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

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.

Study Overview

• Status: Completed
• Conditions: Crohn Disease
• Intervention / Treatment: Drug: Etrolizumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1035
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1181ACH
    • Hospital Italiano
• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2065
      • The Canberra Hospital
  • New South Wales
    • Bankstown, New South Wales, Australia, 2200
      • Bankstown-Lidcombe Hospital
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital
    • Sippy Downs, Queensland, Australia, 4556
      • University of the Sunshine Coast
    • South Brisbane, Queensland, Australia, 4101
      • Mater Adult Hospital
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre Clayton
    • Fitzroy, Victoria, Australia, 3065
      • St Vincent's Hospital Melbourne
    • Footscray, Victoria, Australia, 3011
      • Footscray Hospital; Gastroenterology
    • Malvern, Victoria, Australia, 3144
      • St Frances Xavier Cabrini Hospital
    • Melbourne, Victoria, Australia, 3004
      • Alfred Hospital
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
• Austria
  • Salzburg, Austria, 5020
    • LKH - Universitätsklinikum der PMU Salzburg
  • Wien, Austria, 1090
    • Medizinische Universitat Wien
• Belgium
  • Brussel, Belgium, 1090
    • UZ Brussel
  • Brussels, Belgium, 1000
    • CHU St Pierre (St Pierre)
  • Bruxelles, Belgium, 1070
    • Hospital Erasme
  • Edegem, Belgium, 2650
    • UZ Antwerpen
  • Gent, Belgium, 9000
    • AZ Maria Middelares
• Brazil
  • DF
    • Brasilia, DF, Brazil, 70200-730
      • L2IP -Instituto de Pesquisas Clínicas Ltda.
  • GO
    • Goiânia, GO, Brazil, 74535-170
      • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
  • MG
    • Belo Horizonte, MG, Brazil, 30110-068
      • Hospital Felício Rocho
  • PR
    • Curitiba, PR, Brazil, 80430-160
      • Centro Digestivo de Curitiba
  • RJ
    • Rio de Janeiro, RJ, Brazil, 21941-590
      • Hospital Universitario Clementino Fraga Filho - UFRJ; Gastroenterologia
    • Rio de Janeiro, RJ, Brazil, 22271-100
      • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
  • RS
    • Passo Fundo, RS, Brazil, 99010-080
      • Hospital São Vicente de Paulo; Institute of Education and Reseach / Cardiovascular Research Unit
    • Porto Alegre, RS, Brazil, 90035-903
      • Hospital das Clinicas - UFRGS
    • Porto Alegre, RS, Brazil, 90160-092
      • Hospital Ernesto Dornelles
  • SP
    • Botucatu, SP, Brazil, 18618-970
      • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
    • Santo Andre, SP, Brazil, 09080-000
      • Pesquisare Saúde Sociedade Simples
    • Santo Andre, SP, Brazil, 09090-790
      • Praxis Pesquisa Médica
    • Santo Andre, SP, Brazil, 09190-610
      • Hospital Estadual Mario Covas
    • Sao Jose do Rio Preto, SP, Brazil, 15090-000
      • Hospital de Base de Sao Jose do Rio Preto
    • Sao Paulo, SP, Brazil, 01308-050
      • Hospital Sírio-Libanês
    • Sao Paulo, SP, Brazil, 04037-002
      • Hospital São Paulo
    • São Paulo, SP, Brazil, 04039-901
      • Hospital do Servidor Público Estadual/HSPE-SP
• Bulgaria
  • Sofia, Bulgaria, 1407
    • "City Clinic UMHAC" EOOD
  • Sofia, Bulgaria, 1431
    • UMHAT "Sv. Ivan Rilski", EAD
  • Sofia, Bulgaria, 1527
    • UMHAT Tsaritsa Yoanna - ISUL, EAD
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • University of Calgary
    • Edmonton, Alberta, Canada, T6G 2X8
      • Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2K5
      • (G.I.R.I.) GI Research Institute
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Winnipeg Regional Health Authority
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • University Hospital - London Health Sciences Centre
    • Oshawa, Ontario, Canada, L1H 7K4
      • Taunton Health Centre
    • Ottawa, Ontario, Canada, K1H 1A2
      • The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital
    • Vaughan, Ontario, Canada, L4L 4Y7
      • Toronto Digestive Disease Associates
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre - Glen Site
    • Montreal, Quebec, Canada, H1T 2M4
      • Hôpital Maisonneuve - Rosemont
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital
• Croatia
  • Osijek, Croatia, 31000
    • Clinical Hospital Centre Osijek
  • Pula, Croatia, 52000
    • General Hospital Pula
  • Zagreb, Croatia, 10000
    • University Hospital Center Zagreb
  • Zagreb, Croatia, 10000
    • Clinical Hospital Center Sestre Milosrdnice
• Czechia
  • Brno, Czechia, 656 91
    • Fakultni nemocnice u sv. Anny v Brne
  • Brno, Czechia, 636 00
    • Vojenska nemocnice Brno
  • Ceske Budejovice, Czechia, 370 01
    • Nemocnice Ceske Budejovice a.s.
  • Hradec Kralove, Czechia, 500 05
    • Fakultni nemocnice Hradec Kralove
  • Hradec Kralove, Czechia, 500 12
    • Hepato-gastroenterologie HK, s.r.o.
  • Hradec Kralove, Czechia, 500 02
    • Gastroenterologie s.r.o.
  • Olomouc, Czechia, 779 00
    • PreventaMed, s.r.o.
  • Ostrava - Poruba, Czechia, 708 52
    • Fakultni Nemocnice Ostrava
  • Praha, Czechia, 110 34
    • Fakultni nemocnice Kralovske Vinohrady
  • Praha 7, Czechia, 170 00
    • Klinicke centrum ISCARE Lighthouse
• Estonia
  • Tallinn, Estonia, 10617
    • West Tallinn Central Hospital
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre Foundation
  • Tartu, Estonia, 51014
    • Tartu University Hospital
• France
  • Amiens, France, 80054
    • CHU Amiens - Hopital Sud
  • Caen, France, 14033
    • CHU de Caen - Hopital Cote de Nacre
  • Clichy cedex, France, 92110
    • Hopital Beaujon
  • Lille, France, 59037
    • Hopital Claude Huriez - CHU Lille
  • Nantes, France, 44093
    • CHU NANTES - Hôtel Dieu; Pharmacy
  • Nice, France, 06202
    • CHU Nice - Hopital de l'Archet 2
  • Paris, France, 75475
    • Hopital Saint-Louis
  • Pessac, France, 33604
    • Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN
  • Pierre-Benite, France, 69495
    • Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie
  • Reims, France, 51092
    • CHU du Reims - Hopital Robert Debré
  • Rennes cedex 09, France, 35033
    • CHU Rennes - Hôpital Pontchaillou
  • Saint Etienne, France, 42055
    • CHU Saint Etienne - Hopital Nord
  • Strasbourg, France, 67098
    • Höpital Hautepierre; Pediatrie1
  • Vandoeuvre-les-nancy, France, 54511
    • Hôpital de Brabois Adultes
• Germany
  • Berlin, Germany, 14163
    • Krankenhaus Waldfriede e. V.
  • Berlin, Germany, 13353
    • Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie
  • Bochum, Germany, 44789
    • Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
  • Frankfurt, Germany, 60590
    • Klinikum Der Johann Wolfgang Goethe-Universitaet
  • Halle, Germany, 06120
    • Universitaetsklinikum Halle (Saale)
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover; Gastroenterology and Hepatology dept
  • Koeln, Germany, 50937
    • Universitatsklinikum Koeln
  • Mannheim, Germany, 68167
    • Klinikum Mannheim GmbH Universitätsklinikum
  • Offenburg, Germany, 77652
    • Gemeinschaftspraxis
  • Tuebingen, Germany, 72076
    • Universitaetsklinikum Tuebingen
  • Ulm, Germany, 89081
    • Universitaetsklinikum Ulm
• Hungary
  • Bekescsaba, Hungary, 5600
    • Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem
  • Budapest, Hungary, 1036
    • Obudai Egeszsegugyi Centrum Kft.
  • Budapest, Hungary, 1125
    • Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz és Szakrendelo
  • Budapest, Hungary, 1135
    • Pannónia Magánorvosi Centrum
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem
  • Gyor, Hungary, 9024
    • Petz Aladar Megyei Oktato Korhaz
  • Kistarcsa, Hungary, 2143
    • Pest Megyei Flor Ferenc Korhaz
  • Pecs, Hungary, 7624
    • Pecsi Tudomanyegyetem
  • Székesfehérvár, Hungary, 8000
    • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
• Israel
  • Afula, Israel, 18101
    • Haemek Medical Center
  • Beer Sheva, Israel, 8410101
    • Soroka University Medical Centre
  • Holon, Israel, 5822012
    • Wolfson Medical Center; Obstetrics and Gynecology
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center
  • Jerusalem, Israel, 9112001
    • Hadassah University Hospital - Ein Kerem
  • Nazareth, Israel, 16100
    • Holy Family Hospital
  • Petach Tikva, Israel, 4941492
    • Rabin Medical Center-Beilinson Campus
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Center; Pharmacy
• Italy
  • Emilia-Romagna
    • Modena, Emilia-Romagna, Italy, 40124
      • A.O.U. Policlinico di Modena
  • Lazio
    • Roma, Lazio, Italy, 00152
      • Azienda Ospedaliera San Camillo Forlanini
    • Roma, Lazio, Italy, 00168
      • Policlinico Universitario Agostino Gemelli; Farmacia
  • Lombardia
    • Milano, Lombardia, Italy, 20121
      • Asst Fatebenefratelli Sacco (Fatebenefratelli)
    • Milano, Lombardia, Italy, 20157
      • ASST FATEBENEFRATELLI SACCO (Sacco)
    • Milano, Lombardia, Italy, 20162
      • Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
    • Rozzano (MI), Lombardia, Italy, 20089
      • Istituto Clinico Humanitas
    • San Donato Milanese (MI), Lombardia, Italy, 20097
      • I.R.C.C.S Policlinico San Donato
  • Piemonte
    • Torino, Piemonte, Italy, 10128
      • Ospedale Umberto I di Torino
  • Toscana
    • Florence, Toscana, Italy, 50134
      • Azienda Ospedaliera Universitaria Careggi
• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Pusan National University Hospital
  • Busan, Korea, Republic of, 49201
    • Dong-A University Hospital
  • Busan, Korea, Republic of, 47392
    • Inje University Busan Paik Hospital
  • Daegu, Korea, Republic of, 41944
    • Kyungpook National University Hospital
  • Daegu, Korea, Republic of, 705-717
    • Yeungnam Univ. Hospital
  • Gyeonggi-do, Korea, Republic of, 15355
    • Korea University Ansan Hospital
  • Gyeonggi-do, Korea, Republic of, 11923
    • Hanyang University Guri Hospital
  • Seongnam, Korea, Republic of, 13520
    • CHA Bundang Medical Centre; CHA university
  • Seongnam-si, Korea, Republic of, 13605
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 03181
    • Kangbuk Samsung Hospital
  • Wonju-Si, Korea, Republic of, 220-701
    • Yonsei University Wonju Severance Christian Hospital
• Latvia
  • Riga, Latvia, LV 1002
    • Riga East Clinical University Hospital; Clinic Gailezers
  • Rīga, Latvia, LV-1002
    • Pauls Stradins Clinical University Hospital
• Lithuania
  • Kaunas, Lithuania, 50009
    • Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
  • Vilnius, Lithuania, LT-08661
    • Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology
• Mexico
  • Mexico CITY (federal District)
    • Tlalnepantla de Baz, Mexico CITY (federal District), Mexico, 54055
      • Clinical Research Institute
  • Yucatan
    • Mérida, Yucatan, Mexico, 97070
      • Medical Care & Research SA de CV
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Amsterdam UMC, Locatie VUMC; Neurology
  • Amsterdam, Netherlands, 1105 AZ
    • Amsterdam UMC location AMC
  • Leiden, Netherlands, 2333 ZA
    • Leids Universitair Medisch Centrum
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University Medical Center
  • Rotterdam, Netherlands, 3000 CA
    • Erasmus Medisch Centrum
  • Sittard-Geleen, Netherlands, 6162 BG
    • Zuyderland Medisch Centrum - Sittard Geleen
  • Tilburg, Netherlands, 5042AD
    • ETZ TweeSteden
• New Zealand
  • Auckland, New Zealand, 0620
    • North Shore Hospital
  • Christchurch, New Zealand, 8011
    • Christchurch Hospital NZ
  • Dunedin, New Zealand, 9016
    • Dunedin Public Hospital
  • Hamilton, New Zealand, 3248
    • Waikato Hospital
  • Takapuna, New Zealand, 0620
    • Shakespeare Specialist Group
  • Tauranga, New Zealand, 3143
    • Tauranga Hospital
• Poland
  • Białystok, Poland, 15-275
    • SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
  • Bydgoszcz, Poland, 85-312
    • Nasz Lekarz Osrodek Badan Klinicznych
  • Elblag, Poland, 82-300
    • Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ
  • Kielce, Poland, 25-355
    • ETG Kielce
  • Ksawerow, Poland, 95-054
    • Centrum Opieki Zdrowotnej Orkan-med
  • Lublin, Poland, 20-015
    • Indywidualna Specjalistyczna Praktyka Lekarska
  • Nowy Targ, Poland, 34-400
    • Allmedica Badania Kliniczne Sp z o.o. Sp K.
  • Rzeszow, Poland, 35-055
    • Centrum Medyczne "MEDYK"
  • Rzeszów, Poland, 35-302
    • Gabinet Lekarski, Bartosz Korczowski
  • Sopot, Poland, 81-756
    • Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia
  • Szczecin, Poland, 71-434
    • Twoja Przychodnia-Szczecinskie Centrum Medyczne
  • Szczecin, Poland, 70-351
    • Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
  • Toruń, Poland, 87-100
    • Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
  • Warszawa, Poland, 00-631
    • Centrum Zdrowia MDM
  • Warszawa, Poland, 00-728
    • Warsaw IBD Point Profesor Kierkus
  • Warszawa, Poland, 02-018
    • Zespó Przychodni Specjalistycznych PRIMA
  • Wroclaw, Poland, 53-114
    • LexMedica Osrodek Badan Klinicznych
  • Wroclaw, Poland, 54-144
    • EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu
  • Wrocław, Poland, 52-210
    • PlanetMed sp. z o.o.
• Romania
  • Bucharest, Romania, 772202
    • Spitalul Clinic Colentina
  • Bucuresti, Romania, 010719
    • S.C MedLife S.A
  • Timisoara, Romania, 300002
    • Centrul de Gastroenterologie Dr. Goldis
• Russian Federation
  • Barnaul, Russian Federation, 656050
    • SBEI HPE Altai StateMedicalUniversityofMoH andSD
  • Irkutsk, Russian Federation
    • Irkutsk State Medical Academy of Continuing Education
  • Novosibirsk, Russian Federation, 630091
    • SBEIHPE Novosibirsk State Medical University
  • Omsk, Russian Federation, 644013
    • BHI of Omsk region Clinical Oncology Dispensary
  • Pushkin, Russian Federation, 196603
    • Evromedservis LCC
  • Rostov-on-Don, Russian Federation, 344022
    • SEIHPE "Rostov SMU of MoH of RF"
  • St. Petersburg, Russian Federation, 194044
    • Federal State Military Educational Institution; High Professional Education Military Medical Acad
  • Adygeja
    • Moskva, Adygeja, Russian Federation, 127015
      • Yusupov Hospital
  • Altaj
    • Novosibirsk, Altaj, Russian Federation, 630007
      • LLC "Novosibirsk GastroCenter"
  • Leningrad
    • St.Petersburg, Leningrad, Russian Federation, 194356
      • Baltic Medicine
  • Sankt Petersburg
    • Sankt-peterburg, Sankt Petersburg, Russian Federation, 191015
      • North-Western Medical University n.a. I.I. Mechnikov; Rheumatology
    • Sankt-peterburg, Sankt Petersburg, Russian Federation, 197110
      • SBIH City Clinical Hospital #31
• Serbia
  • Belgrade, Serbia, 11080
    • University Hospital Medical Center Bezanijska kosa
  • Belgrade, Serbia, 11000
    • Clinical Helth Centre Zvezdara
  • Belgrade, Serbia, 11040
    • Military Medical Academy
  • Novi Sad, Serbia, 21000
    • Clinical Center of Vojvodina
  • Zrenjanin, Serbia, 23000
    • General Hospital Djordje Joanovic
• Slovakia
  • Bratislava, Slovakia, 83104
    • IBDcentrum s.r.o.
  • Nitra, Slovakia, 94901
    • KM Management spol. s r.o.
  • Vranov nad Topľou, Slovakia, 093 01
    • Endomed, s.r.o.
  • Šahy, Slovakia, 936 01
    • Accout Center s.r.o.
• South Africa
  • Cape Town, South Africa, 7405
    • Dr D Epstein Practice
  • Pretoria, South Africa, 0002
    • Emmed Research
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clínic i Provincial; Servicio de Farmacia
  • Barcelona, Spain
    • Centro Médico Teknon
  • Cordoba, Spain, 14004
    • Hospital Reina Sofia; Medical Oncology
  • Huelva, Spain, 21005
    • Hospital Juan Ramon Jimenez
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa
  • Madrid, Spain, 280146
    • Hospital Universitario La Paz
  • Madrid, Spain, 28942
    • Hospital Universitario de Fuenlabrada
  • Pontevedra, Spain, 36071
    • Complejo Hospitalario de Pontevedra
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitario de Bellvitge
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro Majadahonda; Hepatology studies
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital-Universitaetsspital Bern
  • Bern, Switzerland, 3012
    • Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
  • Zürich, Switzerland, 8091
    • Universitatsspital Zurich
• Turkey
  • Ankara, Turkey, 06100
    • Ankara University Medical Faculty
  • Ankara, Turkey, 06500
    • Gazi University Medical Faculty
  • Ankara, Turkey, 06100
    • Hacettepe University Medical Faculty; Gastroenterology
  • Istanbul, Turkey, 34349
    • Acibadem Fulya Hospital; Neurology
  • Istanbul, Turkey, 34668
    • Haydarpasa Numune Training and Research Hospital; Medical Oncology
  • Istanbul, Turkey, 34722
    • Medeniyet University Goztepe Training and Research Hospital; Chest Diseases
  • Izmir, Turkey, 35100
    • Ege University Medical Faculty
  • Kocaeli, Turkey, 41380
    • Kocaeli Universitesi Tip Fakultesi; Infectious Diseases
  • Kozyataği, Turkey, 34742
    • Acibadem Kozyatagi Hospital; Gastroenterology
• Ukraine
  • Kharkiv, Ukraine, 61039
    • GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
  • Kharkiv, Ukraine, 61124
    • CHI Kharkiv City Clinical Hospital #13
  • Kyiv, Ukraine, 01030
    • Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU
  • Mykolaiv, Ukraine, 54003
    • City Hospital #1
  • Odesa, Ukraine, 65059
    • Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2
  • Vinnytsia, Ukraine, 21018
    • M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
  • Vinnytsia, Ukraine, 21001
    • Private Small Enterprise Medical Center Pulse
  • Vinnytsia, Ukraine, 21029
    • MCIC MC LLC Health Clinic
  • Zaporizhzhia, Ukraine, 69106
    • LLC Diaservis
  • KIEV Governorate
    • Kyiv, KIEV Governorate, Ukraine, 1023
      • Medical Center of Limited Liability Company Medical Clinic Blagomed
    • Kyiv, KIEV Governorate, Ukraine, 2091
      • Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
    • Kyiv, KIEV Governorate, Ukraine, 4073
      • CI of Kyiv RC Regional Clinical Hospital #2
    • Lviv, KIEV Governorate, Ukraine, 79010
      • Lviv Regional Clinical Hospital
  • Kharkiv Governorate
    • Kharkiv, Kharkiv Governorate, Ukraine, 61037
      • CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2
    • Kharkiv, Kharkiv Governorate, Ukraine, 61204
      • CI of Healthcare Kharkiv Reg Clin Hosp-Center of Med Emergency & Accident Medicine
  • Kuban People's Republica
    • Ivano-Frankivsk, Kuban People's Republica, Ukraine, 76000
      • Ivano-Frankivsk Regional Clinical Hospital
  • Podolia Governorate
    • Chernivtsi, Podolia Governorate, Ukraine, 58002
      • RCNECRCH Dept of Surgery, SHEI Ukr BSMU
  • Poltava Governorate
    • Kremenchuk, Poltava Governorate, Ukraine, 39617
      • Kremenchuk first city hospital n.a. O.T. Bohaievskyi; Gastroenterology department
  • Tavria Okruha
    • Zaporizhzhia, Tavria Okruha, Ukraine, 69104
      • CI City Hospital #1
• United Kingdom
  • Belfast, United Kingdom, BT12 6BA
    • Royal Victoria Hospital
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrooke's Hospital
  • Coventry, United Kingdom, CV2 2DX
    • University Hospital Coventry
  • Exeter, United Kingdom, EX2 5DW
    • Royal Devon and Exeter Hospital (Wonford)
  • Kings Lynn, United Kingdom, PE30 4ET
    • Queen Elizabeth Hospital
  • Leeds, United Kingdom, LS9 7TF
    • St James University Hospital
  • Liverpool, United Kingdom, L7 8XP
    • Royal Liverpool University Hospital
  • London, United Kingdom, NW1 - 2PG
    • University College London Hospital
  • London, United Kingdom, E11 1NR
    • Whipps Cross Hospital
  • Manchester, United Kingdom, M8 5RB
    • Fairfield General Hospital
  • Newcastle Upon Tyne, United Kingdom, NE1 4LP
    • Royal Victoria Infirmary; Stroke unit
  • Nottingham, United Kingdom, NG7 2UH
    • Nottingham University Hospitals Queen's Medical Centre
  • Reading, United Kingdom, RG1 5AN
    • Royal Berkshire Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital
  • Wolverhampton, United Kingdom, WV10 0QP
    • Royal Wolverhampton hospital; McHale Building
• United States
  • California
    • Arcadia, California, United States, 91006
      • Valley Gastroenterology Consultants
    • La Jolla, California, United States, 92093-5354
      • University of California San Diego Medical Center
    • Long Beach, California, United States, 90822
      • VA Long Beach Healthcare System
    • San Carlos, California, United States, 94070
      • Digestive Care Associates, A Medical Corporation
    • San Diego, California, United States, 92103
      • SDG Clinical Research
    • San Francisco, California, United States, 94158
      • University of California at San Francisco (PARENT); Gastroenterology, Hepatology & Nutrition
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Peak Gastroenterology Associates; Gastroenterology
  • Florida
    • Aventura, Florida, United States, 33180
      • Innovative Medical Research of South Florida
    • Clearwater, Florida, United States, 33762
      • West Central Gastroenterology d/b/a Gastro Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida College of Medicine
    • Jacksonville, Florida, United States, 32256
      • Borland-Groover Clinic
    • Miami Beach, Florida, United States, 33140
      • IMIC, Inc
    • Miramar, Florida, United States, 33025
      • FQL Research, LLC
    • Trinity, Florida, United States, 34655
      • Advanced Research Institute, Inc.
    • Winter Park, Florida, United States, 32789
      • Shafran Gastroenterology Center
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Gastroenterology Associates
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital
    • Columbus, Georgia, United States, 31904
      • Gastrointestinal Diseases Research
    • Decatur, Georgia, United States, 30033
      • Atlanta Center for Gastroenterology, PC
    • Macon, Georgia, United States, 31201
      • Gastroenterology Associates of Central Georgia
    • Marietta, Georgia, United States, 30060
      • Gastrointestinal Specialists of Georgia, PC
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Advanced Clinical Research
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Medical Center
    • Chicago, Illinois, United States, 60611
      • Northwestern University-Feinberg School of Medicine; Division of Gastroenterology and Hepatology
    • Oak Lawn, Illinois, United States, 60453-3767
      • Southwest Gastroenterology; DM Clinical Research
    • Urbana, Illinois, United States, 61801-2500
      • Carle Foundation Hospital
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton-O'Neil Clinical Research Center, Digestive Health
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Gastroenterology Associates, LLC
    • Shreveport, Louisiana, United States
      • Louisiana Research Center, LLC
  • Massachusetts
    • Brockton, Massachusetts, United States, 02302
      • Commonwealth Clinical Studies
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0666
      • University of Michigan Health System
    • Grand Rapids, Michigan, United States, 49506
      • Gastroenterology Associates of Western Michigan, P.L.C.
    • Troy, Michigan, United States, 48098
      • Center for Digestive Health
    • West Bloomfield, Michigan, United States, 48322
      • Henry Ford Health System
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Rochester; Gastrology
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center; Division of Gastroenterology
  • Missouri
    • Belton, Missouri, United States, 64012
      • Ehrhardt Clinical Research, LLC
  • New York
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
    • New York, New York, United States, 10016
      • Concorde Medical Group
    • New York, New York, United States, 10021
      • Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina at Chapel Hill
    • Charlotte, North Carolina, United States, 28207
      • Charlotte Gastroenterology and Hepatology, P.L.L.C
    • Kinston, North Carolina, United States, 28501
      • Kinston Medical Specialists
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Consultants for Clinical Research Inc.
    • Mentor, Ohio, United States, 44060
      • Great Lakes Gastroenterology Research, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Digestive Disease Specialists, Inc.
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17110
      • Great Lakes Medical Research, LLC
  • South Carolina
    • Greenville, South Carolina, United States, 29604
      • Innovative Clinical Research
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Gastroenterology Center of the MidSouth PC
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75231
      • Texas Digestive Disease Consultants - Dallas
    • Dallas, Texas, United States, 75390-9151
      • University of Texas Southwestern Medical Center; Internal Medicne
    • Houston, Texas, United States, 77030
      • Methodist Hospital Research Institute
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine; Gastroenterology
    • San Antonio, Texas, United States, 78232
      • Wellness Clinical Research Center
    • Southlake, Texas, United States, 76092
      • Texas Digestive Disease Consultants - Southlake
    • Tyler, Texas, United States, 75701
      • Tyler Research Institute, LLC
  • Utah
    • Clinton, Utah, United States, 84015
      • Ericksen Research and Development
    • Salt Lake City, Utah, United States, 84132
      • University of Utah School of Medicine
  • Virginia
    • Richmond, Virginia, United States, 23249
      • McGuire Research Institute; Gastroenterology
  • Washington
    • Seattle, Washington, United States, 98101
      • Digestive Disease Institute; Virginia Mason Medical Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

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:

• 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

Exclusion Criteria:

• 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)
• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Induction Phase - Cohort 1 (Exploratory): Etrolizumab 210 mg; Cohort 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.	Drug: Etrolizumab; Etrolizumab will be administered as per regimen specified in individual arms.; Other Names: RO5490261; RG7413; Drug: Placebo; Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
Experimental: Induction Phase - Cohort 1 (Exploratory): Etrolizumab 105 mg; Cohort 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.	Drug: Etrolizumab; Etrolizumab will be administered as per regimen specified in individual arms.; Other Names: RO5490261; RG7413; Drug: Placebo; Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
Placebo Comparator: Induction Phase - Cohort 1 (Exploratory): Placebo; Cohort 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.	Drug: Placebo; Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
Experimental: Induction Phase - Cohort 2 (Open-Label): Etrolizumab 210 mg; Cohort 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.	Drug: Etrolizumab; Etrolizumab will be administered as per regimen specified in individual arms.; Other Names: RO5490261; RG7413; Drug: Placebo; Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
Experimental: Induction Phase - Cohort 2 (Open-Label): Etrolizumab 105 mg; Cohort 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.	Drug: Etrolizumab; Etrolizumab will be administered as per regimen specified in individual arms.; Other Names: RO5490261; RG7413; Drug: Placebo; Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
Experimental: Induction Phase - Cohort 3 (Pivotal): Etrolizumab 210 mg; Cohort 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.	Drug: Etrolizumab; Etrolizumab will be administered as per regimen specified in individual arms.; Other Names: RO5490261; RG7413; Drug: Placebo; Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
Experimental: Induction Phase - Cohort 3 (Pivotal): Etrolizumab 105 mg; Cohort 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.	Drug: Etrolizumab; Etrolizumab will be administered as per regimen specified in individual arms.; Other Names: RO5490261; RG7413; Drug: Placebo; Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
Placebo Comparator: Induction Phase - Cohort 3 (Pivotal): Placebo; Cohort 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.	Drug: Placebo; Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
Placebo Comparator: Maintenance Phase - Placebo Responders: Placebo; Participants 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.	Drug: Placebo; Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
Placebo Comparator: Maintenance Phase - Etrolizumab Responders: Placebo; Participants 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.	Drug: Placebo; Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
Experimental: Maintenance Phase - Etrolizumab Responders: Etrolizumab 105 mg; Participants 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.	Drug: Etrolizumab; Etrolizumab will be administered as per regimen specified in individual arms.; Other Names: RO5490261; RG7413

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 14
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.	Week 14
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.	Week 14
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.	Week 14
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.	Baseline and Week 66
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.	Week 66

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 6
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.	Week 6
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.	Week 14
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.	Week 14
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.	Baseline and Week 14
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.	Baseline and Week 14
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	Baseline, Weeks 14 and 66
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	Baseline and Week 66
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	Baseline, Weeks 14 and 66
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.	Week 66
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	Week 14 up to Week 66 (assessed at Weeks 24, 28, 32, 44, 56, and 66)
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	Baseline and from Week 14 up to Week 66
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.	Baseline and Week 66
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.	From Baseline up to Week 78
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.	From Baseline up to Week 78
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'	From Baseline up to Week 78
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	From Baseline up to Week 78
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.	From Baseline up to Week 78
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.	From Baseline up to Week 78
Overall Number of Participants Who Develop Malignancies	Participants with malignancies are reported. 'Malignancies are identified by SMQ Malignant and unspecified tumors (narrow)	From Baseline up to Week 78
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	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)
Observed Trough Serum Concentration (Ctrough) of Etrolizumab	Serum Etrolizumab Trough Concentration	Induction Phase at Weeks 10 and 14, Maintenance Phase at Weeks 16, 24, 28, 32, 44, and 66

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• 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. 2022 Oct 11:S2468-1253(22)00303-X. doi: 10.1016/S2468-1253(22)00303-X. Online ahead of print.
• 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 α4β7 and αEβ7 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2015
• Primary Completion (Actual): September 7, 2021
• Study Completion (Actual): September 7, 2021

Study Registration Dates

• First Submitted: February 27, 2015
• First Submitted That Met QC Criteria: March 16, 2015
• First Posted (Estimate): March 20, 2015

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Physiological Effects of Drugs; Immunologic Factors; Gastrointestinal Agents; Etrolizumab
• Other Study ID Numbers: GA29144; 2014-003824-36 (EudraCT Number)

Drug and device information, study documents

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