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
NCT ID: NCT02100696
Last Updated: 2021-08-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
609 participants
INTERVENTIONAL
2014-05-21
2020-04-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort 1: Etrolizumab (Open-Label Induction (OLI) Phase)
Participants assigned to this arm will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) for 14 weeks during the induction phase.
Etrozulimab
Participants will receive 105 mg etrolizumab administered by SC injection Q4W.
Cohort 2: Placebo (Double-Blind Induction Phase)
Participants randomized to this arm will receive treatment with double-blind placebo SC injection Q4W for 14 weeks during the induction phase.
Placebo
Participants will receive placebo (matched with etrolizumab) administered by SC injection Q4W.
Cohort 2: Etrolizumab (Double-Blind Induction Phase)
Participants randomized to this arm will receive treatment with double-blind etrolizumab 105 mg SC injection Q4W for 14 weeks during the induction phase.
Etrozulimab
Participants will receive 105 mg etrolizumab administered by SC injection Q4W.
Placebo Responders: Placebo (Maintenance Phase)
Participants who received placebo during the induction phase, Cohort 2: Placebo (Double-Blind Induction Phase), and achieve a clinical response with placebo at Week 14 will continue to receive blinded placebo from Week 16 up to Week 66 during the maintenance phase.
Placebo
Participants will receive placebo (matched with etrolizumab) administered by SC injection Q4W.
Etrolizumab Responders: Placebo (Maintenance Phase)
Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive placebo SC injection Q4W from Week 16 up to Week 66.
Placebo
Participants will receive placebo (matched with etrolizumab) administered by SC injection Q4W.
Etrolizumab Responders: Etrolizumab (Maintenance Phase)
Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive etrolizumab 105 mg SC injection Q4W from Week 16 up to Week 66.
Etrozulimab
Participants will receive 105 mg etrolizumab administered by SC injection Q4W.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California San Diego Medical Center
La Jolla, California, 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
Rocky Mountain Gastroenterology Associates
Denver, Colorado, United States
Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology
Lakewood, Colorado, United States
FQL Research, LLC
Miramar, Florida, United States
Center For Digestive Health
Orlando, Florida, United States
Internal Medicine Specialists
Orlando, Florida, United States
Shafran Gastroenterology Center
Winter Park, Florida, United States
Gastroenterology Associates of Central Georgia
Macon, Georgia, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States
Atlanta Gastroenterology Specialists, PC
Suwanee, Georgia, United States
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States
Southwest Gastroenterology
Oak Lawn, Illinois, United States
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, United States
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Massachusetts General Hospital; Crohn's & Colitis Center
Boston, Massachusetts, United States
University of Michigan; Michigan Institute for Clinical and Health Research (MICHR)
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Center for Digestive Health
Troy, Michigan, United States
Kansas City Research Institute, LLC
Kansas City, Missouri, United States
Clinica Peruano Americana S.A.
Great Neck, New York, United States
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Consultants for Clinical Research Inc.
Cincinnati, Ohio, United States
UC Health, LLC.
Cincinnati, Ohio, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Gastroenterology Center of the Midsouth, P.C.
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
Ericksen Research and Development
Clinton, Utah, United States
University of Utah School of Medicine
Salt Lake City, Utah, United States
Digestive and Liver Disease Specialists, Ltd.
Norfolk, Virginia, United States
McGuire Research Institute; Gastroenterology
Richmond, Virginia, United States
Washington Gastroenterology
Bellevue, Washington, United States
Hospital Provincial del Centenario
Rosario, , Argentina
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Mater Adult Hospital
South Brisbane, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Launceston General Hospital; Gastroenterology Research
Launceston, Tasmania, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Footscray Hospital; Gastroenterology
Footscray, Victoria, Australia
St Frances Xavier Cabrini Hospital
Malvern, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Klinikum Klagenfurt am Wörtersee; Acute geriatric care
Klagenfurt, , Austria
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, , Austria
Medizinische Universität Wien
Vienna, , Austria
Imeldaziekenhuis
Bonheiden, , Belgium
CHU St Pierre (St Pierre)
Brussels, , Belgium
UZ Brussel
Brussels, , Belgium
UZ Gent
Ghent, , 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, , Belgium
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
Goiânia, Goiás, Brazil
Hospital Felicio Rocho
Belo Horizonte, Minas Gerais, Brazil
Centro Digestivo de Curitiba
Curitiba, Paraná, Brazil
Hospital Universitario Clementino Fraga Filho - UFRJ
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre X
Porto Alegre, Rio Grande do Sul, Brazil
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, São Paulo, Brazil
CAEP - Centro Avancado de Estudos e Pesquisas Ltda.
Campinas, São Paulo, Brazil
Hospital Estadual Mario Covas
Santo André, São Paulo, Brazil
University of Calgary; Heritage Medical Research Clinic
Calgary, Alberta, Canada
Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
Edmonton, Alberta, Canada
Pacific Gastroenterology Associates
Vancouver, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
Halifax, Nova Scotia, Canada
Taunton Health Centre
Oshawa, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Toronto Liver Centre
Toronto, Ontario, Canada
Toronto Digestive Disease Associates
Vaughan, Ontario, Canada
Hotel Dieu de Levis
Lévis, Quebec, Canada
Hôpital Maisonneuve - Rosemont
Montreal, Quebec, Canada
Fakultni nemocnice Brno; Interni kardiologicka klinika
Brno, , Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, , Czechia
Pardubicka krajska nemocnice, a.s.
Pardubice, , Czechia
ISCARE a.s.
Prague, , Czechia
Nemocnice Na Bulovce
Prague, , Czechia
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni
Ústí nad Labem, , Czechia
Ålborg Universitets Hospital; Gastromedicinsk
Aalborg, , Denmark
Rigshospitalet; Medicinsk gastroenterologisk klinik
København Ø, , Denmark
CHU Amiens - Hopital Sud; Pharmacie - Secteur des Essais cliniques
Amiens Cedex01, , France
Hôpital Beaujon
Clichy, , France
Hopital Claude Huriez - CHU Lille
Lille, , France
Hôpital Nord - CHU Marseille; Gastroenterology and Hepatology
Marseille, , 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, , France
Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy, , France
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 im Breisgau, , Germany
Universitaetsklinikum Halle (Saale)
Halle, , Germany
Hamburgisches Forschungsinstitut fuer CED
Hamburg, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Gastroenterologie Eppendorfer Baum
Hamburg, , Germany
Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie
Hanover, , Germany
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, , Germany
Klinikum Mannheim GmbH Universitätsklinikum
Mannheim, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
Anticancer Hospital of Thessaliniki " Theagenio"
Thessaloniki, , Greece
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
Békéscsaba, , Hungary
Obudai Egeszsegugyi Centrum Kft.
Budapest, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo
Budapest, , Hungary
Pannonia Maganorvosi Centrum
Budapest, , Hungary
Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
Budapest, , Hungary
Debreceni Egyetem
Debrecen, , Hungary
Markhot Ferenc Oktato Korhaz es Rendelointezet
Eger, , Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, , Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; II. Belgyogyaszat
Miskolc, , Hungary
Pecsi Tudomanyegyetem
Pécs, , Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, , Hungary
Shaare Zedek Medical Center
Jerusalem, , Israel
Hadassah University Hospital - Ein Kerem; Neurosurgery
Jerusalem, , Israel
Rabin Medical Center-Beilinson Campus; Gaucher Clinic, Genetics Institute
Petach Tiqwa, , Israel
Kaplan Medical Center
Rehovot, , Israel
Assaf Harofeh
Rishon LeZiyyon, , Israel
Azienda Ospedaliera S. Orsola-Malpighi
Bologna, Emilia-Romagna, Italy
A.O.U. Policlinico di Modena
Modena, Emilia-Romagna, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, Lazio, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
Milan, Lombardy, Italy
Ospedale di Circolo; Neuropsichiatria Infantile
Rho, Lombardy, Italy
Istituto Clinico Humanitas
Rozzano (MI), Lombardy, Italy
I.R.C.C.S Policlinico San Donato
San Donato Milanese (MI), Lombardy, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, Italy
Azienda Ospedaliera Di Padova
Padua, Veneto, Italy
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
Kaunas, , Lithuania
Vilnius University Hospital Santariskiu Clinic Public Insti
Vilnius, , Lithuania
Centro Regiomontano de Estudios Clínicos Roma S.C.
Monterrey, Nuevo León, Mexico
Amsterdam UMC, Locatie VUMC; Neurology
Amsterdam, , Netherlands
Amsterdam UMC Location AMC
Amsterdam, , Netherlands
Rijnstate; Internal Medicine Department
Arnhem, , Netherlands
Radboudumc
NL -nijmegen, , Netherlands
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
Warsaw, , Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw, , Poland
Nzoz Vivamed
Warsaw, , Poland
PlanetMed
Wroclaw, , Poland
LexMedica Osrodek Badan Klinicznych
Wroclaw, , Poland
EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu
Wroclaw, , Poland
SC Euroclinic Hospital SA
Bucharest, , Romania
Kyungpook National University Hospital; Opthalmology
Daegu, , South Korea
Korea University Ansan Hospital
Gyeonggi-do, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Asan Medical Center.
Seoul, , South Korea
The Catholic University of Korea St. Vincent's Hospital
Suwon, , South Korea
Fundacion Hospital de Alcorcon; Servicio de Digestivo
Alcorcón, Madrid, Spain
Hospital Universitari de Girona Dr Josep Trueta
Girona, , Spain
Hospital Universitario de la Princesa
Madrid, , Spain
Hospital Universitario de Fuenlabrada
Madrid, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Inselspital-Universitaetsspital Bern; Institut fuer Spitalpharmazie
Bern, , Switzerland
Cliniques Universitaires Saint-Luc; Nephrology
Bern, , Switzerland
Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
Bern, , Switzerland
Addenbrooke's Hospital
Cambridge, , United Kingdom
Royal Devon and Exeter Hospital (Wonford)
Exeter, , United Kingdom
The Royal London Hospital
London, , United Kingdom
University College London Hospital
London, , United Kingdom
St Thomas Hospital
London, , United Kingdom
King's College London
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 Kingdom
Countries
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References
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Peyrin-Biroulet L, Hart A, Bossuyt P, Long M, Allez M, Juillerat P, Armuzzi A, Loftus EV Jr, Ostad-Saffari E, Scalori A, Oh YS, Tole S, Chai A, Pulley J, Lacey S, Sandborn WJ; HICKORY Study Group. Etrolizumab as induction and maintenance therapy for ulcerative colitis in patients previously treated with tumour necrosis factor inhibitors (HICKORY): a phase 3, randomised, controlled trial. Lancet Gastroenterol Hepatol. 2022 Feb;7(2):128-140. doi: 10.1016/S2468-1253(21)00298-3. Epub 2021 Nov 17.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2013-004278-88
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GA28950
Identifier Type: -
Identifier Source: org_study_id
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