Trial Outcomes & Findings for Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis (NCT NCT02611830)

Last Updated: 2022-05-25

Results Overview

Clinical remission is defined as a complete Mayo score ≤ 2 points and no individual subscore \> 1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

383 participants

Primary outcome timeframe

Week 52

Results posted on

2022-05-25

Participant Flow

Participants took part in the study at one hundred forty-one investigative sites in North America, South America, Western/Northern Europe, Central Europe, Eastern Europe and Africa/Asia/Australia from 18-Dec-2015 to 21-Aug-2018.

A total of 383 participants were enrolled in open-label (OL) induction phase, 353 participants completed. 216 participants achieved clinical response at Week 6 were randomized into maintenance phase and participants who did not achieve clinical response at Week 6, received 3rd dose of open label vedolizumab IV 300 mg and completed Week 14 visit.

Participant milestones

Participant milestones
Measure	Open-Label Induction Phase: Vedolizumab 300 mg IV Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 in the open-label induction phase.	Maintenance Phase: Induction IV + Placebo Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50.	Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50.	Maintenance Phase: Induction IV + Vedolizumab 300 mg IV Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
OL Induction Phase STARTED	383	0	0	0
OL Induction Phase COMPLETED	353	0	0	0
OL Induction Phase NOT COMPLETED	30	0	0	0
Maintenance Phase STARTED	0	56	106	54
Maintenance Phase COMPLETED	0	20	75	39
Maintenance Phase NOT COMPLETED	0	36	31	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Open-Label Induction Phase: Vedolizumab 300 mg IV Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 in the open-label induction phase.	Maintenance Phase: Induction IV + Placebo Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50.	Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50.	Maintenance Phase: Induction IV + Vedolizumab 300 mg IV Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
OL Induction Phase Pretreatment Event/Adverse Event	9	0	0	0
OL Induction Phase Significant Protocol Deviation	4	0	0	0
OL Induction Phase Voluntary Withdrawal	5	0	0	0
OL Induction Phase Lack of Efficacy	9	0	0	0
OL Induction Phase Reason not specified	3	0	0	0
Maintenance Phase Lack of Efficacy	0	29	18	6
Maintenance Phase Pretreatment Event/Adverse Event	0	5	5	2
Maintenance Phase Significant Protocol Deviation	0	0	1	1
Maintenance Phase Lost to Follow-up	0	0	0	1
Maintenance Phase Voluntary Withdrawal	0	1	2	5
Maintenance Phase Pregnancy	0	0	1	0
Maintenance Phase Reason not specified	0	1	4	0

Baseline Characteristics

Data for duration of ulcerative colitis prior therapy was collected only for maintenance phase arm groups.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vedolizumab IV 300 mg, Induction Phase Only n=167 Participants Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 in the open-label induction phase. Participants who did not achieve clinical response at Week 6 were not randomized into the maintenance phase and received a 3rd dose of vedolizumab 300 mg IV infusion at Week 6.	Maintenance Phase: Induction IV + Placebo n=56 Participants Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50.	Maintenance Phase: Induction IV + Vedolizumab 108 mg SC n=106 Participants Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50.	Maintenance Phase: Induction IV + Vedolizumab 300 mg IV n=54 Participants Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.	Total n=383 Participants Total of all reporting groups
Region of Enrollment Croatia	8 Participants n=167 Participants	1 Participants n=56 Participants	0 Participants n=106 Participants	1 Participants n=54 Participants	10 Participants n=383 Participants
Region of Enrollment Slovakia	3 Participants n=167 Participants	0 Participants n=56 Participants	4 Participants n=106 Participants	3 Participants n=54 Participants	10 Participants n=383 Participants
Region of Enrollment Bosnia	0 Participants n=167 Participants	0 Participants n=56 Participants	2 Participants n=106 Participants	0 Participants n=54 Participants	2 Participants n=383 Participants
Region of Enrollment Bulgaria	3 Participants n=167 Participants	1 Participants n=56 Participants	1 Participants n=106 Participants	1 Participants n=54 Participants	6 Participants n=383 Participants
Age, Continuous	42.7 years n=167 Participants	39.4 years n=56 Participants	38.1 years n=106 Participants	41.6 years n=54 Participants	40.79 years n=383 Participants
Sex: Female, Male Female	79 Participants n=167 Participants	22 Participants n=56 Participants	41 Participants n=106 Participants	23 Participants n=54 Participants	165 Participants n=383 Participants
Sex: Female, Male Male	88 Participants n=167 Participants	34 Participants n=56 Participants	65 Participants n=106 Participants	31 Participants n=54 Participants	218 Participants n=383 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=167 Participants	1 Participants n=56 Participants	0 Participants n=106 Participants	0 Participants n=54 Participants	1 Participants n=383 Participants
Race/Ethnicity, Customized Non-Hispanic and Latino	24 Participants n=167 Participants	6 Participants n=56 Participants	7 Participants n=106 Participants	8 Participants n=54 Participants	45 Participants n=383 Participants
Race/Ethnicity, Customized Not Collected	143 Participants n=167 Participants	49 Participants n=56 Participants	99 Participants n=106 Participants	46 Participants n=54 Participants	337 Participants n=383 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=167 Participants	1 Participants n=56 Participants	0 Participants n=106 Participants	0 Participants n=54 Participants	3 Participants n=383 Participants
Race/Ethnicity, Customized Asian	39 Participants n=167 Participants	13 Participants n=56 Participants	14 Participants n=106 Participants	5 Participants n=54 Participants	71 Participants n=383 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=167 Participants	0 Participants n=56 Participants	0 Participants n=106 Participants	2 Participants n=54 Participants	3 Participants n=383 Participants
Race/Ethnicity, Customized White	125 Participants n=167 Participants	42 Participants n=56 Participants	92 Participants n=106 Participants	47 Participants n=54 Participants	306 Participants n=383 Participants
Region of Enrollment Australia	1 Participants n=167 Participants	0 Participants n=56 Participants	2 Participants n=106 Participants	1 Participants n=54 Participants	4 Participants n=383 Participants
Region of Enrollment Japan	27 Participants n=167 Participants	10 Participants n=56 Participants	10 Participants n=106 Participants	2 Participants n=54 Participants	49 Participants n=383 Participants
Region of Enrollment Korea, Republic Of	10 Participants n=167 Participants	3 Participants n=56 Participants	4 Participants n=106 Participants	3 Participants n=54 Participants	20 Participants n=383 Participants
Region of Enrollment Czech Republic	2 Participants n=167 Participants	3 Participants n=56 Participants	10 Participants n=106 Participants	4 Participants n=54 Participants	19 Participants n=383 Participants
Region of Enrollment Hungary	2 Participants n=167 Participants	2 Participants n=56 Participants	2 Participants n=106 Participants	6 Participants n=54 Participants	12 Participants n=383 Participants
Region of Enrollment Poland	37 Participants n=167 Participants	13 Participants n=56 Participants	35 Participants n=106 Participants	10 Participants n=54 Participants	95 Participants n=383 Participants
Region of Enrollment Serbia	1 Participants n=167 Participants	1 Participants n=56 Participants	0 Participants n=106 Participants	1 Participants n=54 Participants	3 Participants n=383 Participants
Region of Enrollment Estonia	2 Participants n=167 Participants	0 Participants n=56 Participants	0 Participants n=106 Participants	0 Participants n=54 Participants	2 Participants n=383 Participants
Region of Enrollment Israel	2 Participants n=167 Participants	0 Participants n=56 Participants	0 Participants n=106 Participants	0 Participants n=54 Participants	2 Participants n=383 Participants
Region of Enrollment Romania	4 Participants n=167 Participants	0 Participants n=56 Participants	3 Participants n=106 Participants	0 Participants n=54 Participants	7 Participants n=383 Participants
Region of Enrollment Russia	12 Participants n=167 Participants	0 Participants n=56 Participants	5 Participants n=106 Participants	3 Participants n=54 Participants	20 Participants n=383 Participants
Region of Enrollment Turkey	1 Participants n=167 Participants	2 Participants n=56 Participants	0 Participants n=106 Participants	0 Participants n=54 Participants	3 Participants n=383 Participants
Region of Enrollment Ukraine	11 Participants n=167 Participants	4 Participants n=56 Participants	6 Participants n=106 Participants	2 Participants n=54 Participants	23 Participants n=383 Participants
Region of Enrollment Canada	4 Participants n=167 Participants	3 Participants n=56 Participants	2 Participants n=106 Participants	2 Participants n=54 Participants	11 Participants n=383 Participants
Region of Enrollment United States	24 Participants n=167 Participants	6 Participants n=56 Participants	7 Participants n=106 Participants	8 Participants n=54 Participants	45 Participants n=383 Participants
Region of Enrollment Brazil	4 Participants n=167 Participants	0 Participants n=56 Participants	3 Participants n=106 Participants	1 Participants n=54 Participants	8 Participants n=383 Participants
Region of Enrollment Mexico	2 Participants n=167 Participants	1 Participants n=56 Participants	0 Participants n=106 Participants	0 Participants n=54 Participants	3 Participants n=383 Participants
Region of Enrollment Belgium	0 Participants n=167 Participants	2 Participants n=56 Participants	0 Participants n=106 Participants	0 Participants n=54 Participants	2 Participants n=383 Participants
Region of Enrollment Denmark	0 Participants n=167 Participants	1 Participants n=56 Participants	0 Participants n=106 Participants	0 Participants n=54 Participants	1 Participants n=383 Participants
Region of Enrollment Germany	0 Participants n=167 Participants	3 Participants n=56 Participants	3 Participants n=106 Participants	1 Participants n=54 Participants	7 Participants n=383 Participants
Region of Enrollment Italy	4 Participants n=167 Participants	0 Participants n=56 Participants	2 Participants n=106 Participants	3 Participants n=54 Participants	9 Participants n=383 Participants
Region of Enrollment Lithuania	0 Participants n=167 Participants	0 Participants n=56 Participants	4 Participants n=106 Participants	1 Participants n=54 Participants	5 Participants n=383 Participants
Region of Enrollment Netherlands	1 Participants n=167 Participants	0 Participants n=56 Participants	0 Participants n=106 Participants	0 Participants n=54 Participants	1 Participants n=383 Participants
Region of Enrollment Spain	1 Participants n=167 Participants	0 Participants n=56 Participants	0 Participants n=106 Participants	0 Participants n=54 Participants	1 Participants n=383 Participants
Region of Enrollment United Kingdom	1 Participants n=167 Participants	0 Participants n=56 Participants	1 Participants n=106 Participants	1 Participants n=54 Participants	3 Participants n=383 Participants
Height	169.3 cm n=167 Participants	172.4 cm n=56 Participants	171.9 cm n=106 Participants	171.2 cm n=54 Participants	170.7 cm n=383 Participants
Weight	68.20 kg n=167 Participants	73.96 kg n=56 Participants	71.58 kg n=106 Participants	76.95 kg n=54 Participants	71.21 kg n=383 Participants
Body Mass Index (BMI)	23.65 kg/m^2 n=167 Participants	24.66 kg/m^2 n=56 Participants	24.07 kg/m^2 n=106 Participants	26.21 kg/m^2 n=54 Participants	24.28 kg/m^2 n=383 Participants
Female Reproductive Status Postmenopausal	17 Participants n=167 Participants	4 Participants n=56 Participants	3 Participants n=106 Participants	8 Participants n=54 Participants	32 Participants n=383 Participants
Female Reproductive Status Surgically Sterile	8 Participants n=167 Participants	1 Participants n=56 Participants	2 Participants n=106 Participants	3 Participants n=54 Participants	14 Participants n=383 Participants
Female Reproductive Status Female of Childbearing Potential	54 Participants n=167 Participants	17 Participants n=56 Participants	36 Participants n=106 Participants	12 Participants n=54 Participants	119 Participants n=383 Participants
Female Reproductive Status Participant is a male	88 Participants n=167 Participants	34 Participants n=56 Participants	65 Participants n=106 Participants	31 Participants n=54 Participants	218 Participants n=383 Participants
Smoking Classification Has never smoked	107 Participants n=167 Participants	38 Participants n=56 Participants	70 Participants n=106 Participants	33 Participants n=54 Participants	248 Participants n=383 Participants
Smoking Classification Is a current smoker	7 Participants n=167 Participants	0 Participants n=56 Participants	11 Participants n=106 Participants	10 Participants n=54 Participants	28 Participants n=383 Participants
Smoking Classification is an ex-smoker	53 Participants n=167 Participants	18 Participants n=56 Participants	25 Participants n=106 Participants	11 Participants n=54 Participants	107 Participants n=383 Participants
Duration of Ulcerative Colitis	—	7.36 years STANDARD_DEVIATION 7.147 • n=56 Participants • Data for duration of ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	7.96 years STANDARD_DEVIATION 6.217 • n=106 Participants • Data for duration of ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	8.18 years STANDARD_DEVIATION 5.929 • n=54 Participants • Data for duration of ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	7.86 years STANDARD_DEVIATION 6.380 • n=216 Participants • Data for duration of ulcerative colitis prior therapy was collected only for maintenance phase arm groups.
Ulcerative Colitis Prior Therapy Without Prior Corticosteroids or Immunomodulators · Yes	—	1 Participants n=56 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	1 Participants n=106 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	0 Participants n=54 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	2 Participants n=216 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.
Ulcerative Colitis Prior Therapy Without Prior Corticosteroids or Immunomodulators · No	—	55 Participants n=56 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	105 Participants n=106 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	54 Participants n=54 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	214 Participants n=216 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.
Ulcerative Colitis Prior Therapy Only Prior Corticosteroids · Yes	—	22 Participants n=56 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	28 Participants n=106 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	21 Participants n=54 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	71 Participants n=216 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.
Ulcerative Colitis Prior Therapy Only Prior Corticosteroids · No	—	34 Participants n=56 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	78 Participants n=106 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	33 Participants n=54 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	145 Participants n=216 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.
Ulcerative Colitis Prior Therapy Only Prior Immunomodulators · Yes	—	1 Participants n=56 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	6 Participants n=106 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	1 Participants n=54 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	8 Participants n=216 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.
Ulcerative Colitis Prior Therapy Only Prior Immunomodulators · No	—	55 Participants n=56 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	100 Participants n=106 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	53 Participants n=54 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	208 Participants n=216 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.
Ulcerative Colitis Prior Therapy With Prior Corticosteroids and Immunomodulators · Yes	—	32 Participants n=56 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	71 Participants n=106 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	32 Participants n=54 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	135 Participants n=216 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.
Ulcerative Colitis Prior Therapy With Prior Corticosteroids and Immunomodulators · No	—	24 Participants n=56 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	35 Participants n=106 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	22 Participants n=54 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.	81 Participants n=216 Participants • Data for ulcerative colitis prior therapy was collected only for maintenance phase arm groups.
Participants with Prior TNF-alpha Antagonist Use Yes	—	20 Participants n=56 Participants • Data for prior TNF-alpha antagonist use was collected only for maintenance phase arm groups.	40 Participants n=106 Participants • Data for prior TNF-alpha antagonist use was collected only for maintenance phase arm groups.	24 Participants n=54 Participants • Data for prior TNF-alpha antagonist use was collected only for maintenance phase arm groups.	84 Participants n=216 Participants • Data for prior TNF-alpha antagonist use was collected only for maintenance phase arm groups.
Participants with Prior TNF-alpha Antagonist Use No	—	36 Participants n=56 Participants • Data for prior TNF-alpha antagonist use was collected only for maintenance phase arm groups.	66 Participants n=106 Participants • Data for prior TNF-alpha antagonist use was collected only for maintenance phase arm groups.	30 Participants n=54 Participants • Data for prior TNF-alpha antagonist use was collected only for maintenance phase arm groups.	132 Participants n=216 Participants • Data for prior TNF-alpha antagonist use was collected only for maintenance phase arm groups.
Participants with Prior TNF-alpha Antagonist Failure	—	20 Participants n=20 Participants • Data for prior TNF-alpha antagonist failure was collected only for maintenance phase arm groups.	40 Participants n=40 Participants • Data for prior TNF-alpha antagonist failure was collected only for maintenance phase arm groups.	24 Participants n=24 Participants • Data for prior TNF-alpha antagonist failure was collected only for maintenance phase arm groups.	84 Participants n=84 Participants • Data for prior TNF-alpha antagonist failure was collected only for maintenance phase arm groups.
Participants with Prior Immunomodulator Failure and Prior TNF-alpha Antagonist Failure Yes	—	12 Participants n=17 Participants • Data for prior immunomodulator failure and prior TNF-alpha antagonist failure was collected only for maintenance phase arm groups.	21 Participants n=34 Participants • Data for prior immunomodulator failure and prior TNF-alpha antagonist failure was collected only for maintenance phase arm groups.	13 Participants n=19 Participants • Data for prior immunomodulator failure and prior TNF-alpha antagonist failure was collected only for maintenance phase arm groups.	46 Participants n=70 Participants • Data for prior immunomodulator failure and prior TNF-alpha antagonist failure was collected only for maintenance phase arm groups.
Participants with Prior Immunomodulator Failure and Prior TNF-alpha Antagonist Failure No	—	5 Participants n=17 Participants • Data for prior immunomodulator failure and prior TNF-alpha antagonist failure was collected only for maintenance phase arm groups.	13 Participants n=34 Participants • Data for prior immunomodulator failure and prior TNF-alpha antagonist failure was collected only for maintenance phase arm groups.	6 Participants n=19 Participants • Data for prior immunomodulator failure and prior TNF-alpha antagonist failure was collected only for maintenance phase arm groups.	24 Participants n=70 Participants • Data for prior immunomodulator failure and prior TNF-alpha antagonist failure was collected only for maintenance phase arm groups.
Worst Prior Treatment Failure Prior TNF-alpha Antagonist Failure · Inadequate Response	—	9 Participants n=20 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	21 Participants n=40 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	13 Participants n=24 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	43 Participants n=84 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.
Worst Prior Treatment Failure Prior TNF-alpha Antagonist Failure · Loss of Response	—	8 Participants n=20 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	17 Participants n=40 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	9 Participants n=24 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	34 Participants n=84 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.
Worst Prior Treatment Failure Prior TNF-alpha Antagonist Failure · Intolerance	—	3 Participants n=20 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	2 Participants n=40 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	2 Participants n=24 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	7 Participants n=84 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.
Worst Prior Treatment Failure Prior Immunomodulator Failure · Inadequate Response	—	1 Participants n=5 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	6 Participants n=22 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	2 Participants n=5 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	9 Participants n=32 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.
Worst Prior Treatment Failure Prior Immunomodulator Failure · Loss of Response	—	0 Participants n=5 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	3 Participants n=22 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	0 Participants n=5 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	3 Participants n=32 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.
Worst Prior Treatment Failure Prior Immunomodulator Failure · Intolerance	—	4 Participants n=5 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	13 Participants n=22 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	3 Participants n=5 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	20 Participants n=32 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.
Worst Prior Treatment Failure Prior Corticosteroid Failure · Inadequate Response	—	5 Participants n=13 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	14 Participants n=23 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	5 Participants n=15 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	24 Participants n=51 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.
Worst Prior Treatment Failure Prior Corticosteroid Failure · Loss of Response	—	4 Participants n=13 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	6 Participants n=23 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	9 Participants n=15 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	19 Participants n=51 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.
Worst Prior Treatment Failure Prior Corticosteroid Failure · Intolerance	—	4 Participants n=13 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	3 Participants n=23 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	1 Participants n=15 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.	8 Participants n=51 Participants • Data for worst prior treatment failure was collected only for maintenance phase arm groups.
Baseline Disease Activity Moderate (Mayo Score=6 to 8)	—	20 Participants n=56 Participants • Data for baseline disease activity was collected only for maintenance phase arm groups.	46 Participants n=106 Participants • Data for baseline disease activity was collected only for maintenance phase arm groups.	17 Participants n=54 Participants • Data for baseline disease activity was collected only for maintenance phase arm groups.	83 Participants n=216 Participants • Data for baseline disease activity was collected only for maintenance phase arm groups.
Baseline Disease Activity Severe (Mayo Score=9 to 12)	—	36 Participants n=56 Participants • Data for baseline disease activity was collected only for maintenance phase arm groups.	60 Participants n=106 Participants • Data for baseline disease activity was collected only for maintenance phase arm groups.	37 Participants n=54 Participants • Data for baseline disease activity was collected only for maintenance phase arm groups.	133 Participants n=216 Participants • Data for baseline disease activity was collected only for maintenance phase arm groups.
Baseline Fecal Calprotectin	—	2393.4 ug/g STANDARD_DEVIATION 2859.66 • n=56 Participants • Data for Baseline fecal calprotectin was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for baseline fecal calprotectin.	2607.2 ug/g STANDARD_DEVIATION 2908.67 • n=102 Participants • Data for Baseline fecal calprotectin was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for baseline fecal calprotectin.	3173.5 ug/g STANDARD_DEVIATION 4785.48 • n=52 Participants • Data for Baseline fecal calprotectin was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for baseline fecal calprotectin.	2690.4 ug/g STANDARD_DEVIATION 3451.64 • n=210 Participants • Data for Baseline fecal calprotectin was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for baseline fecal calprotectin.
Extraintestinal Manifestations Yes	—	5 Participants n=56 Participants • Data for extraintestinal manifestations was collected only for maintenance phase arm groups.	13 Participants n=106 Participants • Data for extraintestinal manifestations was collected only for maintenance phase arm groups.	7 Participants n=54 Participants • Data for extraintestinal manifestations was collected only for maintenance phase arm groups.	25 Participants n=216 Participants • Data for extraintestinal manifestations was collected only for maintenance phase arm groups.
Extraintestinal Manifestations No	—	51 Participants n=56 Participants • Data for extraintestinal manifestations was collected only for maintenance phase arm groups.	93 Participants n=106 Participants • Data for extraintestinal manifestations was collected only for maintenance phase arm groups.	47 Participants n=54 Participants • Data for extraintestinal manifestations was collected only for maintenance phase arm groups.	191 Participants n=216 Participants • Data for extraintestinal manifestations was collected only for maintenance phase arm groups.
Disease Localization Proctosigmoiditis	—	7 Participants n=56 Participants • Data for disease localization was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for disease localization.	15 Participants n=105 Participants • Data for disease localization was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for disease localization.	7 Participants n=54 Participants • Data for disease localization was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for disease localization.	29 Participants n=215 Participants • Data for disease localization was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for disease localization.
Disease Localization Left Sided Colitis	—	24 Participants n=56 Participants • Data for disease localization was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for disease localization.	46 Participants n=105 Participants • Data for disease localization was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for disease localization.	21 Participants n=54 Participants • Data for disease localization was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for disease localization.	91 Participants n=215 Participants • Data for disease localization was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for disease localization.
Disease Localization Extensive Colitis	—	4 Participants n=56 Participants • Data for disease localization was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for disease localization.	7 Participants n=105 Participants • Data for disease localization was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for disease localization.	7 Participants n=54 Participants • Data for disease localization was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for disease localization.	18 Participants n=215 Participants • Data for disease localization was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for disease localization.
Disease Localization Pancolitis	—	21 Participants n=56 Participants • Data for disease localization was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for disease localization.	37 Participants n=105 Participants • Data for disease localization was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for disease localization.	19 Participants n=54 Participants • Data for disease localization was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for disease localization.	77 Participants n=215 Participants • Data for disease localization was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for disease localization.
Corticosteroid Use at Baseline Yes	—	24 Participants n=56 Participants • Data for corticosteroid use at Baseline was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for corticosteroid use at baseline.	45 Participants n=106 Participants • Data for corticosteroid use at Baseline was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for corticosteroid use at baseline.	21 Participants n=54 Participants • Data for corticosteroid use at Baseline was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for corticosteroid use at baseline.	90 Participants n=216 Participants • Data for corticosteroid use at Baseline was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for corticosteroid use at baseline.
Corticosteroid Use at Baseline No	—	32 Participants n=56 Participants • Data for corticosteroid use at Baseline was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for corticosteroid use at baseline.	61 Participants n=106 Participants • Data for corticosteroid use at Baseline was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for corticosteroid use at baseline.	33 Participants n=54 Participants • Data for corticosteroid use at Baseline was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for corticosteroid use at baseline.	126 Participants n=216 Participants • Data for corticosteroid use at Baseline was collected only for maintenance phase arm groups. Number analyzed is the number of participants with data available for corticosteroid use at baseline.

PRIMARY outcome

Timeframe: Week 52

Population: The Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug. Participants who only received induction IV therapy and were not randomized into the maintenance phase were not included in the FAS; participants were analyzed according to the randomized treatment assignment.

Outcome measures

Outcome measures
Measure	Maintenance Phase: Induction IV + Placebo n=56 Participants Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50.	Maintenance Phase: Induction IV + Vedolizumab 108 mg SC n=106 Participants Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50.	Maintenance Phase: Induction IV + Vedolizumab 300 mg IV n=54 Participants Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
Percentage of Participants Achieving Clinical Remission at Week 52	14.3 percentage of participants Interval 6.4 to 26.2	46.2 percentage of participants Interval 36.5 to 56.2	42.6 percentage of participants Interval 29.2 to 56.8

SECONDARY outcome

Timeframe: Week 52

Population: The FAS included all randomized participants who received at least 1 dose of study drug. Participants who only received induction IV therapy and were not randomized into the maintenance phase were not included in the FAS; participants were analyzed according to the randomized treatment assignment.

Mucosal healing is defined as Mayo endoscopic subscore ≤1 point. The findings on endoscopy scale ranges from 0 to 3, where 0=normal or inactive disease 1=mild disease (erythema, decreased vascular pattern, mild friability) 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions) 3=severe disease (spontaneous bleeding, ulceration).

Outcome measures

Outcome measures
Measure	Maintenance Phase: Induction IV + Placebo n=56 Participants Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50.	Maintenance Phase: Induction IV + Vedolizumab 108 mg SC n=106 Participants Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50.	Maintenance Phase: Induction IV + Vedolizumab 300 mg IV n=54 Participants Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
Percentage of Participants Achieving Mucosal Healing at Week 52	21.4 percentage of participants Interval 11.6 to 34.4	56.6 percentage of participants Interval 46.6 to 66.2	53.7 percentage of participants Interval 39.6 to 67.4

SECONDARY outcome

Timeframe: Baseline, Weeks 6 and 52

Durable clinical response is defined as clinical response at both Weeks 6 and 52, where clinical response is defined as a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).

Outcome measures

Outcome measures
Measure	Maintenance Phase: Induction IV + Placebo n=56 Participants Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50.	Maintenance Phase: Induction IV + Vedolizumab 108 mg SC n=106 Participants Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50.	Maintenance Phase: Induction IV + Vedolizumab 300 mg IV n=54 Participants Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
Percentage of Participants Achieving Durable Clinical Response at Week 6 and Week 52	28.6 percentage of participants Interval 17.3 to 42.2	64.2 percentage of participants Interval 54.3 to 73.2	72.2 percentage of participants Interval 58.4 to 83.5

SECONDARY outcome

Timeframe: Weeks 6 and 52

Durable clinical remission is defined as clinical remission at both Weeks 6 and 52. Clinical remission is defined as a complete Mayo score of less than or equal to (≤) 2 points and no individual subscore greater than (\>) 1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).

Outcome measures

Outcome measures
Measure	Maintenance Phase: Induction IV + Placebo n=56 Participants Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50.	Maintenance Phase: Induction IV + Vedolizumab 108 mg SC n=106 Participants Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50.	Maintenance Phase: Induction IV + Vedolizumab 300 mg IV n=54 Participants Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
Percentage of Participants Achieving Durable Clinical Remission at Week 6 and Week 52	5.4 percentage of participants Interval 1.1 to 14.9	15.1 percentage of participants Interval 8.9 to 23.4	16.7 percentage of participants Interval 7.9 to 29.3

SECONDARY outcome

Timeframe: Week 52

Population: Participants from FAS, who used concomitant oral corticosteroid at Baseline. FAS included all randomized participants who received at least 1 dose of study drug and who only received induction IV therapy and were not randomized into maintenance phase were not included in FAS; participants were analyzed according to randomized treatment assignment.

Corticosteroid-free remission is defined as participants using oral corticosteroids at Baseline (Week 0) who have discontinued oral corticosteroids and are in clinical remission at Week 52. Clinical remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore \> 1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).

Outcome measures

Outcome measures
Measure	Maintenance Phase: Induction IV + Placebo n=24 Participants Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50.	Maintenance Phase: Induction IV + Vedolizumab 108 mg SC n=45 Participants Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50.	Maintenance Phase: Induction IV + Vedolizumab 300 mg IV n=21 Participants Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
Percentage of Participants Achieving Corticosteroid-free Remission at Week 52	8.3 percentage of participants Interval 1.0 to 27.0	28.9 percentage of participants Interval 16.4 to 44.3	28.6 percentage of participants Interval 11.3 to 52.2

Adverse Events

Vedolizumab IV 300 mg, Induction Phase Only

Serious events: 17 serious events

Other events: 34 other events

Deaths: 0 deaths

Maintenance Phase: Induction IV + Placebo

Serious events: 6 serious events

Other events: 31 other events

Deaths: 0 deaths

Maintenance Phase: Induction IV + Vedolizumab 108 mg SC

Serious events: 10 serious events

Other events: 42 other events

Deaths: 0 deaths

Maintenance Phase: Induction IV + Vedolizumab 300 mg IV

Serious events: 7 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Vedolizumab IV 300 mg, Induction Phase Only n=167 participants at risk Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 in the open-label induction phase. Participants who did not achieve clinical response at Week 6 were not randomized into the maintenance phase and received a 3rd dose of vedolizumab 300 mg IV infusion at Week 6.	Maintenance Phase: Induction IV + Placebo n=56 participants at risk Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50.	Maintenance Phase: Induction IV + Vedolizumab 108 mg SC n=106 participants at risk Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50.	Maintenance Phase: Induction IV + Vedolizumab 300 mg IV n=54 participants at risk Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
Blood and lymphatic system disorders Anaemia	5.4% 9/167 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.6% 2/56 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.7% 5/106 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.3% 5/54 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Colitis ulcerative	4.2% 7/167 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 14/56 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.3% 12/106 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.3% 5/54 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Nasopharyngitis	2.4% 4/167 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	19.6% 11/56 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.4% 11/106 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	18.5% 10/54 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Upper respiratory tract infection	1.8% 3/167 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.8% 1/56 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.4% 10/106 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.7% 2/54 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Sinusitis	0.00% 0/167 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.4% 3/56 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.94% 1/106 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/54 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Urinary tract infection	3.0% 5/167 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.6% 2/56 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/106 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.4% 4/54 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Alanine aminotransferase increased	0.60% 1/167 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/56 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.94% 1/106 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 3/54 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood creatine phosphokinase increased	0.00% 0/167 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/56 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.94% 1/106 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 3/54 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	2.4% 4/167 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.8% 1/56 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.7% 6/106 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.4% 4/54 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Headache	3.0% 5/167 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.7% 6/56 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.5% 9/106 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/54 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Insomnia	0.00% 0/167 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/56 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.94% 1/106 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 3/54 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/167 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.8% 1/56 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.94% 1/106 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 3/54 • From first dose up to 18 weeks post last dose of study drug (Up to approximately 68 weeks) At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER