AzTrials
AzTrials

Crohn DiseasePhase 3BERGAMOTNCT02394028

A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease

A Phase 3 study testing Etrolizumab in people with Crohn Disease, run by Hoffmann-La Roche at 327 sites in 33 countries.

Completed

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

Official record
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Trial summary

This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderately to severely active Crohn's Disease (CD). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Crohn Disease
What is being tested?
Etrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,035 participants
Where
327 sitesin 33 countries
Study dates
20 Mar 2015to 7 Sep 2021
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

  • Moderately to severely active Crohn's Disease (CD) as determined by the CDAI, patient reported outcomes and endoscopically defined disease activity in the ileum and/or colon
  • Intolerance, refractory disease, or no response to corticosteroids (CS), immunosuppressants (IS), or anti-TNF therapy within 5 years from screening. Participants who have not previously demonstrated inadequate response or intolerance to one or more anti-TNF therapies are eligible to participate in the study provided they are intolerant or refractory to CS or IS therapy
  • Use of effective contraception as defined by the protocol

Who cannot join

  • A history of, or current conditions affecting the digestive tract, such as ulcerative colitis, indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome
  • Planned surgery for CD
  • Ileostomy or colostomy
  • Has received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efalizumab, as stated in the protocol)
  • Any prior treatment with ustekinumab within 14 weeks prior to randomization
  • Chronic hepatitis B or C infection, human immunodeficiency virus (HIV), active or latent tuberculosis (participants with prior history of Bacillus Calmette-Guérin [BCG] vaccination must pass protocol-defined screening criteria)
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  • Sinus tract with evidence for infection (e.g., purulent discharge) in the clinical judgment of the investigator. Fistulas related to CD are not exclusionary
  • Any prior treatment with anti-adhesion molecules (e.g., anti-mucosal addressin cell adhesion molecule [anti-MAdCAM-1])
  • Any major episode of infection requiring treatment with intravenous antibiotics ≤8 weeks prior to screening or oral antibiotics ≤4 weeks prior to screening. Treatment with antibiotics as adjunctive therapy for CD in the absence of documented infection is not exclusionary
  • Hospitalization (other than for elective reasons) within 4 weeks prior to randomization

Trial locations and contacts

327 sites in 33 countries.

327 sites in 33 countries

United States62 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109-0666

  • Valley Gastroenterology Consultants

    Arcadia, California, 91006

  • Emory University Hospital

    Atlanta, Georgia, 30308

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • Innovative Medical Research of South Florida

    Aventura, Florida, 33180

  • Gastroenterology Associates, LLC

    Baton Rouge, Louisiana, 70809

  • Ehrhardt Clinical Research, LLC

    Belton, Missouri, 64012

  • Commonwealth Clinical Studies

    Brockton, Massachusetts, 02302

  • University of North Carolina At Chapel Hill

    Chapel Hill, North Carolina, 27514

  • Charlotte Gastroenterology and Hepatology, P.L.L.C

    Charlotte, North Carolina, 28207

  • Northwestern University-Feinberg School of Medicine; Division of Gastroenterology and Hepatology

    Chicago, Illinois, 60611

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Consultants for Clinical Research Inc.

    Cincinnati, Ohio, 45219

  • West Central Gastroenterology d/b/a Gastro Florida

    Clearwater, Florida, 33762

  • Ericksen Research and Development

    Clinton, Utah, 84015

  • Peak Gastroenterology Associates; Gastroenterology

    Colorado Springs, Colorado, 80907

  • Gastrointestinal Diseases Research

    Columbus, Georgia, 31904

  • Texas Digestive Disease Consultants - Dallas

    Dallas, Texas, 75231

  • University of Texas Southwestern Medical Center; Internal Medicne

    Dallas, Texas, 75390-9151

  • Atlanta Center for Gastroenterology, PC

    Decatur, Georgia, 30033

  • University of Florida College of Medicine

    Gainesville, Florida, 32610

  • Gastroenterology Center of the MidSouth PC

    Germantown, Tennessee, 38138

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

    Grand Rapids, Michigan, 49506

  • Innovative Clinical Research

    Greenville, South Carolina, 29604

  • Great Lakes Medical Research, LLC

    Harrisburg, Pennsylvania, 17110

  • Baylor College of Medicine; Gastroenterology

    Houston, Texas, 77030

  • Methodist Hospital Research Institute

    Houston, Texas, 77030

  • University of Mississippi Medical Center; Division of Gastroenterology

    Jackson, Mississippi, 39216

  • Borland-Groover Clinic

    Jacksonville, Florida, 32256

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • University of California San Diego Medical Center

    La Jolla, California, 92093-5354

  • VA Long Beach Healthcare System

    Long Beach, California, 90822

  • Gastroenterology Associates of Central Georgia

    Macon, Georgia, 31201

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Gastrointestinal Specialists of Georgia, PC

    Marietta, Georgia, 30060

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio, 44060

  • Advanced Clinical Research

    Meridian, Idaho, 83642

  • IMIC, Inc

    Miami Beach, Florida, 33140

  • FQL Research, LLC

    Miramar, Florida, 33025

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Concorde Medical Group

    New York, New York, 10016

  • Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)

    New York, New York, 10021

  • Lenox Hill Hospital

    New York, New York, 10075

  • Southwest Gastroenterology; DM Clinical Research

    Oak Lawn, Illinois, 60453-3767

  • Digestive Disease Specialists, Inc.

    Oklahoma City, Oklahoma, 73112

  • McGuire Research Institute; Gastroenterology

    Richmond, Virginia, 23249

  • Mayo Clinic - Rochester; Gastrology

    Rochester, Minnesota, 55905

  • University of Utah School of Medicine

    Salt Lake City, Utah, 84132

  • Wellness Clinical Research Center

    San Antonio, Texas, 78232

  • Digestive Care Associates, A Medical Corporation

    San Carlos, California, 94070

  • SDG Clinical Research

    San Diego, California, 92103

  • University of California at San Francisco (PARENT); Gastroenterology, Hepatology & Nutrition

    San Francisco, California, 94158

  • Digestive Disease Institute; Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Louisiana Research Center, LLC

    Shreveport, Louisiana

  • Texas Digestive Disease Consultants - Southlake

    Southlake, Texas, 76092

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

    Topeka, Kansas, 66606

  • Advanced Research Institute, Inc.

    Trinity, Florida, 34655

  • Center for Digestive Health

    Troy, Michigan, 48098

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

  • Carle Foundation Hospital

    Urbana, Illinois, 61801-2500

  • Henry Ford Health System

    West Bloomfield, Michigan, 48322

  • Shafran Gastroenterology Center

    Winter Park, Florida, 32789

Other trials in United States

Poland19 sites

  • SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

    Bialystok, 15-275

  • Nasz Lekarz Osrodek Badan Klinicznych

    Bydgoszcz, 85-312

  • Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ

    Elblag, 82-300

  • ETG Kielce

    Kielce, 25-355

  • Centrum Opieki Zdrowotnej Orkan-Med

    Ksawerów, 95-054

  • Indywidualna Specjalistyczna Praktyka Lekarska

    Lublin, 20-015

  • Allmedica Badania Kliniczne Sp z o.o. Sp K.

    Nowy Targ, 34-400

  • Centrum Medyczne "MEDYK"

    Rzeszów, 35-055

  • Gabinet Lekarski, Bartosz Korczowski

    Rzeszów, 35-302

  • Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia

    Sopot, 81-756

  • Niepubliczny Zaklad Opieki Zdrowotnej SONOMED

    Szczecin, 70-351

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne

    Szczecin, 71-434

  • Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj

    Torun, 87-100

  • Centrum Zdrowia MDM

    Warsaw, 00-631

  • Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728

  • Zespó Przychodni Specjalistycznych PRIMA

    Warsaw, 02-018

  • PlanetMed sp. z o.o.

    Wroclaw, 52-210

  • LexMedica Osrodek Badan Klinicznych

    Wroclaw, 53-114

  • EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu

    Wroclaw, 54-144

Other trials in Poland

Ukraine19 sites

  • RCNECRCH Dept of Surgery, SHEI Ukr BSMU

    Chernivtsi, Podolia Governorate, 58002

  • Ivano-Frankivsk Regional Clinical Hospital

    Ivano-Frankivsk, Kuban People's Republica, 76000

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

    Kharkiv, Kharkiv Governorate, 61037

  • CI of Healthcare Kharkiv Reg Clin Hosp-Center of Med Emergency & Accident Medicine

    Kharkiv, Kharkiv Governorate, 61204

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

    Kharkiv, 61039

  • CHI Kharkiv City Clinical Hospital #13

    Kharkiv, 61124

  • Kremenchuk first city hospital n.a. O.T. Bohaievskyi; Gastroenterology department

    Kremenchuk, Poltava Governorate, 39617

  • Medical Center of Limited Liability Company Medical Clinic Blagomed

    Kyiv, KIEV Governorate, 1023

  • Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"

    Kyiv, KIEV Governorate, 2091

  • CI of Kyiv RC Regional Clinical Hospital #2

    Kyiv, KIEV Governorate, 4073

  • Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU

    Kyiv, 01030

  • Lviv Regional Clinical Hospital

    Lviv, KIEV Governorate, 79010

  • City Hospital #1

    Mykolaiv, 54003

  • Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2

    Odesa, 65059

  • Private Small Enterprise Medical Center Pulse

    Vinnytsia, 21001

  • M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

    Vinnytsia, 21018

  • MCIC MC LLC Health Clinic

    Vinnytsia, 21029

  • CI City Hospital #1

    Zaporizhzhya, Tavria Okruha, 69104

  • LLC Diaservis

    Zaporizhzhya, 69106

Other trials in Ukraine

Brazil17 sites

  • Hospital Felicio Rocho

    Belo Horizonte, Minas Gerais, 30110-068

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

    Botucatu, São Paulo, 18618-970

  • L2IP -Instituto de Pesquisas Clínicas Ltda.

    Brasília, Federal District, 70200-730

  • Centro Digestivo de Curitiba

    Curitiba, Paraná, 80430-160

  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

    Goiânia, Goiás, 74535-170

  • Hospital São Vicente de Paulo; Institute of Education and Reseach / Cardiovascular Research Unit

    Passo Fundo, Rio Grande do Sul, 99010-080

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Ernesto Dornelles

    Porto Alegre, Rio Grande do Sul, 90160-092

  • Hospital Universitario Clementino Fraga Filho - UFRJ; Gastroenterologia

    Rio de Janeiro, Rio de Janeiro, 21941-590

  • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A

    Rio de Janeiro, Rio de Janeiro, 22271-100

  • Pesquisare Saúde Sociedade Simples

    Santo André, São Paulo, 09080-000

  • Praxis Pesquisa Médica

    Santo André, São Paulo, 09090-790

  • Hospital Estadual Mario Covas

    Santo André, São Paulo, 09190-610

  • Hospital de Base de Sao Jose do Rio Preto

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

  • Hospital Sírio-Libanês

    São Paulo, São Paulo, 01308-050

  • Hospital Sao Paulo

    São Paulo, São Paulo, 04037-002

  • Hospital do Servidor Público Estadual/HSPE-SP

    São Paulo, São Paulo, 04039-901

Other trials in Brazil

Australia15 sites

  • Bankstown-Lidcombe Hospital

    Bankstown, New South Wales, 2200

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Monash Medical Centre Clayton

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Footscray Hospital; Gastroenterology

    Footscray, Victoria, 3011

  • The Canberra Hospital

    Garran, Australian Capital Territory, 2065

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • St Frances Xavier Cabrini Hospital

    Malvern, Victoria, 3144

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics

    Parkville, Victoria, 3050

  • University of the Sunshine Coast

    Sippy Downs, Queensland, 4556

  • Mater Adult Hospital

    South Brisbane, Queensland, 4101

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

South Korea15 sites

  • Inje University Busan Paik Hospital

    Busan, 47392

  • Dong-A University Hospital

    Busan, 49201

  • Pusan National University Hospital

    Busan, 49241

  • Kyungpook National University Hospital

    Daegu, 41944

  • Yeungnam Univ. Hospital

    Daegu, 705-717

  • Hanyang University Guri Hospital

    Gyeonggi-do, 11923

  • Korea University Ansan Hospital

    Gyeonggi-do, 15355

  • CHA Bundang Medical Centre; CHA university

    Seongnam, 13520

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, 220-701

Other trials in South Korea

United Kingdom15 sites

  • Royal Victoria Hospital

    Belfast, BT12 6BA

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • University Hospital Coventry

    Coventry, CV2 2DX

  • Royal Devon and Exeter Hospital (Wonford)

    Exeter, EX2 5DW

  • Queen Elizabeth Hospital

    Kings Lynn, PE30 4ET

  • St James University Hospital

    Leeds, LS9 7TF

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP

  • Whipps Cross Hospital

    London, E11 1NR

  • University College London Hospital

    London, NW1 - 2PG

  • Fairfield General Hospital

    Manchester, M8 5RB

  • Royal Victoria Infirmary; Stroke unit

    Newcastle upon Tyne, NE1 4LP

  • Nottingham University Hospitals Queen's Medical Centre

    Nottingham, NG7 2UH

  • Royal Berkshire Hospital

    Reading, RG1 5AN

  • Southampton General Hospital

    Southampton, SO16 6YD

  • Royal Wolverhampton hospital; McHale Building

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

France14 sites

  • CHU Amiens - Hopital Sud

    Amiens, 80054

  • CHU de Caen - Hopital Cote de Nacre

    Caen, 14033

  • Hôpital Beaujon

    Clichy, 92110

  • Hopital Claude Huriez - CHU Lille

    Lille, 59037

  • CHU NANTES - Hôtel Dieu; Pharmacy

    Nantes, 44093

  • CHU Nice - Hopital de l'Archet 2

    Nice, 06202

  • Hôpital Saint-Louis

    Paris, 75475

  • Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN

    Pessac, 33604

  • Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie

    Pierre-Bénite, 69495

  • CHU du Reims - Hopital Robert Debré

    Reims, 51092

  • CHU Rennes - Hopital Pontchaillou

    Rennes, 35033

  • CHU Saint Etienne - Hôpital Nord

    Saint-Etienne, 42055

  • Höpital Hautepierre; Pediatrie1

    Strasbourg, 67098

  • Hôpital de Brabois Adultes

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Spain14 sites

  • Hospital Clínic i Provincial; Servicio de Farmacia

    Barcelona, 08036

  • Centro Médico Teknon

    Barcelona

  • Hospital Reina Sofia; Medical Oncology

    Córdoba, 14004

  • Hospital Juan Ramón Jiménez

    Huelva, 21005

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario de la Princesa

    Madrid, 28006

  • Hospital Universitario La Paz

    Madrid, 280146

  • Hospital Universitario de Fuenlabrada

    Madrid, 28942

  • Hospital Universitario Puerta de Hierro Majadahonda; Hepatology studies

    Majadahonda, Madrid, 28222

  • Complejo Hospitalario de Pontevedra

    Pontevedra, 36071

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Canada13 sites

  • University of Calgary

    Calgary, Alberta, T2N 2T9

  • Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology

    Edmonton, Alberta, T6G 2X8

  • Queen Elizabeth II Health Sciences Centre; Gastroenterology Research

    Halifax, Nova Scotia, B3H 1V7

  • University Hospital - London Health Sciences Centre

    London, Ontario, N6A 5A5

  • Hôpital Maisonneuve - Rosemont

    Montreal, Quebec, H1T 2M4

  • McGill University Health Centre - Glen Site

    Montreal, Quebec, H4A 3J1

  • Taunton Health Centre

    Oshawa, Ontario, L1H 7K4

  • The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit

    Ottawa, Ontario, K1H 1A2

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

  • (G.I.R.I.) GI Research Institute

    Vancouver, British Columbia, V6Z 2K5

  • Toronto Digestive Disease Associates

    Vaughan, Ontario, L4L 4Y7

  • Winnipeg Regional Health Authority

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Russia12 sites

  • SBEI HPE Altai StateMedicalUniversityofMoH andSD

    Barnaul, 656050

  • Irkutsk State Medical Academy of Continuing Education

    Irkutsk

  • Yusupov Hospital

    Moskva, Adygeya Republic, 127015

  • LLC "Novosibirsk GastroCenter"

    Novosibirsk, Altaj, 630007

  • SBEIHPE Novosibirsk State Medical University

    Novosibirsk, 630091

  • BHI of Omsk region Clinical Oncology Dispensary

    Omsk, 644013

  • Evromedservis LCC

    Pushkin, 196603

  • SEIHPE "Rostov SMU of MoH of RF"

    Rostov-on-Don, 344022

  • North-Western Medical University n.a. I.I. Mechnikov; Rheumatology

    Saint Petersburg, Sankt-Peterburg, 191015

  • Baltic Medicine

    Saint Petersburg, Sankt-Peterburg, 194356

  • SBIH City Clinical Hospital #31

    Saint Petersburg, Sankt-Peterburg, 197110

  • Federal State Military Educational Institution; High Professional Education Military Medical Acad

    Saint Petersburg, 194044

Other trials in Russia

Germany11 sites

  • Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie

    Berlin, 13353

  • Krankenhaus Waldfriede e. V.

    Berlin, 14163

  • Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

    Bochum, 44789

  • Universitätsklinikum Koeln

    Cologne, 50937

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt, 60590

  • Universitaetsklinikum Halle (Saale)

    Halle, 06120

  • Medizinische Hochschule Hannover; Gastroenterology and Hepatology dept

    Hanover, 30625

  • Klinikum Mannheim GmbH Universitätsklinikum

    Mannheim, 68167

  • Gemeinschaftspraxis

    Offenburg, 77652

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

  • Universitaetsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Czechia10 sites

  • Vojenska nemocnice Brno

    Brno, 636 00

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91

  • Nemocnice Ceske Budejovice a.s.

    České Budějovice, 370 01

  • Gastroenterologie s.r.o.

    Hradec Králové, 500 02

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

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

    Hradec Králové, 500 12

  • PreventaMed, s.r.o.

    Olomouc, 779 00

  • Fakultni nemocnice Ostrava

    Ostrava - Poruba, 708 52

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 110 34

  • Klinicke centrum ISCARE Lighthouse

    Prague, 170 00

Other trials in Czechia

Hungary10 sites

  • Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

    Békéscsaba, 5600

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, 1036

  • Semmelweis Egyetem

    Budapest, 1083

  • Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo

    Budapest, 1125

  • Pannonia Maganorvosi Centrum

    Budapest, 1135

  • Debreceni Egyetem

    Debrecen, 4032

  • Petz Aladar Megyei Oktato Korhaz

    Győr, 9024

  • Pest Megyei Flor Ferenc Korhaz

    Kistarcsa, 2143

  • Pecsi Tudomanyegyetem

    Pécs, 7624

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000

Other trials in Hungary

Italy10 sites

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Tuscany, 50134

  • Asst Fatebenefratelli Sacco (Fatebenefratelli)

    Milan, Lombardy, 20121

  • ASST FATEBENEFRATELLI SACCO (Sacco)

    Milan, Lombardy, 20157

  • Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

    Milan, Lombardy, 20162

  • A.O.U. Policlinico di Modena

    Modena, Emilia-Romagna, 40124

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, Lazio, 00152

  • Policlinico Universitario Agostino Gemelli; Farmacia

    Rome, Lazio, 00168

  • Istituto Clinico Humanitas

    Rozzano (MI), Lombardy, 20089

  • I.R.C.C.S Policlinico San Donato

    San Donato Milanese (MI), Lombardy, 20097

  • Ospedale Umberto I di Torino

    Turin, Piedmont, 10128

Other trials in Italy

Turkey (Türkiye)9 sites

  • Ankara University Medical Faculty

    Ankara, 06100

  • Hacettepe University Medical Faculty; Gastroenterology

    Ankara, 06100

  • Gazi University Medical Faculty

    Ankara, 06500

  • Acibadem Fulya Hospital; Neurology

    Istanbul, 34349

  • Haydarpasa Numune Training and Research Hospital; Medical Oncology

    Istanbul, 34668

  • Medeniyet University Goztepe Training and Research Hospital; Chest Diseases

    Istanbul, 34722

  • Ege University Medical Faculty

    Izmir, 35100

  • Kocaeli Universitesi Tip Fakultesi; Infectious Diseases

    Kocaeli, 41380

  • Acibadem Kozyatagi Hospital; Gastroenterology

    Kozyataği, 34742

Other trials in Turkey (Türkiye)

Israel8 sites

  • Haemek Medical Center

    Afula, 18101

  • Soroka University Medical Centre

    Beersheba, 8410101

  • Wolfson Medical Center; Obstetrics and Gynecology

    Holon, 5822012

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001

  • Holy Family Hospital

    Nazareth, 16100

  • Rabin Medical Center-Beilinson Campus

    Petah Tikva, 4941492

  • Tel Aviv Sourasky Medical Center; Pharmacy

    Tel Aviv, 6423906

Other trials in Israel

Netherlands7 sites

  • Amsterdam UMC, Locatie VUMC; Neurology

    Amsterdam, 1081 HV

  • Amsterdam UMC Location AMC

    Amsterdam, 1105 AZ

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA

  • Maastricht University Medical Center

    Maastricht, 6229 HX

  • Erasmus Medisch Centrum

    Rotterdam, 3000 CA

  • Zuyderland Medisch Centrum - Sittard Geleen

    Sittard-Geleen, 6162 BG

  • ETZ TweeSteden

    Tilburg, 5042AD

Other trials in Netherlands

New Zealand6 sites

  • North Shore Hospital

    Auckland, 0620

  • Christchurch Hospital NZ

    Christchurch, 8011

  • Dunedin Public Hospital

    Dunedin, 9016

  • Waikato Hospital

    Hamilton, 3248

  • Shakespeare Specialist Group

    Takapuna, 0620

  • Tauranga Hospital

    Tauranga, 3143

Other trials in New Zealand

Belgium5 sites

  • CHU St Pierre (St Pierre)

    Brussels, 1000

  • Hospital Erasme

    Brussels, 1070

  • UZ Brussel

    Brussels, 1090

  • UZ Antwerpen

    Edegem, 2650

  • AZ Maria Middelares

    Ghent, 9000

Other trials in Belgium

Serbia5 sites

  • Clinical Helth Centre Zvezdara

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11040

  • University Hospital Medical Center Bezanijska kosa

    Belgrade, 11080

  • Clinical Center of Vojvodina

    Novi Sad, 21000

  • General Hospital Djordje Joanovic

    Zrenjanin, 23000

Other trials in Serbia

Croatia4 sites

  • Clinical Hospital Centre Osijek

    Osijek, 31000

  • General Hospital Pula

    Pula, 52000

  • Clinical Hospital Center Sestre Milosrdnice

    Zagreb, 10000

  • University Hospital Center Zagreb

    Zagreb, 10000

Other trials in Croatia

Slovakia4 sites

  • IBDcentrum s.r.o.

    Bratislava, 83104

  • KM Management spol. s r.o.

    Nitra, 94901

  • Accout Center s.r.o.

    Šahy, 936 01

  • Endomed, s.r.o.

    Vranov nad Topľou, 093 01

Other trials in Slovakia

Bulgaria3 sites

  • "City Clinic UMHAC" EOOD

    Sofia, 1407

  • UMHAT "Sv. Ivan Rilski", EAD

    Sofia, 1431

  • UMHAT Tsaritsa Yoanna - ISUL, EAD

    Sofia, 1527

Other trials in Bulgaria

Estonia3 sites

  • West Tallinn Central Hospital

    Tallinn, 10617

  • North Estonia Medical Centre Foundation

    Tallinn, 13419

  • Tartu University Hospital

    Tartu, 51014

Other trials in Estonia

Romania3 sites

  • S.C MedLife S.A

    Bucharest, 010719

  • Spitalul Clinic Colentina

    Bucharest, 772202

  • Centrul de Gastroenterologie Dr. Goldis

    Timișoara, 300002

Other trials in Romania

Switzerland3 sites

  • Inselspital-Universitaetsspital Bern

    Bern, 3010

  • Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner

    Bern, 3012

  • Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

Austria2 sites

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg, 5020

  • Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

Latvia2 sites

  • Riga East Clinical University Hospital; Clinic Gailezers

    Riga, LV 1002

  • Pauls Stradins Clinical University Hospital

    Riga, LV-1002

Other trials in Latvia

Lithuania2 sites

  • Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

    Kaunas, 50009

  • Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology

    Vilnius, LT-08661

Other trials in Lithuania

Mexico2 sites

  • Medical Care & Research SA de CV

    Mérida, Yucatán, 97070

  • Clinical Research Institute

    Tlalnepantla, Mexico CITY (federal District), 54055

Other trials in Mexico

South Africa2 sites

  • Dr D Epstein Practice

    Cape Town, 7405

  • Emmed Research

    Pretoria, 0002

Other trials in South Africa

Argentina1 site

  • Hospital Italiano

    Buenos Aires, C1181ACH

Other trials in Argentina

About this study

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction And Maintenance Treatment For Patients With Moderately to Severely Active Crohn's Disease

This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderately to severely active Crohn's Disease (CD). The target population includes participants with CD who are refractory or intolerant to corticosteroids (CS) and/or immunosuppressant (IS) therapy and who have either not received prior anti-tumor necrosis factor (anti-TNF) therapy (TNF-naive) or who have had prior exposure to anti-TNF therapies and demonstrated inadequate responses or intolerance to anti-TNFs.

The study period will consist of a Screening Phase (up to 35 days) plus (+) a 14-week Induction Phase + a 52-week Maintenance Phase + a 12-week Safety Follow-up Phase. At Week 14 (end of Induction Phase), participants achieving a decrease from baseline of at least 70 points in the Crohn's Disease Activity Index (CDAI) score (CDAI-70 response) without the use of rescue therapy will continue to the Maintenance Phase.

Conditions
Crohn Disease
Being tested
Etrolizumab, Placebo
Medical subject headings
Crohn Disease

What participants receive

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

  • EtrolizumabDrug

    Also called RO5490261, RG7413

    Etrolizumab will be administered as per regimen specified in individual arms.

  • PlaceboDrug

    Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.

Study groups in NCT02394028
Study groupRoleWhat they receive
Induction Phase - Cohort 1 (Exploratory): Etrolizumab 210 mgExperimentalCohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Receives: Drug: Etrolizumab; Drug: Placebo
Induction Phase - Cohort 1 (Exploratory): Etrolizumab 105 mgExperimentalCohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Receives: Drug: Etrolizumab; Drug: Placebo
Induction Phase - Cohort 1 (Exploratory): PlaceboPlacebo comparatorCohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Receives: Drug: Placebo
Induction Phase - Cohort 2 (Open-Label): Etrolizumab 210 mgExperimentalCohort 2 is enrolling participants after Cohort 1 and is considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm will receive one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Receives: Drug: Etrolizumab; Drug: Placebo
Induction Phase - Cohort 2 (Open-Label): Etrolizumab 105 mgExperimentalCohort 2 is enrolling participants after Cohort 1 and is considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm will receive one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Receives: Drug: Etrolizumab; Drug: Placebo
Induction Phase - Cohort 3 (Pivotal): Etrolizumab 210 mgExperimentalCohort 3 is the last to enroll participants (after Cohort 2) and will be the pivotal cohort for the Induction Phase. Participants randomized to this arm will receive one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Receives: Drug: Etrolizumab; Drug: Placebo
Induction Phase - Cohort 3 (Pivotal): Etrolizumab 105 mgExperimentalCohort 3 is the last to enroll participants (after Cohort 2) and will be the pivotal cohort for the Induction Phase. Participants randomized to this arm will receive one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Receives: Drug: Etrolizumab; Drug: Placebo
Induction Phase - Cohort 3 (Pivotal): PlaceboPlacebo comparatorCohort 3 is the last to enroll participants (after Cohort 2) and will be the pivotal cohort for the Induction Phase. Participants randomized to this arm will receive two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Receives: Drug: Placebo
Maintenance Phase - Placebo Responders: PlaceboPlacebo comparatorParticipants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 will undergo a sham randomization into the Maintenance Phase. Placebo responders from induction will receive blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Receives: Drug: Placebo
Maintenance Phase - Etrolizumab Responders: PlaceboPlacebo comparatorParticipants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy will be re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm will receive blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Receives: Drug: Placebo
Maintenance Phase - Etrolizumab Responders: Etrolizumab 105 mgExperimentalParticipants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy will be re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm will receive blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Receives: Drug: Etrolizumab

What is being measured

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

  1. Induction Phase: Cohort 1: Percentage of Participants With Clinical Remission at Week 14

    Clinical remission is defined as liquid/soft stool frequency (SF) mean daily score less than or equal (≤)3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.

    Measured: Week 14

  2. Induction Phase: Cohort 2 and 3: Percentage of Participants With Clinical Remission at Week 14

    Clinical remission is defined as liquid/soft stool frequency (SF) mean daily score less than or equal (≤)3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.

    Measured: Week 14

  3. Induction Phase: Cohort 1: Percentage of Participants With Endoscopic Improvement at Week 14

    Endoscopic improvement is defined as 50 percent (%) reduction from baseline in Simplified Endoscopic Index for Crohn's Disease (SES-CD) score.

    Measured: Week 14

  4. Induction Phase: Cohort 2 and 3: Percentage of Participants With Endoscopic Improvement at Week 14

    Endoscopic improvement is defined as 50 percent (%) reduction from baseline in Simplified Endoscopic Index for Crohn's Disease (SES-CD) score.

    Measured: Week 14

  5. Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66

    Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.

    Maintenance phase participants were evaluated.

    Measured: Baseline and Week 66

  6. Maintenance Phase: Percentage of Participants With Endoscopic Improvement at Week 66

    Endoscopic improvement is defined as 50% reduction from baseline in SES-CD score. Maintenance phase participants were evaluated.

    Measured: Week 66

Secondary outcomes (22)

  1. Induction Phase: Cohort 1: Percentage of Participants With Clinical Remission at Week 6

    Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.

    Measured: Week 6

  2. Induction Phase: Cohort 2 and 3: Percentage of Participants With Clinical Remission at Week 6

    Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.

    Measured: Week 6

  3. Induction Phase: Cohort 1: Percentage of Participants With SES-CD Score ≤4 (≤2 for Ileal Participants), With No Segment Having a Subcategory Score Greater Than (>)1, at Week 14

    Endoscopic Remission is defined as SES-CD total score <=4 (<=2 for ileal only patients), with no segment having a subcategory score >1. SES-CD = Simple Endoscopic Score for Crohn's Disease. A composite of four assessments, each rated from 0 to 3: size of ulcers, proportion of the surface covered by ulcers, proportion of the surface with any other lesions, and presence of narrowings (stenosis). The SES-CD total score ranges from 0 to 60, a higher score indicates worse disease activity.

    Measured: Week 14

  4. Induction Phase: Cohort 2 and 3: Percentage of Participants With SES-CD Score ≤4 (≤2 for Ileal Participants), With No Segment Having a Subcategory Score Greater Than (>)1, at Week 14

    Endoscopic Remission is defined as SES-CD total score <=4 (<=2 for ileal only patients), with no segment having a subcategory score >1. SES-CD = Simple Endoscopic Score for Crohn's Disease. A composite of four assessments, each rated from 0 to 3: size of ulcers, proportion of the surface covered by ulcers, proportion of the surface with any other lesions, and presence of narrowings (stenosis). The SES-CD total score ranges from 0 to 60, a higher score indicates worse disease activity.

    Measured: Week 14

  5. Induction Phase: Cohort 1: Change From Baseline in Crohn's Disease-Patient-Reported Outcome Signs and Symptoms (CD-PRO/SS) Score at Week 14

    CD-PRO/SS: Crohn's Disease Patient Reported Outcomes Signs and Symptoms. For each item, the score is taken as the average across 4-7 days eDiary data within a 9 day window from visit, else the score is considered missing. The CD-PRO/SS Bowel domain is a total score summed across 3 items and ranges from 0 - 16. The Functional domain score is a total score summed across 3 items and ranges from 0 - 12. A higher CD-PRO/SS score indicates worse quality of life. Participants are included in the analysis if they have both Baseline and at least one post-baseline score available.

    Measured: Baseline and Week 14

  6. Induction Phase: Cohort 2 and 3: Change From Baseline in Crohn's Disease-Patient-Reported Outcome Signs and Symptoms (CD-PRO/SS) Score at Week 14

    CD-PRO/SS: Crohn's Disease Patient Reported Outcomes Signs and Symptoms. For each item, the score is taken as the average across 4-7 days eDiary data within a 9 day window from visit, else the score is considered missing. The CD-PRO/SS Bowel domain is a total score summed across 3 items and ranges from 0 - 16. The Functional domain score is a total score summed across 3 items and ranges from 0 - 12. A higher CD-PRO/SS score indicates worse quality of life. Participants are included in the analysis if they have both Baseline and at least one post-baseline score available.

    Measured: Baseline and Week 14

  7. Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66, Among Those Who Achieved Clinical Remission at Week 14

    Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.

    Induction Phase Cohorts are not included

    Measured: Baseline, Weeks 14 and 66

  8. Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 66, Among Those Who Were Receiving Corticosteroids at Baseline

    Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.

    Induction Phase Cohorts are not included

    Measured: Baseline and Week 66

  9. Maintenance Phase: Percentage of Participants With Endoscopic Improvement at Week 66 Among Participants Who Achieved Endoscopic Improvement at Week 14

    Endoscopic improvement is defined as 50% reduction from baseline in SES-CD score. Induction Phase Cohorts are not included

    Measured: Baseline, Weeks 14 and 66

  10. Maintenance Phase: Percentage of Participants With SES-CD Score ≤4 (≤2 for Ileal Participants), With No Segment Having a Subcategory Score >1, at Week 66

    Endoscopic Remission is defined as SES-CD total score <=4 (<=2 for ileal only patients), with no segment having a subcategory score >1. SES-CD = Simple Endoscopic Score for Crohn's Disease. A composite of four assessments, each rated from 0 to 3: size of ulcers, proportion of the surface covered by ulcers, proportion of the surface with any other lesions, and presence of narrowings (stenosis). The SES-CD total score ranges from 0 to 60, a higher score indicates worse disease activity.

    Measured: Week 66

  11. Maintenance Phase: Percentage of Participants With Durable Clinical Remission

    Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit. Durable clinical remission was defined as clinical remission at ≥4 of the 6 in-clinic assessment visits conducted during the Maintenance Phase at Weeks 24, 28, 32, 44, 56, and 66. Induction Phase Cohorts are not included

    Measured: Week 14 up to Week 66 (assessed at Weeks 24, 28, 32, 44, 56, and 66)

  12. Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission for at Least 24 Weeks at Week 66, Among Those Who Were Receiving Corticosteroids at Baseline

    Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit. Percentage of participants with clinical remission who will be off corticosteroids for at least 24 weeks prior to Week 66 will be reported.

    Induction Phase Cohorts are not included

    Measured: Baseline and from Week 14 up to Week 66

  13. Maintenance Phase: Change From Baseline in CD-PRO/SS Score at Week 66

    CD-PRO/SS: Crohn's Disease Patient Reported Outcomes Signs and Symptoms. For each item, the score is taken as the average across 4-7 days eDiary data within a 9 day window from visit, else the score is considered missing. The CD-PRO/SS Bowel domain is a total score summed across 3 items and ranges from 0 - 16. The Functional domain score is a total score summed across 3 items and ranges from 0 - 12. A higher CD-PRO/SS score indicates worse quality of life. Participants are included in the analysis if they have both Baseline and at least one post-baseline score available.

    Measured: Baseline and Week 66

  14. Overall Number of Participants Who Experienced at Least One Adverse Event by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0)

    Investigator text for AEs is coded using MedDRA version 24.0. For participants counts, multiple occurrences of AEs in the same category for an individual are counted only once. For event counts, multiple occurrences of AEs in the same category for an individual are counted separately. Severity Grades from 1 to 5.

    Measured: From Baseline up to Week 78

  15. Overall Number of Participants With Adverse Events Leading to Study Drug Discontinuation

    Number of participants who discontinued the study due to the adverse events is reported.

    Measured: From Baseline up to Week 78

  16. Overall Number of Participants Who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0

    Participants who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0 are reported. Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = Death. The terms 'severe' and 'serious' are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs are counted only once per participant at the highest (worst) grade. Infections are identified by Primary System Organ Class term 'Infections and Infestations'

    Measured: From Baseline up to Week 78

  17. Overall Number of Participants Who Experienced at Least One Infection-Related Serious Adverse Event

    Investigator text for AEs is coded using MedDRA version 24.0. Infections are identified by primary System Organ Class term 'Infections and Infestations'. The terms 'severe' and 'serious' are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs in the same category for an individual are counted only once

    Measured: From Baseline up to Week 78

  18. Overall Number of Participants Who Experienced at Least One Injection-Site Reaction by Severity, According to NCI-CTCAE v4.0

    Investigator test for AEs is coding using MedDRA version 24.0. Injection-Site Reactions are identified by eCRF checkbox for local injection site reactions, and/or primary or secondary HLT Injection Site Reactions. Multiple occurrences of AEs for an individual are counted only once, under the worst grade reported.

    Measured: From Baseline up to Week 78

  19. Overall Number of Participants Who Experienced at Least One Hypersensitivity Reaction by Severity, According to NCI-CTCAE v4.0

    Investigator text for AEs is coded using MedDRA version 24.0. Multiple occurrences of AEs for an individual are counted only once, under the worst grade reported.

    Measured: From Baseline up to Week 78

  20. Overall Number of Participants Who Develop Malignancies

    Participants with malignancies are reported. 'Malignancies are identified by SMQ Malignant and unspecified tumors (narrow)

    Measured: From Baseline up to Week 78

  21. Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab

    Participants who received at least one dose of study treatment and had at least one baseline or post-baseline ATA result. Induction: treatment groups were pooled across cohorts 1-3. Maintenance: treatment group is stratified by induction dose

    Measured: Baseline, Pre-dose (Hour 0) on Weeks 4, 14, 24, 32, 44, 66 or early termination, 12 weeks after last dose (up to Week 78)

  22. Observed Trough Serum Concentration (Ctrough) of Etrolizumab

    Serum Etrolizumab Trough Concentration

    Measured: Induction Phase at Weeks 10 and 14, Maintenance Phase at Weeks 16, 24, 28, 32, 44, and 66

Timeline

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

  1. First posted20 Mar 2015 (estimated)
  2. Study start20 Mar 2015
  3. Primary completion7 Sep 2021
  4. Study completion7 Sep 2021

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
Double blind
Who is masked
Participant, Investigator
Enrolment
1,035 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02394028
Sponsor's protocol ID
GA29144
Other IDs
2014-003824-36, 2014
Acronym
BERGAMOT
Status last verified
Oct 2022
First submitted
27 Feb 2015
Last updated
16 Nov 2022
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Moein A, Langenhorst J, Kassir N. A Longitudinal Disease Progression Model Characterizing Endoscopic Response and Remission in Crohn's Disease. J Pharmacokinet Pharmacodyn. 2026 Jul 11;53(5):38. doi: 10.1007/s10928-026-10042-x.

    PubMed 42436336

  • Sandborn WJ, Panes J, Danese S, Sharafali Z, Hassanali A, Jacob-Moffatt R, Eden C, Daperno M, Valentine JF, Laharie D, Baia C, Atreya R, Panaccione R, Rydzewska G, Aguilar H, Vermeire S; BERGAMOT Study Group. Etrolizumab as induction and maintenance therapy in patients with moderately to severely active Crohn's disease (BERGAMOT): a randomised, placebo-controlled, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. 2023 Jan;8(1):43-55. doi: 10.1016/S2468-1253(22)00303-X. Epub 2022 Oct 12.

    PubMed 36240801

  • Dai B, Hackney JA, Ichikawa R, Nguyen A, Elstrott J, Orozco LD, Sun KH, Modrusan Z, Gogineni A, Scherl A, Gubatan J, Habtezion A, Deswal M, Somsouk M, Faubion WA, Chai A, Sharafali Z, Hassanali A, Oh YS, Tole S, McBride J, Keir ME, Yi T. Dual targeting of lymphocyte homing and retention through alpha4beta7 and alphaEbeta7 inhibition in inflammatory bowel disease. Cell Rep Med. 2021 Aug 17;2(8):100381. doi: 10.1016/j.xcrm.2021.100381. eCollection 2021 Aug 17.

    PubMed 34467254

  • Reinisch W, Mishkin DS, Oh YS, Schreiber S, Hussain F, Jacob R, Hassanali A, Daperno M. Impact of various central endoscopy reading models on treatment outcome in Crohn's disease using data from the randomized, controlled, exploratory cohort arm of the BERGAMOT trial. Gastrointest Endosc. 2021 Jan;93(1):174-182.e2. doi: 10.1016/j.gie.2020.05.020. Epub 2020 May 25.

    PubMed 32464142

  • Sandborn WJ, Vermeire S, Tyrrell H, Hassanali A, Lacey S, Tole S, Tatro AR; Etrolizumab Global Steering Committee. Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program. Adv Ther. 2020 Jul;37(7):3417-3431. doi: 10.1007/s12325-020-01366-2. Epub 2020 May 22.

    PubMed 32445184

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etrolizumab in people with Crohn Disease, run by Hoffmann-La Roche at 327 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 3 inclusion and 10 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 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 327 sites in United States, Poland, Ukraine, Brazil, Australia 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. 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 16 Nov 2022). 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?

Induction Phase: Cohort 1: Percentage of Participants With Clinical Remission at Week 14 (time frame: Week 14). The study lists 6 primary outcomes in all. 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 NCT02394028, which also lists 5 linked publications.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.

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