Trial Outcomes & Findings for A Phase I Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients With Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn's Disease (NCT NCT03478956)

Last Updated: 2024-12-27

Results Overview

Etrolizumab concentrations in all pharmacokinetics (PK) samples were measured using a validated assay method. Non-compartmental analysis methods were employed to calculate PK parameters.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

Arm Etro Q4W: Day 1, 84 and Arm Etro Q8W: Day 1, 56

Results posted on

2024-12-27

Participant Flow

The study was conducted in 3 parts: Randomized Treatment Period, Open-label Extension (OLE) Period and Progressive Multifocal Leukoencephalopathy (PML) Safety Monitoring (SM) Period. Participants who completed the randomized treatment period were given the option to continue treatment in OLE period. After the randomized treatment period (if they did not enter OLE) or after the OLE period, participants were given the option to continue in PML SM period during which they were monitored for PML.

Participant milestones

Participant milestones
Measure	Etrolizumab Q4W Etrolizumab 1.5 milligrams per kilogram of body weight (mg/kg) was administered by subcutaneous (SC) injection once every 4 weeks (Q4W) for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	Etrolizumab Q8W Etrolizumab 3.0 milligrams per kilogram of body weight (mg/kg) was administered by SC injection once every 8 weeks (Q8W) for a total of 2 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	OLE: Etrolizumab 1.5 mg Q4W Participants from Etrolizumab Q4W and Etrolizumab Q8W who completed the randomized treatment period, were given the option to participate in the OLE period. All participants who chose to enter the OLE period were administered etrolizumab 1.5 mg/kg SC Q4W for a maximum of 183 weeks. Post treatment discontinuation participants entered a 12-week safety follow up.	PML Safety Monitoring After the randomized treatment period (if participants did not enter the OLE period) or after the OLE period, participants who chose to continue in PML safety surveillance phase were monitored for PML for approximately 92 weeks. Participants who chose to enter PML surveillance phase were only followed up for PML and did not receive any study treatment.
Randomized Treatment Period STARTED	12	12	0	0
Randomized Treatment Period Received at Least One Dose of Study Drug	12	12	0	0
Randomized Treatment Period Completed Treatment	11	10	0	0
Randomized Treatment Period COMPLETED	11	11	0	0
Randomized Treatment Period NOT COMPLETED	1	1	0	0
Open Label Extension Period STARTED	0	0	21	0
Open Label Extension Period COMPLETED	0	0	0	0
Open Label Extension Period NOT COMPLETED	0	0	21	0
PML Safety Monitoring Period STARTED	0	0	0	13
PML Safety Monitoring Period COMPLETED	0	0	0	4
PML Safety Monitoring Period NOT COMPLETED	0	0	0	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Etrolizumab Q4W Etrolizumab 1.5 milligrams per kilogram of body weight (mg/kg) was administered by subcutaneous (SC) injection once every 4 weeks (Q4W) for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	Etrolizumab Q8W Etrolizumab 3.0 milligrams per kilogram of body weight (mg/kg) was administered by SC injection once every 8 weeks (Q8W) for a total of 2 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	OLE: Etrolizumab 1.5 mg Q4W Participants from Etrolizumab Q4W and Etrolizumab Q8W who completed the randomized treatment period, were given the option to participate in the OLE period. All participants who chose to enter the OLE period were administered etrolizumab 1.5 mg/kg SC Q4W for a maximum of 183 weeks. Post treatment discontinuation participants entered a 12-week safety follow up.	PML Safety Monitoring After the randomized treatment period (if participants did not enter the OLE period) or after the OLE period, participants who chose to continue in PML safety surveillance phase were monitored for PML for approximately 92 weeks. Participants who chose to enter PML surveillance phase were only followed up for PML and did not receive any study treatment.
Randomized Treatment Period Adverse Event	1	0	0	0
Randomized Treatment Period Withdrawal by Subject	0	1	0	0
Open Label Extension Period Adverse Event	0	0	4	0
Open Label Extension Period Lack of Efficacy	0	0	8	0
Open Label Extension Period Reason Not Provided	0	0	1	0
Open Label Extension Period Study Terminated by Sponsor	0	0	6	0
Open Label Extension Period Withdrawal by Subject	0	0	2	0
PML Safety Monitoring Period Study Terminated by Sponsor	0	0	0	9

Baseline Characteristics

A Phase I Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients With Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etrolizumab Q4W n=12 Participants Etrolizumab 1.5 mg/kg was administered by SC injection Q4W for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	Etrolizumab Q8W n=12 Participants Etrolizumab 3.0 mg/kg was administered by SC injection Q8W for a total of 2 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	Total n=24 Participants Total of all reporting groups
Age, Continuous	12.25 Years STANDARD_DEVIATION 3.62 • n=5 Participants	13.42 Years STANDARD_DEVIATION 4.46 • n=7 Participants	12.83 Years STANDARD_DEVIATION 4.02 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Disease Indication: Crohn's Disease or Ulcerative Colitis Crohn's Disease	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Disease Indication: Crohn's Disease or Ulcerative Colitis Ulcerative Colitis	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Randomization Stratification Factor: Body Weight <40 kg or ≥40 kg <40 kg	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Randomization Stratification Factor: Body Weight <40 kg or ≥40 kg ≥40 kg	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: Arm Etro Q4W: Day 1, 84 and Arm Etro Q8W: Day 1, 56

Population: Pharmacokinetics (PK) Evaluable Population: all participants who received at least one dose of study drug and had evaluable PK data. This analysis included data from participants who had received their first dose (Day 1 for both arms) and last dose (on Day 56 for Q8W arm and Day 84 for Q4W arm) of study drug.

Etrolizumab concentrations in all pharmacokinetics (PK) samples were measured using a validated assay method. Non-compartmental analysis methods were employed to calculate PK parameters.

Outcome measures

Outcome measures
Measure	Etrolizumab Q4W n=11 Participants Etrolizumab 1.5 mg/kg was administered by SC injection Q4W for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	Etrolizumab Q8W n=12 Participants Etrolizumab 3.0 mg/kg was administered by SC injection Q8W for a total of 2 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).
Maximum Serum Concentration (Cmax) of Etrolizumab After First and Last Dose During the Randomized Treatment Phase After First Dose (Day 1)	7.73 micrograms per millilitre (μg/mL) Standard Deviation 2.18	19.0 micrograms per millilitre (μg/mL) Standard Deviation 8.21
Maximum Serum Concentration (Cmax) of Etrolizumab After First and Last Dose During the Randomized Treatment Phase After Last Dose (Q4W Day 84, Q8WDay 56)	9.80 micrograms per millilitre (μg/mL) Standard Deviation 4.86	18.1 micrograms per millilitre (μg/mL) Standard Deviation 6.25

PRIMARY outcome

Timeframe: Arm Etro Q4W: Days 1, 84 and Arm Etro Q8W: Days 1, 56

Etrolizumab concentrations in all pharmacokinetics (PK) samples were measured using a validated assay method. Non-compartmental analysis methods were employed to calculate PK parameters.

Outcome measures

Outcome measures
Measure	Etrolizumab Q4W n=11 Participants Etrolizumab 1.5 mg/kg was administered by SC injection Q4W for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	Etrolizumab Q8W n=12 Participants Etrolizumab 3.0 mg/kg was administered by SC injection Q8W for a total of 2 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).
Time to Maximum Serum Concentration (Tmax) of Etrolizumab After First and Last Dose During the Randomized Treatment Phase After First Dose (Day 1)	4.65 Day Standard Deviation 1.43	4.00 Day Standard Deviation 1.48
Time to Maximum Serum Concentration (Tmax) of Etrolizumab After First and Last Dose During the Randomized Treatment Phase After Last Dose (Q4W Day 84, Q8WDay 56)	5.04 Day Standard Deviation 2.92	4.94 Day Standard Deviation 3.28

PRIMARY outcome

Timeframe: Arm Etro Q4W: Days 56, 84, 88, 98, 112 and Arm Etro Q8W: Day 56, 60, 70, 84, 88, 98, 112

Population: Pharmacokinetics (PK) Evaluable Population: all participants who received at least one dose of study drug and had evaluable PK data. This analysis included data from participants who had received their last dose of study drug (on Day 56 for Q8W arm and Day 84 for Q4W arm).

Etrolizumab concentrations in all pharmacokinetics (PK) samples were measured using a validated assay method. Non-compartmental analysis methods were employed to calculate PK parameters.

Outcome measures

Outcome measures
Measure	Etrolizumab Q4W n=11 Participants Etrolizumab 1.5 mg/kg was administered by SC injection Q4W for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	Etrolizumab Q8W n=12 Participants Etrolizumab 3.0 mg/kg was administered by SC injection Q8W for a total of 2 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).
Area Under the Concentration-Time Curve Within the Last Dosing Interval (AUC-tau) of Etrolizumab During the Randomized Treatment Phase AUC56-112	—	521 Day*μg/mL Standard Deviation 306
Area Under the Concentration-Time Curve Within the Last Dosing Interval (AUC-tau) of Etrolizumab During the Randomized Treatment Phase AUC84-112	167 Day*μg/mL Standard Deviation 86.9	—

PRIMARY outcome

Timeframe: Arm Etro Q4W: Days 84, 88, 98, 112, 126, 140, 168 and Arm Etro Q8W: Days 56, 60, 70, 84, 88, 98, 112, 126, 140, 168

Population: Pharmacokinetics (PK) Evaluable Population: all participants who received at least one dose of study drug and had evaluable PK data. This analysis included data from participants who had received their last dose of study drug (on Day 56 for Q8W arm and Day 84 for Q4W arm).

Etrolizumab concentrations in all pharmacokinetics (PK) samples were measured using a validated assay method. Non-compartmental analysis methods were employed to calculate PK parameters.

Outcome measures

Outcome measures
Measure	Etrolizumab Q4W n=11 Participants Etrolizumab 1.5 mg/kg was administered by SC injection Q4W for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	Etrolizumab Q8W n=10 Participants Etrolizumab 3.0 mg/kg was administered by SC injection Q8W for a total of 2 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).
Elimination Half-Life (t1/2) of Etrolizumab After Last Dose During the Randomized Treatment Phase	7.31 Day Standard Deviation 1.76	8.65 Day Standard Deviation 3.74

PRIMARY outcome

Timeframe: Arm Etro Q4W: Predose on Days 28, 56, 84, 112 and Arm Etro Q8W: Predose on Days 56, 112

Population: Pharmacokinetics (PK) Evaluable Population: all participants who received at least one dose of study drug and had evaluable PK data. This analysis included data from participants at the end of each dosing interval (on Days 28, 56, 84, and 112 for Q4W arm and Days 56 and 112 for Q8W arm).

Etrolizumab concentrations in all pharmacokinetics (PK) samples were measured using a validated assay method.

Outcome measures

Outcome measures
Measure	Etrolizumab Q4W n=11 Participants Etrolizumab 1.5 mg/kg was administered by SC injection Q4W for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	Etrolizumab Q8W n=12 Participants Etrolizumab 3.0 mg/kg was administered by SC injection Q8W for a total of 2 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).
Serum Trough Concentration (Ctrough) of Etrolizumab at the End of Each Dosing Interval During the Randomized Treatment Phase Day 84	3.00 micrograms per millilitre (μg/mL) Standard Deviation 2.38	—
Serum Trough Concentration (Ctrough) of Etrolizumab at the End of Each Dosing Interval During the Randomized Treatment Phase Day 112	2.79 micrograms per millilitre (μg/mL) Standard Deviation 2.01	3.70 micrograms per millilitre (μg/mL) Standard Deviation 4.64
Serum Trough Concentration (Ctrough) of Etrolizumab at the End of Each Dosing Interval During the Randomized Treatment Phase Day 28	1.87 micrograms per millilitre (μg/mL) Standard Deviation 1.32	—
Serum Trough Concentration (Ctrough) of Etrolizumab at the End of Each Dosing Interval During the Randomized Treatment Phase Day 56	3.22 micrograms per millilitre (μg/mL) Standard Deviation 2.24	1.82 micrograms per millilitre (μg/mL) Standard Deviation 1.99

PRIMARY outcome

Timeframe: Predose (dosing days only) at Baseline (Day 1) and on Days 4, 56, 84, 98, and 112 (Treatment Period), and Days 126, 140, and 168 (Follow-Up Period)

Population: Pharmacodynamics (PD) Evaluable Population: all participants who received at least one dose of study treatment and had evaluable PD data.

Target engagement of etrolizumab was assessed via measurement of Beta7 receptor occupancy on Beta7 receptor-expressing gut homing lymphocyte subsets in peripheral blood, including CD3, CD4, and CD8 T cells and CD19 B cells, using qualified flow cytometry methods. A decrease to 0% of baseline (BL) in median absolute cell counts of Beta7 receptor-expressing T and B cell subsets with unoccupied Beta7 receptors following etrolizumab treatment indicated maximal receptor occupancy by etrolizumab.

Outcome measures

SECONDARY outcome

Timeframe: From Baseline until 12 weeks (Q4W arm only) or 16 weeks (Q8W arm only) after the last dose of study drug during the randomized treatment phase (up to 24 weeks)

Population: Safety Population: all participants who received at least one dose of study drug.

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

Outcome measures
Measure	Etrolizumab Q4W n=12 Participants Etrolizumab 1.5 mg/kg was administered by SC injection Q4W for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	Etrolizumab Q8W n=12 Participants Etrolizumab 3.0 mg/kg was administered by SC injection Q8W for a total of 2 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).
Number of Participants With Adverse Events by Highest Severity Grade, Assessed According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0), During the Randomized Treatment Phase Any Adverse Event - Any Grade	9 Participants	10 Participants
Number of Participants With Adverse Events by Highest Severity Grade, Assessed According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0), During the Randomized Treatment Phase Any Adverse Event - Grade 1	2 Participants	2 Participants
Number of Participants With Adverse Events by Highest Severity Grade, Assessed According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0), During the Randomized Treatment Phase Any Adverse Event - Grade 2	4 Participants	5 Participants
Number of Participants With Adverse Events by Highest Severity Grade, Assessed According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0), During the Randomized Treatment Phase Any Adverse Event - Grade 3	3 Participants	3 Participants
Number of Participants With Adverse Events by Highest Severity Grade, Assessed According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0), During the Randomized Treatment Phase Any Adverse Event - Grade 4	0 Participants	0 Participants
Number of Participants With Adverse Events by Highest Severity Grade, Assessed According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0), During the Randomized Treatment Phase Any Adverse Event - Grade 5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Baseline until 12 weeks (Q4W arm only) or 16 weeks (Q8W arm only) after the last dose of study drug during the randomized treatment phase (up to 24 weeks)

Population: Safety Population: all participants who received at least one dose of study treatment.

Serious infection-related AEs were assessed using NCI-CTCAE v4.0.

Outcome measures

Outcome measures
Measure	Etrolizumab Q4W n=12 Participants Etrolizumab 1.5 mg/kg was administered by SC injection Q4W for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	Etrolizumab Q8W n=12 Participants Etrolizumab 3.0 mg/kg was administered by SC injection Q8W for a total of 2 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).
Number of Participants With Serious Infection-Related Adverse Events During the Randomized Treatment Phase	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Baseline until 12 weeks (Q4W arm only) or 16 weeks (Q8W arm only) after the last dose of study drug during the randomized treatment phase (up to 24 weeks)

Population: Safety Population: all participants who received at least one dose of study treatment.

Hypersensitivity reactions were assessed using NCI-CTCAE v4.0.

Outcome measures

Outcome measures
Measure	Etrolizumab Q4W n=12 Participants Etrolizumab 1.5 mg/kg was administered by SC injection Q4W for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	Etrolizumab Q8W n=12 Participants Etrolizumab 3.0 mg/kg was administered by SC injection Q8W for a total of 2 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).
Number of Participants With Hypersensitivity Reactions During the Randomized Treatment Phase	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Baseline until 12 weeks (Q4W arm only) or 16 weeks (Q8W arm only) after the last dose of study drug during the randomized treatment phase (up to 24 weeks)

Population: Safety Population: all participants who received at least one dose of study treatment.

Malignancies were assessed using NCI-CTCAE v4.0.

Outcome measures

Outcome measures
Measure	Etrolizumab Q4W n=12 Participants Etrolizumab 1.5 mg/kg was administered by SC injection Q4W for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	Etrolizumab Q8W n=12 Participants Etrolizumab 3.0 mg/kg was administered by SC injection Q8W for a total of 2 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).
Number of Participants With Malignancies During the Randomized Treatment Phase	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Predose (dosing days only) on Days 1, 28, 84, 112, and 168 (up to the end of the randomized treatment phase at Week 24)

Population: ADA Evaluable Population: all participants who received at least one dose of study treatment and had at least one baseline or post-baseline ADA result from at least one sample.

Participants were considered to be etrolizumab anti-drug antibody (ADA) positive if they were ADA negative or had missing data at Baseline (BL) but developed an ADA response following study drug exposure (i.e., treatment-induced ADA positive), or if they were ADA positive at baseline and the titer of one or more postbaseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (i.e., treatment-enhanced ADA positive); these ADA positive responses are summarized together (induced + enhanced) in the 'treatment-emergent ADA positive' category. Participants were considered to be ADA negative if they were ADA negative or had missing data at Baseline (BL) and all postbaseline samples were negative (i.e., treatment-emergent ADA negative).

Outcome measures

Outcome measures
Measure	Etrolizumab Q4W n=12 Participants Etrolizumab 1.5 mg/kg was administered by SC injection Q4W for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	Etrolizumab Q8W n=12 Participants Etrolizumab 3.0 mg/kg was administered by SC injection Q8W for a total of 2 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).
Number of Participants With Anti-Drug Antibodies (ADAs) to Etrolizumab at Baseline and Post-Baseline During the Randomized Treatment Phase Baseline (BL): ADA Positive	1 Participants	0 Participants
Number of Participants With Anti-Drug Antibodies (ADAs) to Etrolizumab at Baseline and Post-Baseline During the Randomized Treatment Phase BL: ADA Negative	11 Participants	12 Participants
Number of Participants With Anti-Drug Antibodies (ADAs) to Etrolizumab at Baseline and Post-Baseline During the Randomized Treatment Phase Post-BL: Treatment-Emergent ADA Positive	4 Participants	2 Participants
Number of Participants With Anti-Drug Antibodies (ADAs) to Etrolizumab at Baseline and Post-Baseline During the Randomized Treatment Phase Post-BL: Treatment-Emergent ADA Negative	7 Participants	10 Participants

SECONDARY outcome

Timeframe: OLE Period: From end of Week 24 to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks

Population: Safety Population: all participants who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Etrolizumab Q4W n=21 Participants Etrolizumab 1.5 mg/kg was administered by SC injection Q4W for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	Etrolizumab Q8W n=13 Participants Etrolizumab 3.0 mg/kg was administered by SC injection Q8W for a total of 2 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).
Long-Term Safety of Etrolizumab: Number of Participants With Adverse Events by Highest Severity Grade, Assessed According to NCI-CTCAE v4.0 Any Adverse Event - Any Grade	20 Participants	4 Participants
Long-Term Safety of Etrolizumab: Number of Participants With Adverse Events by Highest Severity Grade, Assessed According to NCI-CTCAE v4.0 Any Adverse Event - Grade 1	0 Participants	2 Participants
Long-Term Safety of Etrolizumab: Number of Participants With Adverse Events by Highest Severity Grade, Assessed According to NCI-CTCAE v4.0 Any Adverse Event - Grade 2	12 Participants	2 Participants
Long-Term Safety of Etrolizumab: Number of Participants With Adverse Events by Highest Severity Grade, Assessed According to NCI-CTCAE v4.0 Any Adverse Event - Grade 3	8 Participants	0 Participants
Long-Term Safety of Etrolizumab: Number of Participants With Adverse Events by Highest Severity Grade, Assessed According to NCI-CTCAE v4.0 Any Adverse Event - Grade 4	0 Participants	0 Participants
Long-Term Safety of Etrolizumab: Number of Participants With Adverse Events by Highest Severity Grade, Assessed According to NCI-CTCAE v4.0 Any Adverse Event - Grade 5	0 Participants	0 Participants

SECONDARY outcome

Population: Safety Population: all participants who received at least one dose of study treatment.

Serious infection-related AEs were assessed using NCI-CTCAE v4.0.

Outcome measures

Outcome measures
Measure	Etrolizumab Q4W n=21 Participants Etrolizumab 1.5 mg/kg was administered by SC injection Q4W for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	Etrolizumab Q8W n=13 Participants Etrolizumab 3.0 mg/kg was administered by SC injection Q8W for a total of 2 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).
Long-Term Safety of Etrolizumab: Number of Participants With Serious Infection-Related Adverse Events	1 Participants	0 Participants

SECONDARY outcome

Population: Safety Population: all participants who received at least one dose of study treatment.

Hypersensitivity reactions were assessed using NCI-CTCAE v4.0.

Outcome measures

Outcome measures
Measure	Etrolizumab Q4W n=21 Participants Etrolizumab 1.5 mg/kg was administered by SC injection Q4W for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	Etrolizumab Q8W n=13 Participants Etrolizumab 3.0 mg/kg was administered by SC injection Q8W for a total of 2 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).
Long-Term Safety of Etrolizumab: Number of Participants With Hypersensitivity Reactions	4 Participants	1 Participants

SECONDARY outcome

Population: Safety Population: all participants who received at least one dose of study treatment.

Malignancies were assessed using NCI-CTCAE v4.0.

Outcome measures

Outcome measures
Measure	Etrolizumab Q4W n=21 Participants Etrolizumab 1.5 mg/kg was administered by SC injection Q4W for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	Etrolizumab Q8W n=13 Participants Etrolizumab 3.0 mg/kg was administered by SC injection Q8W for a total of 2 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).
Long-Term Safety of Etrolizumab: Number of Participants With Malignancies	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Predose (dosing days only) at Baseline (Day 1), Days 28, 84, and 112, Weeks 24, 36, 72, and 120, and every 12 weeks thereafter for up to 4.25 years

Population: ADA Evaluable Population: all participants who received at least one dose of study treatment and had at least one baseline or post-baseline ADA result from at least one sample.

Outcome measures

Outcome measures
Measure	Etrolizumab Q4W n=12 Participants Etrolizumab 1.5 mg/kg was administered by SC injection Q4W for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	Etrolizumab Q8W n=12 Participants Etrolizumab 3.0 mg/kg was administered by SC injection Q8W for a total of 2 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).
Long-Term Safety of Etrolizumab: Number of Participants With Anti-Drug Antibodies (ADAs) to Etrolizumab at Baseline and Post-Baseline Baseline (BL): ADA Positive	1 Participants	0 Participants
Long-Term Safety of Etrolizumab: Number of Participants With Anti-Drug Antibodies (ADAs) to Etrolizumab at Baseline and Post-Baseline BL: ADA Negative	11 Participants	12 Participants
Long-Term Safety of Etrolizumab: Number of Participants With Anti-Drug Antibodies (ADAs) to Etrolizumab at Baseline and Post-Baseline Post-BL: Treatment-Emergent ADA Positive	4 Participants	3 Participants
Long-Term Safety of Etrolizumab: Number of Participants With Anti-Drug Antibodies (ADAs) to Etrolizumab at Baseline and Post-Baseline Post-BL: Treatment-Emergent ADA Negative	7 Participants	9 Participants

SECONDARY outcome

Timeframe: PML Period: After completion of safety follow up in Randomized Treatment period or after completion of safety follow up after OLE treatment, up to approximately 92 weeks

Population: Safety Population: all participants who received at least one dose of study treatment.

The safety surveillance PML-monitoring phase (no etrolizumab treatment) consisted of telephone calls approximately every 6 months with administration of the protocol's PML Subjective Checklist. If there were any signs or symptoms suggestive of PML identified on this subjective checklist during the telephone call, the participant was asked to come into the clinic for a neurologic examination. The protocol's PML Algorithm was followed for any suspected case of PML, and any confirmed case of PML would be reported as a serious adverse event.

Outcome measures

Outcome measures
Measure	Etrolizumab Q4W n=13 Participants Etrolizumab 1.5 mg/kg was administered by SC injection Q4W for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	Etrolizumab Q8W Etrolizumab 3.0 mg/kg was administered by SC injection Q8W for a total of 2 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).
Number of Participants With Confirmed Progressive Multifocal Leukoencephalopathy (PML) During the Post-Treatment PML Monitoring Phase	0 Participants	—

Adverse Events

Etrolizumab Q4W

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Etrolizumab Q8W

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

OLE: Etrolizumab 1.5 mg/kg Q4W

Serious events: 6 serious events

Other events: 20 other events

Deaths: 0 deaths

PML Safety Monitoring

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Etrolizumab Q4W n=12 participants at risk Etrolizumab 1.5 mg/kg was administered by SC injection Q4W for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	Etrolizumab Q8W n=12 participants at risk Etrolizumab 3.0 mg/kg was administered by SC injection Q8W for a total of 2 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	OLE: Etrolizumab 1.5 mg/kg Q4W n=21 participants at risk Participants from Etrolizumab Q4W and Etrolizumab Q8W who completed the randomized treatment period, were given the option to participate in the OLE period. All participants who chose to enter the OLE period were administered etrolizumab 1.5 mg/kg SC Q4W for a maximum of 183 weeks. Post treatment discontinuation patients entered a 12-week safety follow up.	PML Safety Monitoring n=13 participants at risk After the randomized treatment period (if participants did not enter the OLE period) or after the OLE period, participants who chose to continue in PML safety surveillance phase were monitored for PML for approximately 92 weeks. Participants who chose to enter PML surveillance phase were only followed up for PML and did not receive any study treatment.
Blood and lymphatic system disorders Anaemia	8.3% 1/12 • Number of events 1 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/12 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/21 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/13 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/12 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	8.3% 1/12 • Number of events 1 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	9.5% 2/21 • Number of events 2 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/13 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.
Gastrointestinal disorders Crohn's disease	0.00% 0/12 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	8.3% 1/12 • Number of events 1 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	9.5% 2/21 • Number of events 2 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/13 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.
Gastrointestinal disorders Diarrhoea	8.3% 1/12 • Number of events 1 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/12 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/21 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/13 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.
Gastrointestinal disorders Gastritis	8.3% 1/12 • Number of events 1 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/12 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/21 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/13 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.
Gastrointestinal disorders Vomiting	8.3% 1/12 • Number of events 1 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/12 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/21 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/13 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.
Psychiatric disorders Anxiety disorder	8.3% 1/12 • Number of events 1 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/12 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/21 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/13 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.
Infections and infestations Sinusitis	0.00% 0/12 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/12 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	4.8% 1/21 • Number of events 1 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/13 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.
Nervous system disorders Idiopathic intracranial hypertension	0.00% 0/12 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/12 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	4.8% 1/21 • Number of events 1 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/13 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.
Psychiatric disorders Drug abuse	0.00% 0/12 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/12 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	4.8% 1/21 • Number of events 1 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/13 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.
Psychiatric disorders Intentional self-injury	0.00% 0/12 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/12 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	4.8% 1/21 • Number of events 1 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/13 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.
Reproductive system and breast disorders Balanoposthitis	0.00% 0/12 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/12 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	4.8% 1/21 • Number of events 1 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.	0.00% 0/13 • From Baseline up to the last dose of drug in the Randomized Treatment phase (up to 24 weeks); OLE Period: From end of Week 24 up to end of 12-week safety follow-up (up to 195 weeks); PML Period: After completion of safety follow up in the Randomized Treatment phase or after completion of safety follow up after OLE treatment, up to approximately 92 weeks After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were reported. After initiation of study drug, all AEs were reported until the last study visit or 12 weeks after the last dose of study drug. After this period, only serious AEs related to prior study drug were reported. Safety population included all treated participants in the study.

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

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

Measure	Etrolizumab Q4W n=12 Participants Etrolizumab 1.5 mg/kg was administered by SC injection Q4W for a total of 4 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).	Etrolizumab Q8W n=12 Participants Etrolizumab 3.0 mg/kg was administered by SC injection Q8W for a total of 2 doses over the course of the 24-week randomized treatment phase (16-week treatment plus 8-week safety follow-up).
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD3 T Cells: Baseline	100 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 0.0	100 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 0.0
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD3 T Cells: Day 4	0.18 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 0.2	0.40 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 0.4
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD3 T Cells: Day 56	1.92 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 1.9	13.74 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 13.5
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD3 T Cells: Day 84	7.43 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 6.0	1.06 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 1.1
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD3 T Cells: Day 98	0.36 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 0.4	1.06 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 1.1
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD3 T Cells: Day 112	4.06 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 2.6	6.01 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 5.6
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD3 T Cells: Day 126	12.00 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 12.0	27.24 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 24.6
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD3 T Cells: Day 140	47.47 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 21.9	56.82 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 22.2
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD3 T Cells: Day 168	71.64 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 22.4	51.79 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 23.1
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD4 T Cells: Baseline	100 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 0.0	100 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 0.0
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD4 T Cells: Day 4	0.17 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 0.2	0.00 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 0.0
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD4 T Cells: Day 56	3.33 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 3.3	16.56 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 16.1
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD4 T Cells: Day 84	7.14 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 7.1	1.28 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 1.0
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD4 T Cells: Day 98	0.24 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 0.2	1.28 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 1.3
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD4 T Cells: Day 112	3.60 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 3.1	6.74 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 6.4
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD4 T Cells: Day 126	13.33 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 13.3	37.03 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 33.7
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD4 T Cells: Day 140	55.34 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 23.9	62.01 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 20.3
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD4 T Cells: Day 168	74.49 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 26.1	50.00 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 16.3
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD8 T Cells: Baseline	100 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 0.0	100 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 0.0
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD8 T Cells: Day 4	0.00 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 0.0	0.00 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 0.0
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD8 T Cells: Day 56	1.56 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 1.6	8.41 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 8.4
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD8 T Cells: Day 84	2.72 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 2.7	0.00 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 0.0
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD8 T Cells: Day 98	1.10 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 1.1	2.33 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 2.3
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD8 T Cells: Day 112	0.97 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 1.0	2.46 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 2.5
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD8 T Cells: Day 126	20.00 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 20.0	14.51 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 14.5
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD8 T Cells: Day 140	54.17 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 18.8	40.98 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 24.7
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD8 T Cells: Day 168	63.34 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 40.1	55.56 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 21.1
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD19 B Cells: Baseline	100 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 0.0	100 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 0.0
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD19 B Cells: Day 4	0.00 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 0.0	0.00 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 0.0
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD19 B Cells: Day 56	3.57 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 3.6	19.14 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 17.1
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD19 B Cells: Day 84	10.71 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 10.7	0.00 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 0.0
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD19 B Cells: Day 98	0.00 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 0.0	0.00 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 0.0
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD19 B Cells: Day 112	7.14 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 7.1	7.14 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 7.1
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD19 B Cells: Day 126	42.86 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 21.4	33.93 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 32.3
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD19 B Cells: Day 140	68.00 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 30.5	77.78 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 32.6
Percentage of Baseline Absolute Numbers of Beta7 Receptor-Expressing Gut Homing CD3, CD4, and CD8 T Cells and CD19 B Cells With Unoccupied Beta7 Receptors in Peripheral Blood, Assessed by Flow Cytometry, During the Randomized Treatment Phase CD19 B Cells: Day 168	73.21 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 17.7	40.00 Percentage of BL Unoccupied Beta7 Cells Standard Deviation 13.2