Trial Outcomes & Findings for A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors (NCT NCT02165215)

NCT ID: NCT02165215

Last Updated: 2021-08-19

Results Overview

MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Clinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1. Remission is MCS ≤2 with individual subscores ≤1 and a rectal bleeding subscore of 0.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 359 participants
• Primary outcome timeframe: Week 62
• Results posted on: 2021-08-19

Participant Flow

359 participants were enrolled into the OLI phase of the study. A total of 210 participants were randomized into the Maintenance phase and received either Etrolizumab or Placebo.

Participant milestones

Measure	Open-Label Induction Phase: Etrolizumab All participants will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) up to Week 10.	Double-Blind Maintenance Phase: Etrolizumab Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Induction Phase STARTED	359	0	0
Induction Phase Dosed	358	0	0
Induction Phase COMPLETED	336	0	0
Induction Phase NOT COMPLETED	23	0	0
Maintenance Phase STARTED	0	108	106
Maintenance Phase Dosed	0	108	102
Maintenance Phase COMPLETED	0	96	101
Maintenance Phase NOT COMPLETED	0	12	5

Reasons for withdrawal

Measure	Open-Label Induction Phase: Etrolizumab All participants will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) up to Week 10.	Double-Blind Maintenance Phase: Etrolizumab Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Induction Phase Adverse Event	1	0	0
Induction Phase Withdrawal by Subject	10	0	0
Induction Phase Protocol Violation	1	0	0
Induction Phase Physician Decision	1	0	0
Induction Phase Lack of Efficacy	2	0	0
Induction Phase Non-Compliance	2	0	0
Induction Phase Lost to Follow-up	6	0	0
Maintenance Phase Withdrawal by Subject	0	7	3
Maintenance Phase Multiple reasons	0	2	1
Maintenance Phase Lost to Follow-up	0	2	0
Maintenance Phase Adverse Event	0	1	1

Baseline Characteristics

Participants in the Maintenance Phase of the study

Baseline characteristics by cohort

Measure	Open-Label Induction Phase: Etrolizumab n=359 Participants All participants will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) up to Week 10.	Double-Blind Maintenance Phase: Etrolizumab n=108 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=106 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.	Total n=573 Participants Total of all reporting groups
Age, Continuous	39.2 years STANDARD_DEVIATION 13.9 • n=359 Participants • Participants in the Induction Phase of the study	38.3 years STANDARD_DEVIATION 13.7 • n=108 Participants • Participants in the Maintenance Phase of the study	39.2 years STANDARD_DEVIATION 13.5 • n=106 Participants • Participants in the Maintenance Phase of the study	39.2 years STANDARD_DEVIATION 13.9 • n=359 Participants • Participants in the Induction Phase of the study
Sex: Female, Male Female	156 Participants n=359 Participants • Participants in the Induction Phase of the study	48 Participants n=108 Participants • Participants in the Maintenance Phase of the study	54 Participants n=106 Participants • Participants in the Maintenance Phase of the study	156 Participants n=359 Participants • Participants in the Induction Phase of the study
Sex: Female, Male Male	203 Participants n=359 Participants • Participants in the Induction Phase of the study	60 Participants n=108 Participants • Participants in the Maintenance Phase of the study	52 Participants n=106 Participants • Participants in the Maintenance Phase of the study	203 Participants n=359 Participants • Participants in the Induction Phase of the study
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=359 Participants • Participants in the Induction Phase of the study	2 Participants n=108 Participants • Participants in the Maintenance Phase of the study	2 Participants n=106 Participants • Participants in the Maintenance Phase of the study	5 Participants n=359 Participants • Participants in the Induction Phase of the study
Race (NIH/OMB) Asian	58 Participants n=359 Participants • Participants in the Induction Phase of the study	21 Participants n=108 Participants • Participants in the Maintenance Phase of the study	13 Participants n=106 Participants • Participants in the Maintenance Phase of the study	58 Participants n=359 Participants • Participants in the Induction Phase of the study
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=359 Participants • Participants in the Induction Phase of the study	0 Participants n=108 Participants • Participants in the Maintenance Phase of the study	0 Participants n=106 Participants • Participants in the Maintenance Phase of the study	0 Participants n=359 Participants • Participants in the Induction Phase of the study
Race (NIH/OMB) Black or African American	13 Participants n=359 Participants • Participants in the Induction Phase of the study	2 Participants n=108 Participants • Participants in the Maintenance Phase of the study	6 Participants n=106 Participants • Participants in the Maintenance Phase of the study	13 Participants n=359 Participants • Participants in the Induction Phase of the study
Race (NIH/OMB) White	269 Participants n=359 Participants • Participants in the Induction Phase of the study	79 Participants n=108 Participants • Participants in the Maintenance Phase of the study	78 Participants n=106 Participants • Participants in the Maintenance Phase of the study	269 Participants n=359 Participants • Participants in the Induction Phase of the study
Race (NIH/OMB) More than one race	0 Participants n=359 Participants • Participants in the Induction Phase of the study	0 Participants n=108 Participants • Participants in the Maintenance Phase of the study	0 Participants n=106 Participants • Participants in the Maintenance Phase of the study	0 Participants n=359 Participants • Participants in the Induction Phase of the study
Race (NIH/OMB) Unknown or Not Reported	14 Participants n=359 Participants • Participants in the Induction Phase of the study	4 Participants n=108 Participants • Participants in the Maintenance Phase of the study	7 Participants n=106 Participants • Participants in the Maintenance Phase of the study	14 Participants n=359 Participants • Participants in the Induction Phase of the study

PRIMARY outcome

Timeframe: Week 62

Population: Participants in the Maintenance phase of the study that received an intervention

MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment.

Clinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1.

Remission is MCS ≤2 with individual subscores ≤1 and a rectal bleeding subscore of 0.

Outcome measures

Measure	Double-Blind Maintenance Phase: Etrolizumab n=108 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=102 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Maintenance Phase: Percentage of Participants in Remission at Week 62 Among Randomized Participants With a Clinical Response at Week 10, as Determined by the Mayo Clinic Score (MCS)	29.6 percentage of participants	20.6 percentage of participants	—

SECONDARY outcome

Timeframe: Week 62

Population: Participants in the Maintenance phase of the study that had Clinical Remission at Week 10

MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment.

Clinical Remission is MCS ≤2 with individual subscores ≤1.

Outcome measures

Measure	Double-Blind Maintenance Phase: Etrolizumab n=45 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=44 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Maintenance Phase: Percentage of Participants Who Maintained Clinical Remission at Week 62 Among Randomized Participants in Clinical Remission at Week 10, as Determined by the MCS	44.4 percentage of participants	27.3 percentage of participants	—

SECONDARY outcome

Timeframe: Week 62

Population: Participants in the Maintenance phase of the study that received an intervention

MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment.

Clinical Remission is MCS ≤2 with individual subscores ≤1.

Outcome measures

Measure	Double-Blind Maintenance Phase: Etrolizumab n=108 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=102 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Maintenance Phase: Percentage of Participants in Clinical Remission at Week 62, as Determined by the MCS	30.6 percentage of participants	20.6 percentage of participants	—

SECONDARY outcome

Timeframe: Week 62

Population: Participants in the Maintenance phase of the study that had Remission at Week 10

MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment.

Remission is MCS ≤2 with individual subscores ≤1 and a rectal bleeding subscore of 0.

Outcome measures

Measure	Double-Blind Maintenance Phase: Etrolizumab n=40 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=41 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Maintenance Phase: Percentage of Participants in Remission at Week 62 Among Randomized Participants in Remission at Week 10, as Determined by the MCS	40.0 percentage of participants	26.8 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Week 62

Population: Participants in the Maintenance phase of the study that received an intervention

MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment.

Improvement in endoscopic appearance of the mucosa is Endoscopy subscore ≤1.

Outcome measures

Measure	Double-Blind Maintenance Phase: Etrolizumab n=108 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=102 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Maintenance Phase: Percentage of Participants With Improvement From Baseline in Endoscopic Appearance of the Mucosa at Week 62, as Determined by the MCS Endoscopic Subscore	38.0 percentage of participants	22.5 percentage of participants	—

SECONDARY outcome

Timeframe: Week 62

Population: Participants in the Maintenance phase of the study that received an intervention

MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment.

Endoscopic Remission is Endoscopy subscore = 0.

Outcome measures

Measure	Double-Blind Maintenance Phase: Etrolizumab n=108 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=102 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Maintenance Phase: Percentage of Participants With Endoscopic Remission at Week 62, as Determined by the MCS Endoscopic Subscore	30.6 percentage of participants	16.7 percentage of participants	—

SECONDARY outcome

Timeframe: Week 62

Population: Participants in the Maintenance phase of the study that were evaluated using the Nancy histological index (enrolled after the latest protocol amendment)

Nancy Histological Index (NHI) is a 5-level classification ranging from grade 0 (No histologically significant disease) to grade 4 (severely active disease). Histologic remission is defined as a Nancy histological index of 0 or 1.

Outcome measures

Measure	Double-Blind Maintenance Phase: Etrolizumab n=85 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=78 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Maintenance Phase: Percentage of Participants With Histologic Remission at Week 62, as Determined by the Nancy Histological Index	42.4 percentage of participants	21.8 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Week 62

Population: Participants in the Maintenance phase of the study receiving Corticosteroids at baseline

MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment.

Clinical Remission is MCS ≤2 with individual subscores ≤1.

Outcome measures

Measure	Double-Blind Maintenance Phase: Etrolizumab n=55 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=50 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 62 Among Participants Who Were Receiving Corticosteroids at Baseline, as Determined by the MCS	18.2 percentage of participants	8.0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Week 62

Population: Participants in the Maintenance phase of the study receiving Corticosteroids at baseline

MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment.

Remission is MCS ≤2 with individual subscores ≤1 and a rectal bleeding subscore of 0.

Outcome measures

Measure	Double-Blind Maintenance Phase: Etrolizumab n=55 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=50 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Maintenance Phase: Percentage of Participants With Corticosteroid-Free Remission at Week 62 Among Participants Who Were Receiving Corticosteroids at Baseline, as Determined by the MCS	18.2 percentage of participants	8.0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Week 62

Population: Participants in the Maintenance phase of the study that completed a baseline and at least 1 post-baseline questionnaire

The UC-PRO questionnaire is collected in the e-diary and completed by participants for at least 9-12 consecutive days prior to a study visit. The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS).

The bowel domain score ranges from 0-27, with a higher score indicating a worse disease state.

Outcome measures

Measure	Double-Blind Maintenance Phase: Etrolizumab n=68 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=73 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Maintenance Phase: Change From Baseline to Week 62 in UC Bowel Movement Signs and Symptoms, as Assessed by the Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Questionnaire	-9.6 score on a scale Standard Error 0.8	-6.7 score on a scale Standard Error 0.9	—

SECONDARY outcome

Timeframe: Baseline, Week 62

Population: Participants in the Maintenance phase of the study that completed a baseline and at least 1 post-baseline questionnaire

The UC-PRO questionnaire is collected in the e-diary and completed by participants for at least 9-12 consecutive days prior to a study visit. The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS).

The functional domain score ranges from 0-12, with a higher score indicating a worse disease state.

Outcome measures

Measure	Double-Blind Maintenance Phase: Etrolizumab n=68 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=73 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Maintenance Phase: Change From Baseline to Week 62 in UC Functional Symptoms, as Assessed by the UC-PRO/SS Questionnaire	-3.0 score on a scale Standard Error 0.3	-1.8 score on a scale Standard Error 0.4	—

SECONDARY outcome

Timeframe: Baseline, Week 62

Population: Participants in the Maintenance phase of the study that received an intervention

The IBDQ is used to assess participant's health-related quality of life (QOL). The 32-item questionnaire contains four domains: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). The items are scored on a 7-point Likert scale with a higher score indicating better health-related QOL.

IBDQ score is a total score summed up from across all 32 questions on the questionnaire. The score can range from 32-224 and the higher score indicates a better quality of life.

Outcome measures

Measure	Double-Blind Maintenance Phase: Etrolizumab n=108 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=102 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Maintenance Phase: Change From Baseline to Week 62 in Health-Related Quality of Life, as Assessed by the Overall Score of the Inflammatory Bowel Disease Questionnaire (IBDQ)	66.9 scores on a scale Standard Error 3.39	64.8 scores on a scale Standard Error 3.45	—

SECONDARY outcome

Timeframe: From Baseline up to Week 74

Population: All participants that received an intervention

All adverse events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade.

Outcome measures

Measure	Double-Blind Maintenance Phase: Etrolizumab n=358 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=108 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=102 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Number of Participants With at Least One Adverse Event by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) Grade 4	3 participants	2 participants	0 participants
Number of Participants With at Least One Adverse Event by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) Grade 1	95 participants	24 participants	23 participants
Number of Participants With at Least One Adverse Event by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) Grade 2	58 participants	30 participants	44 participants
Number of Participants With at Least One Adverse Event by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) Grade 3	24 participants	14 participants	15 participants
Number of Participants With at Least One Adverse Event by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) Grade 5	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: From Baseline up to Week 74

Population: All participants that received an intervention

Outcome measures

Measure	Double-Blind Maintenance Phase: Etrolizumab n=358 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=108 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=102 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Number of Participants With Adverse Events Leading to Study Drug Discontinuation	9 participants	5 participants	9 participants

SECONDARY outcome

Timeframe: From Baseline up to Week 74

Population: All participants that received an intervention

Outcome measures

Measure	Double-Blind Maintenance Phase: Etrolizumab n=358 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=108 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=102 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Number of Participants With Serious Infection-Related Adverse Events	6 participants	2 participants	2 participants

SECONDARY outcome

Timeframe: From Baseline up to Week 74

Population: All participants that received an intervention

All adverse events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade.

Outcome measures

Measure	Double-Blind Maintenance Phase: Etrolizumab n=358 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=108 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=102 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Number of Participants With Infection-Related Adverse Events by Severity, According to NCI-CTCAE v4.0 Grade 1	39 participants	18 participants	22 participants
Number of Participants With Infection-Related Adverse Events by Severity, According to NCI-CTCAE v4.0 Grade 2	21 participants	17 participants	10 participants
Number of Participants With Infection-Related Adverse Events by Severity, According to NCI-CTCAE v4.0 Grade 3	6 participants	1 participants	2 participants
Number of Participants With Infection-Related Adverse Events by Severity, According to NCI-CTCAE v4.0 Grade 4	0 participants	1 participants	0 participants
Number of Participants With Infection-Related Adverse Events by Severity, According to NCI-CTCAE v4.0 Grade 5	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: From Baseline up to Week 74

Population: All participants that received an intervention

All adverse events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade.

Outcome measures

Measure	Double-Blind Maintenance Phase: Etrolizumab n=358 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=108 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=102 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Number of Participants With Injection-Site Reactions by Severity, According to NCI-CTCAE v4.0 Grade 1	8 participants	4 participants	3 participants
Number of Participants With Injection-Site Reactions by Severity, According to NCI-CTCAE v4.0 Grade 2	0 participants	0 participants	0 participants
Number of Participants With Injection-Site Reactions by Severity, According to NCI-CTCAE v4.0 Grade 3	0 participants	0 participants	0 participants
Number of Participants With Injection-Site Reactions by Severity, According to NCI-CTCAE v4.0 Grade 4	0 participants	0 participants	0 participants
Number of Participants With Injection-Site Reactions by Severity, According to NCI-CTCAE v4.0 Grade 5	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: From Baseline up to Week 74

Population: All participants that received an intervention

All adverse events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade.

Outcome measures

Measure	Double-Blind Maintenance Phase: Etrolizumab n=358 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=108 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=102 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Number of Participants With Hypersensitivity Reaction Events by Severity, According to NCI-CTCAE v4.0 Grade 3	0 participants	0 participants	0 participants
Number of Participants With Hypersensitivity Reaction Events by Severity, According to NCI-CTCAE v4.0 Grade 1	0 participants	0 participants	0 participants
Number of Participants With Hypersensitivity Reaction Events by Severity, According to NCI-CTCAE v4.0 Grade 2	1 participants	0 participants	0 participants
Number of Participants With Hypersensitivity Reaction Events by Severity, According to NCI-CTCAE v4.0 Grade 4	0 participants	0 participants	0 participants
Number of Participants With Hypersensitivity Reaction Events by Severity, According to NCI-CTCAE v4.0 Grade 5	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: From Baseline up to Week 74

Population: All participants that received an intervention

Outcome measures

Measure	Double-Blind Maintenance Phase: Etrolizumab n=358 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=108 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=102 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Number of Participants With Malignancies	0 participants	2 participants	1 participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 12, 24, 44, and 62, and and Early Termination/End of Safety Follow-Up (up to Week 74)

Population: Participants who received at least one dose of study treatment and had at least one baseline or post-baseline ATA result from at least one sample.

Outcome measures

Measure	Double-Blind Maintenance Phase: Etrolizumab n=337 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=108 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=102 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Number of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab	62 participants	35 participants	33 participants

SECONDARY outcome

Timeframe: Pre-dose (0 hour) at Baseline and Weeks 12, 24, 44, and 62

Population: All participants who received at least one dose of study drug and had evaluable PK data.

As per protocol, the timepoints for each arm where more than a third of the samples were above the lower limit of quantitation (LLOQ), full summary statistics (Mean and Standard Deviation) were reported. For timepoints below the LLOQ, only the Median and Max were reported as a separate outcome measure below.

Outcome measures

Measure	Double-Blind Maintenance Phase: Etrolizumab n=105 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=100 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Maintenance Phase: Etrolizumab Serum Trough Concentration (for Arms/Timepoints Above LLOQ) Week 12	7.66 micrograms per millilitre (μg/mL) Standard Deviation 4.21	7.63 micrograms per millilitre (μg/mL) Standard Deviation 3.67	—
Maintenance Phase: Etrolizumab Serum Trough Concentration (for Arms/Timepoints Above LLOQ) Week 24	10 micrograms per millilitre (μg/mL) Standard Deviation 4.86	—	—
Maintenance Phase: Etrolizumab Serum Trough Concentration (for Arms/Timepoints Above LLOQ) Week 44	10 micrograms per millilitre (μg/mL) Standard Deviation 4.88	—	—
Maintenance Phase: Etrolizumab Serum Trough Concentration (for Arms/Timepoints Above LLOQ) Week 62	15.4 micrograms per millilitre (μg/mL) Standard Deviation 7.46	—	—

SECONDARY outcome

Timeframe: Pre-dose (0 hour) at Baseline and Weeks 12, 24, 44, and 62

Population: All participants who received at least one dose of study drug, had evaluable PK data and were part of the timepoint that had more than a third of samples below LLOQ.

As per protocol, the timepoints for each arm where more than a third of the samples were below the LLOQ only the Median and Max were reported.

Outcome measures

Measure	Double-Blind Maintenance Phase: Etrolizumab n=100 Participants Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Maintenance Phase: Etrolizumab Serum Trough Concentration (for Arms/Timepoints Below LLOQ) Week 24	0.0963 micrograms per millilitre (μg/mL) Interval to 1.89 As per protocol, only the Median and Max were reported for timepoints where more than a third of the samples were LLOQ.	—	—
Maintenance Phase: Etrolizumab Serum Trough Concentration (for Arms/Timepoints Below LLOQ) Week 44	0.0400 micrograms per millilitre (μg/mL) Interval to 0.04 As per protocol, only the Median and Max were reported for timepoints where more than a third of the samples were LLOQ.	—	—
Maintenance Phase: Etrolizumab Serum Trough Concentration (for Arms/Timepoints Below LLOQ) Week 62	0.0400 micrograms per millilitre (μg/mL) Interval to 0.04 As per protocol, only the Median and Max were reported for timepoints where more than a third of the samples were LLOQ.	—	—

Adverse Events

Open-Label Induction Phase: Etrolizumab

Serious events: 17 serious events

Other events: 64 other events

Deaths: 0 deaths

Double-Blind Maintenance Phase: Etrolizumab

Serious events: 10 serious events

Other events: 30 other events

Deaths: 0 deaths

Double-Blind Maintenance Phase: Placebo

Serious events: 8 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Measure	Open-Label Induction Phase: Etrolizumab n=358 participants at risk All participants will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) up to Week 10.	Double-Blind Maintenance Phase: Etrolizumab n=108 participants at risk Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=102 participants at risk Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Blood and lymphatic system disorders Anaemia	0.28% 1/358 • Number of events 1 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
Blood and lymphatic system disorders Bone marrow failure	0.28% 1/358 • Number of events 1 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/358 • From Baseline up to Week 74	0.93% 1/108 • Number of events 1 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
Cardiac disorders Myocardial infarction	0.28% 1/358 • Number of events 1 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
Gastrointestinal disorders Anal fistula	0.28% 1/358 • Number of events 1 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
Gastrointestinal disorders Colitis ulcerative	1.7% 6/358 • Number of events 7 • From Baseline up to Week 74	1.9% 2/108 • Number of events 2 • From Baseline up to Week 74	2.0% 2/102 • Number of events 2 • From Baseline up to Week 74
Gastrointestinal disorders Crohn's disease	0.28% 1/358 • Number of events 1 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/358 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	0.98% 1/102 • Number of events 1 • From Baseline up to Week 74
Gastrointestinal disorders Intestinal obstruction	0.28% 1/358 • Number of events 1 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
Gastrointestinal disorders Intestinal perforation	0.28% 1/358 • Number of events 1 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
Gastrointestinal disorders Pancreatitis	0.28% 1/358 • Number of events 1 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
General disorders Systemic inflammatory response syndrome	0.00% 0/358 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	0.98% 1/102 • Number of events 1 • From Baseline up to Week 74
Hepatobiliary disorders Bile duct stone	0.00% 0/358 • From Baseline up to Week 74	0.93% 1/108 • Number of events 1 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
Hepatobiliary disorders Hepatitis	0.00% 0/358 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	2.0% 2/102 • Number of events 2 • From Baseline up to Week 74
Infections and infestations Appendicitis	0.00% 0/358 • From Baseline up to Week 74	0.93% 1/108 • Number of events 1 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
Infections and infestations Clostridium difficile colitis	0.28% 1/358 • Number of events 1 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
Infections and infestations Hepatitis B	0.28% 1/358 • Number of events 1 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
Infections and infestations Pulmonary tuberculosis	0.28% 1/358 • Number of events 1 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
Infections and infestations Rectal abscess	0.28% 1/358 • Number of events 1 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	0.98% 1/102 • Number of events 1 • From Baseline up to Week 74
Infections and infestations Septic shock	0.28% 1/358 • Number of events 1 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
Infections and infestations Upper respiratory tract infection	0.00% 0/358 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	0.98% 1/102 • Number of events 1 • From Baseline up to Week 74
Infections and infestations Urinary tract infection	0.28% 1/358 • Number of events 1 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
Investigations Blood creatine phosphokinase increased	0.00% 0/358 • From Baseline up to Week 74	0.93% 1/108 • Number of events 1 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/358 • From Baseline up to Week 74	0.93% 1/108 • Number of events 1 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/358 • From Baseline up to Week 74	0.93% 1/108 • Number of events 1 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/358 • From Baseline up to Week 74	0.93% 1/108 • Number of events 1 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer	0.00% 0/358 • From Baseline up to Week 74	0.93% 1/108 • Number of events 1 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
Renal and urinary disorders Renal failure	0.28% 1/358 • Number of events 1 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.28% 1/358 • Number of events 1 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.28% 1/358 • Number of events 1 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	0.00% 0/102 • From Baseline up to Week 74
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/358 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	0.98% 1/102 • Number of events 1 • From Baseline up to Week 74
Vascular disorders Deep vein thrombosis	0.00% 0/358 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	0.98% 1/102 • Number of events 1 • From Baseline up to Week 74

Other adverse events

Measure	Open-Label Induction Phase: Etrolizumab n=358 participants at risk All participants will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) up to Week 10.	Double-Blind Maintenance Phase: Etrolizumab n=108 participants at risk Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.	Double-Blind Maintenance Phase: Placebo n=102 participants at risk Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Gastrointestinal disorders Abdominal pain	0.28% 1/358 • Number of events 1 • From Baseline up to Week 74	5.6% 6/108 • Number of events 9 • From Baseline up to Week 74	8.8% 9/102 • Number of events 11 • From Baseline up to Week 74
Gastrointestinal disorders Colitis ulcerative	6.7% 24/358 • Number of events 24 • From Baseline up to Week 74	13.0% 14/108 • Number of events 16 • From Baseline up to Week 74	33.3% 34/102 • Number of events 35 • From Baseline up to Week 74
Gastrointestinal disorders Diarrhoea	1.4% 5/358 • Number of events 10 • From Baseline up to Week 74	3.7% 4/108 • Number of events 4 • From Baseline up to Week 74	7.8% 8/102 • Number of events 9 • From Baseline up to Week 74
General disorders Pyrexia	2.2% 8/358 • Number of events 9 • From Baseline up to Week 74	0.00% 0/108 • From Baseline up to Week 74	5.9% 6/102 • Number of events 6 • From Baseline up to Week 74
Infections and infestations Nasopharyngitis	6.1% 22/358 • Number of events 22 • From Baseline up to Week 74	7.4% 8/108 • Number of events 10 • From Baseline up to Week 74	2.9% 3/102 • Number of events 4 • From Baseline up to Week 74
Musculoskeletal and connective tissue disorders Arthralgia	2.5% 9/358 • Number of events 11 • From Baseline up to Week 74	7.4% 8/108 • Number of events 10 • From Baseline up to Week 74	10.8% 11/102 • Number of events 11 • From Baseline up to Week 74

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER