A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors

Ulcerative Colitis Clinical Trial

— HICKORY  

Official title:

Phase III, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients With Moderate to Severe Active Ulcerative Colitis Who Have Been Previously Exposed to TNF Inhibitors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100696
• Other study ID #: GA28950
• Secondary ID: 2013-004278-88
• Status: Completed
• Phase: Phase 3
• Start date: May 21, 2014
• Est. completion date: April 16, 2020

Study information

• Verified date: July 2021
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (UC) who have been previously exposed to TNF inhibitors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 609
• Est. completion date: April 16, 2020
• Est. primary completion date: April 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of UC established at least 3 months prior to Day 1
• Moderately to severely active UC as determined by the Mayo Clinic Score (MCS) assessment
• Treatment within 5 years prior to screening with one or two induction regimens that contain TNF inhibitors (including TNF inhibitor biosimilars)
• Washout of anti-TNF therapy for at least 8 weeks preceding Day 1
• Background regimen for UC may include oral 5-aminosalicylic acid (5-ASA), oral corticosteroids, budesonide, probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the screening period
• Use of highly effective contraception as defined by the protocol
• Must have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening

Exclusion Criteria:

• A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic colitis, radiation colitis, or microscopic colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps
• Prior or planned surgery for UC
• Past or present ileostomy or colostomy
• Any prior treatment with etrolizumab or other anti-integrin agents (including natalizumab, vedolizumab, and efalizumab)
• Any prior treatment with anti-adhesion molecules (e.g. anti-MAdCAM-1)
• Any prior treatment with rituximab
• Any treatment with tofacitinib during screening
• Congenital or acquired immune deficiency, chronic hepatitis B or C infection, human immunodeficiency virus (HIV) positive, or history of tuberculosis (active or latent)
• Evidence of or treatment for Clostridium difficile or clinically significant cytomegalovirus (CMV) colitis within 60 days prior to Day 1
• Evidence of or treatment for other intestinal pathogens within 30 days prior to Day 1
• History of recurrent opportunistic infections and/or severe disseminated viral infections
• History of organ transplant
• Any major episode of infection requiring treatment with intravenous (IV) antibiotics within 8 weeks prior to screening or oral antibiotics within 4 weeks prior to screening
• Received a live attenuated vaccine within 4 weeks prior to Day 1

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Etrozulimab
Participants will receive 105 mg etrolizumab administered by SC injection Q4W.
• Placebo
Participants will receive placebo (matched with etrolizumab) administered by SC injection Q4W.

Locations

Country	Name	City	State
Argentina	Hospital Provincial del Centenario	Rosario
Australia	St Vincent's Hospital Melbourne	Fitzroy	Victoria
Australia	Footscray Hospital; Gastroenterology	Footscray	Victoria
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Launceston General Hospital; Gastroenterology Research	Launceston	Tasmania
Australia	St Frances Xavier Cabrini Hospital	Malvern	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Mater Adult Hospital	South Brisbane	Queensland
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Austria	Klinikum Klagenfurt am Wörtersee; Acute geriatric care	Klagenfurt
Austria	LKH - Universitätsklinikum der PMU Salzburg	Salzburg
Austria	Medizinische Universität Wien	Wien
Belgium	Imeldaziekenhuis	Bonheiden
Belgium	UZ Brussel	Brussel
Belgium	CHU St Pierre (St Pierre)	Brussels
Belgium	UZ Gent	Gent
Belgium	AZ Sint Elisabeth Herentals	Herentals
Belgium	UZ Leuven; Neurology	Leuven
Belgium	CHU de Liège; Tour de Pathologie	Liège
Belgium	AZ Delta (Stedelijk Ziekenhuis)	Roeselare
Brazil	Hospital Felicio Rocho	Belo Horizonte	MG
Brazil	UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu	Botucatu	SP
Brazil	CAEP - Centro Avancado de Estudos e Pesquisas Ltda.	Campinas	SP
Brazil	Centro Digestivo de Curitiba	Curitiba	PR
Brazil	Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda	Goiânia	GO
Brazil	Hospital de Clínicas de Porto Alegre X	Porto Alegre	RS
Brazil	Hospital Moinhos de Vento	Porto Alegre	RS
Brazil	Hospital Universitario Clementino Fraga Filho - UFRJ	Rio de Janeiro	RJ
Brazil	Hospital Estadual Mario Covas	Santo Andre	SP
Canada	University of Calgary; Heritage Medical Research Clinic	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	Hotel Dieu de Levis	Levis	Quebec
Canada	Hôpital Maisonneuve - Rosemont	Montreal	Quebec
Canada	Taunton Health Centre	Oshawa	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Toronto Liver Centre	Toronto	Ontario
Canada	Pacific Gastroenterology Associates	Vancouver	British Columbia
Canada	Toronto Digestive Disease Associates	Vaughan	Ontario
Czechia	Fakultni nemocnice Brno; Interni kardiologicka klinika	Brno
Czechia	Hepato-Gastroenterologie HK, s.r.o.	Hradec Kralove
Czechia	Pardubicka krajska nemocnice, a.s.	Pardubice
Czechia	Nemocnice Na Bulovce	Prague
Czechia	ISCARE a.s.	Praha 7
Czechia	Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni	Usti Nad Labem
Denmark	Ålborg Universitets Hospital; Gastromedicinsk	Ålborg
Denmark	Rigshospitalet; Medicinsk gastroenterologisk klinik	København Ø
France	CHU Amiens - Hopital Sud; Pharmacie - Secteur des Essais cliniques	Amiens Cedex01
France	Hôpital Beaujon	Clichy cedex
France	Hopital Claude Huriez - CHU Lille	Lille
France	Hôpital Nord - CHU Marseille; Gastroenterology and Hepatology	Marseille cedex 20
France	CHU Nice - Hopital de l'Archet 2	Nice
France	Hôpital Saint-Louis	Paris
France	Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN	Pessac
France	CHU Saint Etienne - Hôpital Nord	Saint Etienne
France	Höpital Hautepierre; Pediatrie1	Strasbourg
France	CHU de Toulouse - Hôpital Rangueil	Toulouse Cedex 09
France	Hôpital de Brabois Adultes	Vandoeuvre-les-nancy
Germany	Charite Universitaetsmedizin Berlin - Campus Charite Mitte	Berlin
Germany	DRK Kliniken Berlin Westend	Berlin
Germany	Universitaetsklinikum Erlangen	Erlangen
Germany	Klinikum der Johann Wolfgang Goethe-Universitaet	Frankfurt
Germany	Universitätsklinikum Freiburg; Innere Medizin I; Hämatologie, Onkologie und Stammzelltransplantation	Freiburg
Germany	Universitaetsklinikum Halle (Saale)	Halle
Germany	Gastroenterologie Eppendorfer Baum	Hamburg
Germany	Hamburgisches Forschungsinstitut fuer CED	Hamburg
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie	Hannover
Germany	Universitaetsklinikum Schleswig-Holstein, Campus Kiel	Kiel
Germany	Klinikum Mannheim GmbH Universitätsklinikum	Mannheim
Germany	Universitaetsklinikum Muenster	Muenster
Germany	Universitaetsklinikum Ulm	Ulm
Greece	Anticancer Hospital of Thessaliniki " Theagenio"	Thessaloniki
Hungary	Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza	Bekescsaba
Hungary	Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo	Budapest
Hungary	Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely	Budapest
Hungary	Obudai Egeszsegugyi Centrum Kft.	Budapest
Hungary	Pannonia Maganorvosi Centrum	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Debreceni Egyetem	Debrecen
Hungary	Markhot Ferenc Oktato Korhaz es Rendelointezet	Eger
Hungary	Petz Aladar Megyei Oktato Korhaz	Gyor
Hungary	Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; II. Belgyogyaszat	Miskolc
Hungary	Pecsi Tudomanyegyetem	Pecs
Hungary	Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz	Székesfehérvár
Israel	Hadassah University Hospital - Ein Kerem; Neurosurgery	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Rabin Medical Center-Beilinson Campus; Gaucher Clinic, Genetics Institute	Petach Tiqwa
Israel	Kaplan Medical Center	Rehovot
Israel	Assaf Harofeh	Rishon Lezion
Italy	Azienda Ospedaliera S. Orsola-Malpighi	Bologna	Emilia-Romagna
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze	Toscana
Italy	Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)	Milano	Lombardia
Italy	A.O.U. Policlinico di Modena	Modena	Emilia-Romagna
Italy	Azienda Ospedaliera Di Padova	Padova	Veneto
Italy	Ospedale di Circolo; Neuropsichiatria Infantile	Rho	Lombardia
Italy	Azienda Ospedaliera San Camillo Forlanini	Roma	Lazio
Italy	Azienda Ospedaliera Universitaria Policlinico Tor Vergata	Roma	Lazio
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma	Lazio
Italy	Istituto Clinico Humanitas	Rozzano (MI)	Lombardia
Italy	I.R.C.C.S Policlinico San Donato	San Donato Milanese (MI)	Lombardia
Korea, Republic of	Kyungpook National University Hospital; Opthalmology	Daegu
Korea, Republic of	Korea University Ansan Hospital	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Asan Medical Center.	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University	Seoul
Korea, Republic of	The Catholic University of Korea St. Vincent's Hospital	Suwon-si,
Lithuania	Hospital of Lithuanian University of Health. Sciences Kaunas Clinics	Kaunas
Lithuania	Vilnius University Hospital Santariskiu Clinic Public Insti	Vilnius
Mexico	Centro Regiomontano de Estudios Clínicos Roma S.C.	Monterrey	Nuevo LEON
Netherlands	Amsterdam UMC Location AMC	Amsterdam
Netherlands	Amsterdam UMC, Locatie VUMC; Neurology	Amsterdam
Netherlands	Rijnstate; Internal Medicine Department	Arnhem
Netherlands	Radboudumc	NL -nijmegen
Poland	Nasz Lekarz Osrodek Badan Klinicznych	Bydgoszcz
Poland	Nzoz All-Medicus	Katowice
Poland	Gabinet Lekarski, Bartosz Korczowski	Rzeszów
Poland	Niepubliczny Zaklad Opieki Zdrowotnej SONOMED	Szczecin
Poland	Centrum Zdrowia MDM	Warszawa
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy	Warszawa
Poland	Nzoz Vivamed	Warszawa
Poland	EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu	Wroclaw
Poland	LexMedica Osrodek Badan Klinicznych	Wroclaw
Poland	PlanetMed	Wroclaw
Romania	SC Euroclinic Hospital SA	Bucuresti
Spain	Fundacion Hospital de Alcorcon; Servicio de Digestivo	Alcorcon	Madrid
Spain	Hospital Universitari de Girona Dr Josep Trueta	Girona
Spain	Hospital Universitario de Fuenlabrada	Madrid
Spain	Hospital Universitario de la Princesa	Madrid
Spain	Hospital Universitari i Politecnic La Fe	Valencia
Spain	Hospital Universitario Miguel Servet	Zaragoza
Switzerland	Cliniques Universitaires Saint-Luc; Nephrology	Bern
Switzerland	Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner	Bern
Switzerland	Inselspital-Universitaetsspital Bern; Institut fuer Spitalpharmazie	Bern
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	Royal Devon and Exeter Hospital (Wonford)	Exeter
United Kingdom	King's College London	London
United Kingdom	St Thomas Hospital	London
United Kingdom	The Royal London Hospital	London
United Kingdom	University College London Hospital	London
United Kingdom	Fairfield General Hospital	Manchester
United Kingdom	Royal Victoria Infirmary	Newcastle upon Tyne
United Kingdom	Nottingham University Hospitals; QMC Campus	Nottingham
United Kingdom	Southampton General Hospital	Southampton
United States	University of Michigan; Michigan Institute for Clinical and Health Research (MICHR)	Ann Arbor	Michigan
United States	Gastroenterology Associates, LLC	Baton Rouge	Louisiana
United States	Washington Gastroenterology	Bellevue	Washington
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital; Crohn's & Colitis Center	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Northwestern University Feinberg School Of Medicine	Chicago	Illinois
United States	Consultants for Clinical Research Inc.	Cincinnati	Ohio
United States	UC Health, LLC.	Cincinnati	Ohio
United States	Ericksen Research and Development	Clinton	Utah
United States	Rocky Mountain Gastroenterology Associates	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	Clinica Peruano Americana S.A.	Great Neck	New York
United States	Kansas City Research Institute, LLC	Kansas City	Missouri
United States	University of California San Diego Medical Center	La Jolla	California
United States	Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology	Lakewood	Colorado
United States	Gastroenterology Associates of Central Georgia	Macon	Georgia
United States	Gastrointestinal Specialists of Georgia, PC	Marietta	Georgia
United States	Gastroenterology Center of the Midsouth, P.C.	Memphis	Tennessee
United States	Great Lakes Gastroenterology Research, LLC	Mentor	Ohio
United States	FQL Research, LLC	Miramar	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Weill Cornell Medical College-New York Presbyterian Hospital	New York	New York
United States	Digestive and Liver Disease Specialists, Ltd.	Norfolk	Virginia
United States	Southwest Gastroenterology	Oak Lawn	Illinois
United States	Center For Digestive Health	Orlando	Florida
United States	Internal Medicine Specialists	Orlando	Florida
United States	McGuire Research Institute; Gastroenterology	Richmond	Virginia
United States	University of Utah School of Medicine	Salt Lake City	Utah
United States	Clinical Applications Laboratories, Inc.	San Diego	California
United States	Precision Research Institute, LLC	San Diego	California
United States	University of California at San Francisco	San Francisco	California
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	Atlanta Gastroenterology Specialists, PC	Suwanee	Georgia
United States	Cotton-O'Neil Clinical Research Center, Digestive Health	Topeka	Kansas
United States	Center for Digestive Health	Troy	Michigan
United States	Tyler Research Institute, LLC	Tyler	Texas
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,  Canada,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Korea, Republic of,  Lithuania,  Mexico,  Netherlands,  Poland,  Romania,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Induction Phase: Percentage of Participants With Remission at Week 14, as Determined by the Mayo Clinic Score (MCS)	The Mayo Clinic Score (MCS) ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Remission was defined as MCS less than or equal to (=)2 with individual subscores =1 and a rectal bleeding subscore of 0.	Week 14
Primary	Maintenance Phase: Percentage of Participants With Remission at Week 66 Among Participants Who Had Achieved a Clinical Response at Week 14, as Determined by the MCS	The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Remission was defined as MCS less than or equal to (=)2 with individual subscores =1 and a rectal bleeding subscore of 0. Clinical Response is MCS with =3-point decrease and 30% reduction from baseline as well as =1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1.	Week 66
Secondary	Induction Phase: Percentage of Participants With Clinical Remission at Week 14, as Determined by the MCS	The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Clinical Remission is MCS =2 with individual subscores =1.	Week 14
Secondary	Induction Phase: Percentage of Participants With Clinical Response at Week 14, as Determined by the MCS	The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Remission was defined as MCS less than or equal to (=)2 with individual subscores =1 and a rectal bleeding subscore of 0. Clinical Response is MCS with =3-point decrease and 30% reduction from baseline as well as =1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1.	Week 14
Secondary	Induction Phase: Percentage of Participants With Improvement From Baseline in Endoscopic Appearance of the Mucosa at Week 14, as Determined by the MCS Endoscopic Subscore	The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Improvement in endoscopic appearance of the mucosa is Endoscopy subscore =1.	Baseline and Week 14
Secondary	Induction Phase: Percentage of Participants With Endoscopic Remission at Week 14, as Determined by the MCS Endoscopic Subscore	The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Endoscopic Remission is Endoscopy subscore = 0.	Week 14
Secondary	Induction Phase: Percentage of Participants With Histologic Remission at Week 14, as Determined by the Nancy Histological Index	Nancy Histological Index (NHI) is a 5-level classification ranging from grade 0 (No histologically significant disease) to grade 4 (severely active disease). Histologic remission is defined as a Nancy Histological Index of 0 or 1.	Week 14
Secondary	Induction Phase: Change From Baseline to Week 6 in MCS Rectal Bleed Subscore	Rectal bleeding data were collected via the participant's diaries and each day a participant provided a score from 0 to 3 according to the following definitions: 0 = no blood in the stool; 1 = streaks of blood with stool less than half the time; 2 = obvious blood with stool most of the time; 3 = blood alone passed. The Mayo Clinic Score (MCS) rectal bleeding subscore was calculated as the worst value of three days of daily diary scores closest to anchor dates at baseline and post-baseline. The data was considered non-parametric and was reported using RANK analysis of covariance (ANCOVA). Participants were stratified by concomitant treatment with corticosteroids or immunosuppressants at randomization and disease activity measured during screening (MCS =9/MCS =10); the model adjusted for these stratification factors along with the baseline rectal bleeding (RB) subscore.	Baseline and Week 6
Secondary	Induction Phase: Change From Baseline to Week 6 in MCS Stool Frequency Subscore	Stool frequency data were collected via the participant's diaries and each day a participant provided a score from 0 to 3 according to the following definitions: 0 = normal number of stools; 1 = 1 to 2 more stools than normal; 2 = 3 to 4 more stools than normal; 3 = 5 or more stools than normal. The Mayo Clinic Score (MCS) stool frequency subscore was calculated as the average of three days daily diary scores closest to anchor dates at baseline and post-baseline. The data was considered non-parametric and was reported using RANK analysis of covariance (ANCOVA). Participants were stratified by concomitant treatment with corticosteroids or immunosuppressants at randomization and disease activity measured during screening (MCS =9/MCS =10); the model adjusted for these stratification factors along with the baseline stool frequency (SF) subscore.	Baseline and Week 6
Secondary	Induction Phase: Change From Baseline to Week 14 in UC Bowel Movement Signs and Symptoms, as Assessed by the Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Questionnaire	The UC-PRO questionnaire is collected in the e-diary and completed by participants for at least 9-12 consecutive days prior to a study visit. The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The bowel domain score ranges from 0-27, with a higher score indicating a worse disease state.	Baseline and Week 14
Secondary	Induction Phase: Change From Baseline to Week 14 in UC Functional Symptoms, as Assessed by the UC-PRO/SS Questionnaire	The UC-PRO questionnaire is collected in the e-diary and completed by participants for at least 9-12 consecutive days prior to a study visit. The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The functional (abdominal symptoms) domain score ranges from 0-12, with a higher score indicating a worse disease state.	Baseline and Week 14
Secondary	Induction Phase: Change From Baseline to Week 14 in Health-Related Quality of Life, as Assessed by the Overall Score of the Inflammatory Bowel Disease Questionnaire (IBDQ)	The IBDQ score is a Total Score summed up from across all 32 questions on the questionnaire. The Total Score range is from 32 to 224 with higher scores representing a better quality of life.	Baseline and Week 14
Secondary	Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66 Among Participants Who Had Achieved Clinical Remission at Week 14, as Determined by the MCS	The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Remission was defined as MCS less than or equal to (=)2 with individual subscores =1 and a rectal bleeding subscore of 0. Clinical Remission is MCS =2 with individual subscores =1.	Week 66
Secondary	Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66, as Determined by the MCS	The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Remission was defined as MCS less than or equal to (=)2 with individual subscores =1 and a rectal bleeding subscore of 0. Clinical Remission is MCS =2 with individual subscores =1.	Week 66
Secondary	Maintenance Phase: Percentage of Participants With Remission at Week 66 Among Participants Who Had Achieved Remission at Week 14, as Determined by the MCS	The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Remission was defined as MCS less than or equal to (=)2 with individual subscores =1 and a rectal bleeding subscore of 0.	Week 66
Secondary	Maintenance Phase: Percentage of Participants With Improvement From Baseline in Endoscopic Appearance of the Mucosa at Week 66, as Determined by the MCS Endoscopic Subscore	The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Improvement in endoscopic appearance of the mucosa is Endoscopy subscore =1.	Baseline and Week 66
Secondary	Maintenance Phase: Percentage of Participants With Histologic Remission at Week 66, as Determined by the Nancy Histological Index	Nancy Histological Index (NHI) is a 5-level classification ranging from grade 0 (No histologically significant disease) to grade 4 (severely active disease). Histologic remission is defined as a Nancy Histological Index of 0 or 1.	Week 66
Secondary	Maintenance Phase: Percentage of Participants With Endoscopic Remission at Week 66, as Determined by the MCS Endoscopic Subscore	The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Endoscopic Remission is Endoscopy subscore = 0.	Week 66
Secondary	Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 66 Among Participants Who Were Receiving Corticosteroids at Baseline, as Determined by the MCS	The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Corticosteroid-Free analysis was conducted only on a subgroup of participants who were randomized into the maintenance phase and receiving Corticosteroids (CS) at baseline. Participants were defined as being off CS if they had no record of taking CS on the date that was 24 weeks prior to Week 66.	Week 66
Secondary	Maintenance Phase: Percentage of Participants With Corticosteroid-Free Remission at Week 66 Among Participants Who Were Receiving Corticosteroids at Baseline, as Determined by the MCS	The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Corticosteroid-Free analysis was conducted only on a subgroup of participants who were randomized into the maintenance phase and receiving Corticosteroids (CS) at baseline. Participants were defined as being off CS if they had no record of taking CS on the date that was 24 weeks prior to Week 66.	Week 66
Secondary	Maintenance Phase: Change From Baseline to Week 66 in UC Bowel Movement Signs and Symptoms, as Assessed by the UC-PRO/SS Questionnaire	The UC-PRO questionnaire is collected in the e-diary and completed by participants for at least 9-12 consecutive days prior to a study visit. The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The bowel domain score ranges from 0-27, with a higher score indicating a worse disease state.	Baseline and Week 66
Secondary	Maintenance Phase: Change From Baseline to Week 66 in UC Functional Symptoms, as Assessed by the UC-PRO/SS Questionnaire	The UC-PRO questionnaire is collected in the e-diary and completed by participants for at least 9-12 consecutive days prior to a study visit. The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The functional (abdominal symptoms) domain score ranges from 0-12, with a higher score indicating a worse disease state.	Baseline and Week 66
Secondary	Maintenance Phase: Change From Baseline to Week 66 in Health-Related Quality of Life, as Assessed by the Overall Score of the IBDQ	The IBDQ is used to assess participant's health-related quality of life (QOL). The IBDQ score is a Total Score summed up from across all 32 questions on the questionnaire. The Total Score range is from 32 to 224 with higher scores representing a better quality of life.	Baseline and Week 66
Secondary	Number of Participants With 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)	All Adverse Events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: 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 or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade.	From Baseline up to Week 78
Secondary	Number of Participants With Adverse Events Leading to Study Drug Discontinuation		From Baseline up to Week 78
Secondary	Number of Participants With Serious Infection-Related Adverse Events		From Baseline up to Week 78
Secondary	Number of Participants With Infection-Related Adverse Events	All Adverse Events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: 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 or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade.	From Baseline up to Week 78
Secondary	Number of Participants With Injection-Site Reaction-Related Adverse Events		From Baseline up to Week 78
Secondary	Number of Participants With Hypersensitivity Reaction-Related Adverse Events		From Baseline up to Week 78
Secondary	Number of Participants With Malignancies		From Baseline up to Week 78
Secondary	Number of Participants With Anti-Therapeutic Antibodies to Etrolizumab at Baseline and During the Study	A tiered strategy was used to detect and characterize etrolizumab antibodies within this clinical study. When determining post baseline incidence, participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following etrolizumab drug exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post baseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants were considered to be ADA negative if they were ADA negative or had missing data at baseline and all post baseline samples were negative, or if they were ADA positive at baseline but did not have any post baseline samples with a titer that was at least 0.60 titer unit greater than the titer of the baseline sample (treatment unaffected).	Pre-dose at Baseline, Weeks 4, 14, 24, 44, and 66, and Early Termination/End of Safety Follow-Up (up to Week 78)
Secondary	Etrolizumab Serum Trough Concentration (for Arms/Timepoints Above LLOQ)	As per Protocol, the timepoints for each arm where more than a third of the samples were above the lower limit of quantification (LLOQ), full summary statistics (Mean and Standard Deviation) were reported. For timepoints below the LLOQ, only the Median and Max were reported as a separate outcome measure below.	Pre-dose (0 hour) at Baseline and Weeks 14, 24, 44 and 66
Secondary	Etrolizumab Serum Trough Concentration (for Arms/Timepoints Below LLOQ)	As per Protocol, the timepoints for each arm where more than a third of the samples were below the LLOQ only the Median and Max were reported.	Weeks 44 and 66