plasma concentration curve from time zero to end of dosing interval (2 weeks) was reported.
Time Frame	Pre-dose, within 1 hour post-end of infusion on Day 1; Day 2, 4, 7, pre-dose on Week 2

Outcome Measure Data

Analysis Population Description

All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Anrukinzumab 200 mg	Anrukinzumab 400 mg	Anrukinzumab 600 mg
Arm/Group Description	Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Measure Participants	19	20	20
Mean (Standard Deviation) [nanogram*hour/milliliter (ng*hr/mL)]	8346000 (3622500)	14670000 (6055800)	24430000 (7657300)

5. Secondary Outcome

Title	Plasma Decay Half-Life (t1/2) for Anrukinzumab
Description	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame	Within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32

Outcome Measure Data

Analysis Population Description

All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Anrukinzumab 200 mg	Anrukinzumab 400 mg	Anrukinzumab 600 mg
Arm/Group Description	Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Measure Participants	14	16	7
Mean (Standard Deviation) [hours]	392.4 (99.107)	470.5 (361.46)	362.4 (111.18)

6. Secondary Outcome

Title	Systemic Clearance (CL) for Anrukinzumab
Description	CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Time Frame	Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32

Outcome Measure Data

Analysis Population Description

All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Anrukinzumab 200 mg	Anrukinzumab 400 mg	Anrukinzumab 600 mg
Arm/Group Description	Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Measure Participants	15	16	13
Mean (Standard Deviation) [liters/day]	0.2844 (0.15918)	0.3090 (0.14268)	0.3789 (0.23249)

7. Secondary Outcome

Title	Volume of Distribution (Vz) for Anrukinzumab
Description	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Time Frame	Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32

Outcome Measure Data

Analysis Population Description

All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Anrukinzumab 200 mg	Anrukinzumab 400 mg	Anrukinzumab 600 mg
Arm/Group Description	Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Measure Participants	14	16	7
Mean (Standard Deviation) [liters]	5.726 (2.5057)	9.704 (13.186)	6.143 (2.1013)

8. Secondary Outcome

Title	Fold Change From Baseline in Fecal Calprotectin at Week 2, 4, 8 and 12
Description	The fold change from baseline in fecal calprotectin at post-baseline visit, is the ratio of the measurement of fecal calprotectin at post-baseline visit to baseline measurement; this was calculated as the change from baseline in natural log transformed fecal calprotectin at post-baseline visit.
Time Frame	Baseline, Week 2, 4, 8, 12

Outcome Measure Data

Analysis Population Description

mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. "Number of Participants Analyzed" signifies participants in mITT population; "n" signifies participants in mITT DAO population for specified time point.

Arm/Group Title	Placebo	Anrukinzumab 200 mg	Anrukinzumab 400 mg	Anrukinzumab 600 mg
Arm/Group Description	Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Measure Participants	21	21	21	21
Fold Change at Week 2 (n=15, 17, 18, 13)	0.70	0.81	0.71	0.77
Fold change at Week 4 (n=14, 18, 19, 16)	0.92	0.47	0.92	0.55
Fold change at Week 8 (n=10, 16, 17, 16)	0.78	0.36	1.14	0.52
Fold change at Week 12 (n=9, 13, 14, 11)	0.64	0.19	0.96	0.67

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS mean
	Estimated Value	0.70
	Confidence Interval	(2-Sided) 80%; 0.466 to 1.048
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 200 mg
	Comments	Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS mean
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 80%; 0.552 to 1.185
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 400 mg
	Comments	Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS mean
	Estimated Value	0.71
	Confidence Interval	(2-Sided) 80%; 0.488 to 1.027
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 600 mg
	Comments	Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS mean
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 80%; 0.500 to 1.195
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS mean
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 80%; 0.631 to 1.328
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 200 mg
	Comments	Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS mean
	Estimated Value	0.47
	Confidence Interval	(2-Sided) 80%; 0.339 to 0.655
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 400 mg
	Comments	Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS mean
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 80%; 0.669 to 1.269
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 600 mg
	Comments	Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS mean
	Estimated Value	0.55
	Confidence Interval	(2-Sided) 80%; 0.388 to 0.779
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS mean
	Estimated Value	0.78
	Confidence Interval	(2-Sided) 80%; 0.454 to 1.331
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 200 mg
	Comments	Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS mean
	Estimated Value	0.36
	Confidence Interval	(2-Sided) 80%; 0.236 to 0.553
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 400 mg
	Comments	Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS mean
	Estimated Value	1.14
	Confidence Interval	(2-Sided) 80%; 0.757 to 1.722
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 600 mg
	Comments	Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS mean
	Estimated Value	0.52
	Confidence Interval	(2-Sided) 80%; 0.338 to 0.788
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS mean
	Estimated Value	0.64
	Confidence Interval	(2-Sided) 80%; 0.374 to 1.084
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 200 mg
	Comments	Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS mean
	Estimated Value	0.19
	Confidence Interval	(2-Sided) 80%; 0.122 to 0.297
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 400 mg
	Comments	Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS mean
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 80%; 0.623 to 1.465
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 600 mg
	Comments	Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS mean
	Estimated Value	0.67
	Confidence Interval	(2-Sided) 80%; 0.411 to 1.076
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 200 mg
	Comments	Week 2: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7352
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean ratio
	Estimated Value	1.16
	Confidence Interval	(2-Sided) 80%; 0.663 to 2.021
	Parameter Dispersion	Type: Value:
	Estimation Comments	LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 400 mg
	Comments	Week 2: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9754
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 80%; 0.586 to 1.753
	Parameter Dispersion	Type: Value:
	Estimation Comments	LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 600 mg
	Comments	Week 2: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8277
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean ratio
	Estimated Value	1.11
	Confidence Interval	(2-Sided) 80%; 0.609 to 2.008
	Parameter Dispersion	Type: Value:
	Estimation Comments	LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 200 mg
	Comments	Week 4: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0885
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean ratio
	Estimated Value	0.51
	Confidence Interval	(2-Sided) 80%; 0.313 to 0.846
	Parameter Dispersion	Type: Value:
	Estimation Comments	LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 400 mg
	Comments	Week 4: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9856
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean ratio
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 80%; 0.617 to 1.644
	Parameter Dispersion	Type: Value:
	Estimation Comments	LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 600 mg
	Comments	Week 4: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1996
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean ratio
	Estimated Value	0.60
	Confidence Interval	(2-Sided) 80%; 0.361 to 1.000
	Parameter Dispersion	Type: Value:
	Estimation Comments	LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 200 mg
	Comments	Week 8: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1553
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean ratio
	Estimated Value	0.46
	Confidence Interval	(2-Sided) 80%; 0.233 to 0.926
	Parameter Dispersion	Type: Value:
	Estimation Comments	LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 400 mg
	Comments	Week 8: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4633
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean ratio
	Estimated Value	1.47
	Confidence Interval	(2-Sided) 80%; 0.748 to 2.882
	Parameter Dispersion	Type: Value:
	Estimation Comments	LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 600 mg
	Comments	Week 8: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4409
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean ratio
	Estimated Value	0.66
	Confidence Interval	(2-Sided) 80%; 0.335 to 1.316
	Parameter Dispersion	Type: Value:
	Estimation Comments	LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 200 mg
	Comments	Week 12: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0283
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean ratio
	Estimated Value	0.30
	Confidence Interval	(2-Sided) 80%; 0.150 to 0.598
	Parameter Dispersion	Type: Value:
	Estimation Comments	LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 400 mg
	Comments	Week 12: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4434
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean ratio
	Estimated Value	1.50
	Confidence Interval	(2-Sided) 80%; 0.758 to 2.970
	Parameter Dispersion	Type: Value:
	Estimation Comments	LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 600 mg
	Comments	Week 12: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9372
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean ratio
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 80%; 0.510 to 2.141
	Parameter Dispersion	Type: Value:
	Estimation Comments	LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.

9. Secondary Outcome

Title	Total Interleukin-13 (IL-13) Level
Time Frame	Baseline, Day 2, 4, 7, Week 2, 4, 8, 12, 14, 16, 20, 24, 28, 32

Outcome Measure Data

Analysis Population Description

mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. "Number of Participants Analyzed" signifies participants in mITT population; "n" signifies participants in mITT DAO population for specified time point.

Arm/Group Title	Placebo	Anrukinzumab 200 mg	Anrukinzumab 400 mg	Anrukinzumab 600 mg
Arm/Group Description	Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Measure Participants	21	21	21	21
Baseline (n=15, 21, 20, 19)	0.6247 (0.97041)	1.6231 (2.95190)	1.2900 (2.07219)	0.7525 (1.59494)
Day 2 (n=21, 19, 17, 18)	0.5980 (0.81335)	3.6373 (4.69500)	6.6673 (7.29515)	5.0474 (4.97368)
Day 4 (n=16, 16, 20, 15)	0.7056 (1.29166)	7.7698 (9.02951)	12.3410 (11.84611)	10.1349 (10.24068)
Day 7 (n=7, 12, 9, 13)	0.8991 (1.15883)	15.6742 (34.90836)	16.6700 (16.73533)	11.3600 (16.79136)
Week 2 (n=20, 21, 19, 19)	0.7177 (0.98373)	16.6373 (54.71391)	17.7895 (18.53571)	21.5021 (27.03784)
Week 4 (n=18, 21, 19, 17)	0.8949 (1.47538)	15.1244 (43.76893)	17.1853 (15.00105)	8.7807 (5.39145)
Week 8 (n=16, 18, 18, 15)	0.7310 (1.09524)	21.4964 (72.31269)	16.8200 (15.47020)	6.8027 (3.44810)
Week 12 (n=12, 14, 17, 11)	0.8925 (1.38386)	19.3543 (52.00880)	22.4335 (27.04635)	6.8461 (4.19321)
Week 14 (n=12, 14, 16, 13)	1.0545 (1.15526)	33.6697 (110.9546)	20.0044 (37.36283)	8.9492 (6.33317)
Week 16 (n=10, 12, 12, 7)	0.5054 (0.29982)	15.0002 (40.41488)	16.4423 (24.54910)	3.7570 (2.91709)
Week 20 (n=8, 15, 15, 8)	1.5140 (1.82370)	9.8396 (25.99516)	7.4261 (8.00205)	4.1745 (2.84220)
Week 24 (n=10, 12, 12, 8)	1.3300 (1.41349)	3.0140 (3.23912)	6.3665 (7.85116)	3.0913 (1.99098)
Week 28 (n=10, 12, 13, 8)	1.2151 (2.23797)	0.9936 (0.75719)	2.8005 (2.67967)	3.1724 (2.15647)
Week 32 (n=9, 12, 13, 8)	0.4727 (0.37875)	1.0548 (0.80675)	1.9379 (1.99196)	2.4725 (2.54141)

10. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. Treatment-emergent are events between first dose of study drug and up to Week 32 that were absent before treatment or that worsened relative to pretreatment state. All causality AEs included SAEs as well as non-serious AEs, without regard to relationship to the study drug, which occurred during the trial.
Time Frame	Baseline up to Week 32

Outcome Measure Data

Analysis Population Description

Safety analysis set included all randomized participants who received at least 1 dose of study treatment.

Arm/Group Title	Placebo	Anrukinzumab 200 mg	Anrukinzumab 400 mg	Anrukinzumab 600 mg
Arm/Group Description	Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Measure Participants	21	21	21	21
AEs	15 71.4%	19 90.5%	17 81%	17 81%
SAEs	4 19%	4 19%	2 9.5%	4 19%

11. Secondary Outcome

Title	Number of Participants Who Discontinued From the Study Due to Adverse Events
Time Frame	Baseline up to Week 32

Outcome Measure Data

Analysis Population Description

Safety analysis set included all randomized participants who received at least 1 dose of study treatment.

Arm/Group Title	Placebo	Anrukinzumab 200 mg	Anrukinzumab 400 mg	Anrukinzumab 600 mg
Arm/Group Description	Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Measure Participants	21	21	21	21
Number [participants]	4 19%	5 23.8%	1 4.8%	5 23.8%

12. Secondary Outcome

Title	Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody
Description	Neutralizing antibody was not analyzed as no participant had positive ADA samples.
Time Frame	Day 1, Week 4, 8, 12, 14, 16, 20, 24, 28, 32

Outcome Measure Data

Analysis Population Description

mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. "Number of Participants Analyzed" signifies participants in mITT population; "n" signifies participants in mITT DAO population for specified time point.

Arm/Group Title	Placebo	Anrukinzumab 200 mg	Anrukinzumab 400 mg	Anrukinzumab 600 mg
Arm/Group Description	Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Measure Participants	21	21	21	21
Day 1 (n=18, 20, 19, 21)	0 0%	0 0%	0 0%	0 0%
Week 4 (n=17, 18, 20, 18)	0 0%	0 0%	0 0%	0 0%
Week 8 (n=15, 17, 18, 13)	0 0%	0 0%	0 0%	0 0%
Week 12 (n=14, 15, 17, 13)	0 0%	0 0%	0 0%	0 0%
Week 14 (n=13, 14, 15, 13)	0 0%	0 0%	0 0%	0 0%
Week 16 (n=10, 15, 14, 7)	0 0%	0 0%	0 0%	0 0%
Week 20 (n=11, 14, 15, 7)	0 0%	0 0%	0 0%	0 0%
Week 24 (n=10, 12, 14, 7)	0 0%	0 0%	0 0%	0 0%
Week 28 (n=8, 12, 13, 7)	0 0%	0 0%	0 0%	0 0%
Week 32 (n=10, 13, 15, 6)	0 0%	0 0%	0 0%	0 0%

13. Other Pre-specified Outcome

Title	Clinical Response Rate at Week 14
Description	Clinical response rate is defined as percentage of participants with at least 3 point decrease from baseline in total Mayo score with at least 30% change along with 1 point decrease from baseline or absolute score of 0 or 1 in rectal bleeding. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy [endoscopy] and physician's global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.
Time Frame	Week 14

Outcome Measure Data

Analysis Population Description

mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. "Number of Participants Analyzed" signifies participants in the mITT DAO population for specified endpoint.

Arm/Group Title	Placebo	Anrukinzumab 200 mg	Anrukinzumab 400 mg	Anrukinzumab 600 mg
Arm/Group Description	Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Measure Participants	12	15	16	13
Number (95% Confidence Interval) [percentage of participants]	41.67 198.4%	60.00 285.7%	50.00 238.1%	15.38 73.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percentage of participants
	Estimated Value	41.67
	Confidence Interval	(2-Sided) 80%; 25.53 to 59.81
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI was assessed by Wilson score method.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 200 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percentage of participants
	Estimated Value	60.00
	Confidence Interval	(2-Sided) 80%; 43.59 to 74.43
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI was assessed by Wilson score method.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 400 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percentage of participants
	Estimated Value	50.00
	Confidence Interval	(2-Sided) 80%; 34.74 to 65.26
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI was assessed by Wilson score method.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 600 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percentage of participants
	Estimated Value	15.38
	Confidence Interval	(2-Sided) 80%; 6.58 to 31.96
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI was assessed by Wilson score method.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 200 mg
	Comments	Two-sided p-value was calculated by Fisher's exact test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4495
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	18.33
	Confidence Interval	(2-Sided) 80%; -6.13 to 39.98
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI was assessed by Wilson score method.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 400 mg
	Comments	Two-sided p-value was calculated by Fisher's exact test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7177
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	8.33
	Confidence Interval	(2-Sided) 80%; -15.37 to 30.54
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI was assessed by Wilson score method.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 600 mg
	Comments	Two-sided p-value was calculated by Fisher's exact test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2016
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	-26.28
	Confidence Interval	(2-Sided) 80%; -46.45 to -3.15
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI was assessed by Wilson score method.

14. Other Pre-specified Outcome

Title	Clinical Remission Rate at Week 14
Description	Clinical remission rate is defined as percentage of participants with a total Mayo score less than or equal to 2, with no individual subscore greater than 1 at post baseline visit. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy and physician's global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.
Time Frame	Week 14

Outcome Measure Data

Analysis Population Description

mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. "Number of Participants Analyzed" signifies participants in the mITT DAO population for specified endpoint.

Arm/Group Title	Placebo	Anrukinzumab 200 mg	Anrukinzumab 400 mg	Anrukinzumab 600 mg
Arm/Group Description	Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Measure Participants	12	15	16	13
Number (95% Confidence Interval) [percentage of participants]	16.67 79.4%	33.33 158.7%	18.75 89.3%	0.00 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percentage of participants
	Estimated Value	16.67
	Confidence Interval	(2-Sided) 80%; 7.14 to 34.22
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI was assessed by Wilson score method.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 200 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percentage of participants
	Estimated Value	33.33
	Confidence Interval	(2-Sided) 80%; 20.08 to 49.88
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI was assessed by Wilson score method.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 400 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percentage of participants
	Estimated Value	18.75
	Confidence Interval	(2-Sided) 80%; 9.40 to 33.92
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI was assessed by Wilson score method.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 600 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percentage of participants
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 80%; 0.00 to 11.22
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI was assessed by Wilson score method.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 200 mg
	Comments	Two-sided p-value was calculated by Fisher's exact test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4082
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	16.67
	Confidence Interval	(2-Sided) 80%; -5.33 to 35.76
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI was assessed by Wilson score method.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 400 mg
	Comments	Two-sided p-value was calculated by Fisher's exact test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	1.0000
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	2.08
	Confidence Interval	(2-Sided) 80%; -17.80 to 19.99
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI was assessed by Wilson score method.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 600 mg
	Comments	Two-sided p-value was calculated by Fisher's exact test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2200
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	percent difference
	Estimated Value	-16.67
	Confidence Interval	(2-Sided) 80%; -34.22 to -1.95
	Parameter Dispersion	Type: Value:
	Estimation Comments	CI was assessed by Wilson score method.

15. Other Pre-specified Outcome

Title	Change From Baseline in Total Mayo Score at Week 14
Description	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy [endoscopy] and physician's global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.
Time Frame	Baseline, Week 14

Outcome Measure Data

Analysis Population Description

mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. "Number of Participants Analyzed" signifies participants in the mITT DAO population for specified endpoint.

Arm/Group Title	Placebo	Anrukinzumab 200 mg	Anrukinzumab 400 mg	Anrukinzumab 600 mg
Arm/Group Description	Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Measure Participants	12	15	16	13
Least Squares Mean (95% Confidence Interval) [unit on a scale]	-1.32	-2.28	-2.30	-0.79

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS mean
	Estimated Value	-1.32
	Confidence Interval	(2-Sided) 80%; -2.332 to -0.300
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 200 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS mean
	Estimated Value	-2.28
	Confidence Interval	(2-Sided) 80%; -3.190 to -1.374
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 400 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS mean
	Estimated Value	-2.30
	Confidence Interval	(2-Sided) 80%; -3.178 to -1.419
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Anrukinzumab 600 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS mean
	Estimated Value	-0.79
	Confidence Interval	(2-Sided) 80%; -1.761 to 0.190
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 200 mg
	Comments	P-value was analyzed from ANCOVA model with terms for treatment group and baseline.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3639
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.97
	Confidence Interval	(2-Sided) 80%; -2.335 to 0.403
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 400 mg
	Comments	P-value was analyzed from ANCOVA model with terms for treatment group and baseline.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3446
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.98
	Confidence Interval	(2-Sided) 80%; -2.320 to 0.355
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Anrukinzumab 600 mg
	Comments	P-value was analyzed from ANCOVA model with terms for treatment group and baseline.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6285
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.53
	Confidence Interval	(2-Sided) 80%; -0.884 to 1.945
	Parameter Dispersion	Type: Value:
	Estimation Comments

16. Other Pre-specified Outcome

Title	Number of Participants With Change From Baseline in Stool Frequency at Week 14
Description	Stool frequency is a sub score of Mayo score used to measure the disease activity of ulcerative colitis. The score for stool frequency ranges from 0 to 3, where higher score indicates more severe disease activity. Participant's score for stool frequency at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.
Time Frame	Baseline, Week 14

Outcome Measure Data

Analysis Population Description

mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. "Number of Participants Analyzed" signifies participants in the mITT DAO population for specified endpoint.

Arm/Group Title	Placebo	Anrukinzumab 200 mg	Anrukinzumab 400 mg	Anrukinzumab 600 mg
Arm/Group Description	Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Measure Participants	12	15	16	13
Improvement	4 19%	7 33.3%	7 33.3%	3 14.3%
No Change	8 38.1%	4 19%	8 38.1%	6 28.6%
Worsening	0 0%	4 19%	1 4.8%	4 19%

17. Other Pre-specified Outcome

Title	Number of Participants With Change From Baseline in Rectal Bleeding at Week 14
Description	Mayo score is used to measure the disease activity of ulcerative colitis. Rectal bleeding is a sub score of Mayo score. The score for rectal bleeding ranges from 0 to 3, where higher score indicates more severe disease activity. Participant's score for rectal bleeding at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.
Time Frame	Baseline, Week 14

Outcome Measure Data

Analysis Population Description

mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. "Number of Participants Analyzed" signifies participants in the mITT DAO population for specified endpoint.

Arm/Group Title	Placebo	Anrukinzumab 200 mg	Anrukinzumab 400 mg	Anrukinzumab 600 mg
Arm/Group Description	Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Measure Participants	12	15	16	13
Improvement	4 19%	8 38.1%	7 33.3%	5 23.8%
No Change	6 28.6%	6 28.6%	6 28.6%	7 33.3%
Worsening	2 9.5%	1 4.8%	3 14.3%	1 4.8%

18. Secondary Outcome

Title	Number of Participants With Change From Baseline in Endoscopic Subscore at Week 14
Description	Mayo score is used to measure the disease activity of ulcerative colitis. Endoscopy or flexible sigmoidoscopy is a sub score of Mayo score. The score for endoscopic subscore ranges from 0 to 3, where higher score indicates more severe disease activity. Participant's score for endoscopy or flexible sigmoidoscopy at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.
Time Frame	Baseline, Week 14

Outcome Measure Data

Analysis Population Description

mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. "Number of Participants Analyzed" signifies participants in the mITT DAO population for specified endpoint.

Arm/Group Title	Placebo	Anrukinzumab 200 mg	Anrukinzumab 400 mg	Anrukinzumab 600 mg
Arm/Group Description	Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.	Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
Measure Participants	12	15	16	13
Improvement	6 28.6%	8 38.1%	11 52.4%	2 9.5%
No Change	3 14.3%	5 23.8%	5 23.8%	11 52.4%
Worsening	3 14.3%	2 9.5%	0 0%	0 0%

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Placebo		Anrukinzumab 200 mg		Anrukinzumab 400 mg		Anrukinzumab 600 mg
Arm/Group Description	Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.		Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.		Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.		Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
All Cause Mortality
	Placebo		Anrukinzumab 200 mg		Anrukinzumab 400 mg		Anrukinzumab 600 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Anrukinzumab 200 mg		Anrukinzumab 400 mg		Anrukinzumab 600 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/21 (19%)		4/21 (19%)		2/21 (9.5%)		4/21 (19%)
Blood and lymphatic system disorders
Anaemia	1/21 (4.8%)		0/21 (0%)		0/21 (0%)		0/21 (0%)
Gastrointestinal disorders
Abdominal pain	0/21 (0%)		1/21 (4.8%)		0/21 (0%)		0/21 (0%)
Colitis ulcerative	3/21 (14.3%)		2/21 (9.5%)		1/21 (4.8%)		3/21 (14.3%)
Hepatobiliary disorders
Cholangitis sclerosing	0/21 (0%)		0/21 (0%)		1/21 (4.8%)		0/21 (0%)
Infections and infestations
Cellulitis	0/21 (0%)		1/21 (4.8%)		0/21 (0%)		0/21 (0%)
Clostridium difficile infection	0/21 (0%)		0/21 (0%)		0/21 (0%)		1/21 (4.8%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/21 (0%)		1/21 (4.8%)		0/21 (0%)		0/21 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Anrukinzumab 200 mg		Anrukinzumab 400 mg		Anrukinzumab 600 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/21 (57.1%)		18/21 (85.7%)		13/21 (61.9%)		15/21 (71.4%)
Blood and lymphatic system disorders
Anaemia	3/21 (14.3%)		1/21 (4.8%)		4/21 (19%)		1/21 (4.8%)
Eosinophilia	1/21 (4.8%)		1/21 (4.8%)		0/21 (0%)		2/21 (9.5%)
Eye disorders
Vision blurred	0/21 (0%)		2/21 (9.5%)		0/21 (0%)		0/21 (0%)
Gastrointestinal disorders
Abdominal pain	3/21 (14.3%)		2/21 (9.5%)		2/21 (9.5%)		3/21 (14.3%)
Colitis ulcerative	3/21 (14.3%)		7/21 (33.3%)		5/21 (23.8%)		8/21 (38.1%)
Diarrhoea	2/21 (9.5%)		2/21 (9.5%)		2/21 (9.5%)		0/21 (0%)
Flatulence	1/21 (4.8%)		0/21 (0%)		2/21 (9.5%)		0/21 (0%)
Nausea	2/21 (9.5%)		2/21 (9.5%)		2/21 (9.5%)		3/21 (14.3%)
Vomiting	3/21 (14.3%)		1/21 (4.8%)		2/21 (9.5%)		0/21 (0%)
General disorders
Chest pain	2/21 (9.5%)		0/21 (0%)		0/21 (0%)		0/21 (0%)
Fatigue	0/21 (0%)		1/21 (4.8%)		2/21 (9.5%)		1/21 (4.8%)
Oedema peripheral	3/21 (14.3%)		0/21 (0%)		0/21 (0%)		0/21 (0%)
Pyrexia	2/21 (9.5%)		2/21 (9.5%)		1/21 (4.8%)		0/21 (0%)
Infections and infestations
Influenza	2/21 (9.5%)		1/21 (4.8%)		1/21 (4.8%)		0/21 (0%)
Nasopharyngitis	1/21 (4.8%)		4/21 (19%)		1/21 (4.8%)		2/21 (9.5%)
Upper respiratory tract infection	1/21 (4.8%)		2/21 (9.5%)		3/21 (14.3%)		2/21 (9.5%)
Urinary tract infection	1/21 (4.8%)		2/21 (9.5%)		3/21 (14.3%)		1/21 (4.8%)
Investigations
Blood creatine phosphokinase increased	0/21 (0%)		1/21 (4.8%)		0/21 (0%)		2/21 (9.5%)
Metabolism and nutrition disorders
Hypokalaemia	2/21 (9.5%)		0/21 (0%)		0/21 (0%)		0/21 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/21 (9.5%)		2/21 (9.5%)		0/21 (0%)		1/21 (4.8%)
Joint swelling	3/21 (14.3%)		0/21 (0%)		1/21 (4.8%)		0/21 (0%)
Nervous system disorders
Headache	4/21 (19%)		4/21 (19%)		0/21 (0%)		3/21 (14.3%)
Skin and subcutaneous tissue disorders
Acne	0/21 (0%)		2/21 (9.5%)		0/21 (0%)		0/21 (0%)
Pruritus	1/21 (4.8%)		1/21 (4.8%)		2/21 (9.5%)		0/21 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.