An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice

Last updated: February 26, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Not Recruiting

Phase

4

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

Ozanimod

Clinical Study ID

NCT05369832
IM047-029
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to explore the safety, efficacy, effects on quality of life (QOL), and biomarker response of ozanimod in participants with moderate to severely active ulcerative colitis (UC) in clinical practice.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A diagnosis of ulcerative colitis (UC), with signs and symptoms consistent with UCfor at least 3 months prior to the first study intervention administration

  • Moderate to severely active UC disease activity, defined as a modified Mayo score of 4 through 9, inclusive, with the following minimum subscores: i) An SF subscore ≥ 1, AND ii) An RB subscore ≥ 1, AND iii) An ES ≥ 2 (endoscopyperformed within 60 days of the first study intervention administration).

  • Report of a previous colonoscopy that documents extent of disease

Exclusion

Exclusion Criteria:

  • Current or recent (within 3 months of screening) evidence of fulminant colitis,toxic megacolon, or bowel perforation

  • Extensive colonic resection or current stoma

  • Colonic dysplasia that has not been removed

Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Ozanimod
Phase: 4
Study Start date:
December 16, 2022
Estimated Completion Date:
April 15, 2025

Connect with a study center

  • Local Institution - 0110

    Toulouse, Haute-Garonne 31400
    France

    Site Not Available

  • Local Institution - 0081

    Magdeburg, Sachsen-Anhalt 39120
    Germany

    Site Not Available

  • Wellness Clinical Research - Puerto Rico

    Vega Baja, 00694
    Puerto Rico

    Site Not Available

  • Local Institution - 0088

    Pontevedra, 36071
    Spain

    Site Not Available

  • Local Institution - 0143

    las Palmas de Gran Canaria, 35001
    Spain

    Site Not Available

  • Local Institution - 0150

    London, Greater London E11 1NR
    United Kingdom

    Site Not Available

  • Local Institution - 0121

    Cardiff, NP20 2UB
    United Kingdom

    Site Not Available

  • Digestive Health Specialists of the Southeast

    Dothan, Alabama 36301
    United States

    Site Not Available

  • GUT P.C., dba Digestive Health Specialists

    Dothan, Alabama 36305-1156
    United States

    Active - Recruiting

  • Local Institution - 0048

    Dothan, Alabama 36305-1156
    United States

    Site Not Available

  • Arizona Gastrointestinal Associates, PLC - Chandler - Advanced Gastroenterology

    Chandler, Arizona 85224-1636
    United States

    Active - Recruiting

  • Local Institution - 0206

    Chandler, Arizona 85224-1636
    United States

    Site Not Available

  • Arizona Arthritis & Rheumatology Research, PLLC

    Gilbert, Arizona 85297-0425
    United States

    Active - Recruiting

  • Local Institution - 0216

    Gilbert, Arizona 85297-0425
    United States

    Site Not Available

  • Arizona Digestive Health: Scottsdale - GI Alliance

    Scottsdale, Arizona 85250-7004
    United States

    Site Not Available

  • Local Institution - 0125

    Sun City, Arizona 85351-2867
    United States

    Site Not Available

  • Texas Digestive Disease Consultants - Sun City - TDDC - PPDS

    Sun City, Arizona 85351-2867
    United States

    Active - Recruiting

  • Local Institution - 0195

    Tucson, Arizona 85724-0001
    United States

    Site Not Available

  • University of Arizona

    Tucson, Arizona 85724-0001
    United States

    Active - Recruiting

  • Arkansas Gastroenterology

    North Little Rock, Arkansas 72117-2927
    United States

    Active - Recruiting

  • Arkansas Gastroenterology, P.A.

    North Little Rock, Arkansas 72117
    United States

    Site Not Available

  • Local Institution - 0045

    North Little Rock, Arkansas 72117-2927
    United States

    Site Not Available

  • Local Institution - 0165

    Apple Valley, California 92307-1329
    United States

    Site Not Available

  • OM Research LLC - Apple Valley - ClinEdge - PPDS

    Apple Valley, California 92307-1329
    United States

    Site Not Available

  • Om Research, LLC Apple Valley

    Apple Valley, California 92307-1329
    United States

    Site Not Available

  • Local Institution - 0162

    Camarillo, California 93012-5156
    United States

    Site Not Available

  • OM Research LLC - Camarillo - ClinEdge - PPDS

    Camarillo, California 93012-5156
    United States

    Active - Recruiting

  • Local Institution - 0014

    Lancaster, California 93534-5856
    United States

    Site Not Available

  • OM Research

    Lancaster, California 93534
    United States

    Site Not Available

  • OM Research LLC - Lancaster - ClinEdge - PPDS

    Lancaster, California 93534-5856
    United States

    Site Not Available

  • Local Institution - 0209

    Los Angeles, California 90045-3119
    United States

    Site Not Available

  • Southern California Research Institute Medical Group, Inc.

    Los Angeles, California 90045
    United States

    Site Not Available

  • United Clinical Research Institute - Clinedge - PPDS

    Murrieta, California 92563-1405
    United States

    Site Not Available

  • Clinical Applications Laboratories Inc

    San Diego, California 92103-5639
    United States

    Active - Recruiting

  • Clinical Applications Laboratories, Inc.

    San Diego, California 92103-5639
    United States

    Site Not Available

  • Local Institution - 0002

    San Diego, California 92103-5639
    United States

    Site Not Available

  • Local Institution - 0149

    San Diego, California 92103-5639
    United States

    Site Not Available

  • Local Institution - 0208

    San Diego, California 92123-4207
    United States

    Site Not Available

  • Medical Associates Research Group, Inc.

    San Diego, California 92123-4207
    United States

    Active - Recruiting

  • Local Institution - 0185

    San Jose, California 95116
    United States

    Site Not Available

  • San Jose Gastroenterology

    San Jose, California 95116
    United States

    Site Not Available

  • San Jose Gastroenterology - 2340 Montpelier Dr

    San Jose, California 95116
    United States

    Active - Recruiting

  • Local Institution - 0178

    Littleton, Colorado 80120-5641
    United States

    Site Not Available

  • Rocky Mountain Gastroenterology (RMG) - Littleton

    Littleton, Colorado 80120-5641
    United States

    Active - Recruiting

  • Gastro Florida

    Clearwater, Florida 33756-3839
    United States

    Site Not Available

  • Local Institution - 0018

    Clearwater, Florida 33756-3839
    United States

    Site Not Available

  • Local Institution - 0050

    Homestead, Florida 33033
    United States

    Site Not Available

  • Nature Coast Clinical Research

    Inverness, Florida 34452-4705
    United States

    Site Not Available

  • Alliance Medical Research

    Lighthouse Point, Florida 33064
    United States

    Site Not Available

  • Alliance Medical Research LLC

    Lighthouse Point, Florida 33064-7058
    United States

    Active - Recruiting

  • Local Institution - 0026

    Lighthouse Point, Florida 33064-7058
    United States

    Site Not Available

  • Homestead Associates in Research Inc

    Miami, Florida 33032
    United States

    Active - Recruiting

  • Local Institution - 0167

    Miami, Florida 33136-1002
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

  • University of Miami Hospitals and Clinics

    Miami, Florida 33136-1002
    United States

    Active - Recruiting

  • Local Institution - 0049

    Miami Lakes, Florida 33016-5861
    United States

    Site Not Available

  • Wellness Clinical Research-Miami Florida

    Miami Lakes, Florida 33016-5861
    United States

    Site Not Available

  • Gastroenterology Group of Naples

    Naples, Florida 34102-5449
    United States

    Site Not Available

  • Local Institution - 0003

    Naples, Florida 34102-5449
    United States

    Site Not Available

  • Digestive Disease Consultants

    Orange Park, Florida 32073
    United States

    Site Not Available

  • Digestive Disease Consultants, PA

    Orange Park, Florida 32073-4752
    United States

    Active - Recruiting

  • Local Institution - 0058

    Orange Park, Florida 32073-4752
    United States

    Site Not Available

  • Local Institution - 0205

    Orlando, Florida 32806-1110
    United States

    Site Not Available

  • Orlando Health Digestive Health Institute - 22 W Underwood St

    Orlando, Florida 32806-1110
    United States

    Active - Recruiting

  • Advanced Gastroenterology Associates, LLC

    Palm Harbor, Florida 34684
    United States

    Active - Recruiting

  • Local Institution - 0037

    Palm Harbor, Florida 34684
    United States

    Site Not Available

  • Gastro Florida- Riverview

    Riverview, Florida 33578-9498
    United States

    Site Not Available

  • Bayfront Health St. Petersburg

    Saint Petersburg, Florida 33701
    United States

    Site Not Available

  • R&B Medical Center

    Tampa, Florida 33614-1874
    United States

    Site Not Available

  • Gastroenterology Associates of Florida (GI Allianc

    Wellington, Florida 33414-3187
    United States

    Active - Recruiting

  • Gastroenterology Associates of Florida (GI Alliance)

    Wellington, Florida 33414-3187
    United States

    Active - Recruiting

  • Local Institution - 0179

    Wellington, Florida 33414-3187
    United States

    Site Not Available

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia 30342-5020
    United States

    Site Not Available

  • Gastroenterology Consultants, PC

    Roswell, Georgia 30076-4969
    United States

    Active - Recruiting

  • Local Institution - 0027

    Roswell, Georgia 30076-4969
    United States

    Site Not Available

  • Local Institution - 0198

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • Northwest Gastroenterologists

    Arlington Heights, Illinois 60005
    United States

    Active - Recruiting

  • Feinberg School of Medicine Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Local Institution - 0033

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Local Institution - 0051

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Local Institution - 0172

    Chicago, Illinois 60637-1426
    United States

    Site Not Available

  • Northwestern Medicine Prentice Women's Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Northwestern University Feinberg Sch of Medicine Division of Gastroenterology

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Rush University Medical Center -1725 W Harrison St

    Chicago, Illinois 60612-3988
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Illinois Gastroenterology Group- Gurnee (GI Alliance)

    Gurnee, Illinois 60031
    United States

    Active - Recruiting

  • Local Institution - 0098

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • Local Institution - 0192

    Kansas City, Kansas 66160-8500
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160-8500
    United States

    Active - Recruiting

  • Olathe Health

    Olathe, Kansas 66061-7209
    United States

    Site Not Available

  • Local Institution - 0181

    Topeka, Kansas 66606-1539
    United States

    Site Not Available

  • Stormont Vail Health Care

    Topeka, Kansas 66606-1539
    United States

    Active - Recruiting

  • Local Institution - 0183

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • University Of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Local Institution - 0200

    Baton Rouge, Louisiana 70809-2440
    United States

    Site Not Available

  • Local Institution - 0217

    Baton Rouge, Louisiana 70809-2440
    United States

    Site Not Available

  • Texas Digestive Disease Consultants - PPDS

    Baton Rouge, Louisiana 70809-2440
    United States

    Active - Recruiting

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland 20815-7313
    United States

    Active - Recruiting

  • Local Institution - 0171

    Chevy Chase, Maryland 20815-7313
    United States

    Site Not Available

  • Local Institution - 0191

    Glen Burnie, Maryland 21061-9121
    United States

    Site Not Available

  • Woodholme Gastroenterology Associates

    Glen Burnie, Maryland 21061-9121
    United States

    Active - Recruiting

  • Boston Specialists

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

  • Local Institution - 0199

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Local Institution - 0196

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • UMass Memorial Medical Center

    Worcester, Massachusetts 01655
    United States

    Active - Recruiting

  • Local Institution - 0174

    Plymouth, Minnesota 55446-3661
    United States

    Site Not Available

  • MNGI Digestive Health PA-Plymouth

    Plymouth, Minnesota 55446-3661
    United States

    Active - Recruiting

  • MNGI Digestive Health, PA

    Plymouth, Minnesota 55446
    United States

    Active - Recruiting

  • Digestive Health Center - Ocean Springs

    Ocean Springs, Mississippi 39564-5803
    United States

    Active - Recruiting

  • Digestive Health Center PA

    Ocean Springs, Mississippi 39564-5803
    United States

    Site Not Available

  • Local Institution - 0184

    Ocean Springs, Mississippi 39564-5803
    United States

    Site Not Available

  • Clinical Research Professionals

    Chesterfield, Missouri 63005
    United States

    Site Not Available

  • Local Institution - 0024

    Chesterfield, Missouri 63005-1248
    United States

    Site Not Available

  • Clinical Research Professionals

    Creve Coeur, Missouri 63141-7146
    United States

    Site Not Available

  • Local Institution - 0213

    Weldon Spring, Missouri 63304-9103
    United States

    Site Not Available

  • St. Charles Clinical Research, LLC

    Weldon Spring, Missouri 63304-9103
    United States

    Active - Recruiting

  • Local Institution - 0180

    Englewood, New Jersey 07631-4141
    United States

    Site Not Available

  • The Gastroenterology Group of Northern NJ LLC

    Englewood, New Jersey 07631-4141
    United States

    Active - Recruiting

  • The Gastroenterology Group of Northern New Jersey, LLC

    Englewood, New Jersey 07631-4141
    United States

    Active - Recruiting

  • Kings County Hospital Center

    Brooklyn, New York 11203-2054
    United States

    Site Not Available

  • Local Institution - 0084

    Brooklyn, New York 11203-2054
    United States

    Site Not Available

  • NYC Health and Hospitals/Kings County - BRANY - PPDS

    Brooklyn, New York 11203-2054
    United States

    Active - Recruiting

  • NYC Health and Hospitals/Kings County Hospital - BRANY - PPDS

    Brooklyn, New York 11203-2054
    United States

    Active - Recruiting

  • Local Institution - 0059

    New York, New York 10016-9401
    United States

    Site Not Available

  • Local Institution - 0176

    New York, New York 10021
    United States

    Site Not Available

  • Local Institution - 0187

    New York, New York 10016-6821
    United States

    Site Not Available

  • NYU Langone Health -Inflammatory Bowel Disease Center

    New York, New York 10016-9401
    United States

    Site Not Available

  • New York Gastroenterology Associates

    New York, New York 10075-0999
    United States

    Site Not Available

  • Vanguard Gastroenterology LLP (Midtown)

    New York, New York 10016-6821
    United States

    Active - Recruiting

  • Weill Cornell Medical College

    New York, New York 10021
    United States

    Active - Recruiting

  • Digestive Disease Medicine of Central New York

    Utica, New York 13502
    United States

    Active - Recruiting

  • Local Institution - 0170

    Utica, New York 13502
    United States

    Site Not Available

  • Carolina Digestive Diseases

    Greenville, North Carolina 27834-3761
    United States

    Site Not Available

  • Gastroenterology Associates of the Piedmont

    Winston-Salem, North Carolina 27103-3914
    United States

    Site Not Available

  • Local Institution - 0005

    Cincinnati, Ohio 45229-3019
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • University of Cincinnati Physicians Company

    Cincinnati, Ohio 45229-3019
    United States

    Site Not Available

  • Cleveland Clinic Hospital

    Cleveland, Ohio 44195-0001
    United States

    Site Not Available

  • Local Institution - 0188

    Columbus, Ohio 43235-5424
    United States

    Site Not Available

  • Optimed Research Ltd - Clinedge - PPDS

    Columbus, Ohio 43235-5424
    United States

    Site Not Available

  • Local Institution - 0061

    Mentor, Ohio 44060-6521
    United States

    Site Not Available

  • The Endoscopy Center of Lake County

    Mentor, Ohio 44060-6521
    United States

    Active - Recruiting

  • Eastern Pennsylvania Gastroenterology & Liver Specialists, P.C

    Allentown, Pennsylvania 18104-2309
    United States

    Site Not Available

  • Local Institution - 0060

    Providence, Rhode Island 02905-3105
    United States

    Site Not Available

  • University Gastroenterology

    Providence, Rhode Island 02905-3105
    United States

    Active - Recruiting

  • Local Institution - 0160

    Charleston, South Carolina 29425-8900
    United States

    Site Not Available

  • Medical University of South Carolina - PPDS

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Gastro One-8110 Walnut Run Rd

    Cordova, Tennessee 38018-6362
    United States

    Active - Recruiting

  • Local Institution - 0177

    Cordova, Tennessee 38018-6362
    United States

    Site Not Available

  • Gastroenterology Center of The Midsouth PC

    Germantown, Tennessee 38138-1741
    United States

    Site Not Available

  • Local Institution - 0168

    Nashville, Tennessee 37211-4981
    United States

    Site Not Available

  • Nashville Gastrointestinal Specialists Inc

    Nashville, Tennessee 37211-4981
    United States

    Active - Recruiting

  • Local Institution - 0038

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Novel Research LLC

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Baylor Research Institute

    Dallas, Texas 75204
    United States

    Active - Recruiting

  • Baylor Scott and White Research Institute - Dallas Clinical Trials Office

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • Local Institution - 0138

    Dallas, Texas 75246
    United States

    Site Not Available

  • Local Institution - 0218

    Dallas, Texas 75246-2034
    United States

    Site Not Available

  • Brooke Army Medical Center - DoD - PPDS

    Fort Sam Houston, Texas 78234-4504
    United States

    Site Not Available

  • Digestive Health Associates of Texas - Richardson

    Garland, Texas 75044-2210
    United States

    Site Not Available

  • Ace Clinical Research Group: Digestive Health Associates

    Houston, Texas 77024
    United States

    Site Not Available

  • Biopharma Informatic Inc.

    Houston, Texas 77043-2742
    United States

    Site Not Available

  • Digestive Health Associates of Texas

    Houston, Texas 77024-2469
    United States

    Active - Recruiting

  • Digestive Health Associates of Texas - Richardson

    Houston, Texas 77024-2469
    United States

    Active - Recruiting

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Local Institution - 0036

    Houston, Texas 77024-2469
    United States

    Site Not Available

  • Local Institution - 0052

    Houston, Texas 77030
    United States

    Site Not Available

  • Local Institution - 0163

    Houston, Texas 77024-2469
    United States

    Site Not Available

  • Katy Integrative Gastroenterology

    Katy, Texas 77494
    United States

    Active - Recruiting

  • Local Institution - 0129

    Katy, Texas 77494
    United States

    Site Not Available

  • Local Institution - 0161

    Lubbock, Texas 79410-2014
    United States

    Site Not Available

  • Lubbock Digestive Disease Associates

    Lubbock, Texas 79410-2014
    United States

    Active - Recruiting

  • GI Alliance-Mansfield

    Mansfield, Texas 76063-6083
    United States

    Site Not Available

  • GI Alliance: Mansfield - TDDC

    Mansfield, Texas 76063-6083
    United States

    Site Not Available

  • Local Institution - 0039

    Mansfield, Texas 76063-6083
    United States

    Site Not Available

  • Gastroenterology Research of San Antonio (GERSA)

    San Antonio, Texas 78229-3270
    United States

    Active - Recruiting

  • Local Institution - 0043

    San Antonio, Texas 78229-4463
    United States

    Site Not Available

  • Local Institution - 0201

    San Antonio, Texas 78229-3270
    United States

    Site Not Available

  • San Antonio Gastroenterology

    San Antonio, Texas 78229-4463
    United States

    Site Not Available

  • Local Institution - 0166

    San Marcos, Texas 78666-7502
    United States

    Site Not Available

  • Texas Digestive Disease Consultants - San Marcos - PPDS

    San Marcos, Texas 78666-7502
    United States

    Active - Recruiting

  • Texas Digestive Disease Consultants: San Marcos

    San Marcos, Texas 78666-7502
    United States

    Site Not Available

  • Local Institution - 0046

    Tyler, Texas 75701-4464
    United States

    Site Not Available

  • Tyler Research Institute, LLC

    Tyler, Texas 75701-4464
    United States

    Site Not Available

  • Local Institution - 0091

    Webster, Texas 77598
    United States

    Site Not Available

  • Texas Digestive Disease Consultants - TDDC - PPDS

    Webster, Texas 77598
    United States

    Active - Recruiting

  • Local Institution - 0193

    Ogden, Utah 84403-3294
    United States

    Site Not Available

  • Ogden Clinic Gastrenterology - CAR

    Ogden, Utah 84403-3294
    United States

    Active - Recruiting

  • Local Institution - 0169

    Salt Lake City, Utah 84132-0001
    United States

    Site Not Available

  • University of Utah - PPDS

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

  • University of Utah - Salt Lake City - PPDS

    Salt Lake City, Utah 84132-0001
    United States

    Active - Recruiting

  • Granite Peaks Gastroenterology

    Sandy, Utah 84092-4350
    United States

    Site Not Available

  • Blue Ridge Medical Research

    Lynchburg, Virginia 24502
    United States

    Active - Recruiting

  • Local Institution - 0197

    Lynchburg, Virginia 24502
    United States

    Site Not Available

  • Local Institution - 0130

    Seattle, Washington 98104-1356
    United States

    Site Not Available

  • Swedish Gastroenterology - First Hill

    Seattle, Washington 98104-1356
    United States

    Active - Recruiting

  • Local Institution - 0189

    Tacoma, Washington 98405-2318
    United States

    Site Not Available

  • Washington Gastroenterology - Tacoma

    Tacoma, Washington 98405-2318
    United States

    Active - Recruiting

  • Local Institution - 0017

    Madison, Wisconsin 53705-1311
    United States

    Site Not Available

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin 53792
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.