AzTrials
AzTrials

Colitis, UlcerativePhase 3NCT02611830

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

A Phase 3 study testing Vedolizumab 300 mg IV and Vedolizumab 108 mg SC in people with Colitis, Ulcerative, run by Takeda at 174 sites in 31 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Colitis, Ulcerative
What is being tested?
Vedolizumab 300 mg IV and Vedolizumab 108 mg SC
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
383 participants
Where
174 sitesin 31 countries
Study dates
18 Dec 2015to 21 Aug 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Evidence of abdominal abscess or toxic megacolon at the initial Screening Visit.
  • Extensive colonic resection, subtotal or total colectomy.
  • Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
  • 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).
  • Prior exposure to any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of screening (whichever is longer).
  • Prior exposure to vedolizumab
Show all 12Show fewer
  • Surgical intervention for UC required at any time during the study.
  • History or evidence of adenomatous colonic polyps that have not been removed or has a history or evidence of colonic mucosal dysplasia.
  • Suspected or confirmed diagnosis of Crohn's entercolitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
  • Active infections
  • 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.
  • History of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, demyelinating or neurodegenerative disease.

Trial locations and contacts

174 sites in 31 countries.

174 sites in 31 countries

United States28 sites

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • Gastroenterology Associates, LLC

    Baton Rouge, Louisiana, 70809

  • Ehrhardt Clinical Research, LLC

    Belton, Missouri, 64012

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Tri-State Gastroenterology Associates

    Crestview Hills, Kentucky, 41017

  • Dayton Gastroenterology, Inc

    Dayton, Ohio, 45415

  • Gastro One

    Germantown, Tennessee, 38138

  • Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • Nature Coast Clinical Research, LLC

    Inverness, Florida, 34452

  • Florida Center for Gastroenterology

    Largo, Florida, 33777

  • Arkansas Primary Care Clinic, PA

    Little Rock, Arkansas, 72204

  • Gastroenterology Associates of Central Georgia

    Macon, Georgia, 31201

  • L & L Research Choices, Inc.

    Miami, Florida, 33176

  • Middlesex Gastroenterology Associates

    Middletown, Connecticut, 06457

  • Gastroenterology Group of Naples

    Naples, Florida, 34102

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Research Concierge, LLC

    Owensboro, Kentucky, 42303

  • Premier Medical Group of the Hudson Valley, PC

    Poughkeepsie, New York, 12601

  • Virginia Mason Seattle Main Clinic

    Seattle, Washington, 98101

  • Atlanta Gastroenterology Specialists, PC

    Suwanee, Georgia, 30024

  • Cotton-O'Neil Clinical Research Center, Digestive Health

    Topeka, Kansas, 66606

  • Options Health Research

    Tulsa, Oklahoma, 74104

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

  • Rocky Mountain Clinical Research, LLC

    Wheat Ridge, Colorado, 80033

  • Shafran Gastroenterology Center

    Winter Park, Florida, 32789

  • Gastroenterology Associates of Western Michigan, P.L.C.

    Wyoming, Michigan, 49519

Other trials in United States

Japan19 sites

  • Study site

    Bunkyō City, Tokyo-To

  • Study site

    Chikushino-shi, Fukuoka

  • Study site

    Hamamatsu, Shizuoka

  • Study site

    Hiroshima, Hiroshima

  • Study site

    Kamakura-shi, Kanagawa

  • Study site

    Matsuyama, Ehime

  • Study site

    Minatoku, Tokyo-To

  • Study site

    Mitaka-shi, Tokyo-To

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Nishinomiya-shi, Hyōgo

  • Study site

    Okayama, Okayama-ken

  • Study site

    Osaka, Osaka

  • Study site

    Ōtsu, Shiga

  • Study site

    Saga, Saga-ken

  • Study site

    Sakura-shi, Chiba

  • Study site

    Sapporo, Hokkaido

  • Study site

    Shinjuku-ku, Tokyo-To

  • Study site

    Takamatsu, Kagawa-ken

  • Study site

    Wakayama, Wakayama

Other trials in Japan

Poland14 sites

  • SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

    Bialystok, 15-275

  • NZOZ Vitamed

    Bydgoszcz, 85-079

  • SP CSK im. prof. K. Gibinskiego SUM

    Katowice, 40-752

  • Gabinet Endoskopii Przewodu Pokarmowego

    Krakow, 31-009

  • SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM

    Lodz, 90-153

  • Santa Familia Centrum Badan, Profilaktyki i Leczenia

    Lodz, 90-302

  • GASTROMED Sp. z o.o.

    Lublin, 20-582

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne

    Szczecin, 71-270

  • Centrum Zdrowia Matki, Dziecka i Mlodziezy

    Warsaw, 00-632

  • Centralny Szpital Kliniczny MSW w Warszawie

    Warsaw, 02-507

  • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

    Warsaw, 02-781

  • Nzoz Vivamed

    Warsaw, 03-580

  • LexMedica Osrodek Badan Klinicznych

    Wroclaw, 53-114

  • Ars-Medica S.C Rybak Maria, Rybak Zbigniew

    Wroclaw, 53-333

Other trials in Poland

Ukraine13 sites

  • RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU

    Chernivtsi, 58002

  • SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU

    Dnipro, 49074

  • Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU

    Ivano-Frankivsk, 76008

  • CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2

    Kharkiv, 61037

  • GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine

    Kharkiv, 61039

  • CI A.and O. Tropiny City Clinical Hospital

    Kherson, 73000

  • Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU

    Kyiv, 01103

  • MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE

    Kyiv, 01601

  • CI Odesa Regional Clinical Hospital

    Odesa, 65025

  • SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU

    Uzhhorod, 88009

  • Private Small Enterprise Medical Center Pulse

    Vinnytsia, 21001

  • MCIC MC LLC Health Clinic

    Vinnytsia, 21029

  • SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU

    Zaporizhzhya, 69104

Other trials in Ukraine

Russia9 sites

  • TSBIH "Territorial Clinical Hospital"

    Krasnoyarsk, 660022

  • FSBIH "Central Clinical Hospital of Russian Academy of Sciences"

    Moscow, 119333

  • SBEIHPE Novosibirsk State Medical University

    Novosibirsk, 630091

  • FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS

    Novosibirsk, 630117

  • BHI of Omsk region Clinical Oncology Dispensary

    Omsk, 644013

  • SBEI HPE "Rostov State Medical University" of the MoH of the RF

    Rostov-on-Don, 344022

  • SPb SBIH "City Hospital of Saint Martyr Elizaveta"

    Saint Petersburg, 195257

  • LLC "RIAT SPb"

    Saint Petersburg, 197373

  • SBIH of Yaroslavl region " Regional Clinical Hospital "

    Yaroslavl, 150062

Other trials in Russia

Bulgaria8 sites

  • MHAT 'Avis Medica' OOD

    Pleven, 5800

  • MHAT - Silistra AD

    Silistra, 7500

  • MHAT "Hadzhi Dimitar", OOD

    Sliven, 8800

  • Second MHAT - Sofia AD

    Sofia, 1202

  • "City Clinic UMHAC" EOOD

    Sofia, 1407

  • UMHAT "Sv. Ivan Rilski", EAD

    Sofia, 1431

  • UMHAT 'Tsaritsa Yoanna - ISUL', EAD

    Sofia, 1527

  • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

    Stara Zagora, 6000

Other trials in Bulgaria

Italy7 sites

  • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

    Milan, 20157

  • Azienda Ospedaliera di Padova

    Padova, 35128

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, 00152

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

  • I.R.C.C.S Policlinico San Donato

    San Donato Milanese, Milano, 20097

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia, 71013

Other trials in Italy

Hungary6 sites

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, 1036

  • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

    Budapest, 1125

  • Pest Megyei Flor Ferenc Korhaz

    Kistarcsa, 2143

  • Karolina Korhaz-Rendelointezet

    Mosonmagyaróvár, H-9200

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000

  • Tolna Megyei Balassa Janos Korhaz

    Szekszárd, 7100

Other trials in Hungary

Mexico6 sites

  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

    Durango, 34000

  • Morales Vargas Centro de Investigacion, S.C.

    León, Guanajuato, 37000

  • Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo León, 64460

  • Christus Muguerza Sur S.A. de C.V.

    Monterrey, Nuevo León, 64908

  • Sociedad de Metabolismo y Corazon S.C

    Veracruz, 91910

  • iBiomed Guadalajara

    Zapopan, Jalisco, 45030

Other trials in Mexico

Australia5 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • The Alfred Hospital

    Melbourne, Victoria, 3181

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Czechia5 sites

  • Ccbr-Synarc A/S

    Brno, 60200

  • Hepato-Gastroenterologie HK, s.r.o.

    Hradec Králové, 500 12

  • A-SHINE s.r.o.

    Pilsen, 31200

  • Ccbr-Synarc A/S

    Prague, 13000

  • Axon Clinical, s.r.o.

    Prague, 182 00

Other trials in Czechia

Serbia5 sites

  • Clinical Center Zvezdara

    Belgrade, 11000

  • Clinical Center Bezanijska kosa

    Belgrade, 11080

  • Clinical Center Zemun

    Belgrade, 11080

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • Clinical Center of Vojvodina

    Novi Sad, 21000

Other trials in Serbia

South Korea5 sites

  • Kyungpook National University Hospital

    Daegu, 41944

  • Yeungnam University Hospital

    Daegu, 42415

  • Kyung Hee University Hospital

    Seoul, 02447

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

Other trials in South Korea

Brazil4 sites

  • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

    Botucatu, São Paulo, 18618-970

  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

    Goiânia, Goiás, 74535-170

  • HUCFF-UFRJ - Hospital Universitario Clementino Fraga Filho - Universidade Federal do Rio de Janeiro

    Rio de Janeiro, Rio Do Janeiro, 21941-913

  • Faculdade de Medicina do ABC

    Santo André, São Paulo, 09060-650

Other trials in Brazil

Croatia4 sites

  • Clinical Hospital Centre Osijek

    Osijek, 31000

  • Clinical Hospital Centre Rijeka

    Rijeka, 51000

  • Clinical Hospital Centre Zagreb

    Zagreb, 10000

  • Clinical Hospital Dubrava

    Zagreb, 10000

Other trials in Croatia

Canada3 sites

  • London Health Science Centre

    London, Ontario, N6A 5A5

  • LHSC - Victoria Hospital

    London, Ontario, N6A 5W9

  • Toronto Digestive Disease Associates, Inc.

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

Germany3 sites

  • Krankenhaus Waldfriede e. V.

    Berlin, 14163

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • EUGASTRO GmbH

    Leipzig, Saxony, 04103

Other trials in Germany

Lithuania3 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas, 50009

  • Klaipeda Republican Hospital, Public Institution

    Klaipėda, 92231

  • Vilnius University Hospital Santariskiu Clinic, Public Institution

    Vilnius, LT-08661

Other trials in Lithuania

Netherlands3 sites

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

  • Albert Schweitzer Ziekenhuis, Dordwijk

    Dordrecht, 3318 AT

  • Maastricht University Medical Center

    Maastricht, 6229 HX

Other trials in Netherlands

Romania3 sites

  • Spitalul Clinic Colentina

    Bucharest, 020125

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • S.C Centrul de Gastroenterologie Dr. Goldis S.R.L

    Timișoara, 300002

Other trials in Romania

Slovakia3 sites

  • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

    Bratislava, 82606

  • KM Management spol. s r.o.

    Nitra, 949 01

  • Gastro I, s.r.o.

    Prešov, 080 01

Other trials in Slovakia

Turkey (Türkiye)3 sites

  • Ankara University Medical Faculty

    Ankara, 06100

  • Acibadem Fulya Hospital

    Istanbul, 34349

  • Marmara University Pendik Research and Training Hospital

    Istanbul, 34899

Other trials in Turkey (Türkiye)

United Kingdom3 sites

  • Royal Devon and Exeter Hospital (Wonford)

    Exeter, Devon, EX2 5DW

  • Whipps Cross University Hospital

    London, Greater London, E11 1NR

  • Royal Free Hospital

    London, Greater London, NW3 2QG

Other trials in United Kingdom

Belgium2 sites

  • Clinique Saint-Pierre

    Ottignies, 1340

  • AZ Delta

    Roeselare, 8800

Other trials in Belgium

Israel2 sites

  • Wolfson Medical Center

    Holon, 58100

  • Chaim Sheba Medical Center

    Ramat Gan, 52621

Other trials in Israel

Spain2 sites

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Complejo Hospitalario de Pontevedra

    Pontevedra, 36164

Other trials in Spain

Sweden2 sites

  • Karolinska Universitetssjukhuset - Solna

    Stockholm, 17176

  • Danderyds Sjukhus AB

    Stockholm, 18288

Other trials in Sweden

Argentina1 site

  • Expertia S.A- Mautalen Salud e Investigacion

    Ciudad Autonoma Buenos Aires, C1128AAE

Other trials in Argentina

Bosnia and Herzegovina1 site

  • University Clinical Centre of the Republic of Srpska

    Banja Luka, 78000

Other trials in Bosnia and Herzegovina

Denmark1 site

  • Odense Universitetshospital

    Odense C, 5000

Other trials in Denmark

Estonia1 site

  • West Tallinn Central Hospital

    Tallinn, 10617

Other trials in Estonia

About this study

Official title: 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.

Read the 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.

Being tested
Vedolizumab 300 mg IV, Placebo IV, Vedolizumab 108 mg SC, Placebo SC
Keywords
Drug therapy
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vedolizumab 300 mg IVDrug

    Vedolizumab intravenous infusion

  • Placebo IVDrug

    Vedolizumab intravenous infusion placebo

  • Vedolizumab 108 mg SCDrug

    Vedolizumab subcutaneous injection

  • Placebo SCDrug

    Vedolizumab subcutaneous injection placebo

Study groups in NCT02611830
Study groupRoleWhat they receive
Maintenance Phase: Induction IV + Vedolizumab 108 mg SCExperimentalParticipants 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.
Receives: Drug: Vedolizumab 300 mg IV; Drug: Placebo IV; Drug: Vedolizumab 108 mg SC
Maintenance Phase: Induction IV + Vedolizumab 300 mg IVExperimentalParticipants 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.
Receives: Drug: Vedolizumab 300 mg IV; Drug: Placebo SC
Maintenance Phase: Induction IV + PlaceboExperimentalParticipants 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.
Receives: Drug: Vedolizumab 300 mg IV; Drug: Placebo IV; Drug: Placebo SC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Week 52

Secondary outcomes (4)

  1. 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).

    Measured: Week 52

  2. 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).

    Measured: Baseline, Weeks 6 and 52

  3. 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).

    Measured: Weeks 6 and 52

  4. 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).

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2015 (estimated)
  2. Study start18 Dec 2015
  3. Primary completion30 May 2018
  4. Study completion21 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
383 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02611830
Sponsor's protocol ID
MLN0002SC-3027
Other IDs
2015-000480-14, U1111-1168-0813, 16/LO/0089, NL55501.056.15, JapicCTI-163222, 189732, 163300410A0046, 2015
Status last verified
May 2022
First submitted
19 Nov 2015
Last updated
25 May 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • D'Haens G, Baert F, Danese S, Kobayashi T, Loftus EV Jr, Sandborn WJ, Dornic Q, Lindner D, Kisfalvi K, Marins EG, Vermeire S. 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. Eur J Gastroenterol Hepatol. 2024 Apr 1;36(4):404-415. doi: 10.1097/MEG.0000000000002728. Epub 2024 Feb 21.

    PubMed 38417060

  • 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.

    PubMed 32806876

  • 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.

    PubMed 31470005

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vedolizumab 300 mg IV and Vedolizumab 108 mg SC in people with Colitis, Ulcerative, run by Takeda at 174 sites in 31 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 174 sites in United States, Japan, Poland, Ukraine, Russia and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Clinical Remission at Week 52 (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02611830, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.

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