AzTrials
AzTrials

Crohn's DiseasePhase 3NCT02611817

Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)

A Phase 3 study testing Vedolizumab SC 108 mg and Vedolizumab IV 300 mg in people with Crohn's Disease, run by Takeda at 194 sites in 30 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 purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active CD who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Crohn's Disease
What is being tested?
Vedolizumab SC 108 mg and Vedolizumab IV 300 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
644 participants
Where
194 sitesin 30 countries
Study dates
4 Jan 2016to 6 Aug 2019
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 CD established at least 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report.
  • Moderately to severely active CD as determined by a CDAI score of 220 to 450 and 1 of the following:
  • C-reactive protein (CRP) level greater than (>) 2.87 milligram per liter (mg/L) OR
  • Ileocolonoscopy with photographic documentation of a minimum of 3 nonanastomotic ulcerations (each >0.5 centimeter [cm] in diameter) or 10 aphthous ulcerations (involving a minimum of 10 contiguous cm of intestine) consistent with CD OR
  • Fecal calprotectin >250 microgram per gram (mcg/g) stool during the screening period in conjunction with computed tomography enterography (CTE), magnetic resonance enterography (MRE), contrast-enhanced small bowel radiography, or wireless capsule endoscopy revealing CD ulcerations (aphthae not sufficient).
  • CD involvement of the ileum and/or colon, at a minimum.
  • 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 at Screening.
  • Extensive colonic resection, subtotal or total colectomy.
  • History of >3 small bowel resections or diagnosis of short bowel syndrome.
  • Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
  • Prior exposure to investigational or approved non-biologic therapies (example, cyclosporine, tacrolimus, thalidomide, 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).
Show all 13Show fewer
  • Prior exposure to vedolizumab.
  • Surgical intervention for CD required at any time during the study.
  • History or evidence of adenomatous colonic polyps that have not been removed, or of colonic mucosal dysplasia.
  • Suspected or confirmed diagnosis of ulcerative colitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
  • Active infections.
  • Chronic hepatitis B virus (HBV) or C (HCV) infection, tuberculosis (TB) (active or latent), or congenital or acquired immunodeficiency. HBV immune participants (that is, 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, or neurodegenerative disease.

Trial locations and contacts

194 sites in 30 countries.

194 sites in 30 countries

United States30 sites

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 33176

  • Gastroenterology Associates, LLC

    Baton Rouge, Louisiana, 85307

  • Ehrhardt Clinical Research, LLC

    Belton, Missouri, 60612

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 41017

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 49519

  • Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research

    Chevy Chase, Maryland

  • Rush University Medical Center

    Chicago, Illinois, 33028

  • Tri-State Gastroenterology Associates

    Crestview Hills, Kentucky, 06457

  • Gastroenterology Center of the MidSouth PC

    Germantown, Tennessee, 78212

  • Long Island Clinical Research Associates

    Great Neck, New York, 71105

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut, 11021

  • Grand Teton Research Group, PLL

    Idaho Falls, Idaho

  • Nature Coast Clinical Research, LLC

    Inverness, Florida, 55905

  • Gastro-Enterology Research of Lima

    Lima, Ohio, 39581

  • Gastroenterology Associates of Central Georgia

    Macon, Georgia, 53226

  • L & L Research Choices, Inc.

    Miami, Florida

  • Middlesex Gastroenterology Associates

    Middletown, Connecticut

  • Allegiance Research Specialists, LLC

    Milwaukee, Wisconsin, 64012

  • Gastroenterology Group of Naples

    Naples, Florida, 30342

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 61801

  • Arizona Arthritis & Rheumatology Research, PLLC

    Phoenix, Arizona, 45806

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 30024

  • San Antonio Gastroenterology

    San Antonio, Texas

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 32789

  • Atlanta Gastroenterology Specialists, PC

    Suwanee, Georgia, 48047

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

    Topeka, Kansas, 06518

  • Options Health Research

    Tulsa, Oklahoma, 83404

  • Carle Foundation Hospital

    Urbana, Illinois, 74104

  • Shafran Gastroenterology Center

    Winter Park, Florida, 70809

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

    Wyoming, Michigan, 34102

Other trials in United States

Japan14 sites

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, Fukuoka, 818-8502

  • Hamamatsu South Hospital

    Hamamatsu, Shizuoka, 430-0846

  • Gokeikai Ofuna Chuo Hospital

    Kamakura-shi, Kanagawa, 247-0056

  • Kitasato University Kitasato Institute Hospital

    Minatoku, Tokyo-To, 108-8642

  • Iwate Medical University Hospital

    Morioka, Iwate, 020-8505

  • Hyogo College of Medicine Hospital

    Nishinomiya-shi, Hyōgo, 663-8501

  • Kinshukai Infusion Clinic

    Osaka, Osaka, 530-0011

  • 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

  • JCHO Tokyo Yamate Medical Center

    Shinjuku-ku, Tokyo-To, 169-0073

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8510

Other trials in Japan

Ukraine14 sites

  • RCI Chernivtsi RCH Dep of Surgery HSEI of Ukr Bukovinian SMU

    Chernivtsi, 21005

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

    Dnipro, 69104

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

    Kharkiv, 58002

  • CI A.and O. Tropiny City Clinical Hospital

    Kherson, 79059

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

    Kyiv, 46002

  • CI of Kyiv RC Kyiv Regional Clinical Hospital

    Kyiv, 49074

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

    Kyiv, 65025

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

    Lviv, 01103

  • CI Odesa Regional Clinical Hospital

    Odesa, 21009

  • Ternopil University Hospital

    Ternopil, CV2 2DX

  • Private Small Enterprise Medical Center Pulse

    Vinnytsia, 01023

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

    Vinnytsia, 21001

  • MCIC MC LLC Health Clinic

    Vinnytsia, 73000

  • CI City Hospital #1

    Zaporizhzhya, EX2 5DW

Other trials in Ukraine

Poland12 sites

  • NZOZ Vitamed

    Bydgoszcz, 85-079

  • 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 MDM

    Warsaw, 00-635

  • 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

Russia11 sites

  • Kazan State Medical University

    Kazan', 420012

  • TSBIH "Territorial Clinical Hospital"

    Krasnoyarsk, 660022

  • SBEIHPE Novosibirsk State Medical University

    Novosibirsk, 630091

  • FSBSI "Scientific and Research Institute of Physiology and Basic Medicine"

    Novosibirsk, 630117

  • BHI of Omsk region Clinical Oncology Dispensary

    Omsk, 644013

  • SBEI of HPE "Omsk SMA" SBEI HPE "Omsk State Medical University" of the MoH of the RF

    Omsk, 644099

  • 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

  • SBIH of Yaroslavl region " Regional Clinical Hospital "

    Yaroslavl, 150062

Other trials in Russia

Italy10 sites

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

    Bologna, 40138

  • Azienda Ospedaliera Ospedale Cannizzaro

    Catania, 95100

  • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

    Milan, 20157

  • A.O.U. Policlinico di Modena

    Modena, 41124

  • 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

  • I.R.C.C.S Policlinico San Donato

    San Donato Milanese (MI), Milano, 20097

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia, 71013

Other trials in Italy

Australia9 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Ballarat Base Hospital

    Ballarat, Victoria, 3350

  • Tennyson Centre Day Hospital

    Bedford Park, South Australia, 5042

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • Royal Melbourne Hospital

    Melbourne, Victoria, 3000

  • The Alfred Hospital

    Melbourne, Victoria, 3181

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • St John of God Subiaco Hospital

    Subiaco, Western Australia, 6008

Other trials in Australia

Hungary9 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

  • Pest Megyei Flor Ferenc Korhaz

    Kistarcsa, 2143

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

    Miskolc, 3526

  • 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

Brazil8 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 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

South Korea8 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

  • Severance Hospital, Yonsei University

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Israel6 sites

  • HaEmek Medical Center

    Afula, 18101

  • Soroka University Medical Center

    Beersheba, 8410101

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Chaim Sheba Medical Center

    Ramat Gan, 5265601

  • Kaplan Medical Center

    Rehovot, 7610001

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Belgium5 sites

  • Imeldaziekenhuis

    Bonheiden, 2820

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • AZ Groeninge - Kennedylaan

    Kortrijk, 8500

  • ZNA Jan Palfijn

    Merksem, 2170

  • AZ Delta

    Roeselare, 8800

Other trials in Belgium

Bulgaria5 sites

  • MHAT "Hadzhi Dimitar", OOD

    Sliven, 8800

  • "City Clinic UMHAC" EOOD

    Sofia, 1407

  • UMHAT "Sv. Ivan Rilski", EAD

    Sofia, 1431

  • UMHAT 'Tsaritsa Yoanna - ISUL', EAD

    Sofia, 1527

  • Fourth MHAT - Sofia EAD

    Sofia, 1606

Other trials in Bulgaria

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

Czechia5 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

  • CCBR Czech Prague, s.r.o.

    Prague, 13000

  • Axon Clinical s.r.o.

    Prague, 15000

Other trials in Czechia

Germany5 sites

  • DRK Kliniken Berlin Westend

    Berlin, 14050

  • Krankenhaus Waldfriede e. V.

    Berlin, 14163

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • EUGASTRO GmbH

    Leipzig, Saxony, 04103

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, Rhineland-Palatinate, 55131

Other trials in Germany

Serbia5 sites

  • Clinical Helth Centre Zvezdara

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • Clinical Center Bezanijska kosa

    Belgrade, 11080

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • Clinical Center of Vojvodina

    Novi Sad, 21000

Other trials in Serbia

Turkey (Türkiye)5 sites

  • Ankara University Medical Faculty

    Ankara, 41380

  • Haydarpasa Numune Training and Research Hospital

    Istanbul, 01023

  • Marmara University Pendik Research and Training Hospital

    Istanbul, 33343

  • Kocaeli Derince Training and Research Hospital

    Kocaeli, 34668

  • Mersin University Medical Faculty

    Mersin, 34098

Other trials in Turkey (Türkiye)

United Kingdom5 sites

  • University Hospital Coventry

    Coventry, West Midlands, NW3 2QG

  • Royal Devon and Exeter Hospital (Wonford)

    Exeter, Devon, SY3 8XQ

  • St George's Hospital

    London, Greater London, 31201

  • Whipps Cross University Hospital

    London, Greater London, SW170QT

  • Royal Shrewsbury Hospital

    Shrewsbury, Shropshire, 34452

Other trials in United Kingdom

Mexico4 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

  • Sociedad de Metabolismo y Corazon S.C

    Veracruz, 91910

Other trials in Mexico

Netherlands3 sites

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

  • Albert Schweitzer Ziekenhuis, Dordwijk

    Dordrecht, 3318 AT

  • Erasmus Medisch Centrum

    Rotterdam, 3015 CE

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

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

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas, 50009

  • Vilnius University Hospital Santariskiu Clinic, Public Institution

    Vilnius, LT-08661

Other trials in Lithuania

Slovakia2 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta

    Banská Bystrica, 97517

  • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

    Bratislava, 82606

Other trials in Slovakia

South Africa2 sites

  • Dr JP Wright Practice

    Cape Town, Western Cape, 7708

  • Dr CCM Ziady Practice

    Pretoria, Gauteng, 0181

Other trials in South Africa

Estonia1 site

  • North Estonia Medical Centre Foundation

    Tallinn, 13419

Other trials in Estonia

Sweden1 site

  • Karolinska Universitetssjukhuset - Solna

    Stockholm, 11490

Other trials in Sweden

Taiwan1 site

  • Mackay Memorial Hospital

    Taipei, 100

Other trials in Taiwan

About this study

Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease 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) as maintenance treatment in participants with moderately to severely active CD 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 SC. Vedolizumab SC is being tested to treat people who have moderate to severely active CD. This study will look at clinical remission, as well as enhanced clinical response and corticosteroid-free remission in participants with CD who receive vedolizumab SC maintenance therapy after having achieved a clinical response to vedolizumab IV induction therapy.

The study will enroll approximately 824 participants. All participants will enter a 6 week Induction Phase where they will be administered open-label vedolizumab IV 300 mg via IV infusion 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 two treatment groups:

  • Vedolizumab SC 108 mg Maintenance Arm
  • Placebo SC Maintenance Arm

Participants who do not achieve a clinical response will not be randomized into the Maintenance Period, and instead 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. 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.

Conditions
Crohn's Disease
Being tested
Vedolizumab SC 108 mg, Placebo, Vedolizumab IV 300 mg
Keywords
Drug Therapy
Medical subject headings
Crohn Disease

What participants receive

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

  • Vedolizumab SC 108 mgDrug

    Vedolizumab SC Injection.

  • PlaceboDrug

    Vedolizumab placebo-matching SC injection.

  • Vedolizumab IV 300 mgDrug

    Vedolizumab IV Injection.

Study groups in NCT02611817
Study groupRoleWhat they receive
Vedolizumab SC 108 mg Maintenance ArmExperimentalOpen-label Induction: vedolizumab IV 300 milligram (mg), infusion at Week 0 (Day 1) and Week 2 (Day 15) Double-blind Maintenance: vedolizumab SC 108 mg injection once every 2 weeks (Q2W) starting at Week 6 up to Week 50
Receives: Drug: Vedolizumab SC 108 mg; Drug: Vedolizumab IV 300 mg
Placebo SC Maintenance ArmPlacebo comparatorOpen-label Induction: vedolizumab IV 300 mg, infusion at Week 0 (Day 1) and Week 2 (Day 15) Double-blind Maintenance: matching placebo to vedolizumab SC injection Q2W starting at Week 6 up to Week 50
Receives: Drug: Placebo; Drug: Vedolizumab IV 300 mg

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 Crohn's Disease Activity Index (CDAI) score less than or equal to (<=) 150 at Week 52. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to (=) sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.

    Measured: Week 52

Secondary outcomes (3)

  1. Percentage of Participants Achieving Enhanced Clinical Response at Week 52

    Enhanced clinical response is defined as a decrease from Baseline of greater than or equal to (>=) 100 points in the CDAI score at Week 52. A CDAI is a multi-item instrument which measures severity of active CD monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.

    Measured: Week 52

  2. 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 CDAI score <=150 at Week 52. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.

    Measured: Week 52

  3. Percentage of TNF-alpha Antagonist Naive Participants Achieving Clinical Remission at Week 52

    Clinical remission is defined as CDAI score <=150 at Week 52. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating 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 start4 Jan 2016
  3. Primary completion6 May 2019
  4. Study completion6 Aug 2019

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
644 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02611817
Sponsor's protocol ID
MLN0002SC-3031
Other IDs
U1111-1168-0845, 2015-000481-58, NL55774.056.16, 16/LO/0090, MLN0002SC-3031CTID, 163300410A0045, 189748, MOH_2017-01-05_000039
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vedolizumab SC 108 mg and Vedolizumab IV 300 mg in people with Crohn's Disease, run by Takeda at 194 sites in 30 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 7 inclusion and 13 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 194 sites in United States, Japan, Ukraine, Poland, Russia and 25 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. Some participants in this study may receive a placebo. 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 Jun 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 NCT02611817, 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 25 May 2022.

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