AzTrials
AzTrials

Colitis, UlcerativePhase 3NCT02620046

A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease

A Phase 3 study testing Vedolizumab SC in people with Colitis, Ulcerative and Crohn's Disease, run by Takeda at 301 sites in 33 countries.

Completed

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

Official record
Search all trials

Trial summary

The main aim of the study is to check for long-term side effects of Vedolizumab Subcutaneous (also known as Vedolizumab SC) in people with ulcerative colitis (UC) and Crohn's disease (CD). Vedolizumab SC will be given as an injection just under the skin. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Colitis, Ulcerative, Crohn's Disease
What is being tested?
Vedolizumab SC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
746 participants
Where
301 sitesin 33 countries
Study dates
15 Apr 2016to 12 Jun 2024
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

  • 1. Prior participation in Study MLN0002SC-3027 or MLN0002SC-3031, and, in the opinion of the investigator, tolerated the study drug well. Early withdrawal from Study MLN0002SC-3027 or MLN0002SC-3031 must have been due to treatment failure during the Maintenance Period.

Who cannot join

  • Surgical intervention for IBD during or after participation in Study MLN0002SC-3027 or MLN0002SC-3031, or at any time during this study.
  • Chronic or severe infection, or, any new, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurologic, oncologic, or other medical disorder developed during or after participation in a prior vedolizumab study that, in the opinion of the investigator, would confound the study results or compromise participant safety.
  • Withdrawal from Study MLN0002SC-3027 or MLN0002SC-3031 due to a study-drug related adverse event (AE).

Trial locations and contacts

301 sites in 33 countries.

301 sites in 33 countries

United States47 sites

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • Gastroenterology Associates, LLC

    Baton Rouge, Louisiana, 70809

  • Ehrhardt Clinical Research, LLC

    Belton, Missouri, 64012

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • 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

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Tri-State Gastroenterology Associates

    Crestview Hills, Kentucky, 41017

  • Dayton Gastroenterology, Inc

    Dayton, Ohio, 45415

  • AGA Clinical Research Associates, LLC

    Egg Harbor, New Jersey, 08234

  • Gastroenterology Center of the MidSouth PC

    Germantown, Tennessee, 38138

  • Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut, 06518

  • Grand Teton Research Group, PLL

    Idaho Falls, Idaho, 83404

  • Nature Coast Clinical Research, LLC

    Inverness, Florida, 34452

  • Lafayette General Medical Center

    Lafayette, Louisiana, 70503

  • Florida Center for Gastroenterology

    Largo, Florida, 33777

  • Gastro-Enterology Research of Lima

    Lima, Ohio, 45806

  • 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

  • Allegiance Research Specialists, LLC

    Milwaukee, Wisconsin, 53226

  • Gastroenterology Group of Naples

    Naples, Florida, 34102

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Digestive Health Center PA

    Ocean Springs, Mississippi, 39564

  • Research Concierge, LLC

    Owensboro, Kentucky, 42303

  • BRCR Medical Center, Inc.

    Pembroke Pines, Florida, 33028

  • Main Line Gastroenterology Associates

    Perkasie, Pennsylvania, 18944

  • Arizona Arthritis & Rheumatology Research, PLLC

    Phoenix, Arizona, 85307

  • Premier Medical Group of the Hudson Valley, PC

    Poughkeepsie, New York, 12601

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • San Antonio Gastroenterology

    San Antonio, Texas, 78212

  • Virginia Mason Seattle Main Clinic

    Seattle, Washington, 98101

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71103

  • 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

  • Carle Foundation Hospital

    Urbana, Illinois, 61801

  • 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

  • Huron Gastroenterology Associates

    Ypsilanti, Michigan, 48197

  • Florida Medical Clinic, P.A.

    Zephyrhills, Florida, 33542

Other trials in United States

Japan27 sites

  • Medical Hospital, Tokyo Medical and Dental University

    Bunkyō City, Tokyo-To, 113-8519

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, Fukuoka, 818-8502

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180

  • Hamamatsu South Hospital

    Hamamatsu, Shizuoka, 430-0846

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551

  • Gokeikai Ofuna Chuo Hospital

    Kamakura-shi, Kanagawa, 247-0056

  • Kurume University Hospital

    Kurume-shi, Fukuoka, 830-0011

  • Ehime Prefectural Central Hospital

    Matsuyama, Ehime, 790-0024

  • Jikei University Hospital

    Minatoku, Tokyo-To, 105-8471

  • Kitasato University Kitasato Institute Hospital

    Minatoku, Tokyo-To, 108-8642

  • Kyorin University Hospital

    Mitaka-shi, Tokyo-To, 181-8611

  • Iwate Medical University Hospital

    Morioka, Iwate, 020-8505

  • Yokoyama IBD Clinic

    Nagoya, Aichi-ken, 460-0022

  • Hyogo College of Medicine Hospital

    Nishinomiya-shi, Hyōgo, 663-8501

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558

  • Kinshukai Infusion Clinic

    Osaka, Osaka, 530-0011

  • Osaka City General Hospital

    Osaka, Osaka, 534-0021

  • Shiga University of Medical Science Hospital

    Ōtsu, Shiga, 520-2192

  • Saga University Hospital

    Saga, Saga-ken, 849-8501

  • Toho University Sakura Medical Center

    Sakura-shi, Chiba, 285-8741

  • Tokushukai Sapporo Tokushukai Hospital

    Sapporo, Hokkaido, 004-0041

  • Sapporo-Kosei General Hospital

    Sapporo, Hokkaido, 060-0033

  • Tokushukai Sapporo Higashi Tokushukai Hospital

    Sapporo, Hokkaido, 065-0033

  • Keio University Hospital

    Shinjuku-ku, Tokyo-To, 160-8582

  • JCHO Tokyo Yamate Medical Center

    Shinjuku-ku, Tokyo-To, 169-0073

  • Kagawa Prefectural Central Hospital

    Takamatsu, Kagawa-ken, 760-8557

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8510

Other trials in Japan

Ukraine15 sites

  • RCNECRCH Dept of Surgery, SHEI Ukr BSMU

    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

  • CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

    Kharkiv, 61037

  • CI A.and O. Tropiny City Clinical Hospital

    Kherson, 73000

  • CI of Kyiv RC Kyiv Regional Clinical Hospital

    Kyiv, 1023

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

    Kyiv, 1023

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

    Kyiv, 1103

  • Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU

    Lviv, 79059

  • CI Odesa Regional Clinical Hospital

    Odesa, 65025

  • Ternopil University Hospital

    Ternopil, 46002

  • Private Small Enterprise Medical Center Pulse

    Vinnytsia, 21001

  • Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU

    Vinnytsia, 21005

  • MCIC MC LLC Health Clinic

    Vinnytsia, 21009

  • CI City Hospital #1

    Zaporizhzhya, 69014

Other trials in Ukraine

Australia14 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Ballarat Base Hospital

    Ballarat, Victoria, 3350

  • Monash Medical Centre Clayton

    Bentleigh East, Victoria, 3165

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • Tennyson Centre Day Hospital

    Kurralta Park, South Australia, 5037

  • St Frances Xavier Cabrini Hospital

    Malvern, Victoria, 3144

  • Royal Melbourne Hospital

    Melbourne, Victoria, 3000

  • The Alfred Hospital

    Melbourne, Victoria, 3181

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Mater Hospital Brisbane

    South Brisbane, Queensland, 4101

  • St John of God Subiaco Hospital

    Subiaco, Western Australia, 6008

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Bulgaria14 sites

  • "MHAT Avis - Medica" OOD

    Pleven, 5800

  • UMHAT 'Dr. Georgi Stranski', EAD

    Pleven, 5800

  • MHAT - Silistra AD

    Silistra, 7500

  • MC "Tsaritsa Yoanna' EOOD

    Sliven, 8800

  • MHAT "Hadzhi Dimitar", OOD

    Sliven, 8800

  • Second MHAT - Sofia AD

    Sofia, 1202

  • "City Clinic UMHAC" EOOD

    Sofia, 1407

  • Medical Center "Excelsior", OOD

    Sofia, 1407

  • UMHAT "Sv. Ivan Rilski", EAD

    Sofia, 1431

  • UMHAT 'Tsaritsa Yoanna - ISUL', EAD

    Sofia, 1527

  • Fourth MHAT - Sofia EAD

    Sofia, 1606

  • Military Medical Academy - MHAT - Sofia

    Sofia, 1606

  • UMHAT 'Sveta Anna' AD

    Sofia, 1750

  • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

    Stara Zagora, 6000

Other trials in Bulgaria

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, 71-434

  • Centrum Zdrowia MDM

    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

Italy13 sites

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

    Bologna, 40138

  • Azienda Ospedaliera Ospedale Cannizzaro

    Catania, 95100

  • Azienda Ospedaliera Universitaria Policlinico G. Martino

    Messina, 98125

  • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

    Milan, 20157

  • A.O.U. Policlinico di Modena

    Modena, 41124

  • Azienda Ospedaliera Universitaria "Federico II"

    Naples, 80131

  • Azienda Ospedaliera di Padova

    Padova, 35128

  • Azienda Ospedaliera Vincenzo Cervello

    Palermo, 90146

  • 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

Germany12 sites

  • Charite - Campus Virchow-Klinikum

    Berlin, 13353

  • DRK Kliniken Berlin Westend

    Berlin, 14050

  • Krankenhaus Waldfriede e. V.

    Berlin, 14163

  • Universitaetsklinikum Koeln

    Cologne, North Rhine-Westphalia, 50937

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt am Main, Hesse, 60590

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel

    Kiel, Schleswig-Holstein, 24105

  • EUGASTRO GmbH

    Leipzig, Saxony, 04103

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

    Lübeck, Schleswig-Holstein, 23538

  • Universitaetsklinikum Magdeburg A.oe.R

    Magdeburg, Saxony-Anhalt, 39120

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, Rhineland-Palatinate, 55131

  • LMU - Campus Grosshadern

    Munich, Bavaria, 81377

Other trials in Germany

Hungary12 sites

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, 1036

  • Semmelweis Egyetem

    Budapest, 1088

  • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

    Budapest, 1125

  • Pannonia Maganorvosi Centrum

    Budapest, 1136

  • Markhot Ferenc Oktatokorhaz es Rendelointezet

    Eger, 3300

  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

    Gyula, 5700

  • Pest Megyei Flor Ferenc Korhaz

    Kistarcsa, 2143

  • Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz

    Miskolc, 3526

  • Karolina Korhaz-Rendelointezet

    Mosonmagyaróvár, H-9200

  • Pecsi Tudomanyegyetem

    Pécs, 7624

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000

  • Tolna Megyei Balassa Janos Korhaz

    Szekszárd, 7100

Other trials in Hungary

Israel10 sites

  • HaEmek Medical Center

    Afula, 18101

  • Barzilai Medical Center

    Ashkelon, 78278

  • Soroka University Medical Center

    Beersheba, 8410101

  • Rambam Health Care Campus

    Haifa, 3109601

  • Wolfson Medical Center

    Holon, 58100

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Galilee Medical Center

    Nahariya, 2210001

  • Chaim Sheba Medical Center

    Ramat Gan, 5265601

  • Kaplan Medical Center

    Rehovot, 7610001

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Russia10 sites

  • Kazan State Medical University

    Kazan', 420012

  • TSBIH "Territorial Clinical Hospital"

    Krasnoyarsk, 660022

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

    Moscow, 119333

  • LLC "Novosibirsk GastroCenter"

    Novosibirsk, 630007

  • SBEIHPE Novosibirsk State Medical University

    Novosibirsk, 630091

  • 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

  • SPb SBIH "City Hospital # 40 of Kurortnyi region"

    Sestroretsk, 197706

Other trials in Russia

Brazil9 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

  • Hospital Sao Vicente de Paulo

    Passo Fundo, Rio Grande do Sul, 99010-080

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • HUGG - Hospital Universitario Gaffree e Guinle

    Rio de Janeiro, Rio Do Janeiro, 20270-004

  • 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

  • Irmandade da Santa Casa da Misericordia de Santos

    Santos, São Paulo, 11075-900

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

Other trials in Brazil

Serbia8 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • Clinical Helth Centre Zvezdara

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • Clinical Center Bezanijska Kosa

    Belgrade, 11080

  • Clinical Center Zemun

    Belgrade, 11080

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • Clinical Center Nis

    Niš, 18000

  • Clinical Center of Vojvodina

    Novi Sad, 21000

Other trials in Serbia

South Korea8 sites

  • Kyungpook National University Hospital

    Daegu, Gyeongsangbuk-do, 41944

  • Yeungnam University Hospital

    Daegu, 42415

  • Kyung Hee University Hospital

    Seoul, 02447

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital, Yonsei University

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Turkey (Türkiye)8 sites

  • Ankara University Medical Faculty

    Ankara, 06100

  • Gazi University Medical Faculty

    Ankara, 06500

  • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Acibadem Fulya Hospital

    Istanbul, 34349

  • Haydarpasa Numune Training and Research Hospital

    Istanbul, 34668

  • Marmara University Pendik Research and Training Hospital

    Istanbul, 34899

  • Kocaeli Derince Training and Research Hospital

    Kocaeli, 41380

  • Mersin University Medical Faculty

    Mersin, 33343

Other trials in Turkey (Türkiye)

United Kingdom8 sites

  • University Hospital Coventry

    Coventry, West Midlands, CV2 2DX

  • 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

  • St George's Hospital

    London, Greater London, SW170QT

  • Norfolk and Norwich University Hospital

    Norwich, Norfolk, NR47UY

  • Royal Shrewsbury Hospital

    Shrewsbury, Shropshire, SY3 8XQ

  • Royal Wolverhampton hospital

    Wolverhampton, West Midlands, WV10 0QP

Other trials in United Kingdom

Belgium7 sites

  • Imeldaziekenhuis

    Bonheiden, 2820

  • AZ Sint-Lucas

    Bruges, 8310

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • AZ Groeninge - Kennedylaan

    Kortrijk, 8500

  • ZNA Jan Palfijn

    Merksem, 2170

  • Clinique Saint-Pierre

    Ottignies, 1340

  • AZ Delta

    Roeselare, 8800

Other trials in Belgium

Czechia7 sites

  • CCBR - Czech Brno, s.r.o..

    Brno, 60200

  • Hepato-Gastroenterologie HK s.r.o.

    Hradec Králové, 500 12

  • A-SHINE s.r.o.

    Pilsen, 31200

  • CLINTRIAL s.r.o.

    Prague, 100 00

  • CCBR Czech Prague, s.r.o.

    Prague, 13000

  • Axon Clinical s.r.o.

    Prague, 15000

  • Nemocnice Tabor a.s.

    Tábor, 39001

Other trials in Czechia

Mexico7 sites

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

    Durango, 34000

  • Morales Vargas Centro de Investigacion, S.C.

    León, Guanajuato, 37000

  • Centro de Investigacion Farmacologica del Bajio, S.C.

    León, Guanajuato, 37520

  • 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

Spain6 sites

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Universitari de Girona Dr Josep Trueta

    Girona, 17007

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Complejo Hospitalario de Pontevedra

    Pontevedra, 36164

Other trials in Spain

Canada5 sites

  • Zeidler Ledcor Centre - University of Alberta

    Edmonton, Alberta, T6G 2X8

  • LHSC - University Hospital

    London, Ontario, N6A 5A5

  • LHSC - Victoria Hospital

    London, Ontario, N6A 5W9

  • Toronto Digestive Disease Associates, Inc.

    Vaughan, Ontario, L4L 4Y7

  • PerCuro Clinical Research Ltd.

    Victoria, British Columbia, V8V 3M9

Other trials in Canada

Croatia5 sites

  • Clinical Hospital Centre Osijek

    Osijek, 31000

  • Clinical Hospital Centre Rijeka

    Rijeka, 51000

  • Special Hospital Medico

    Rijeka, 51000

  • Clinical Hospital Dubrava

    Zagreb, 10000

  • University hospital centre Zagreb

    Zagreb, 10000

Other trials in Croatia

Netherlands5 sites

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

  • Albert Schweitzer Ziekenhuis

    Dordrecht, 3317 NM

  • Universitair Medisch Centrum Groningen (UMCG)

    Groningen, 9713 GZ

  • Maastricht University Medical Center

    Maastricht, 6202 AZ

  • Erasmus Medisch Centrum

    Rotterdam, 3015 CE

Other trials in Netherlands

Slovakia5 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta

    Banská Bystrica, 97517

  • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

    Bratislava, 82606

  • Gastroped s.r.o.

    Košice, 04001

  • KM Management spol. s r.o.

    Nitra, 949 01

  • Gastro I, s.r.o.

    Prešov, 080 01

Other trials in Slovakia

Lithuania4 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas, 50009

  • Klaipeda Republican Hospital, Public Institution

    Klaipėda, 92231

  • Klaipeda University Hospital, Public Institution

    Klaipėda, 92288

  • Vilnius University Hospital Santariskiu Clinics, Public Institution

    Vilnius, LT-08661

Other trials in Lithuania

Argentina3 sites

  • Centro Medico Viamonte SRL

    Buenos Aires, Ciudad Autonoma Buenos Aires, C1120AAC

  • Hospital Italiano

    Ciudad Autonoma Buenos Aires, Buenos Aires, C1181ACH

  • Centro de Investigaciones Medicas Mar del Plata

    Mar del Plata, Buenos Aires, B7600FYK

Other trials in Argentina

Estonia3 sites

  • West Tallinn Central Hospital

    Tallinn, 10617

  • North Estonia Medical Centre Foundation

    Tallinn, 13419

  • Tartu University Hospital

    Tartu, 50406

Other trials in Estonia

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

South Africa3 sites

  • Dr MJ Prins Practice

    Cape Town, Western Cape, 7500

  • Dr JP Wright Practice

    Cape Town, Western Cape, 7708

  • Dr CCM Ziady Practice

    Pretoria, Gauteng, 0181

Other trials in South Africa

Taiwan3 sites

  • National Taiwan University Hospital

    Taipei, 100

  • Mackay Memorial Hospital

    Taipei, 10449

  • Tri-Service General Hospital

    Taipei, 11490

Other trials in Taiwan

Bosnia and Herzegovina2 sites

  • University Clinical Centre of the Republic of Srpska

    Banja Luka, 78000

  • University Clinical Hospital Mostar

    Mostar, 88000

Other trials in Bosnia and Herzegovina

Denmark2 sites

  • Odense Universitetshospital

    Odense C, 5000

  • Regionshospitalet Silkeborg

    Silkeborg, 8600

Other trials in Denmark

Sweden2 sites

  • Karolinska Universitetssjukhuset - Solna

    Stockholm, 171 76

  • Danderyds Sjukhus

    Stockholm, 182 88

Other trials in Sweden

About this study

Official title: A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects With Ulcerative Colitis and Crohn's Disease

The main aim of the study is to check for long-term side effects of Vedolizumab Subcutaneous (also known as Vedolizumab SC) in people with ulcerative colitis (UC) and Crohn's disease (CD). Vedolizumab SC will be given as an injection just under the skin. This type of injection is called a subcutaneous injection or SC for short. Another aim of the study is to collect information on whether the participant's condition remains under control or improves during and after treatment with Vedolizumab SC.

Participants who previously took part in studies MLN0002SC-3027 or MLN0002SC-3031 will be invited to visit the study clinic. At this visit, the study doctor will check if each participant can take part in this study.

Read more

For those who can take part, participants will receive a subcutaneous injection of vedolizumab SC either once a week or once every 2 weeks. How often each participant receives vedolizumab SC will depend on their results from the previous study and on how active their condition is. Participants might be able to self-inject vedolizumab SC after being trained by the study doctors. During this study, the dose of vedolizumab SC might be increased for participants whose condition worsens.

Participants will continue treatment with vedolizumab SC until it is approved in their particular country, the participant decides to stop treatment, or the sponsor stops the study. If the sponsor stops the study before vedolizumab SC is approved in all countries, the sponsor will make sure all affected participants will have access to vedolizumab SC outside of the study.

After their final dose of vedolizumab SC, participants will visit the clinic 18 weeks later for a final check-up. Then, the clinic will telephone the participants 6 months after their final dose of vedolizumab SC to check if they have any health problems.

Read the detailed description

The drug being tested in this study is called vedolizumab subcutaneous (vedolizumab SC). Vedolizumab SC is being tested to assess its long-term safety and effectiveness in treating participants with UC or CD. This study will look at the long-term side effects and response/remission of UC and CD in participants who received vedolizumab SC in a prior vedolizumab SC study.

The study will enroll up to 692 patients. All participants enrolled in this study will have previously participated in the MLN0002SC-3027 or MLN0002SC-3031 study. Participants who completed the Maintenance Period (Week 52) in their previous study, or who did not achieve a clinical response at Week 6 but who did achieve a clinical response at Week 14 after having received a third vedolizumab IV infusion at Week 6 in their previous study, will receive open-label vedolizumab SC 108 mg, once every 2 weeks (Q2W). Participants who withdrew early from the Maintenance Period of their previous study due to disease worsening or need for rescue medications will receive open-label vedolizumab SC 108 mg, once every week (QW). Participants receiving SC 108 mg Q2W who experience treatment failure (disease worsening or need for rescue medications while in the current study will be dose escalated to vedolizumab SC 108 mg QW.

This multi-center trial will be conducted worldwide. Participation in this vedolizumab SC study will continue until vedolizumab SC becomes commercially available, the participant withdraws from the study, or the sponsor decides to close the study. 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.

Being tested
Vedolizumab SC
Keywords
Drug therapy
Medical subject headings
Colitis, Ulcerative, Crohn Disease

What participants receive

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

  • Vedolizumab SCDrug

    Vedolizumab SC 108 mg injection

Study groups in NCT02620046
Study groupRoleWhat they receive
Ulcerative Colitis: Vedolizumab 108 mgExperimentalParticipants with ulcerative colitis (UC) who completed the Maintenance Phase in MLN0002SC-3027 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3027 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3027 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.
Receives: Drug: Vedolizumab SC
Crohn's Disease: Vedolizumab 108 mgExperimentalParticipants with Crohn's disease (CD) who completed the Maintenance Phase in MLN0002SC-3031 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3031 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3031 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.
Receives: Drug: Vedolizumab SC

What is being measured

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

  1. Number of Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment

    A TEAE was defined as an adverse event (AE) that started or worsened on or after study Day 1 (defined as day first dosed) and no more than 18 weeks after the last dose of study drug. An SAE was defined as any untoward medical occurrence that occurs at any dose and resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event such as acute liver failure, pulmonary hypertension, or confirmed or suspected transmission of an infectious agent by a medicinal product. Participant years is defined as the total exposure-time of the participants in the respective treatment group. Incidence per 100 participant years is defined as (Number of participants with events*100/participant years). As per planned analysis, data for this outcome measure is grouped and presented per disease condition.

    Measured: Up to 97.9 months

Secondary outcomes (5)

  1. Number of Adverse Events of Special Interest (AESIs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment

    AESIs included hypersensitivity reactions (including injections site reactions), serious infections, malignancies, hepatotoxicity (abnormal liver function test) and progressive multifocal leukoencephalopathy (PML). Participant years is defined as the total exposure-time of the participants in the respective treatment group. Incidence per 100 participant years is defined as (Number of participants with events*100/participant years). As per planned analysis, data for this outcome measure is grouped and presented per disease condition.

    Measured: Up to 97.9 months

  2. Number of Participants With Ulcerative Colitis Achieving Partial Mayo Scoring Clinical Response at Week 48

    Clinical response is defined as a decrease in the partial Mayo score of at least 2 points and ≥25% from baseline, with an accompanying decrease in rectal bleeding subscore of ≥1 point from baseline or absolute rectal bleeding subscore of ≤1 point. As per planned analysis, data for this outcome measure is grouped and presented for participants with ulcerative colitis.

    Measured: Week 48

  3. Number of Participants With Crohn's Disease Achieving Clinical Response Based on Harvey-Bradshaw Index (HBI) Scores at Week 48

    Clinical response is defined as a decrease in HBI score of ≥3 points from baseline in CD participants (randomized early terminator CD participants only [defined as randomized CD participants withdrawn from the parent study between Week 6 and Week 52]). As per planned analysis, data for this outcome measure is grouped and presented for participants with Crohn's disease.

    Measured: Week 48

  4. Number of Participants With Ulcerative Colitis Achieving Clinical Remission Based on Partial Mayo Score

    Clinical remission is defined as a partial Mayo score of ≤2 with no individual subscore >1. As per planned analysis, data for this outcome measure is grouped and presented for participants with ulcerative colitis.

    Measured: Week 48

  5. Number of Participants With Crohn's Disease Achieving Clinical Remission Based on Harvey-Bradshaw Index (HBI) Scores

    Clinical remission is defined as total HBI score of ≤4 points. As per planned analysis, data for this outcome measure is grouped and presented for participants with Crohn's disease.

    Measured: Week 48

Timeline

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

  1. First posted2 Dec 2015 (estimated)
  2. Study start15 Apr 2016
  3. Primary completion12 Jun 2024
  4. Study completion12 Jun 2024

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
746 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02620046
Sponsor's protocol ID
MLN0002SC-3030
Other IDs
U1111-1168-0921, 2015-000482-31, JapicCTI-163220, MLN0002SC-3030CTIL, 16/LO/0110, NL55765.056.16, 189751, 163300410A0052
Status last verified
Mar 2025
First submitted
19 Nov 2015
Last updated
3 Apr 2025
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

  • Ungaro RC, Kadali H, Zhang W, Adsul S, Reinisch W. Impact of Concomitant 5-Aminosalicylic Acid Therapy on Vedolizumab Efficacy and Safety in Inflammatory Bowel Disease: Post Hoc Analyses of Clinical Trial Data. J Crohns Colitis. 2023 Dec 30;17(12):1949-1961. doi: 10.1093/ecco-jcc/jjad113.

    PubMed 37492976

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vedolizumab SC in people with Colitis, Ulcerative and Crohn's Disease, run by Takeda at 301 sites in 33 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 1 inclusion and 3 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 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 301 sites in United States, Japan, Ukraine, Australia, Bulgaria and 28 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 3 Apr 2025). 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?

Number of Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment (time frame: Up to 97.9 months). 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 NCT02620046, which also lists 1 linked publication.

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 3 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in