Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis

Conditions

Colitis, Ulcerative

Keywords

Drug therapy

Brief summary

The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to severely active ulcerative colitis (UC) who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.

Detailed description

The drug being tested in this study is called vedolizumab subcutaneous (vedolizumab SC). Vedolizumab SC is being tested to treat people who have moderate to severely active ulcerative colitis. This study will look at clinical remission as well as mucosal healing, durable clinical response, durable clinical remission, and corticosteroid free remission in participants with UC who receive vedolizumab SC maintenance therapy after having achieved a clinical response to vedolizumab IV induction therapy. The study enrolled 383 patients. All participants will enter into a 6-week Induction Phase where they will be administered open-label vedolizumab IV 300 mg via intravenous infusion (IV) at Week 0 (Day 1) and Week 2 (Day 15), and will then be assessed for a clinical response at Week 6. Participants who achieve a clinical response at Week 6 will be randomly assigned to one of the three treatment groups: Vedolizumab SC 108 mg Q2W and Placebo IV Q8W Vedolizumab IV 300 mg Q8W and Placebo SC Q2W Placebo SC Q2W and Placebo IV Q8W Participants who do not achieve a clinical response at Week 6 will not be randomized in to the Maintenance Period, and will receive a third infusion of vedolizumab IV 300 mg at Week 6. This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 71 weeks (up to 4 weeks of screening, 52 weeks of treatment and 18 weeks of safety follow-up). Participants will make multiple visits to the clinic, plus a final visit 18 weeks after last dose of study drug for a follow-up assessment. Participants will also participate in a long-term safety follow-up, by phone, at 6 months after the last dose of study drug. After the Week 52 assessments, participants meeting protocol-defined criteria were eligible to enroll in Study MLN0002SC-3030 (NCT02620046; Long-term Safety) to receive open-label vedolizumab treatment. Participants who withdrew early (prior to Week 52) due to sustained nonresponse, disease worsening, or the need for rescue medications may also have been eligible for Study MLN0002SC-3030. Participants who did not enroll into Study MLN0002SC-3030 were to complete a final on-study safety assessment at Week 68 (or final safety visit 18 weeks after the last dose) in the Maintenance Phase of Study MLN0002SC-3027.

Erica Cohen, Angelina Collins, Jill M. Hoffman, Tamara Donaldson, Thais Gift et al. (8 authors)

Inflammatory Bowel Diseases2026-01-22

10.1093/ibd/izag006.091

DOP090 Persistence and treatment patterns of vedolizumab subcutaneous maintenance therapy in patients with Inflammatory Bowel Disease: data from a Canadian cohort

B Bressler, R Moulson, Z Yang, Christopher Pettengell, Joshua Brown et al. (10 authors)

Journal of Crohn s and Colitis2026-01-01

10.1093/ecco-jcc/jjaf231.127

P0588 Efficacy and health-related quality of life associated with second-line vedolizumab after one prior first-line anti-tumour necrosis factor treatment in patients with active ulcerative colitis: A meta-analysis of the GEMINI-1 and VISIBLE-1 trials

Raja Atreya, Julien Kirchgesner, Z Cheah, Patricia Biedermann, L Bakker et al. (7 authors)

Journal of Crohn s and Colitis2025-01-01

10.1093/ecco-jcc/jjae190.0762

Efficacy of vedolizumab during intravenous induction therapy in ulcerative colitis and Crohn’s disease: post hoc analysis of patient-reported outcomes from the VISIBLE 1 and 2 studies

Geert D’Haens, Filip Baert, Silvio Danese, Taku Kobayashi, Edward V. Loftus et al. (11 authors)

European Journal of Gastroenterology & Hepatology2024-02-213 citations

10.1097/meg.0000000000002728

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Ryan C. Ungaro, Harisha Kadali, Wenwen Zhang, Shashi Adsul, Walter Reinisch

Journal of Crohn s and Colitis2023-07-2610 citations

10.1093/ecco-jcc/jjad113

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Taku Kobayashi, Hiroaki Ito, Toshifumi Ashida, Tadashi Yokoyama, Masakazu Nagahori et al. (12 authors)

Intestinal Research2020-08-1817 citations

10.5217/ir.2020.00026

P510 Dose escalation of subcutaneous vedolizumab in patients with ulcerative colitis: A post hoc analysis of the VISIBLE trial data

William J. Sandborn, Douglas C. Wolf, Geert D’Haens, Johan Jansson, J Chen et al. (9 authors)

Journal of Crohn s and Colitis2020-01-014 citations

10.1093/ecco-jcc/jjz203.639

P403 Post hoc examination of VISIBLE 1 data for baseline predictors of response to 2 or 3 IV doses of vedolizumab for adults with moderate-to-severe ulcerative colitis

William J. Sandborn, Edward V. Loftus, Filip Baert, Johan Jansson, Jingjing Chen et al. (8 authors)

Journal of Crohn s and Colitis2020-01-01

10.1093/ecco-jcc/jjz203.532

P424 Economic evaluation of vedolizumab SC for the treatment of moderate-to-severe ulcerative colitis in Canada

A Fischer, Mark Oppe, S Stypa, Vasily Lukyanov, Ioannis Petrakis

Journal of Crohn s and Colitis2020-01-01

10.1093/ecco-jcc/jjz203.553

P530 Cost-effectiveness of vedolizumab SC vs. adalimumab for moderately to severely active ulcerative colitis

I. Diakité, Bob G. Schultz, J Carter, Sonya J. Snedecor, Robin S. Turpin

Journal of Crohn s and Colitis2020-01-01

10.1093/ecco-jcc/jjz203.658

634 Transitioning From Vedolizumab IV to Vedolizumab SC in Patients With Ulcerative Colitis: Results From the VISIBLE Program

Douglas C. Wolf, Silvio Danese, Barbara Matthews, Stephen L. Jones, Jingjing Chen et al. (7 authors)

The American Journal of Gastroenterology2019-10-015 citations

10.14309/01.ajg.0000592072.55730.89

Efficacy and Safety of Vedolizumab Subcutaneous Formulation in a Randomized Trial of Patients With Ulcerative Colitis.

Sandborn WJ, Baert F, Danese S, Krznarić Ž, Kobayashi T, Yao X, Chen J, Rosario M, Bhatia S, Kisfalvi K, D'Haens G, Vermeire S.

2019-08-28216 citations

10.1053/j.gastro.2019.08.027

OTH-12 Efficacy and safety of vedolizumab subcutaneous formulation for ulcerative colitis: results of the visible trial

WJ Sandborn, Filip Baert, Silvio Danese, Z Krznari cacute, Geert D’Haens et al. (10 authors)

2019-06-011 citations

10.1136/gutjnl-2019-bsgabstracts.119

P490 A vedolizumab population pharmacokinetic model including intravenous and subcutaneous formulations for patients with ulcerative colitis

Maria Rosario, Dan Polhamus, C Chen, Wan Sun, Nathanael L. Dirks

Journal of Crohn s and Colitis2019-01-2512 citations

10.1093/ecco-jcc/jjy222.614

P374 Effects of subcutaneous vedolizumab on health-related quality of life and work productivity in patients with ulcerative colitis: results from the Phase 3 VISIBLE 1 trial

Séverine Vermeire, Željko Krznarić, Taku Kobayashi, Jingjing Chen, Christian Agboton et al. (8 authors)

Journal of Crohn s and Colitis2019-01-255 citations

10.1093/ecco-jcc/jjy222.498

P529 Exposure–response relationship of vedolizumab subcutaneous treatment in patients with ulcerative colitis: VISIBLE 1

Maria Rosario, Dan Polhamus, Nathanael L. Dirks, R J Lock, Xinyi Yao et al. (11 authors)

Journal of Crohn s and Colitis2019-01-255 citations

10.1093/ecco-jcc/jjy222.653

P499 Efficacy and safety of 2 or 3 vedolizumab intravenous infusions as induction therapy for ulcerative colitis and Crohn’s disease: results from VISIBLE 1 and 2

Edward V. Loftus, William J. Sandborn, Douglas C. Wolf, Silvio Danese, Jingjing Chen et al. (8 authors)

Journal of Crohn s and Colitis2019-01-25

10.1093/ecco-jcc/jjy222.623

Interventions

DRUGVedolizumab 300 mg IV

Vedolizumab intravenous infusion

DRUGPlacebo IV

Vedolizumab intravenous infusion placebo

DRUGVedolizumab 108 mg SC

Vedolizumab subcutaneous injection

DRUGPlacebo SC

Vedolizumab subcutaneous injection placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

No

Inclusion criteria

1. Diagnosis of ulcerative colitis (UC) established at least 6 months prior to screening, by clinical and endoscopic evidence and corroborated by a histopathology report. 2. Moderately to severely active UC as determined by a complete Mayo score of 6-12 (with an endoscopic subscore ≥2) 3. Evidence of UC extending proximal to the rectum (≥15 cm of involved colon). 4. Inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or Tumor Necrosis Factor-alpha (TNF-α) antagonists

Exclusion criteria

1. Evidence of abdominal abscess or toxic megacolon at the initial Screening Visit. 2. Extensive colonic resection, subtotal or total colectomy. 3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine. 4. Prior exposure to investigational or approved non-biologic therapies (eg, cyclosporine, tacrolimus, thalidomide, methotrexate or tofacitinib) for the treatment of underlying disease within 30 days or 5 half-lives of screening (whichever is longer). 5. Prior exposure to any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of screening (whichever is longer). 6. Prior exposure to vedolizumab 7. Surgical intervention for UC required at any time during the study. 8. History or evidence of adenomatous colonic polyps that have not been removed or has a history or evidence of colonic mucosal dysplasia. 9. Suspected or confirmed diagnosis of Crohn's entercolitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis. 10. Active infections 11. Chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection, HIV or tuberculosis (active or latent), identified congenital or acquired immunodeficiency. HBV immune participants (ie, being hepatitis B surface antigen \[HBsAg\] negative and hepatitis B antibody positive) may, however, be included. 12. History of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, demyelinating or neurodegenerative disease.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Achieving Clinical Remission at Week 52	Week 52	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).

Secondary

Measure	Time frame	Description
Percentage of Participants Achieving Mucosal Healing at Week 52	Week 52	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).
Percentage of Participants Achieving Durable Clinical Response at Week 6 and Week 52	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).
Percentage of Participants Achieving Durable Clinical Remission at Week 6 and Week 52	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).
Percentage of Participants Achieving Corticosteroid-free Remission at Week 52	Week 52	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).

Countries

Argentina, Australia, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Croatia, Czechia, Denmark, Estonia, Germany, Hungary, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Sweden, Turkey (Türkiye), Ukraine, United Kingdom, United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

Arm	Count
Vedolizumab IV 300 mg, Induction Phase Only 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.	167
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.	56
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.	106
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.	54
Total	383

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Maintenance Phase	Lack of Efficacy	0	29	18	6
Maintenance Phase	Lost to Follow-up	0	0	0	1
Maintenance Phase	Pregnancy	0	0	1	0
Maintenance Phase	Pretreatment Event/Adverse Event	0	5	5	2
Maintenance Phase	Reason not specified	0	1	4	0
Maintenance Phase	Significant Protocol Deviation	0	0	1	1
Maintenance Phase	Voluntary Withdrawal	0	1	2	5
OL Induction Phase	Lack of Efficacy	9	0	0	0
OL Induction Phase	Pretreatment Event/Adverse Event	9	0	0	0
OL Induction Phase	Reason not specified	3	0	0	0
OL Induction Phase	Significant Protocol Deviation	4	0	0	0
OL Induction Phase	Voluntary Withdrawal	5	0	0	0

Baseline characteristics

Characteristic	Maintenance Phase: Induction IV + Placebo	Total	Maintenance Phase: Induction IV + Vedolizumab 300 mg IV	Vedolizumab IV 300 mg, Induction Phase Only	Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
Age, Continuous	39.4 years	40.79 years	41.6 years	42.7 years	38.1 years
Baseline Disease Activity Moderate (Mayo Score=6 to 8)	20 Participants	83 Participants	17 Participants	—	46 Participants
Baseline Disease Activity Severe (Mayo Score=9 to 12)	36 Participants	133 Participants	37 Participants	—	60 Participants
Baseline Fecal Calprotectin	2393.4 ug/g STANDARD_DEVIATION 2859.66	2690.4 ug/g STANDARD_DEVIATION 3451.64	3173.5 ug/g STANDARD_DEVIATION 4785.48	—	2607.2 ug/g STANDARD_DEVIATION 2908.67
Body Mass Index (BMI)	24.66 kg/m^2	24.28 kg/m^2	26.21 kg/m^2	23.65 kg/m^2	24.07 kg/m^2
Corticosteroid Use at Baseline No	32 Participants	126 Participants	33 Participants	—	61 Participants
Corticosteroid Use at Baseline Yes	24 Participants	90 Participants	21 Participants	—	45 Participants
Disease Localization Extensive Colitis	4 Participants	18 Participants	7 Participants	—	7 Participants
Disease Localization Left Sided Colitis	24 Participants	91 Participants	21 Participants	—	46 Participants
Disease Localization Pancolitis	21 Participants	77 Participants	19 Participants	—	37 Participants
Disease Localization Proctosigmoiditis	7 Participants	29 Participants	7 Participants	—	15 Participants
Duration of Ulcerative Colitis	7.36 years STANDARD_DEVIATION 7.147	7.86 years STANDARD_DEVIATION 6.38	8.18 years STANDARD_DEVIATION 5.929	—	7.96 years STANDARD_DEVIATION 6.217
Extraintestinal Manifestations No	51 Participants	191 Participants	47 Participants	—	93 Participants
Extraintestinal Manifestations Yes	5 Participants	25 Participants	7 Participants	—	13 Participants
Female Reproductive Status Female of Childbearing Potential	17 Participants	119 Participants	12 Participants	54 Participants	36 Participants
Female Reproductive Status Participant is a male	34 Participants	218 Participants	31 Participants	88 Participants	65 Participants
Female Reproductive Status Postmenopausal	4 Participants	32 Participants	8 Participants	17 Participants	3 Participants
Female Reproductive Status Surgically Sterile	1 Participants	14 Participants	3 Participants	8 Participants	2 Participants
Height	172.4 cm	170.7 cm	171.2 cm	169.3 cm	171.9 cm
Participants with Prior Immunomodulator Failure and Prior TNF-alpha Antagonist Failure No	5 Participants	24 Participants	6 Participants	—	13 Participants
Participants with Prior Immunomodulator Failure and Prior TNF-alpha Antagonist Failure Yes	12 Participants	46 Participants	13 Participants	—	21 Participants
Participants with Prior TNF-alpha Antagonist Failure	20 Participants	84 Participants	24 Participants	—	40 Participants
Participants with Prior TNF-alpha Antagonist Use No	36 Participants	132 Participants	30 Participants	—	66 Participants
Participants with Prior TNF-alpha Antagonist Use Yes	20 Participants	84 Participants	24 Participants	—	40 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants	3 Participants	0 Participants	2 Participants	0 Participants
Race/Ethnicity, Customized Asian	13 Participants	71 Participants	5 Participants	39 Participants	14 Participants
Race/Ethnicity, Customized Black or African American	0 Participants	3 Participants	2 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Non-Hispanic and Latino	6 Participants	45 Participants	8 Participants	24 Participants	7 Participants
Race/Ethnicity, Customized Not Collected	49 Participants	337 Participants	46 Participants	143 Participants	99 Participants
Race/Ethnicity, Customized White	42 Participants	306 Participants	47 Participants	125 Participants	92 Participants
Region of Enrollment Australia	0 Participants	4 Participants	1 Participants	1 Participants	2 Participants
Region of Enrollment Belgium	2 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Region of Enrollment Bosnia	0 Participants	2 Participants	0 Participants	0 Participants	2 Participants
Region of Enrollment Brazil	0 Participants	8 Participants	1 Participants	4 Participants	3 Participants
Region of Enrollment Bulgaria	1 Participants	6 Participants	1 Participants	3 Participants	1 Participants
Region of Enrollment Canada	3 Participants	11 Participants	2 Participants	4 Participants	2 Participants
Region of Enrollment Croatia	1 Participants	10 Participants	1 Participants	8 Participants	0 Participants
Region of Enrollment Czech Republic	3 Participants	19 Participants	4 Participants	2 Participants	10 Participants
Region of Enrollment Denmark	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Region of Enrollment Estonia	0 Participants	2 Participants	0 Participants	2 Participants	0 Participants
Region of Enrollment Germany	3 Participants	7 Participants	1 Participants	0 Participants	3 Participants
Region of Enrollment Hungary	2 Participants	12 Participants	6 Participants	2 Participants	2 Participants
Region of Enrollment Israel	0 Participants	2 Participants	0 Participants	2 Participants	0 Participants
Region of Enrollment Italy	0 Participants	9 Participants	3 Participants	4 Participants	2 Participants
Region of Enrollment Japan	10 Participants	49 Participants	2 Participants	27 Participants	10 Participants
Region of Enrollment Korea, Republic Of	3 Participants	20 Participants	3 Participants	10 Participants	4 Participants
Region of Enrollment Lithuania	0 Participants	5 Participants	1 Participants	0 Participants	4 Participants
Region of Enrollment Mexico	1 Participants	3 Participants	0 Participants	2 Participants	0 Participants
Region of Enrollment Netherlands	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Region of Enrollment Poland	13 Participants	95 Participants	10 Participants	37 Participants	35 Participants
Region of Enrollment Romania	0 Participants	7 Participants	0 Participants	4 Participants	3 Participants
Region of Enrollment Russia	0 Participants	20 Participants	3 Participants	12 Participants	5 Participants
Region of Enrollment Serbia	1 Participants	3 Participants	1 Participants	1 Participants	0 Participants
Region of Enrollment Slovakia	0 Participants	10 Participants	3 Participants	3 Participants	4 Participants
Region of Enrollment Spain	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Region of Enrollment Turkey	2 Participants	3 Participants	0 Participants	1 Participants	0 Participants
Region of Enrollment Ukraine	4 Participants	23 Participants	2 Participants	11 Participants	6 Participants
Region of Enrollment United Kingdom	0 Participants	3 Participants	1 Participants	1 Participants	1 Participants
Region of Enrollment United States	6 Participants	45 Participants	8 Participants	24 Participants	7 Participants
Sex: Female, Male Female	22 Participants	165 Participants	23 Participants	79 Participants	41 Participants
Sex: Female, Male Male	34 Participants	218 Participants	31 Participants	88 Participants	65 Participants
Smoking Classification Has never smoked	38 Participants	248 Participants	33 Participants	107 Participants	70 Participants
Smoking Classification Is a current smoker	0 Participants	28 Participants	10 Participants	7 Participants	11 Participants
Smoking Classification is an ex-smoker	18 Participants	107 Participants	11 Participants	53 Participants	25 Participants
Ulcerative Colitis Prior Therapy Only Prior Corticosteroids No	34 Participants	145 Participants	33 Participants	—	78 Participants
Ulcerative Colitis Prior Therapy Only Prior Corticosteroids Yes	22 Participants	71 Participants	21 Participants	—	28 Participants
Ulcerative Colitis Prior Therapy Only Prior Immunomodulators No	55 Participants	208 Participants	53 Participants	—	100 Participants
Ulcerative Colitis Prior Therapy Only Prior Immunomodulators Yes	1 Participants	8 Participants	1 Participants	—	6 Participants
Ulcerative Colitis Prior Therapy Without Prior Corticosteroids or Immunomodulators No	55 Participants	214 Participants	54 Participants	—	105 Participants
Ulcerative Colitis Prior Therapy Without Prior Corticosteroids or Immunomodulators Yes	1 Participants	2 Participants	0 Participants	—	1 Participants
Ulcerative Colitis Prior Therapy With Prior Corticosteroids and Immunomodulators No	24 Participants	81 Participants	22 Participants	—	35 Participants
Ulcerative Colitis Prior Therapy With Prior Corticosteroids and Immunomodulators Yes	32 Participants	135 Participants	32 Participants	—	71 Participants
Weight	73.96 kg	71.21 kg	76.95 kg	68.20 kg	71.58 kg
Worst Prior Treatment Failure Prior Corticosteroid Failure Inadequate Response	5 Participants	24 Participants	5 Participants	—	14 Participants
Worst Prior Treatment Failure Prior Corticosteroid Failure Intolerance	4 Participants	8 Participants	1 Participants	—	3 Participants
Worst Prior Treatment Failure Prior Corticosteroid Failure Loss of Response	4 Participants	19 Participants	9 Participants	—	6 Participants
Worst Prior Treatment Failure Prior Immunomodulator Failure Inadequate Response	1 Participants	9 Participants	2 Participants	—	6 Participants
Worst Prior Treatment Failure Prior Immunomodulator Failure Intolerance	4 Participants	20 Participants	3 Participants	—	13 Participants
Worst Prior Treatment Failure Prior Immunomodulator Failure Loss of Response	0 Participants	3 Participants	0 Participants	—	3 Participants
Worst Prior Treatment Failure Prior TNF-alpha Antagonist Failure Inadequate Response	9 Participants	43 Participants	13 Participants	—	21 Participants
Worst Prior Treatment Failure Prior TNF-alpha Antagonist Failure Intolerance	3 Participants	7 Participants	2 Participants	—	2 Participants
Worst Prior Treatment Failure Prior TNF-alpha Antagonist Failure Loss of Response	8 Participants	34 Participants	9 Participants	—	17 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 167	0 / 56	0 / 106	0 / 54
other Total, other adverse events	34 / 167	31 / 56	42 / 106	31 / 54
serious Total, serious adverse events	17 / 167	6 / 56	10 / 106	7 / 54

Outcome results

Primary

Percentage of Participants Achieving Clinical Remission at Week 52

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).

Time frame: 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.

Arm	Measure	Value (NUMBER)
Maintenance Phase: Induction IV + Placebo	Percentage of Participants Achieving Clinical Remission at Week 52	14.3 percentage of participants
Maintenance Phase: Induction IV + Vedolizumab 108 mg SC	Percentage of Participants Achieving Clinical Remission at Week 52	46.2 percentage of participants
Maintenance Phase: Induction IV + Vedolizumab 300 mg IV	Percentage of Participants Achieving Clinical Remission at Week 52	42.6 percentage of participants

p-value: <0.00195% CI: [19.7, 45]Cochran-Mantel-Haenszel

Secondary

Percentage of Participants Achieving Corticosteroid-free Remission at Week 52

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).

Time frame: 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.

Arm	Measure	Value (NUMBER)
Maintenance Phase: Induction IV + Placebo	Percentage of Participants Achieving Corticosteroid-free Remission at Week 52	8.3 percentage of participants
Maintenance Phase: Induction IV + Vedolizumab 108 mg SC	Percentage of Participants Achieving Corticosteroid-free Remission at Week 52	28.9 percentage of participants
Maintenance Phase: Induction IV + Vedolizumab 300 mg IV	Percentage of Participants Achieving Corticosteroid-free Remission at Week 52	28.6 percentage of participants

p-value: 0.06795% CI: [-4.5, 43.7]Fisher Exact

Secondary

Percentage of Participants Achieving Durable Clinical Remission at Week 6 and Week 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).

Time frame: Weeks 6 and 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.

Arm	Measure	Value (NUMBER)
Maintenance Phase: Induction IV + Placebo	Percentage of Participants Achieving Durable Clinical Remission at Week 6 and Week 52	5.4 percentage of participants
Maintenance Phase: Induction IV + Vedolizumab 108 mg SC	Percentage of Participants Achieving Durable Clinical Remission at Week 6 and Week 52	15.1 percentage of participants
Maintenance Phase: Induction IV + Vedolizumab 300 mg IV	Percentage of Participants Achieving Durable Clinical Remission at Week 6 and Week 52	16.7 percentage of participants

p-value: 0.07695% CI: [-6.6, 25.7]Fisher Exact

Secondary

Percentage of Participants Achieving Durable Clinical Response at Week 6 and Week 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).

Time frame: Baseline, Weeks 6 and 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.

Arm	Measure	Value (NUMBER)
Maintenance Phase: Induction IV + Placebo	Percentage of Participants Achieving Durable Clinical Response at Week 6 and Week 52	28.6 percentage of participants
Maintenance Phase: Induction IV + Vedolizumab 108 mg SC	Percentage of Participants Achieving Durable Clinical Response at Week 6 and Week 52	64.2 percentage of participants
Maintenance Phase: Induction IV + Vedolizumab 300 mg IV	Percentage of Participants Achieving Durable Clinical Response at Week 6 and Week 52	72.2 percentage of participants

p-value: <0.00195% CI: [21.2, 50.9]Cochran-Mantel-Haenszel

Secondary

Percentage of Participants Achieving Mucosal Healing at Week 52

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).

Time frame: 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.

Arm	Measure	Value (NUMBER)
Maintenance Phase: Induction IV + Placebo	Percentage of Participants Achieving Mucosal Healing at Week 52	21.4 percentage of participants
Maintenance Phase: Induction IV + Vedolizumab 108 mg SC	Percentage of Participants Achieving Mucosal Healing at Week 52	56.6 percentage of participants
Maintenance Phase: Induction IV + Vedolizumab 300 mg IV	Percentage of Participants Achieving Mucosal Healing at Week 52	53.7 percentage of participants

p-value: <0.00195% CI: [22.1, 49.3]Cochran-Mantel-Haenszel

Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis

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Percentage of Participants Achieving Clinical Remission at Week 52

Percentage of Participants Achieving Corticosteroid-free Remission at Week 52

Percentage of Participants Achieving Durable Clinical Remission at Week 6 and Week 52

Percentage of Participants Achieving Durable Clinical Response at Week 6 and Week 52

Percentage of Participants Achieving Mucosal Healing at Week 52