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

Crohn Disease Clinical Trial

— BERGAMOT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02394028
• Other study ID #: GA29144
• Secondary ID: 2014-003824-36
• Status: Completed
• Phase: Phase 3
• Start date: March 20, 2015
• Est. completion date: September 7, 2021

Study information

• Verified date: October 2022
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1035
• Est. completion date: September 7, 2021
• Est. primary completion date: September 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Etrolizumab
Etrolizumab will be administered as per regimen specified in individual arms.
• Placebo
Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.

Locations

Country	Name	City	State
Argentina	Hospital Italiano	Buenos Aires
Australia	Bankstown-Lidcombe Hospital	Bankstown	New South Wales
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Monash Medical Centre Clayton	Clayton	Victoria
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	St Vincent's Hospital Melbourne	Fitzroy	Victoria
Australia	Footscray Hospital; Gastroenterology	Footscray	Victoria
Australia	The Canberra Hospital	Garran	Australian Capital Territory
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	St Frances Xavier Cabrini Hospital	Malvern	Victoria
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics	Parkville	Victoria
Australia	University of the Sunshine Coast	Sippy Downs	Queensland
Australia	Mater Adult Hospital	South Brisbane	Queensland
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Austria	LKH - Universitätsklinikum der PMU Salzburg	Salzburg
Austria	Medizinische Universität Wien	Wien
Belgium	UZ Brussel	Brussel
Belgium	CHU St Pierre (St Pierre)	Brussels
Belgium	Hospital Erasme	Bruxelles
Belgium	UZ Antwerpen	Edegem
Belgium	AZ Maria Middelares	Gent
Brazil	Hospital Felicio Rocho	Belo Horizonte	MG
Brazil	UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu	Botucatu	SP
Brazil	L2IP -Instituto de Pesquisas Clínicas Ltda.	Brasilia	DF
Brazil	Centro Digestivo de Curitiba	Curitiba	PR
Brazil	Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda	Goiânia	GO
Brazil	Hospital São Vicente de Paulo; Institute of Education and Reseach / Cardiovascular Research Unit	Passo Fundo	RS
Brazil	Hospital das Clinicas - UFRGS	Porto Alegre	RS
Brazil	Hospital Ernesto Dornelles	Porto Alegre	RS
Brazil	Hospital Universitario Clementino Fraga Filho - UFRJ; Gastroenterologia	Rio de Janeiro	RJ
Brazil	Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A	Rio de Janeiro	RJ
Brazil	Hospital Estadual Mario Covas	Santo Andre	SP
Brazil	Pesquisare Saúde Sociedade Simples	Santo Andre	SP
Brazil	Praxis Pesquisa Médica	Santo Andre	SP
Brazil	Hospital de Base de Sao Jose do Rio Preto	Sao Jose do Rio Preto	SP
Brazil	Hospital Sao Paulo	Sao Paulo	SP
Brazil	Hospital Sírio-Libanês	Sao Paulo	SP
Brazil	Hospital do Servidor Público Estadual/HSPE-SP	São Paulo	SP
Bulgaria	"City Clinic UMHAC" EOOD	Sofia
Bulgaria	UMHAT "Sv. Ivan Rilski", EAD	Sofia
Bulgaria	UMHAT Tsaritsa Yoanna - ISUL, EAD	Sofia
Canada	University of Calgary	Calgary	Alberta
Canada	Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology	Edmonton	Alberta
Canada	Queen Elizabeth II Health Sciences Centre; Gastroenterology Research	Halifax	Nova Scotia
Canada	University Hospital - London Health Sciences Centre	London	Ontario
Canada	Hôpital Maisonneuve - Rosemont	Montreal	Quebec
Canada	McGill University Health Centre - Glen Site	Montreal	Quebec
Canada	Taunton Health Centre	Oshawa	Ontario
Canada	The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit	Ottawa	Ontario
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	(G.I.R.I.) GI Research Institute	Vancouver	British Columbia
Canada	Toronto Digestive Disease Associates	Vaughan	Ontario
Canada	Winnipeg Regional Health Authority	Winnipeg	Manitoba
Croatia	Clinical Hospital Centre Osijek	Osijek
Croatia	General Hospital Pula	Pula
Croatia	Clinical Hospital Center Sestre Milosrdnice	Zagreb
Croatia	University Hospital Center Zagreb	Zagreb
Czechia	Fakultni nemocnice u sv. Anny v Brne	Brno
Czechia	Vojenska nemocnice Brno	Brno
Czechia	Nemocnice Ceske Budejovice a.s.	Ceske Budejovice
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	Gastroenterologie s.r.o.	Hradec Kralove
Czechia	Hepato-Gastroenterologie HK, s.r.o.	Hradec Kralove
Czechia	PreventaMed, s.r.o.	Olomouc
Czechia	Fakultni nemocnice Ostrava	Ostrava - Poruba
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha
Czechia	Klinicke centrum ISCARE Lighthouse	Praha 7
Estonia	North Estonia Medical Centre Foundation	Tallinn
Estonia	West Tallinn Central Hospital	Tallinn
Estonia	Tartu University Hospital	Tartu
France	CHU Amiens - Hopital Sud	Amiens
France	CHU de Caen - Hopital Cote de Nacre	Caen
France	Hôpital Beaujon	Clichy cedex
France	Hopital Claude Huriez - CHU Lille	Lille
France	CHU NANTES - Hôtel Dieu; Pharmacy	Nantes
France	CHU Nice - Hopital de l'Archet 2	Nice
France	Hôpital Saint-Louis	Paris
France	Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN	Pessac
France	Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie	Pierre-Benite
France	CHU du Reims - Hopital Robert Debré	Reims
France	CHU Rennes - Hopital Pontchaillou	Rennes cedex 09
France	CHU Saint Etienne - Hôpital Nord	Saint Etienne
France	Höpital Hautepierre; Pediatrie1	Strasbourg
France	Hôpital de Brabois Adultes	Vandoeuvre-les-nancy
Germany	Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie	Berlin
Germany	Krankenhaus Waldfriede e. V.	Berlin
Germany	Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH	Bochum
Germany	Klinikum der Johann Wolfgang Goethe-Universitaet	Frankfurt
Germany	Universitaetsklinikum Halle (Saale)	Halle
Germany	Medizinische Hochschule Hannover; Gastroenterology and Hepatology dept	Hannover
Germany	Universitätsklinikum Koeln	Koeln
Germany	Klinikum Mannheim GmbH Universitätsklinikum	Mannheim
Germany	Gemeinschaftspraxis	Offenburg
Germany	Universitaetsklinikum Tuebingen	Tuebingen
Germany	Universitaetsklinikum Ulm	Ulm
Hungary	Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza	Bekescsaba
Hungary	Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo	Budapest
Hungary	Obudai Egeszsegugyi Centrum Kft.	Budapest
Hungary	Pannonia Maganorvosi Centrum	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Debreceni Egyetem	Debrecen
Hungary	Petz Aladar Megyei Oktato Korhaz	Gyor
Hungary	Pest Megyei Flor Ferenc Korhaz	Kistarcsa
Hungary	Pecsi Tudomanyegyetem	Pecs
Hungary	Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz	Székesfehérvár
Israel	Haemek Medical Center	Afula
Israel	Soroka University Medical Centre	Beer Sheva
Israel	Wolfson Medical Center; Obstetrics and Gynecology	Holon
Israel	Hadassah University Hospital - Ein Kerem	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Holy Family Hospital	Nazareth
Israel	Rabin Medical Center-Beilinson Campus	Petach Tikva
Israel	Tel Aviv Sourasky Medical Center; Pharmacy	Tel Aviv
Italy	Azienda Ospedaliera Universitaria Careggi	Florence	Toscana
Italy	Asst Fatebenefratelli Sacco (Fatebenefratelli)	Milano	Lombardia
Italy	ASST FATEBENEFRATELLI SACCO (Sacco)	Milano	Lombardia
Italy	Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)	Milano	Lombardia
Italy	A.O.U. Policlinico di Modena	Modena	Emilia-Romagna
Italy	Azienda Ospedaliera San Camillo Forlanini	Roma	Lazio
Italy	Policlinico Universitario Agostino Gemelli; Farmacia	Roma	Lazio
Italy	Istituto Clinico Humanitas	Rozzano (MI)	Lombardia
Italy	I.R.C.C.S Policlinico San Donato	San Donato Milanese (MI)	Lombardia
Italy	Ospedale Umberto I di Torino	Torino	Piemonte
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Yeungnam Univ. Hospital	Daegu
Korea, Republic of	Hanyang University Guri Hospital	Gyeonggi-do
Korea, Republic of	Korea University Ansan Hospital	Gyeonggi-do
Korea, Republic of	CHA Bundang Medical Centre; CHA university	Seongnam
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Yonsei University Wonju Severance Christian Hospital	Wonju-Si
Latvia	Pauls Stradins Clinical University Hospital	Riga
Latvia	Riga East Clinical University Hospital; Clinic Gailezers	Riga
Lithuania	Hospital of Lithuanian University of Health. Sciences Kaunas Clinics	Kaunas
Lithuania	Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology	Vilnius
Mexico	Medical Care & Research SA de CV	Mérida	Yucatan
Mexico	Clinical Research Institute	Tlalnepantla de Baz	Mexico CITY (federal District)
Netherlands	Amsterdam UMC Location AMC	Amsterdam
Netherlands	Amsterdam UMC, Locatie VUMC; Neurology	Amsterdam
Netherlands	Leids Universitair Medisch Centrum	Leiden
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	Erasmus Medisch Centrum	Rotterdam
Netherlands	Zuyderland Medisch Centrum - Sittard Geleen	Sittard-Geleen
Netherlands	ETZ TweeSteden	Tilburg
New Zealand	North Shore Hospital	Auckland
New Zealand	Christchurch Hospital NZ	Christchurch
New Zealand	Dunedin Public Hospital	Dunedin
New Zealand	Waikato Hospital	Hamilton
New Zealand	Shakespeare Specialist Group	Takapuna
New Zealand	Tauranga Hospital	Tauranga
Poland	SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego	Bialystok
Poland	Nasz Lekarz Osrodek Badan Klinicznych	Bydgoszcz
Poland	Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ	Elblag
Poland	ETG Kielce	Kielce
Poland	Centrum Opieki Zdrowotnej Orkan-Med	Ksawerow
Poland	Indywidualna Specjalistyczna Praktyka Lekarska	Lublin
Poland	Allmedica Badania Kliniczne Sp z o.o. Sp K.	Nowy Targ
Poland	Centrum Medyczne "MEDYK"	Rzeszow
Poland	Gabinet Lekarski, Bartosz Korczowski	Rzeszów
Poland	Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia	Sopot
Poland	Niepubliczny Zaklad Opieki Zdrowotnej SONOMED	Szczecin
Poland	Twoja Przychodnia-Szczecinskie Centrum Medyczne	Szczecin
Poland	Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj	Torun
Poland	Centrum Zdrowia MDM	Warszawa
Poland	Warsaw IBD Point Profesor Kierkus	Warszawa
Poland	Zespó Przychodni Specjalistycznych PRIMA	Warszawa
Poland	EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu	Wroclaw
Poland	LexMedica Osrodek Badan Klinicznych	Wroclaw
Poland	PlanetMed sp. z o.o.	Wroclaw
Romania	Spitalul Clinic Colentina	Bucharest
Romania	S.C MedLife S.A	Bucuresti
Romania	Centrul de Gastroenterologie Dr. Goldis	Timisoara
Russian Federation	SBEI HPE Altai StateMedicalUniversityofMoH andSD	Barnaul
Russian Federation	Irkutsk State Medical Academy of Continuing Education	Irkutsk
Russian Federation	Yusupov Hospital	Moskva	Adygeja
Russian Federation	LLC "Novosibirsk GastroCenter"	Novosibirsk	Altaj
Russian Federation	SBEIHPE Novosibirsk State Medical University	Novosibirsk
Russian Federation	BHI of Omsk region Clinical Oncology Dispensary	Omsk
Russian Federation	Evromedservis LCC	Pushkin
Russian Federation	SEIHPE "Rostov SMU of MoH of RF"	Rostov-on-Don
Russian Federation	North-Western Medical University n.a. I.I. Mechnikov; Rheumatology	Sankt-peterburg	Sankt Petersburg
Russian Federation	SBIH City Clinical Hospital #31	Sankt-peterburg	Sankt Petersburg
Russian Federation	Federal State Military Educational Institution; High Professional Education Military Medical Acad	St. Petersburg
Russian Federation	Baltic Medicine	St.Petersburg	Leningrad
Serbia	Clinical Helth Centre Zvezdara	Belgrade
Serbia	Military Medical Academy	Belgrade
Serbia	University Hospital Medical Center Bezanijska kosa	Belgrade
Serbia	Clinical Center of Vojvodina	Novi Sad
Serbia	General Hospital Djordje Joanovic	Zrenjanin
Slovakia	Accout Center s.r.o.	Šahy
Slovakia	IBDcentrum s.r.o.	Bratislava
Slovakia	KM Management spol. s r.o.	Nitra
Slovakia	Endomed, s.r.o.	Vranov nad Toplou
South Africa	Dr D Epstein Practice	Cape Town
South Africa	Emmed Research	Pretoria
Spain	Centro Médico Teknon	Barcelona
Spain	Hospital Clínic i Provincial; Servicio de Farmacia	Barcelona
Spain	Hospital Reina Sofia; Medical Oncology	Cordoba
Spain	Hospital Universitario de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Hospital Juan Ramón Jiménez	Huelva
Spain	Hospital Universitario de Fuenlabrada	Madrid
Spain	Hospital Universitario de la Princesa	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Puerta de Hierro Majadahonda; Hepatology studies	Majadahonda	Madrid
Spain	Complejo Hospitalario de Pontevedra	Pontevedra
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitari i Politecnic La Fe	Valencia
Spain	Hospital Universitario Miguel Servet	Zaragoza
Switzerland	Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner	Bern
Switzerland	Inselspital-Universitaetsspital Bern	Bern
Switzerland	Universitätsspital Zürich	Zürich
Turkey	Ankara University Medical Faculty	Ankara
Turkey	Gazi University Medical Faculty	Ankara
Turkey	Hacettepe University Medical Faculty; Gastroenterology	Ankara
Turkey	Acibadem Fulya Hospital; Neurology	Istanbul
Turkey	Haydarpasa Numune Training and Research Hospital; Medical Oncology	Istanbul
Turkey	Medeniyet University Goztepe Training and Research Hospital; Chest Diseases	Istanbul
Turkey	Ege University Medical Faculty	Izmir
Turkey	Kocaeli Universitesi Tip Fakultesi; Infectious Diseases	Kocaeli
Turkey	Acibadem Kozyatagi Hospital; Gastroenterology	Kozyatagi
Ukraine	RCNECRCH Dept of Surgery, SHEI Ukr BSMU	Chernivtsi	Podolia Governorate
Ukraine	Ivano-Frankivsk Regional Clinical Hospital	Ivano-Frankivsk	Kuban People's Republica
Ukraine	CHI Kharkiv City Clinical Hospital #13	Kharkiv
Ukraine	CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2	Kharkiv	Kharkiv Governorate
Ukraine	CI of Healthcare Kharkiv Reg Clin Hosp-Center of Med Emergency & Accident Medicine	Kharkiv	Kharkiv Governorate
Ukraine	GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine	Kharkiv
Ukraine	Kremenchuk first city hospital n.a. O.T. Bohaievskyi; Gastroenterology department	Kremenchuk	Poltava Governorate
Ukraine	CI of Kyiv RC Regional Clinical Hospital #2	Kyiv	KIEV Governorate
Ukraine	Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU	Kyiv
Ukraine	Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"	Kyiv	KIEV Governorate
Ukraine	Medical Center of Limited Liability Company Medical Clinic Blagomed	Kyiv	KIEV Governorate
Ukraine	Lviv Regional Clinical Hospital	Lviv	KIEV Governorate
Ukraine	City Hospital #1	Mykolaiv
Ukraine	Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2	Odesa
Ukraine	M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU	Vinnytsia
Ukraine	MCIC MC LLC Health Clinic	Vinnytsia
Ukraine	Private Small Enterprise Medical Center Pulse	Vinnytsia
Ukraine	CI City Hospital #1	Zaporizhzhia	Tavria Okruha
Ukraine	LLC Diaservis	Zaporizhzhia
United Kingdom	Royal Victoria Hospital	Belfast
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	University Hospital Coventry	Coventry
United Kingdom	Royal Devon and Exeter Hospital (Wonford)	Exeter
United Kingdom	Queen Elizabeth Hospital	Kings Lynn
United Kingdom	St James University Hospital	Leeds
United Kingdom	Royal Liverpool University Hospital	Liverpool
United Kingdom	University College London Hospital	London
United Kingdom	Whipps Cross Hospital	London
United Kingdom	Fairfield General Hospital	Manchester
United Kingdom	Royal Victoria Infirmary; Stroke unit	Newcastle Upon Tyne
United Kingdom	Nottingham University Hospitals Queen's Medical Centre	Nottingham
United Kingdom	Royal Berkshire Hospital	Reading
United Kingdom	Southampton General Hospital	Southampton
United Kingdom	Royal Wolverhampton hospital; McHale Building	Wolverhampton
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Valley Gastroenterology Consultants	Arcadia	California
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Emory University Hospital	Atlanta	Georgia
United States	Innovative Medical Research of South Florida	Aventura	Florida
United States	Gastroenterology Associates, LLC	Baton Rouge	Louisiana
United States	Ehrhardt Clinical Research, LLC	Belton	Missouri
United States	Commonwealth Clinical Studies	Brockton	Massachusetts
United States	University of North Carolina At Chapel Hill	Chapel Hill	North Carolina
United States	Charlotte Gastroenterology and Hepatology, P.L.L.C	Charlotte	North Carolina
United States	Northwestern University-Feinberg School of Medicine; Division of Gastroenterology and Hepatology	Chicago	Illinois
United States	The University of Chicago Medical Center	Chicago	Illinois
United States	Consultants for Clinical Research Inc.	Cincinnati	Ohio
United States	West Central Gastroenterology d/b/a Gastro Florida	Clearwater	Florida
United States	Ericksen Research and Development	Clinton	Utah
United States	Peak Gastroenterology Associates; Gastroenterology	Colorado Springs	Colorado
United States	Gastrointestinal Diseases Research	Columbus	Georgia
United States	Texas Digestive Disease Consultants - Dallas	Dallas	Texas
United States	University of Texas Southwestern Medical Center; Internal Medicne	Dallas	Texas
United States	Atlanta Center for Gastroenterology, PC	Decatur	Georgia
United States	University of Florida College of Medicine	Gainesville	Florida
United States	Gastroenterology Center of the MidSouth PC	Germantown	Tennessee
United States	Gastroenterology Associates of Western Michigan, P.L.C.	Grand Rapids	Michigan
United States	Innovative Clinical Research	Greenville	South Carolina
United States	Great Lakes Medical Research, LLC	Harrisburg	Pennsylvania
United States	Baylor College of Medicine; Gastroenterology	Houston	Texas
United States	Methodist Hospital Research Institute	Houston	Texas
United States	University of Mississippi Medical Center; Division of Gastroenterology	Jackson	Mississippi
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	Kinston Medical Specialists	Kinston	North Carolina
United States	University of California San Diego Medical Center	La Jolla	California
United States	VA Long Beach Healthcare System	Long Beach	California
United States	Gastroenterology Associates of Central Georgia	Macon	Georgia
United States	University of Wisconsin	Madison	Wisconsin
United States	Gastrointestinal Specialists of Georgia, PC	Marietta	Georgia
United States	Great Lakes Gastroenterology Research, LLC	Mentor	Ohio
United States	Advanced Clinical Research	Meridian	Idaho
United States	IMIC, Inc	Miami Beach	Florida
United States	FQL Research, LLC	Miramar	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Concorde Medical Group	New York	New York
United States	Lenox Hill Hospital	New York	New York
United States	Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)	New York	New York
United States	Southwest Gastroenterology; DM Clinical Research	Oak Lawn	Illinois
United States	Digestive Disease Specialists, Inc.	Oklahoma City	Oklahoma
United States	McGuire Research Institute; Gastroenterology	Richmond	Virginia
United States	Mayo Clinic - Rochester; Gastrology	Rochester	Minnesota
United States	University of Utah School of Medicine	Salt Lake City	Utah
United States	Wellness Clinical Research Center	San Antonio	Texas
United States	Digestive Care Associates, A Medical Corporation	San Carlos	California
United States	SDG Clinical Research	San Diego	California
United States	University of California at San Francisco (PARENT); Gastroenterology, Hepatology & Nutrition	San Francisco	California
United States	Digestive Disease Institute; Virginia Mason Medical Center	Seattle	Washington
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	Texas Digestive Disease Consultants - Southlake	Southlake	Texas
United States	Cotton-O'Neil Clinical Research Center, Digestive Health	Topeka	Kansas
United States	Advanced Research Institute, Inc.	Trinity	Florida
United States	Center for Digestive Health	Troy	Michigan
United States	Tyler Research Institute, LLC	Tyler	Texas
United States	Carle Foundation Hospital	Urbana	Illinois
United States	Henry Ford Health System	West Bloomfield	Michigan
United States	Shafran Gastroenterology Center	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Croatia,  Czechia,  Estonia,  France,  Germany,  Hungary,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Netherlands,  New Zealand,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Switzerland,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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