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

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Drug: Vedolizumab SC 108 mg; Drug: Vedolizumab IV 300 mg; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 644
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
    • Kingswood, New South Wales, Australia, 2747
      • Nepean Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
    • Bedford Park, South Australia, Australia, 5042
      • Tennyson Centre Day Hospital
  • Victoria
    • Ballarat, Victoria, Australia, 3350
      • Ballarat Base Hospital
    • Melbourne, Victoria, Australia, 3000
      • Royal Melbourne Hospital
    • Melbourne, Victoria, Australia, 3181
      • The Alfred Hospital
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
    • Subiaco, Western Australia, Australia, 6008
      • St John of God Subiaco Hospital
• Belgium
  • Bonheiden, Belgium, 2820
    • Imeldaziekenhuis
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Kortrijk, Belgium, 8500
    • AZ Groeninge - Kennedylaan
  • Merksem, Belgium, 2170
    • ZNA Jan Palfijn
  • Roeselare, Belgium, 8800
    • AZ Delta
• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
    • University Clinical Centre of the Republic of Srpska
  • Mostar, Bosnia and Herzegovina, 88000
    • University Clinical Hospital Mostar
• Brazil
  • Goias
    • Goiania, Goias, Brazil, 74535-170
      • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
  • Rio Do Janeiro
    • Rio de Janeiro, Rio Do Janeiro, Brazil, 20270-004
      • HUGG - Hospital Universitario Gaffree e Guinle
    • Rio de Janeiro, Rio Do Janeiro, Brazil, 21941-913
      • HUCFF-UFRJ - Hospital Universitario Clementino Fraga Filho - Universidade Federal do Rio de Janeiro
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Hospital De Clinicas De Porto Alegre
  • Sao Paulo
    • Botucatu, Sao Paulo, Brazil, 18618-970
      • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
    • Santo Andre, Sao Paulo, Brazil, 09060-650
      • Faculdade de Medicina do ABC
    • Santos, Sao Paulo, Brazil, 11075-900
      • Irmandade da Santa Casa da Misericórdia de Santos
    • Sao Jose do Rio Preto, Sao Paulo, Brazil, 15090-000
      • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
• Bulgaria
  • Sliven, Bulgaria, 8800
    • MHAT "Hadzhi Dimitar", OOD
  • Sofia, Bulgaria, 1407
    • "City Clinic UMHAC" EOOD
  • Sofia, Bulgaria, 1431
    • UMHAT "Sv. Ivan Rilski", EAD
  • Sofia, Bulgaria, 1527
    • UMHAT 'Tsaritsa Yoanna - ISUL', EAD
  • Sofia, Bulgaria, 1606
    • Fourth MHAT - Sofia EAD
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2X8
      • Zeidler Ledcor Centre - University of Alberta
  • British Columbia
    • Victoria, British Columbia, Canada, V8V 3M9
      • PerCuro Clinical Research Ltd.
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • LHSC - University Hospital
    • London, Ontario, Canada, N6A 5W9
      • LHSC - Victoria Hospital
    • Vaughan, Ontario, Canada, L4L 4Y7
      • Toronto Digestive Disease Associates, Inc.
• Czechia
  • Brno, Czechia, 60200
    • CCBR - Czech Brno, s.r.o..
  • Hradec Kralove, Czechia, 500 12
    • Hepato-Gastroenterologie HK s.r.o.
  • Plzen, Czechia, 31200
    • A-SHINE s.r.o.
  • Praha 3, Czechia, 13000
    • CCBR Czech Prague, s.r.o.
  • Praha 5, Czechia, 15000
    • AXON Clinical s.r.o.
• Denmark
  • Odense C, Denmark, 5000
    • Odense Universitetshospital
  • Silkeborg, Denmark, 8600
    • Regionshospitalet Silkeborg
• Estonia
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre Foundation
• Germany
  • Berlin, Germany, 14050
    • DRK Kliniken Berlin Westend
  • Berlin, Germany, 14163
    • Krankenhaus Waldfriede e. V.
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Medizinische Hochschule Hannover
  • Rheinland Pfalz
    • Mainz, Rheinland Pfalz, Germany, 55131
      • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Sachsen
    • Leipzig, Sachsen, Germany, 04103
      • Eugastro GmbH
• Hungary
  • Budapest, Hungary, 1088
    • Semmelweis Egyetem
  • Budapest, Hungary, 1136
    • Pannónia Magánorvosi Centrum
  • Budapest, Hungary, 1036
    • Obudai Egeszsegugyi Centrum Kft.
  • Budapest, Hungary, 1125
    • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
  • Kistarcsa, Hungary, 2143
    • Pest Megyei Flor Ferenc Korhaz
  • Miskolc, Hungary, 3526
    • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
  • Mosonmagyarovar, Hungary, H-9200
    • Karolina Korhaz-Rendelointezet
  • Szekesfehervar, Hungary, 8000
    • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Szekszard, Hungary, 7100
    • Tolna Megyei Balassa Janos Korhaz
• Israel
  • Afula, Israel, 18101
    • Haemek Medical Center
  • Beer Sheva, Israel, 8410101
    • Soroka University Medical Center
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center
  • Ramat Gan, Israel, 5265601
    • Chaim Sheba Medical Center
  • Rechovot, Israel, 7610001
    • Kaplan Medical Center
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Center
• Italy
  • Bologna, Italy, 40138
    • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
  • Catania, Italy, 95100
    • Azienda Ospedaliera Ospedale Cannizzaro
  • Milano, Italy, 20157
    • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
  • Modena, Italy, 41124
    • A.O.U. Policlinico di Modena
  • Padova, Italy, 35128
    • Azienda Ospedaliera di Padova
  • Palermo, Italy, 90146
    • Azienda Ospedaliera Vincenzo Cervello
  • Roma, Italy, 00168
    • Policlinico Universitario Agostino Gemelli
  • Roma, Italy, 00152
    • Azienda Ospedaliera San Camillo Forlanini
  • Foggia
    • San Giovanni Rotondo, Foggia, Italy, 71013
      • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Milano
    • San Donato Milanese (MI), Milano, Italy, 20097
      • I.R.C.C.S Policlinico San Donato
• Japan
  • Chiba-Ken
    • Sakura-shi, Chiba-Ken, Japan, 285-8741
      • Toho University Sakura Medical Center
  • Fukuoka-Ken
    • Chikushino-shi, Fukuoka-Ken, Japan, 818-8502
      • Fukuoka University Chikushi Hospital
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 004-0041
      • Tokushukai Sapporo Tokushukai Hospital
    • Sapporo-shi, Hokkaido, Japan, 060-0033
      • Sapporo-Kosei General Hospital
    • Sapporo-shi, Hokkaido, Japan, 065-0033
      • Tokushukai Sapporo Higashi Tokushukai Hospital
  • Hyogo-Ken
    • Nishinomiya-shi, Hyogo-Ken, Japan, 663-8501
      • Hyogo College of Medicine Hospital
  • Iwate-Ken
    • Morioka-shi, Iwate-Ken, Japan, 020-8505
      • Iwate Medical University Hospital
  • Kanagawa-Ken
    • Kamakura-shi, Kanagawa-Ken, Japan, 247-0056
      • Gokeikai Ofuna Chuo Hospital
  • Osaka-Fu
    • Osaka-shi, Osaka-Fu, Japan, 530-0011
      • Kinshukai Infusion Clinic
  • Saga-Ken
    • Saga-shi, Saga-Ken, Japan, 849-8501
      • Saga University Hospital
  • Shizuoka-Ken
    • Hamamatsu-shi, Shizuoka-Ken, Japan, 430-0846
      • Hamamatsu South Hospital
  • Tokyo-To
    • Minato-ku, Tokyo-To, Japan, 108-8642
      • Kitasato University Kitasato Institute Hospital
    • Shinjuku-ku, Tokyo-To, Japan, 169-0073
      • JCHO Tokyo Yamate Medical Center
  • Wakayama-Ken
    • Wakayama-shi, Wakayama-Ken, Japan, 641-8510
      • Wakayama Medical University Hospital
• Korea, Republic of
  • Daegu, Korea, Republic of, 42415
    • Yeungnam University Hospital
  • Daegu, Korea, Republic of, 41944
    • Kyungpook National University Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 02447
    • Kyung Hee University Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 03181
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University
• Lithuania
  • Kaunas, Lithuania, 50009
    • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
  • Vilnius, Lithuania, LT-08661
    • Vilnius University Hospital Santariskiu Clinic, Public Institution
• Mexico
  • Durango, Mexico, 34000
    • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
  • Veracruz, Mexico, 91910
    • Sociedad de Metabolismo y Corazon S.C
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37000
      • Morales Vargas Centro de Investigacion, S.C.
    • Leon, Guanajuato, Mexico, 37520
      • Centro de Investigacion Farmacologica del Bajío, S.C.
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Academisch Medisch Centrum
  • Dordrecht, Netherlands, 3318 AT
    • Albert Schweitzer Ziekenhuis, Dordwijk
  • Rotterdam, Netherlands, 3015 CE
    • Erasmus Medisch Centrum
• Poland
  • Bydgoszcz, Poland, 85-079
    • NZOZ Vitamed
  • Krakow, Poland, 31-009
    • Gabinet Endoskopii Przewodu Pokarmowego
  • Lodz, Poland, 90-302
    • SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia
  • Lodz, Poland, 90-153
    • SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM
  • Lublin, Poland, 20-582
    • GASTROMED Sp. z o.o.
  • Szczecin, Poland, 71-270
    • Twoja Przychodnia-Szczecinskie Centrum Medyczne
  • Warszawa, Poland, 03-580
    • NZOZ Vivamed
  • Warszawa, Poland, 00-635
    • Centrum Zdrowia MDM
  • Warszawa, Poland, 02-781
    • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
  • Warszawa, Poland, 02-507
    • Centralny Szpital Kliniczny MSW w Warszawie
  • Wroclaw, Poland, 53-114
    • LexMedica Osrodek Badan Klinicznych
  • Wroclaw, Poland, 53-333
    • Ars-Medica S.C Rybak Maria, Rybak Zbigniew
• Romania
  • Bucuresti, Romania, 020125
    • Spitalul Clinic Colentina
  • Bucuresti, Romania, 022328
    • Institutul Clinic Fundeni
  • Timisoara, Romania, 300002
    • S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
• Russian Federation
  • Kazan, Russian Federation, 420012
    • Kazan State Medical University
  • Krasnoyarsk, Russian Federation, 660022
    • TSBIH "Territorial Clinical Hospital"
  • Novosibirsk, Russian Federation, 630091
    • SBEIHPE Novosibirsk State Medical University
  • Novosibirsk, Russian Federation, 630117
    • FSBSI "Scientific and Research Institute of Physiology and Basic Medicine"
  • Omsk, Russian Federation, 644013
    • BHI of Omsk region Clinical Oncology Dispensary
  • Omsk, Russian Federation, 644099
    • SBEI of HPE "Omsk SMA" SBEI HPE "Omsk State Medical University" of the MoH of the RF
  • Rostov-on-Don, Russian Federation, 344022
    • SBEI HPE "Rostov State Medical University" of the MoH of the RF
  • Saint-Petersburg, Russian Federation, 197373
    • LLC "RIAT SPb"
  • Sestroretsk, Russian Federation, 197706
    • SPb SBIH "City Hospital # 40 of Kurortnyi region"
  • St. Petersburg, Russian Federation, 195257
    • SPb SBIH "City Hospital of Saint Martyr Elizaveta"
  • Yaroslavl, Russian Federation, 150062
    • SBIH of Yaroslavl region " Regional Clinical Hospital "
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
  • Belgrade, Serbia, 11080
    • Clinical Center Bezanijska kosa
  • Belgrade, Serbia, 11000
    • Clinical Helth Centre Zvezdara
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac
  • Novi Sad, Serbia, 21000
    • Clinical Center of Vojvodina
• Slovakia
  • Banska Bystrica, Slovakia, 97517
    • Fakultna nemocnica s poliklinikou F.D. Roosevelta
  • Bratislava, Slovakia, 82606
    • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
• South Africa
  • Gauteng
    • Pretoria, Gauteng, South Africa, 0181
      • Dr CCM Ziady Practice
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7708
      • Dr JP Wright Practice
• Sweden
  • Stockholm, Sweden, 11490
    • Karolinska Universitetssjukhuset - Solna
• Taiwan
  • Taipei, Taiwan, 100
    • Mackay Memorial Hospital
• Turkey
  • Ankara, Turkey, 41380
    • Ankara University Medical Faculty
  • Istanbul, Turkey, 01023
    • Haydarpasa Numune Training and Research Hospital
  • Istanbul, Turkey, 33343
    • Marmara University Pendik Research and Training Hospital
  • Kocaeli, Turkey, 34668
    • Kocaeli Derince Training and Research Hospital
  • Mersin, Turkey, 34098
    • Mersin University Medical Faculty
• Ukraine
  • Chernivtsi, Ukraine, 21005
    • RCI Chernivtsi RCH Dep of Surgery HSEI of Ukr Bukovinian SMU
  • Dnipro, Ukraine, 69104
    • SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU
  • Kharkiv, Ukraine, 58002
    • CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
  • Kherson, Ukraine, 79059
    • CI A.and O. Tropiny City Clinical Hospital
  • Kyiv, Ukraine, 46002
    • Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
  • Kyiv, Ukraine, 49074
    • CI of Kyiv RC Kyiv Regional Clinical Hospital
  • Kyiv, Ukraine, 65025
    • MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
  • Lviv, Ukraine, 01103
    • Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
  • Odesa, Ukraine, 21009
    • CI Odesa Regional Clinical Hospital
  • Ternopil, Ukraine, CV2 2DX
    • Ternopil University Hospital
  • Vinnytsia, Ukraine, 01023
    • Private Small Enterprise Medical Center Pulse
  • Vinnytsia, Ukraine, 21001
    • Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
  • Vinnytsia, Ukraine, 73000
    • MCIC MC LLC Health Clinic
  • Zaporizhzhia, Ukraine, EX2 5DW
    • CI City Hospital #1
• United Kingdom
  • Devon
    • Exeter, Devon, United Kingdom, SY3 8XQ
      • Royal Devon and Exeter Hospital (Wonford)
  • Greater London
    • London, Greater London, United Kingdom, 31201
      • St George's Hospital
    • London, Greater London, United Kingdom, SW170QT
      • Whipps Cross University Hospital
  • Shropshire
    • Shrewsbury, Shropshire, United Kingdom, 34452
      • Royal Shrewsbury Hospital
  • West Midlands
    • Coventry, West Midlands, United Kingdom, NW3 2QG
      • University Hospital Coventry
• United States
  • Arizona
    • Phoenix, Arizona, United States, 45806
      • Arizona Arthritis & Rheumatology Research, PLLC
  • Connecticut
    • Hamden, Connecticut, United States, 11021
      • Medical Research Center of Connecticut, LLC
    • Middletown, Connecticut, United States
      • Middlesex Gastroenterology Associates
  • Florida
    • Inverness, Florida, United States, 55905
      • Nature Coast Clinical Research, LLC
    • Miami, Florida, United States
      • L & L Research Choices, Inc.
    • Naples, Florida, United States, 30342
      • Gastroenterology Group Of Naples
    • Winter Park, Florida, United States, 70809
      • Shafran Gastroenterology Center
  • Georgia
    • Atlanta, Georgia, United States, 33176
      • Atlanta Gastroenterology Associates
    • Macon, Georgia, United States, 53226
      • Gastroenterology Associates of Central Georgia
    • Suwanee, Georgia, United States, 48047
      • Atlanta Gastroenterology Specialists, PC
  • Idaho
    • Idaho Falls, Idaho, United States
      • Grand Teton Research Group, PLL
  • Illinois
    • Chicago, Illinois, United States, 33028
      • Rush University Medical Center
    • Urbana, Illinois, United States, 74104
      • Carle Foundation Hospital
  • Kansas
    • Topeka, Kansas, United States, 06518
      • Cotton-O'Neil Clinical Research Center, Digestive Health
  • Kentucky
    • Crestview Hills, Kentucky, United States, 06457
      • Tri-State Gastroenterology Associates
  • Louisiana
    • Baton Rouge, Louisiana, United States, 85307
      • Gastroenterology Associates, LLC
    • Shreveport, Louisiana, United States, 32789
      • Louisiana Research Center, LLC
  • Maryland
    • Chevy Chase, Maryland, United States
      • Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research
  • Michigan
    • Chesterfield, Michigan, United States, 49519
      • Clinical Research Institute of Michigan, LLC
    • Wyoming, Michigan, United States, 34102
      • Gastroenterology Associates of Western Michigan, P.L.C.
  • Minnesota
    • Rochester, Minnesota, United States, 30024
      • Mayo Clinic - Rochester
  • Missouri
    • Belton, Missouri, United States, 60612
      • Ehrhardt Clinical Research, LLC
  • New York
    • Great Neck, New York, United States, 71105
      • Long Island Clinical Research Associates
  • North Carolina
    • Chapel Hill, North Carolina, United States, 41017
      • University of North Carolina at Chapel Hill
  • Ohio
    • Lima, Ohio, United States, 39581
      • Gastro-Enterology Research of Lima
  • Oklahoma
    • Tulsa, Oklahoma, United States, 83404
      • Options Health Research
  • Tennessee
    • Germantown, Tennessee, United States, 78212
      • Gastroenterology Center of the MidSouth PC
    • Nashville, Tennessee, United States, 61801
      • Vanderbilt University Medical Center
  • Texas
    • San Antonio, Texas, United States
      • San Antonio Gastroenterology
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 64012
      • Allegiance Research Specialists, LLC

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Diagnosis of CD established at least 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report.

2. 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).
3. CD involvement of the ileum and/or colon, at a minimum.
4. Inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or Tumor necrosis factor-alpha (TNF-α) antagonists.

Exclusion Criteria:

1. Evidence of abdominal abscess at Screening.
2. Extensive colonic resection, subtotal or total colectomy.
3. History of >3 small bowel resections or diagnosis of short bowel syndrome.
4. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
5. 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).
6. Prior exposure to any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of screening (whichever is longer).
7. Prior exposure to vedolizumab.
8. Surgical intervention for CD required at any time during the study.
9. History or evidence of adenomatous colonic polyps that have not been removed, or of colonic mucosal dysplasia.
10. Suspected or confirmed diagnosis of ulcerative colitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
11. Active infections.
12. 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.
13. History of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vedolizumab SC 108 mg Maintenance Arm; Open-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	Drug: Vedolizumab SC 108 mg; Vedolizumab SC Injection.; Drug: Vedolizumab IV 300 mg; Vedolizumab IV Injection.
Placebo Comparator: Placebo SC Maintenance Arm; Open-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	Drug: Vedolizumab IV 300 mg; Vedolizumab IV Injection.; Drug: Placebo; Vedolizumab placebo-matching SC injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Clinical Remission at Week 52	Clinical remission is defined as a 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.	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 52
Percentage of Participants Achieving Corticosteroid-free Remission at Week 52	Corticosteroid-free remission is defined as participants using oral corticosteroids at Baseline (Week 0) who have discontinued oral corticosteroids and are in clinical remission at Week 52. Clinical remission is defined as a 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.	Week 52
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.	Week 52

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2016
• Primary Completion (Actual): May 6, 2019
• Study Completion (Actual): August 6, 2019

Study Registration Dates

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

Study Record Updates

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

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Gastrointestinal Agents; Vedolizumab
• Other Study ID Numbers: MLN0002SC-3031; U1111-1168-0845 (Registry Identifier: WHO); 2015-000481-58 (EudraCT Number); NL55774.056.16 (Registry Identifier: CCMO); 16/LO/0090 (Registry Identifier: NRES); MLN0002SC-3031CTID (Registry Identifier: Israel); 163300410A0045 (Registry Identifier: NREC); 189748 (Registry Identifier: HC-CTD); MOH_2017-01-05_000039 (Other Identifier: CRS); JapicCTI-163386 (Registry Identifier: JapicCTI)

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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