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

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, With a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

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.

Study Overview

• Status: Completed
• Conditions: Colitis, Ulcerative
• Intervention / Treatment: Drug: Vedolizumab 300 mg IV; Drug: Placebo IV; Drug: Vedolizumab 108 mg SC; Drug: Placebo SC

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.

• Study Type: Interventional
• Enrollment (Actual): 383
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma Buenos Aires, Argentina, C1128AAE
    • Expertia S.A- Mautalen Salud e Investigacion
• Australia
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
    • Kingswood, New South Wales, Australia, 2747
      • Nepean Hospital
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3181
      • The Alfred Hospital
• Belgium
  • Ottignies, Belgium, 1340
    • Clinique Saint-Pierre
  • Roeselare, Belgium, 8800
    • AZ Delta
• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
    • University Clinical Centre of the Republic of Srpska
• Brazil
  • Goias
    • Goiania, Goias, Brazil, 74535-170
      • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
  • Rio Do Janeiro
    • Rio de Janeiro, Rio Do Janeiro, Brazil, 21941-913
      • HUCFF-UFRJ - Hospital Universitario Clementino Fraga Filho - Universidade Federal do Rio de Janeiro
  • Sao Paulo
    • Botucatu, Sao Paulo, Brazil, 18618-970
      • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
    • Santo Andre, Sao Paulo, Brazil, 09060-650
      • Faculdade de Medicina do ABC
• Bulgaria
  • Pleven, Bulgaria, 5800
    • MHAT 'Avis Medica' OOD
  • Silistra, Bulgaria, 7500
    • MHAT - Silistra AD
  • Sliven, Bulgaria, 8800
    • MHAT "Hadzhi Dimitar", OOD
  • Sofia, Bulgaria, 1407
    • "City Clinic UMHAC" EOOD
  • Sofia, Bulgaria, 1431
    • UMHAT "Sv. Ivan Rilski", EAD
  • Sofia, Bulgaria, 1527
    • UMHAT 'Tsaritsa Yoanna - ISUL', EAD
  • Sofia, Bulgaria, 1202
    • Second MHAT - Sofia AD
  • Stara Zagora, Bulgaria, 6000
    • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • LHSC - Victoria Hospital
    • London, Ontario, Canada, N6A 5A5
      • London Health Science Centre
    • Vaughan, Ontario, Canada, L4L 4Y7
      • Toronto Digestive Disease Associates, Inc.
• Croatia
  • Osijek, Croatia, 31000
    • Clinical Hospital Centre Osijek
  • Rijeka, Croatia, 51000
    • Clinical Hospital Centre Rijeka
  • Zagreb, Croatia, 10000
    • Clinical Hospital Centre Zagreb
  • Zagreb, Croatia, 10000
    • Clinical Hospital Dubrava
• Czechia
  • Brno, Czechia, 60200
    • Ccbr-Synarc A/S
  • Hradec Kralove, Czechia, 500 12
    • Hepato-Gastroenterologie HK, s.r.o.
  • Plzen, Czechia, 31200
    • A-Shine s.r.o.
  • Praha 3, Czechia, 13000
    • Ccbr-Synarc A/S
  • Praha 8, Czechia, 182 00
    • Axon Clinical, s.r.o.
• Denmark
  • Odense C, Denmark, 5000
    • Odense Universitetshospital
• Estonia
  • Tallinn, Estonia, 10617
    • West Tallinn Central Hospital
• Germany
  • Berlin, Germany, 14163
    • Krankenhaus Waldfriede e. V.
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Medizinische Hochschule Hannover
  • Sachsen
    • Leipzig, Sachsen, Germany, 04103
      • EUGASTRO GmbH
• Hungary
  • Budapest, Hungary, 1036
    • Obudai Egeszsegugyi Centrum Kft.
  • Budapest, Hungary, 1125
    • Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak
  • Kistarcsa, Hungary, 2143
    • Pest Megyei Flór Ferenc Kórház
  • Mosonmagyarovar, Hungary, H-9200
    • Karolina Korhaz-Rendelointezet
  • Szekesfehervar, Hungary, 8000
    • Fejér Megyei Szent György Egyetemi Oktató Kórház
  • Szekszard, Hungary, 7100
    • Tolna Megyei Balassa Janos Korhaz
• Israel
  • Holon, Israel, 58100
    • Wolfson Medical Center
  • Ramat Gan, Israel, 52621
    • Chaim Sheba Medical Center
• Italy
  • Milano, Italy, 20157
    • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
  • Padova, Italy, 35128
    • Azienda Ospedaliera di Padova
  • Roma, Italy, 00168
    • Policlinico Universitario Agostino Gemelli
  • Roma, Italy, 00152
    • Azienda Ospedaliera San Camillo Forlanini
  • Foggia
    • San Giovanni Rotondo, Foggia, Italy, 71013
      • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Istituto Clinico Humanitas
    • San Donato Milanese, Milano, Italy, 20097
      • I.R.C.C.S Policlinico San Donato
• Japan
  • Aichi-Ken
    • Nagoya-shi, Aichi-Ken, Japan
  • Chiba-Ken
    • Sakura-shi, Chiba-Ken, Japan
  • Ehime-Ken
    • Matsuyama-shi, Ehime-Ken, Japan
  • Fukuoka-Ken
    • Chikushino-shi, Fukuoka-Ken, Japan
  • Hiroshima-Ken
    • Hiroshima-shi, Hiroshima-Ken, Japan
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan
  • Hyogo-Ken
    • Nishinomiya-shi, Hyogo-Ken, Japan
  • Kagawa-Ken
    • Takamatsu-shi, Kagawa-Ken, Japan
  • Kanagawa-Ken
    • Kamakura-shi, Kanagawa-Ken, Japan
  • Okayama-Ken
    • Okayama-shi, Okayama-Ken, Japan
  • Osaka-Fu
    • Osaka-shi, Osaka-Fu, Japan
  • Saga-Ken
    • Saga-shi, Saga-Ken, Japan
  • Shiga-Ken
    • Otsu-shi, Shiga-Ken, Japan
  • Shizuoka-Ken
    • Hamamatsu-shi, Shizuoka-Ken, Japan
  • Tokyo-To
    • Bunkyo-ku, Tokyo-To, Japan
    • Minato-ku, Tokyo-To, Japan
    • Mitaka-shi, Tokyo-To, Japan
    • Shinjuku-ku, Tokyo-To, Japan
  • Wakayama-Ken
    • Wakayama-shi, Wakayama-Ken, Japan
• Korea, Republic of
  • Daegu, Korea, Republic of, 42415
    • Yeungnam University Hospital
  • Daegu, Korea, Republic of, 41944
    • Kyungpook National University Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 02447
    • Kyung Hee University Hospital
  • Seoul, Korea, Republic of, 03181
    • Kangbuk Samsung Hospital
• Lithuania
  • Kaunas, Lithuania, 50009
    • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
  • Klaipeda, Lithuania, 92231
    • Klaipeda Republican Hospital, Public Institution
  • Vilnius, Lithuania, LT-08661
    • Vilnius University Hospital Santariskiu Clinic, Public Institution
• Mexico
  • Durango, Mexico, 34000
    • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
  • Veracruz, Mexico, 91910
    • Sociedad de Metabolismo y Corazon S.C
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37000
      • Morales Vargas Centro de Investigacion, S.C.
  • Jalisco
    • Zapopan, Jalisco, Mexico, 45030
      • iBiomed Guadalajara
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
    • Monterrey, Nuevo Leon, Mexico, 64908
      • Christus Muguerza Sur S.A. de C.V.
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Academisch Medisch Centrum
  • Dordrecht, Netherlands, 3318 AT
    • Albert Schweitzer Ziekenhuis, Dordwijk
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University Medical Center
• Poland
  • Bialystok, Poland, 15-275
    • SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
  • Bydgoszcz, Poland, 85-079
    • NZOZ Vitamed
  • Katowice, Poland, 40-752
    • SP CSK im. prof. K. Gibinskiego SUM
  • Krakow, Poland, 31-009
    • Gabinet Endoskopii Przewodu Pokarmowego
  • Lodz, Poland, 90-302
    • Santa Familia Centrum Badan, Profilaktyki i Leczenia
  • Lodz, Poland, 90-153
    • SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM
  • Lublin, Poland, 20-582
    • GASTROMED Sp. z o.o.
  • Szczecin, Poland, 71-270
    • Twoja Przychodnia-Szczecinskie Centrum Medyczne
  • Warszawa, Poland, 03-580
    • NZOZ Vivamed
  • Warszawa, Poland, 02-781
    • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
  • Warszawa, Poland, 02-507
    • Centralny Szpital Kliniczny MSW w Warszawie
  • Warszawa, Poland, 00-632
    • Centrum Zdrowia Matki, Dziecka i Mlodziezy
  • Wroclaw, Poland, 53-114
    • LexMedica Osrodek Badan Klinicznych
  • Wroclaw, Poland, 53-333
    • Ars-Medica S.C Rybak Maria, Rybak Zbigniew
• Romania
  • Bucuresti, Romania, 020125
    • Spitalul Clinic Colentina
  • Bucuresti, Romania, 022328
    • Institutul Clinic Fundeni
  • Timisoara, Romania, 300002
    • S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
• Russian Federation
  • Krasnoyarsk, Russian Federation, 660022
    • TSBIH "Territorial Clinical Hospital"
  • Moscow, Russian Federation, 119333
    • FSBIH "Central Clinical Hospital of Russian Academy of Sciences"
  • Novosibirsk, Russian Federation, 630091
    • SBEIHPE Novosibirsk State Medical University
  • Novosibirsk, Russian Federation, 630117
    • FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS
  • Omsk, Russian Federation, 644013
    • BHI of Omsk region Clinical Oncology Dispensary
  • Rostov-on-Don, Russian Federation, 344022
    • SBEI HPE "Rostov State Medical University" of the MoH of the RF
  • Saint-Petersburg, Russian Federation, 197373
    • LLC "RIAT SPb"
  • St. Petersburg, Russian Federation, 195257
    • SPb SBIH "City Hospital of Saint Martyr Elizaveta"
  • Yaroslavl, Russian Federation, 150062
    • SBIH of Yaroslavl region " Regional Clinical Hospital "
• Serbia
  • Belgrade, Serbia, 11080
    • Clinical Center Bezanijska Kosa
  • Belgrade, Serbia, 11000
    • Clinical Center Zvezdara
  • Belgrade, Serbia, 11080
    • Clinical Center Zemun
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac
  • Novi Sad, Serbia, 21000
    • Clinical center of Vojvodina
• Slovakia
  • Bratislava, Slovakia, 82606
    • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
  • Nitra, Slovakia, 949 01
    • KM Management spol. s r.o.
  • Presov, Slovakia, 080 01
    • Gastro I, s.r.o.
• Spain
  • Pontevedra, Spain, 36164
    • Complejo Hospitalario de Pontevedra
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro Majadahonda
• Sweden
  • Stockholm, Sweden, 18288
    • Danderyds sjukhus AB
  • Stockholm, Sweden, 17176
    • Karolinska Universitetssjukhuset - Solna
• Turkey
  • Ankara, Turkey, 06100
    • Ankara University Medical Faculty
  • Istanbul, Turkey, 34349
    • Acibadem Fulya Hospital
  • Istanbul, Turkey, 34899
    • Marmara University Pendik Research and Training Hospital
• Ukraine
  • Chernivtsi, Ukraine, 58002
    • RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU
  • Dnipro, Ukraine, 49074
    • SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU
  • Ivano-Frankivsk, Ukraine, 76008
    • Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU
  • Kharkiv, Ukraine, 61039
    • GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
  • Kharkiv, Ukraine, 61037
    • CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2
  • Kherson, Ukraine, 73000
    • CI A.and O. Tropiny City Clinical Hospital
  • Kyiv, Ukraine, 01103
    • Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
  • Kyiv, Ukraine, 01601
    • MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
  • Odesa, Ukraine, 65025
    • CI Odesa Regional Clinical Hospital
  • Uzhgorod, Ukraine, 88009
    • SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU
  • Vinnytsia, Ukraine, 21001
    • Private Small Enterprise Medical Center Pulse
  • Vinnytsia, Ukraine, 21029
    • MCIC MC LLC Health Clinic
  • Zaporizhzhia, Ukraine, 69104
    • SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU
• United Kingdom
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Royal Devon and Exeter Hospital (Wonford)
  • Greater London
    • London, Greater London, United Kingdom, NW3 2QG
      • Royal Free Hospital
    • London, Greater London, United Kingdom, E11 1NR
      • Whipps Cross University Hospital
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72204
      • Arkansas Primary Care Clinic, PA
  • Colorado
    • Wheat Ridge, Colorado, United States, 80033
      • Rocky Mountain Clinical Research, LLC
  • Connecticut
    • Middletown, Connecticut, United States, 06457
      • Middlesex Gastroenterology Associates
  • Florida
    • Inverness, Florida, United States, 34452
      • Nature Coast Clinical Research, LLC
    • Largo, Florida, United States, 33777
      • Florida Center for Gastroenterology
    • Miami, Florida, United States, 33176
      • L & L Research Choices, Inc.
    • Naples, Florida, United States, 34102
      • Gastroenterology Group Of Naples
    • Winter Park, Florida, United States, 32789
      • Shafran Gastroenterology Center
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Gastroenterology Associates
    • Macon, Georgia, United States, 31201
      • Gastroenterology Associates of Central Georgia
    • Suwanee, Georgia, United States, 30024
      • Atlanta Gastroenterology Specialists, PC
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton-O'Neil Clinical Research Center, Digestive Health
  • Kentucky
    • Crestview Hills, Kentucky, United States, 41017
      • Tri-State Gastroenterology Associates
    • Owensboro, Kentucky, United States, 42303
      • Research Concierge, LLC
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Gastroenterology Associates, LLC
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Clinical Research Institute of Michigan, LLC
    • Wyoming, Michigan, United States, 49519
      • Gastroenterology Associates of Western Michigan, P.L.C.
  • Missouri
    • Belton, Missouri, United States, 64012
      • Ehrhardt Clinical Research, LLC
  • New York
    • Great Neck, New York, United States, 11021
      • Long Island Clinical Research Associates
    • Poughkeepsie, New York, United States, 12601
      • Premier Medical Group of the Hudson Valley, PC
  • Ohio
    • Dayton, Ohio, United States, 45415
      • Dayton Gastroenterology, Inc
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Options Health Research
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Gastro One
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Tyler, Texas, United States, 75701
      • Tyler Research Institute, LLC
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Gastroenterology Associates of Tidewater
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Seattle Main Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Vedolizumab 300 mg IV; Vedolizumab intravenous infusion; Drug: Placebo IV; Vedolizumab intravenous infusion placebo; Drug: Vedolizumab 108 mg SC; Vedolizumab subcutaneous injection
Experimental: 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.	Drug: Vedolizumab 300 mg IV; Vedolizumab intravenous infusion; Drug: Placebo SC; Vedolizumab subcutaneous injection placebo
Experimental: 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.	Drug: Vedolizumab 300 mg IV; Vedolizumab intravenous infusion; Drug: Placebo IV; Vedolizumab intravenous infusion placebo; Drug: Placebo SC; Vedolizumab subcutaneous injection placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Week 52
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).	Baseline, Weeks 6 and 52
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).	Weeks 6 and 52
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).	Week 52

Collaborators and Investigators

• Sponsor: Takeda

Publications and helpful links

General Publications

• Kobayashi T, Ito H, Ashida T, Yokoyama T, Nagahori M, Inaba T, Shikamura M, Yamaguchi T, Hori T, Pinton P, Watanabe M, Hibi T. Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis. Intest Res. 2021 Oct;19(4):448-460. doi: 10.5217/ir.2020.00026. Epub 2020 Aug 18.
• Sandborn WJ, Baert F, Danese S, Krznaric Z, Kobayashi T, Yao X, Chen J, Rosario M, Bhatia S, Kisfalvi K, D'Haens G, Vermeire S. Efficacy and Safety of Vedolizumab Subcutaneous Formulation in a Randomized Trial of Patients With Ulcerative Colitis. Gastroenterology. 2020 Feb;158(3):562-572.e12. doi: 10.1053/j.gastro.2019.08.027. Epub 2019 Aug 28.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2015
• Primary Completion (Actual): May 30, 2018
• Study Completion (Actual): August 21, 2018

Study Registration Dates

• First Submitted: November 19, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (Estimate): November 23, 2015

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Drug therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Gastrointestinal Agents; Vedolizumab
• Other Study ID Numbers: MLN0002SC-3027; 2015-000480-14 (EudraCT Number); U1111-1168-0813 (Registry Identifier: WHO); 16/LO/0089 (Registry Identifier: NRES); NL55501.056.15 (Registry Identifier: CCMO); JapicCTI-163222 (Registry Identifier: JapicCTI); 189732 (Registry Identifier: HC-CTD); 163300410A0046 (Registry Identifier: NREC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No