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

NCT02100696 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: GA289502013-004278-88
• Study Type: interventional
• Target: 609
• Locations: 23 countries
• Sites: 181

Brief 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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (31)

• Induction Phase: Percentage of Participants With Clinical Remission at Week 14, as Determined by the MCS

  Week 14

• Induction Phase: Percentage of Participants With Clinical Response at Week 14, as Determined by the MCS

  Week 14

• 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

  Baseline and Week 14

• Induction Phase: Percentage of Participants With Endoscopic Remission at Week 14, as Determined by the MCS Endoscopic Subscore

  Week 14

• Induction Phase: Percentage of Participants With Histologic Remission at Week 14, as Determined by the Nancy Histological Index

  Week 14

Study Arms (6)

Cohort 1: Etrolizumab (Open-Label Induction (OLI) Phase)

EXPERIMENTAL

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.

Drug: Etrozulimab

Cohort 2: Placebo (Double-Blind Induction Phase)

PLACEBO COMPARATOR

Participants randomized to this arm will receive treatment with double-blind placebo SC injection Q4W for 14 weeks during the induction phase.

Drug: Placebo

Cohort 2: Etrolizumab (Double-Blind Induction Phase)

EXPERIMENTAL

Participants randomized to this arm will receive treatment with double-blind etrolizumab 105 mg SC injection Q4W for 14 weeks during the induction phase.

Drug: Etrozulimab

Placebo Responders: Placebo (Maintenance Phase)

PLACEBO COMPARATOR

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.

Drug: Placebo

Etrolizumab Responders: Placebo (Maintenance Phase)

PLACEBO COMPARATOR

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.

Drug: Placebo

Etrolizumab Responders: Etrolizumab (Maintenance Phase)

EXPERIMENTAL

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.

Drug: Etrozulimab

Interventions

Etrozulimab DRUG

Participants will receive 105 mg etrolizumab administered by SC injection Q4W.

Also known as: PRO145223, RO5490261, RG7413

Cohort 1: Etrolizumab (Open-Label Induction (OLI) Phase); Cohort 2: Etrolizumab (Double-Blind Induction Phase); Etrolizumab Responders: Etrolizumab (Maintenance Phase)

Placebo DRUG

Participants will receive placebo (matched with etrolizumab) administered by SC injection Q4W.

Cohort 2: Placebo (Double-Blind Induction Phase); Etrolizumab Responders: Placebo (Maintenance Phase); Placebo Responders: Placebo (Maintenance Phase)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (184)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California San Diego Medical Center

La Jolla, California, 92093-5354, United States

Location

Clinical Applications Laboratories, Inc.

San Diego, California, 92103, United States

Location

Precision Research Institute, LLC

San Diego, California, 92114, United States

Location

University of California at San Francisco

San Francisco, California, 94115, United States

Location

Rocky Mountain Gastroenterology Associates

Denver, Colorado, 80222, United States

Location

Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology

Lakewood, Colorado, 80215, United States

Location

FQL Research, LLC

Miramar, Florida, 33025, United States

Location

Center For Digestive Health

Orlando, Florida, 32803, United States

Location

Internal Medicine Specialists

Orlando, Florida, 32806, United States

Location

Shafran Gastroenterology Center

Winter Park, Florida, 32789, United States

Location

Gastroenterology Associates of Central Georgia

Macon, Georgia, 31201, United States

Location

Gastrointestinal Specialists of Georgia, PC

Marietta, Georgia, 30060, United States

Location

Atlanta Gastroenterology Specialists, PC

Suwanee, Georgia, 30024, United States

Location

Northwestern University Feinberg School Of Medicine

Chicago, Illinois, 60611, United States

Location

Southwest Gastroenterology

Oak Lawn, Illinois, 60453, United States

Location

Cotton-O'Neil Clinical Research Center, Digestive Health

Topeka, Kansas, 66606, United States

Location

Gastroenterology Associates, LLC

Baton Rouge, Louisiana, 70809, United States

Location

Louisiana Research Center, LLC

Shreveport, Louisiana, United States

Location

Massachusetts General Hospital; Crohn's & Colitis Center

Boston, Massachusetts, 02114, United States

Location

University of Michigan; Michigan Institute for Clinical and Health Research (MICHR)

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Center for Digestive Health

Troy, Michigan, 48098, United States

Location

Kansas City Research Institute, LLC

Kansas City, Missouri, 64131, United States

Location

Clinica Peruano Americana S.A.

Great Neck, New York, 11021, United States

Location

Weill Cornell Medical College-New York Presbyterian Hospital

New York, New York, 10021, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Consultants for Clinical Research Inc.

Cincinnati, Ohio, 45219, United States

Location

UC Health, LLC.

Cincinnati, Ohio, 45219, United States

Location

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060, United States

Location

Gastroenterology Center of the Midsouth, P.C.

Memphis, Tennessee, 38120, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Tyler Research Institute, LLC

Tyler, Texas, 75701, United States

Location

Ericksen Research and Development

Clinton, Utah, 84015, United States

Location

University of Utah School of Medicine

Salt Lake City, Utah, 84132, United States

Location

Digestive and Liver Disease Specialists, Ltd.

Norfolk, Virginia, 23502, United States

Location

McGuire Research Institute; Gastroenterology

Richmond, Virginia, 23249, United States

Location

Washington Gastroenterology

Bellevue, Washington, 98004, United States

Location

Hospital Provincial del Centenario

Rosario, 2000, Argentina

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Mater Adult Hospital

South Brisbane, Queensland, 4101, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Launceston General Hospital; Gastroenterology Research

Launceston, Tasmania, 7250, Australia

Location

St Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Footscray Hospital; Gastroenterology

Footscray, Victoria, 3011, Australia

Location

St Frances Xavier Cabrini Hospital

Malvern, Victoria, 3144, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

Klinikum Klagenfurt am Wörtersee; Acute geriatric care

Klagenfurt, 9020, Austria

Location

LKH - Universitätsklinikum der PMU Salzburg

Salzburg, 5020, Austria

Location

Medizinische Universität Wien

Vienna, 1090, Austria

Location

Imeldaziekenhuis

Bonheiden, 2820, Belgium

Location

CHU St Pierre (St Pierre)

Brussels, 1000, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

AZ Sint Elisabeth Herentals

Herentals, 2200, Belgium

Location

UZ Leuven; Neurology

Leuven, 3000, Belgium

Location

CHU de Liège; Tour de Pathologie

Liège, 4000, Belgium

Location

AZ Delta (Stedelijk Ziekenhuis)

Roeselare, 8800, Belgium

Location

Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

Goiânia, Goiás, 74535-170, Brazil

Location

Hospital Felicio Rocho

Belo Horizonte, Minas Gerais, 30110-068, Brazil

Location

Centro Digestivo de Curitiba

Curitiba, Paraná, 80430-160, Brazil

Location

Hospital Universitario Clementino Fraga Filho - UFRJ

Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil

Location

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

Location

Hospital de Clínicas de Porto Alegre X

Porto Alegre, Rio Grande do Sul, Brazil

Location

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

Botucatu, São Paulo, 18618-970, Brazil

Location

CAEP - Centro Avancado de Estudos e Pesquisas Ltda.

Campinas, São Paulo, 13087-567, Brazil

Location

Hospital Estadual Mario Covas

Santo André, São Paulo, 09190-610, Brazil

Location

University of Calgary; Heritage Medical Research Clinic

Calgary, Alberta, T2N 4Z6, Canada

Location

Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology

Edmonton, Alberta, T6G 2X8, Canada

Location

Pacific Gastroenterology Associates

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Queen Elizabeth II Health Sciences Centre; Gastroenterology Research

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Taunton Health Centre

Oshawa, Ontario, L1H 7K4, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Toronto Liver Centre

Toronto, Ontario, M6H 3M1, Canada

Location

Toronto Digestive Disease Associates

Vaughan, Ontario, L4L 4Y7, Canada

Location

Hotel Dieu de Levis

Lévis, Quebec, G6V 3Z1, Canada

Location

Hôpital Maisonneuve - Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Fakultni nemocnice Brno; Interni kardiologicka klinika

Brno, 625 00, Czechia

Location

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, 500 12, Czechia

Location

Pardubicka krajska nemocnice, a.s.

Pardubice, 532 03, Czechia

Location

ISCARE a.s.

Prague, 170 04, Czechia

Location

Nemocnice Na Bulovce

Prague, 180 01, Czechia

Location

Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni

Ústí nad Labem, 401 13, Czechia

Location

Ålborg Universitets Hospital; Gastromedicinsk

Aalborg, 9000, Denmark

Location

Rigshospitalet; Medicinsk gastroenterologisk klinik

København Ø, 2100, Denmark

Location

CHU Amiens - Hopital Sud; Pharmacie - Secteur des Essais cliniques

Amiens Cedex01, 80054, France

Location

Hôpital Beaujon

Clichy, 92110, France

Location

Hopital Claude Huriez - CHU Lille

Lille, 59037, France

Location

Hôpital Nord - CHU Marseille; Gastroenterology and Hepatology

Marseille, 13915, France

Location

CHU Nice - Hopital de l'Archet 2

Nice, 06202, France

Location

Hôpital Saint-Louis

Paris, 75475, France

Location

Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN

Pessac, 33604, France

Location

CHU Saint Etienne - Hôpital Nord

Saint-Etienne, 42055, France

Location

Höpital Hautepierre; Pediatrie1

Strasbourg, 67098, France

Location

CHU de Toulouse - Hôpital Rangueil

Toulouse, 31059, France

Location

Hôpital de Brabois Adultes

Vandœuvre-lès-Nancy, 54511, France

Location

Charite Universitaetsmedizin Berlin - Campus Charite Mitte

Berlin, 10117, Germany

Location

DRK Kliniken Berlin Westend

Berlin, 14050, Germany

Location

Universitaetsklinikum Erlangen

Erlangen, 91054, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universitaet

Frankfurt, 60590, Germany

Location

Universitätsklinikum Freiburg; Innere Medizin I; Hämatologie, Onkologie und Stammzelltransplantation

Freiburg im Breisgau, 79106, Germany

Location

Universitaetsklinikum Halle (Saale)

Halle, 06120, Germany

Location

Hamburgisches Forschungsinstitut fuer CED

Hamburg, 20148, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Gastroenterologie Eppendorfer Baum

Hamburg, 20249, Germany

Location

Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie

Hanover, 30625, Germany

Location

Universitaetsklinikum Schleswig-Holstein, Campus Kiel

Kiel, 24116, Germany

Location

Klinikum Mannheim GmbH Universitätsklinikum

Mannheim, 68167, Germany

Location

Universitaetsklinikum Muenster

Münster, 48149, Germany

Location

Universitaetsklinikum Ulm

Ulm, 89081, Germany

Location

Anticancer Hospital of Thessaliniki " Theagenio"

Thessaloniki, 54007, Greece

Location

Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

Békéscsaba, 5600, Hungary

Location

Obudai Egeszsegugyi Centrum Kft.

Budapest, 1036, Hungary

Location

Semmelweis Egyetem

Budapest, 1083, Hungary

Location

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

Budapest, 1125, Hungary

Location

Pannonia Maganorvosi Centrum

Budapest, 1135, Hungary

Location

Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely

Budapest, H-1077, Hungary

Location

Debreceni Egyetem

Debrecen, 4032, Hungary

Location

Markhot Ferenc Oktato Korhaz es Rendelointezet

Eger, 3300, Hungary

Location

Petz Aladar Megyei Oktato Korhaz

Győr, 9024, Hungary

Location

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; II. Belgyogyaszat

Miskolc, 3526, Hungary

Location

Pecsi Tudomanyegyetem

Pécs, 7624, Hungary

Location

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, 8000, Hungary

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Hadassah University Hospital - Ein Kerem; Neurosurgery

Jerusalem, 9112001, Israel

Location

Rabin Medical Center-Beilinson Campus; Gaucher Clinic, Genetics Institute

Petach Tiqwa, 49100, Israel

Location

Kaplan Medical Center

Rehovot, 7610001, Israel

Location

Assaf Harofeh

Rishon LeZiyyon, 7505001, Israel

Location

Azienda Ospedaliera S. Orsola-Malpighi

Bologna, Emilia-Romagna, 40138, Italy

Location

A.O.U. Policlinico di Modena

Modena, Emilia-Romagna, 40124, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Rome, Lazio, 00133, Italy

Location

Azienda Ospedaliera San Camillo Forlanini

Rome, Lazio, 00152, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, 00168, Italy

Location

Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

Milan, Lombardy, Italy

Location

Ospedale di Circolo; Neuropsichiatria Infantile

Rho, Lombardy, 20017, Italy

Location

Istituto Clinico Humanitas

Rozzano (MI), Lombardy, 20089, Italy

Location

I.R.C.C.S Policlinico San Donato

San Donato Milanese (MI), Lombardy, 20097, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, 50141, Italy

Location

Azienda Ospedaliera Di Padova

Padua, Veneto, 35128, Italy

Location

Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

Kaunas, 50009, Lithuania

Location

Vilnius University Hospital Santariskiu Clinic Public Insti

Vilnius, 08661, Lithuania

Location

Centro Regiomontano de Estudios Clínicos Roma S.C.

Monterrey, Nuevo León, 64610, Mexico

Location

Amsterdam UMC, Locatie VUMC; Neurology

Amsterdam, 1081 HV, Netherlands

Location

Amsterdam UMC Location AMC

Amsterdam, 1105 AZ, Netherlands

Location

Rijnstate; Internal Medicine Department

Arnhem, 6815 AD, Netherlands

Location

Radboudumc

NL -nijmegen, 6525 GA, Netherlands

Location

Nasz Lekarz Osrodek Badan Klinicznych

Bydgoszcz, 85-312, Poland

Location

Nzoz All-Medicus

Katowice, 40-660, Poland

Location

Gabinet Lekarski, Bartosz Korczowski

Rzeszów, 35-302, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej SONOMED

Szczecin, 70-351, Poland

Location

Centrum Zdrowia MDM

Warsaw, 00-631, Poland

Location

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

Warsaw, 02-781, Poland

Location

Nzoz Vivamed

Warsaw, 03-580, Poland

Location

PlanetMed

Wroclaw, 52-210, Poland

Location

LexMedica Osrodek Badan Klinicznych

Wroclaw, 53-114, Poland

Location

EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu

Wroclaw, 54-144, Poland

Location

SC Euroclinic Hospital SA

Bucharest, 014461, Romania

Location

Kyungpook National University Hospital; Opthalmology

Daegu, 700-721, South Korea

Location

Korea University Ansan Hospital

Gyeonggi-do, 15355, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13605, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06531, South Korea

Location

Asan Medical Center.

Seoul, 138-736, South Korea

Location

The Catholic University of Korea St. Vincent's Hospital

Suwon, 442-723, South Korea

Location

Fundacion Hospital de Alcorcon; Servicio de Digestivo

Alcorcón, Madrid, 28922, Spain

Location

Hospital Universitari de Girona Dr Josep Trueta

Girona, 17007, Spain

Location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Hospital Universitario de Fuenlabrada

Madrid, 28942, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Inselspital-Universitaetsspital Bern; Institut fuer Spitalpharmazie

Bern, 3010, Switzerland

Location

Cliniques Universitaires Saint-Luc; Nephrology

Bern, 3012, Switzerland

Location

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

Bern, 3012, Switzerland

Location

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Royal Devon and Exeter Hospital (Wonford)

Exeter, EX2 5DW, United Kingdom

Location

The Royal London Hospital

London, E1 2ES, United Kingdom

Location

University College London Hospital

London, NW1 - 2PG, United Kingdom

Location

St Thomas Hospital

London, SE1 7EH, United Kingdom

Location

King's College London

London, SE5 9NU, United Kingdom

Location

Fairfield General Hospital

Manchester, M8 5RB, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Nottingham University Hospitals; QMC Campus

Nottingham, NG7 2UH, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 34798039 DERIVED

• 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.

  PMID: 32445184 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

etrolizumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 1, 2014
• Study Start: May 21, 2014
• Primary Completion: April 16, 2020
• Study Completion: April 16, 2020
• Last Updated: August 13, 2021
• Results First Posted: June 15, 2021

Record last verified: 2021-07

Locations

ME (1); CZ (6); BR (9); KR (8); IL (5); AR (1); BE (8); LI (2); DK (2); US (38); AU (8); PL (10); NL (4); DE (14); ES (6); RO (1); FR (11); HU (12); CH (3); GB (10); GR (1); CA (10); IT (11)