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 (LAUREL)

• ClinicalTrials.gov Identifier: NCT02165215
• Recruitment Status: Completed
• First Posted: June 17, 2014
• Results First Posted: June 15, 2021
• Last Update Posted: August 19, 2021
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

Brief Summary:

This Phase III, randomized, double-blind, parallel-grouped, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab in maintenance of remission in participants with moderately to severely active UC who are naive to TNF inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.

Condition or disease	Intervention/treatment	Phase
Colitis, Ulcerative	Drug: Etrolizumab; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 359 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Maintenance of Remission) and Safety of Etrolizumab Compared With Placebo in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors
• Actual Study Start Date: August 12, 2014
• Actual Primary Completion Date: April 6, 2020
• Actual Study Completion Date: April 6, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Etrolizumab; Participants will receive 105 mg etrolizumab SC injection Q4W.; Other Names: RG7413; RO5490261; PRO145223; rhuMAb Beta7
Experimental: 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.	Drug: Etrolizumab; Participants will receive 105 mg etrolizumab SC injection Q4W.; Other Names: RG7413; RO5490261; PRO145223; rhuMAb Beta7
Placebo Comparator: 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.	Drug: Placebo; Participants will receive placebo (matched to etrolizumab) SC injection Q4W.

Outcome Measures

Primary Outcome Measures :

1. Maintenance Phase: Percentage of Participants in Remission at Week 62 Among Randomized Participants With a Clinical Response at Week 10, as Determined by the Mayo Clinic Score (MCS) [ Time Frame: Week 62 ]

   MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment.

   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.

   Remission is MCS ≤2 with individual subscores ≤1 and a rectal bleeding subscore of 0.

Secondary Outcome Measures :

1. Maintenance Phase: Percentage of Participants Who Maintained Clinical Remission at Week 62 Among Randomized Participants in Clinical Remission at Week 10, as Determined by the MCS [ Time Frame: Week 62 ]

   MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment.

   Clinical Remission is MCS ≤2 with individual subscores ≤1.

2. Maintenance Phase: Percentage of Participants in Clinical Remission at Week 62, as Determined by the MCS [ Time Frame: Week 62 ]

   MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment.

   Clinical Remission is MCS ≤2 with individual subscores ≤1.

3. Maintenance Phase: Percentage of Participants in Remission at Week 62 Among Randomized Participants in Remission at Week 10, as Determined by the MCS [ Time Frame: Week 62 ]

   MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment.

   Remission is MCS ≤2 with individual subscores ≤1 and a rectal bleeding subscore of 0.

4. Maintenance Phase: Percentage of Participants With Improvement From Baseline in Endoscopic Appearance of the Mucosa at Week 62, as Determined by the MCS Endoscopic Subscore [ Time Frame: Baseline, Week 62 ]

   MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment.

   Improvement in endoscopic appearance of the mucosa is Endoscopy subscore ≤1.

5. Maintenance Phase: Percentage of Participants With Endoscopic Remission at Week 62, as Determined by the MCS Endoscopic Subscore [ Time Frame: Week 62 ]

   MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment.

   Endoscopic Remission is Endoscopy subscore = 0.

6. Maintenance Phase: Percentage of Participants With Histologic Remission at Week 62, as Determined by the Nancy Histological Index [ Time Frame: Week 62 ]
   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.
7. Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 62 Among Participants Who Were Receiving Corticosteroids at Baseline, as Determined by the MCS [ Time Frame: Baseline, Week 62 ]

   MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment.

   Clinical Remission is MCS ≤2 with individual subscores ≤1.

8. Maintenance Phase: Percentage of Participants With Corticosteroid-Free Remission at Week 62 Among Participants Who Were Receiving Corticosteroids at Baseline, as Determined by the MCS [ Time Frame: Baseline, Week 62 ]

   MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment.

   Remission is MCS ≤2 with individual subscores ≤1 and a rectal bleeding subscore of 0.

9. Maintenance Phase: Change From Baseline to Week 62 in UC Bowel Movement Signs and Symptoms, as Assessed by the Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Questionnaire [ Time Frame: Baseline, Week 62 ]

   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.

10. Maintenance Phase: Change From Baseline to Week 62 in UC Functional Symptoms, as Assessed by the UC-PRO/SS Questionnaire [ Time Frame: Baseline, Week 62 ]

    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 domain score ranges from 0-12, with a higher score indicating a worse disease state.

11. Maintenance Phase: Change From Baseline to Week 62 in Health-Related Quality of Life, as Assessed by the Overall Score of the Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline, Week 62 ]

    The IBDQ is used to assess participant's health-related quality of life (QOL). The 32-item questionnaire contains four domains: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). The items are scored on a 7-point Likert scale with a higher score indicating better health-related QOL.

    IBDQ score is a total score summed up from across all 32 questions on the questionnaire. The score can range from 32-224 and the higher score indicates a better quality of life.

12. 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) [ Time Frame: From Baseline up to Week 74 ]
    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.
13. Number of Participants With Adverse Events Leading to Study Drug Discontinuation [ Time Frame: From Baseline up to Week 74 ]
14. Number of Participants With Serious Infection-Related Adverse Events [ Time Frame: From Baseline up to Week 74 ]
15. Number of Participants With Infection-Related Adverse Events by Severity, According to NCI-CTCAE v4.0 [ Time Frame: From Baseline up to Week 74 ]
    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.
16. Number of Participants With Injection-Site Reactions by Severity, According to NCI-CTCAE v4.0 [ Time Frame: From Baseline up to Week 74 ]
    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.
17. Number of Participants With Hypersensitivity Reaction Events by Severity, According to NCI-CTCAE v4.0 [ Time Frame: From Baseline up to Week 74 ]
    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.
18. Number of Participants With Malignancies [ Time Frame: From Baseline up to Week 74 ]
19. Number of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab [ Time Frame: Baseline, Weeks 4, 12, 24, 44, and 62, and and Early Termination/End of Safety Follow-Up (up to Week 74) ]
20. Maintenance Phase: Etrolizumab Serum Trough Concentration (for Arms/Timepoints Above LLOQ) [ Time Frame: Pre-dose (0 hour) at Baseline and Weeks 12, 24, 44, and 62 ]
    As per protocol, the timepoints for each arm where more than a third of the samples were above the lower limit of quantitation (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.
21. Maintenance Phase: Etrolizumab Serum Trough Concentration (for Arms/Timepoints Below LLOQ) [ Time Frame: Pre-dose (0 hour) at Baseline and Weeks 12, 24, 44, and 62 ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Diagnosis of ulcerative colitis (UC) established at least 3 months prior to Day 1 by clinical and endoscopic evidence
• 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:

• 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) 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

Contacts and Locations

Locations

United States, California

University of California, Irvine Medical Center

Orange, California, United States, 92868

Clinical Applications Laboratories, Inc.

San Diego, California, United States, 92103

University of California at San Francisco

San Francisco, California, United States, 94115

Ventura Clinical Trials

Ventura, California, United States, 93003

United States, Colorado

Peak Gastroenterology Associates; Gastroenterology

Colorado Springs, Colorado, United States, 80907

Clinical Research of the Rockies

Lafayette, Colorado, United States, 80026

United States, Florida

West Central Gastroenterology d/b/a Gastro Florida

Clearwater, Florida, United States, 33762

IMIC, Inc

Miami Beach, Florida, United States, 33140

Regenerate Clinical Trials

Miami, Florida, United States, 33155

Advanced Research Institute, Inc.

Trinity, Florida, United States, 34655

Shafran Gastroenterology Center

Winter Park, Florida, United States, 32789

United States, Illinois

Northwestern University-Feinberg School of Medicine; Division of Gastroenterology and Hepatology

Chicago, Illinois, United States, 60611

Southwest Gastroenterology

Oak Lawn, Illinois, United States, 60453

United States, Indiana

Aquiant Research

New Albany, Indiana, United States, 47150

United States, Louisiana

Louisiana Research Center, LLC

Shreveport, Louisiana, United States

United States, Massachusetts

Commonwealth Clinical Studies

Brockton, Massachusetts, United States, 02302

United States, Michigan

Henry Ford Health System

Detroit, Michigan, United States, 48202

Center for Digestive Health

Troy, Michigan, United States, 48098

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455

United States, Mississippi

University of Mississippi Medical Center

Jackson, Mississippi, United States, 39216

United States, Missouri

Ehrhardt Clinical Research, LLC

Belton, Missouri, United States, 64012

United States, New York

Manhattan Clinical Research

New York, New York, United States, 10016

Weill Cornell Medical College-New York Presbyterian Hospital

New York, New York, United States, 10021

United States, North Carolina

Asheville Gastroenterology Associates, P.A.

Asheville, North Carolina, United States, 28801

UNC at Chapel Hill - Dpt of Family Medicine; Center for Functional GI and Motility Disorders

Chapel Hill, North Carolina, United States, 27599

Kinston Medical Specialists

Kinston, North Carolina, United States, 28501

United States, Texas

Texas Digestive Disease Consultants - Dallas

Dallas, Texas, United States, 75231

Texas Digestive Disease Consultants - Southlake

Southlake, Texas, United States, 76092

Digestive Health Specialists of Tyler

Tyler, Texas, United States, 75701

United States, Utah

Ericksen Research and Development

Clinton, Utah, United States, 84015

University of Utah School of Medicine

Salt Lake City, Utah, United States, 84132

United States, Virginia

McGuire Research Institute; Gastroenterology

Richmond, Virginia, United States, 23249

United States, Washington

Northwest Gastroenterology Associates

Bellevue, Washington, United States, 98004

Brazil

Hospital Universitario Walter Cantidio - UFC

Fortaleza, CE, Brazil, 60430-370

Centro Digestivo de Curitiba

Curitiba, PR, Brazil, 80430-160

Hospital Moinhos de Vento

Porto Alegre, RS, Brazil, 90035-001

CECIP - Centro de Estudos Clínicos do Interior Paulista

Jaú, SP, Brazil, 17210-190

Pesquisare Saúde Sociedade Simples

Santo Andre, SP, Brazil, 09080-000

Hospital Estadual Mario Covas

Santo Andre, SP, Brazil, 09190-610

Hospital Sírio-Libanês

Sao Paulo, SP, Brazil, 01308-050

Hospital do Servidor Público Estadual/HSPE-SP

São Paulo, SP, Brazil, 04039-901

Canada, British Columbia

Pacific Gastroenterology Associates

Vancouver, British Columbia, Canada, V6Z 2K5

Canada, Nova Scotia

Queen Elizabeth II Health Sciences Centre; Gastroenterology Research

Halifax, Nova Scotia, Canada, B3H 1V7

Canada, Ontario

LHSC - University Hospital; Movement Disorders Program

London, Ontario, Canada, N6A 5A5

London Health Sciences Centre Victoria Hospital; Research Pharmacy

London, Ontario, Canada, N6A 5W9

Mount Sinai Hospital

Toronto, Ontario, Canada, M5G 1X5

Toronto Digestive Disease Associates

Vaughan, Ontario, Canada, L4L 4Y7

Czechia

Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika

Brno, Czechia, 65691

Hepato-Gastroenterologie HK, s.r.o.

Hradec Kralove, Czechia, 500 12

Nemocnice Na Bulovce

Prague, Czechia, 180 01

Denmark

Alborg Universitets Hospital

Aalborg, Denmark, 9100

Herlev og Gentofte Hospital

Herlev, Denmark, 2730

Germany

Charite Universitaetsmedizin Berlin - Campus Charite Mitte

Berlin, Germany, 10117

Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

Bochum, Germany, 44789

Ärztezentrum Ellwangen; Gemeinschaftspraxis

Ellwangen, Germany, 73479

Klinik Johann Wolfgang von Goethe Uni

Frankfurt, Germany, 60590

Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie

Hannover, Germany, 30625

Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena

Jena, Germany, 07740

Medizinisches Zentrum Klinikum Lueneburg

Lueneburg, Germany, 21339

Klinikum Mannheim GmbH Universitätsklinikum

Mannheim, Germany, 68167

Hungary

DRC Gyogyszervizsgalo Kozpont Kft

Balatonfured, Hungary, 8230

Pannónia Klinika Magánorvosi

Budapest, Hungary, 1136

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4032

Pest Megyei Flor Ferenc Korhaz

Kistarcsa, Hungary, 2143

Csongrad Megyei Dr. Bugyi Istvan Korhaz

Szentes, Hungary, 6600

India

Osmania General Hospital

Hyderabad, Andhra Pradesh, India, 500012

Deccan College of Medical Sciences and Allied Hospitals

Hyderabad, Andhra Pradesh, India, 500058

Pushpawati Singhania Research Institute

New Delhi, Delhi, India, 110017

Shree Giriraj Multispeciality Hospital

Rajkot, Gujarat, India, 360005

Nirmal Hospital

Surat, Gujarat, India, 395002

K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre

Belgaum, Karnataka, India, 590010

M. S. Ramaiah Medical College and Hospital

Bengaluru, Karnataka, India, 560054

Midas institute of Gastroenterology

Nagpur, Maharashtra, India, 440012

Dayanand Medical College and Hospital

Ludhiana, Punjab, India, 141001

S. R. Kalla Memorial General Hospital

Jaipur, India, 302001

Kasturba Medical College & Hospital

Mangalore, India, 575001

Ruby Hall Clinic

Pune, India, 411 001

King Edward Memorial Hospital Research Centre

Pune, India, 411011

Israel

Assaf Harofeh Medical Center

Beer Yaacov, Israel, 6093000

Bnei Zion Medical Center; Department of Internal Medicine B

Haifa, Israel, 31048

Shaare Zedek Medical Center

Jerusalem, Israel, 9103102

Hadassah University Hospital - Ein Kerem

Jerusalem, Israel, 9112001

Holy Family Hospital

Nazareth, Israel, 16100

Italy

Ospedale Sandro Pertini

Roma, Lazio, Italy, 00157

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, Lombardia, Italy, 25124

Ospedale di Circolo; Neuropsichiatria Infantile

Rho, Lombardia, Italy, 20017

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, Sicilia, Italy, 90127

Mexico

Centro Regiomontano de Estudios Clínicos Roma S.C.

Monterrey, Nuevo LEON, Mexico, 64610

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

Durango, Mexico, 34000

Phylasis Clinicas Research S de RL de CV

Estado de México, Mexico, 54769

Poland

Zespó Przychodni Specjalistycznych PRIMA

Warszawa, Poland, 02-018

LexMedica Osrodek Badan Klinicznych

Wroclaw, Poland, 53-114

Slovakia

Fakultna nemocnica Nitra

Nitra, Slovakia, 950 01

Endomed, s.r.o.

Vranov nad Topľou, Slovakia, 093 01

South Africa

Dr JP Wright Practice

Cape Town, South Africa, 7708

Emmed Research

Pretoria, South Africa, 0002

Ukraine

CI of SRC Sumy RCH Dept of Rheumatology Sumy SU MI

Sumy, Kharkiv Governorate, Ukraine, 40022

CI of Kyiv RC Kyiv Regional Clinical Hospital

Kyiv, KIEV Governorate, Ukraine, 04107

Lviv Regional Clinical Hospital

Lviv, KIEV Governorate, Ukraine, 79010

A.Novak Transcarpathian Regional Clinical Hospital

Uzhgorod, KIEV Governorate, Ukraine, 88018

Odessa regional clinical Hospital

Odessa, Ukraine, 65117

M.V. Sklifosovskyi Poltava RCH Dept of Gastroenterology HSEIU UMSA

Poltava, Ukraine, 36011

SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU

Uzhgorod, Ukraine, 88009

M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

Vinnytsia, Ukraine, 21018

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:

Study Protocol  [PDF] August 27, 2018

Statistical Analysis Plan  [PDF] May 4, 2020

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02165215
• Other Study ID Numbers: GA29102; 2013-004280-31 ( EudraCT Number )
• First Posted: June 17, 2014
• Results First Posted: June 15, 2021
• Last Update Posted: August 19, 2021
• Last Verified: July 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Colitis; Colitis, Ulcerative; Ulcer; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Inflammatory Bowel Diseases; Etrolizumab; Gastrointestinal Agents; Immunologic Factors; Physiological Effects of Drugs