A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors
NCT ID: NCT02165215
Last Updated: 2021-08-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
359 participants
INTERVENTIONAL
2014-08-12
2020-04-06
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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Open-Label Induction Phase: Etrolizumab
All participants will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) up to Week 10.
Etrolizumab
Participants will receive 105 mg etrolizumab SC injection Q4W.
Double-Blind Maintenance Phase: Etrolizumab
Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive etrolizumab 105 mg SC injection Q4W from Week 12 up to Week 62.
Etrolizumab
Participants will receive 105 mg etrolizumab SC injection Q4W.
Double-Blind Maintenance Phase: Placebo
Participants who achieved a clinical response at Week 10 during the induction phase and randomized to this arm for the double-blind maintenance phase will receive placebo (matched to etrolizumab) SC injection Q4W from Week 12 up to Week 62.
Placebo
Participants will receive placebo (matched to etrolizumab) SC injection Q4W.
Interventions
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Etrolizumab
Participants will receive 105 mg etrolizumab SC injection Q4W.
Placebo
Participants will receive placebo (matched to etrolizumab) 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 an MCS of 6-12 with an endoscopic subscore greater than or equal to (≥)2 as determined by the central reading procedure (endoscopy to be performed 4-16 days prior to Day 1), a rectal bleeding subscore ≥1, and a stool frequency subscore ≥1 during the screening period (prior to Day 1)
* Evidence of UC extending a minimum of 20 centimeters (cm) from the anal verge as determined by baseline endoscopy (flexible sigmoidoscopy or colonoscopy) performed during screening, 4-16 days prior to Day 1
* Naive to treatment with any anti-TNF therapy
* Participants must have had an inadequate response, loss of response, or intolerance to prior corticosteroid and/or immunosuppressant treatment
* Background regimen for UC may include oral 5-aminosalicylate (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
* 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) as stated in the protocol
* Any prior treatment with anti-adhesion molecules (such as mucosal addressin cell adhesion molecule \[MAdCAM-1\])
* Any prior treatment with rituximab
* Any treatment with tofacitinib during screening
* Cogenital 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 within 60 days prior to Day 1 or 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 California, Irvine Medical Center
Orange, California, United States
Clinical Applications Laboratories, Inc.
San Diego, California, United States
University of California at San Francisco
San Francisco, California, United States
Ventura Clinical Trials
Ventura, California, United States
Peak Gastroenterology Associates; Gastroenterology
Colorado Springs, Colorado, United States
Clinical Research of the Rockies
Lafayette, Colorado, United States
West Central Gastroenterology d/b/a Gastro Florida
Clearwater, Florida, United States
Regenerate Clinical Trials
Miami, Florida, United States
IMIC, Inc
Miami Beach, Florida, United States
Advanced Research Institute, Inc.
Trinity, Florida, United States
Shafran Gastroenterology Center
Winter Park, Florida, United States
Northwestern University-Feinberg School of Medicine; Division of Gastroenterology and Hepatology
Chicago, Illinois, United States
Southwest Gastroenterology
Oak Lawn, Illinois, United States
Aquiant Research
New Albany, Indiana, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Commonwealth Clinical Studies
Brockton, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Center for Digestive Health
Troy, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Ehrhardt Clinical Research, LLC
Belton, Missouri, United States
Manhattan Clinical Research
New York, New York, United States
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, United States
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, United States
UNC at Chapel Hill - Dpt of Family Medicine; Center for Functional GI and Motility Disorders
Chapel Hill, North Carolina, United States
Kinston Medical Specialists
Kinston, North Carolina, United States
Texas Digestive Disease Consultants - Dallas
Dallas, Texas, United States
Texas Digestive Disease Consultants - Southlake
Southlake, Texas, United States
Digestive Health Specialists of Tyler
Tyler, Texas, United States
Ericksen Research and Development
Clinton, Utah, United States
University of Utah School of Medicine
Salt Lake City, Utah, United States
McGuire Research Institute; Gastroenterology
Richmond, Virginia, United States
Northwest Gastroenterology Associates
Bellevue, Washington, United States
Hospital Universitario Walter Cantidio - UFC
Fortaleza, Ceará, Brazil
Centro Digestivo de Curitiba
Curitiba, Paraná, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
CECIP - Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo, Brazil
Pesquisare Saúde Sociedade Simples
Santo André, São Paulo, Brazil
Hospital Estadual Mario Covas
Santo André, São Paulo, Brazil
Hospital Sírio-Libanês
São Paulo, São Paulo, Brazil
Hospital do Servidor Público Estadual/HSPE-SP
São Paulo, São Paulo, Brazil
Pacific Gastroenterology Associates
Vancouver, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
Halifax, Nova Scotia, Canada
LHSC - University Hospital; Movement Disorders Program
London, Ontario, Canada
London Health Sciences Centre Victoria Hospital; Research Pharmacy
London, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Toronto Digestive Disease Associates
Vaughan, Ontario, Canada
Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika
Brno, , Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, , Czechia
Nemocnice Na Bulovce
Prague, , Czechia
Alborg Universitets Hospital
Aalborg, , Denmark
Herlev og Gentofte Hospital
Herlev, , Denmark
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, , Germany
Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
Bochum, , Germany
Ärztezentrum Ellwangen; Gemeinschaftspraxis
Ellwangen, , Germany
Klinik Johann Wolfgang von Goethe Uni
Frankfurt, , Germany
Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie
Hanover, , Germany
Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena
Jena, , Germany
Medizinisches Zentrum Klinikum Lueneburg
Lüneburg, , Germany
Klinikum Mannheim GmbH Universitätsklinikum
Mannheim, , Germany
DRC Gyogyszervizsgalo Kozpont Kft
Balatonfüred, , Hungary
Pannónia Klinika Magánorvosi
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, , Hungary
Csongrad Megyei Dr. Bugyi Istvan Korhaz
Szentes, , Hungary
Osmania General Hospital
Hyderabad, Andhra Pradesh, India
Deccan College of Medical Sciences and Allied Hospitals
Hyderabad, Andhra Pradesh, India
Shree Giriraj Multispeciality Hospital
Rajkot, Gujarat, India
Nirmal Hospital
Surat, Gujarat, India
K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
Belagavi, Karnataka, India
M. S. Ramaiah Medical College and Hospital
Bengaluru, Karnataka, India
Midas institute of Gastroenterology
Nagpur, Maharashtra, India
Pushpawati Singhania Research Institute
New Delhi, National Capital Territory of Delhi, India
Dayanand Medical College and Hospital
Ludhiana, Punjab, India
S. R. Kalla Memorial General Hospital
Jaipur, , India
Kasturba Medical College & Hospital
Mangalore, , India
Ruby Hall Clinic
Pune, , India
King Edward Memorial Hospital Research Centre
Pune, , India
Assaf Harofeh Medical Center
Beer Yaacov, , Israel
Bnei Zion Medical Center; Department of Internal Medicine B
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, , Israel
Holy Family Hospital
Nazareth, , Israel
Ospedale Sandro Pertini
Rome, Lazio, Italy
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Lombardy, Italy
Ospedale di Circolo; Neuropsichiatria Infantile
Rho, Lombardy, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Sicily, Italy
Centro Regiomontano de Estudios Clínicos Roma S.C.
Monterrey, Nuevo León, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, , Mexico
Phylasis Clinicas Research S de RL de CV
Estado de México, , Mexico
Zespó Przychodni Specjalistycznych PRIMA
Warsaw, , Poland
LexMedica Osrodek Badan Klinicznych
Wroclaw, , Poland
Fakultna nemocnica Nitra
Nitra, , Slovakia
Endomed, s.r.o.
Vranov nad Topľou, , Slovakia
Dr JP Wright Practice
Cape Town, , South Africa
Emmed Research
Pretoria, , South Africa
CI of SRC Sumy RCH Dept of Rheumatology Sumy SU MI
Sumy, Kharkiv Governorate, Ukraine
CI of Kyiv RC Kyiv Regional Clinical Hospital
Kyiv, KIEV Governorate, Ukraine
Lviv Regional Clinical Hospital
Lviv, KIEV Governorate, Ukraine
A.Novak Transcarpathian Regional Clinical Hospital
Uzhhorod, KIEV Governorate, Ukraine
Odessa regional clinical Hospital
Odesa, , Ukraine
M.V. Sklifosovskyi Poltava RCH Dept of Gastroenterology HSEIU UMSA
Poltava, , Ukraine
SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU
Uzhhorod, , Ukraine
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
Vinnytsia, , Ukraine
Countries
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References
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Vermeire S, Lakatos PL, Ritter T, Hanauer S, Bressler B, Khanna R, Isaacs K, Shah S, Kadva A, Tyrrell H, Oh YS, Tole S, Chai A, Pulley J, Eden C, Zhang W, Feagan BG; LAUREL Study Group. Etrolizumab for maintenance therapy in patients with moderately to severely active ulcerative colitis (LAUREL): a randomised, placebo-controlled, double-blind, phase 3 study. Lancet Gastroenterol Hepatol. 2022 Jan;7(1):28-37. doi: 10.1016/S2468-1253(21)00295-8. 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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2013-004280-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GA29102
Identifier Type: -
Identifier Source: org_study_id
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