An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice
NCT ID: NCT05369832
Last Updated: 2025-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
139 participants
INTERVENTIONAL
2022-12-16
2025-04-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1 - Advanced therapy-naive
Ozanimod
Specified dose on specified days
Cohort 2 - Advanced therapy-exposed
Ozanimod
Specified dose on specified days
Interventions
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Ozanimod
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 (endoscopy performed within 60 days of the first study intervention administration).
* Report of a previous colonoscopy that documents extent of disease
Exclusion Criteria
* Extensive colonic resection or current stoma
* Colonic dysplasia that has not been removed
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0048
Dothan, Alabama, United States
Local Institution - 0206
Chandler, Arizona, United States
Local Institution - 0216
Gilbert, Arizona, United States
Local Institution - 0125
Sun City, Arizona, United States
Local Institution - 0195
Tucson, Arizona, United States
Local Institution - 0045
North Little Rock, Arkansas, United States
Local Institution - 0165
Apple Valley, California, United States
Local Institution - 0162
Camarillo, California, United States
Local Institution - 0014
Lancaster, California, United States
OM Research LLC - Lancaster - ClinEdge - PPDS
Lancaster, California, United States
Local Institution - 0209
Los Angeles, California, United States
Local Institution - 0002
San Diego, California, United States
Local Institution - 0208
San Diego, California, United States
Local Institution - 0185
San Jose, California, United States
Local Institution - 0178
Littleton, Colorado, United States
Gastro Florida
Clearwater, Florida, United States
Local Institution - 0018
Clearwater, Florida, United States
Local Institution - 0050
Homestead, Florida, United States
Local Institution - 0026
Lighthouse PT, Florida, United States
Local Institution - 0167
Miami, Florida, United States
Local Institution - 0049
Miami Lakes, Florida, United States
Wellness Clinical Research-Miami Florida
Miami Lakes, Florida, United States
Gastroenterology Group of Naples
Naples, Florida, United States
Local Institution - 0003
Naples, Florida, United States
Local Institution - 0058
Orange Park, Florida, United States
Local Institution - 0205
Orlando, Florida, United States
Local Institution - 0037
Palm Harbor, Florida, United States
Local Institution - 0179
Wellington, Florida, United States
Local Institution - 0027
Roswell, Georgia, United States
Local Institution - 0198
Arlington Heights, Illinois, United States
Local Institution - 0051
Chicago, Illinois, United States
Local Institution - 0098
Gurnee, Illinois, United States
Local Institution - 0192
Kansas City, Kansas, United States
Local Institution - 0181
Topeka, Kansas, United States
Local Institution - 0183
Louisville, Kentucky, United States
Local Institution - 0200
Baton Rouge, Louisiana, United States
Local Institution - 0171
Chevy Chase, Maryland, United States
Local Institution - 0191
Glen Burnie, Maryland, United States
Local Institution - 0199
Boston, Massachusetts, United States
Local Institution - 0196
Worcester, Massachusetts, United States
Local Institution - 0174
Plymouth, Minnesota, United States
Local Institution - 0184
Ocean Springs, Mississippi, United States
Local Institution - 0024
Chesterfield, Missouri, United States
Local Institution - 0213
Weldon Spring, Missouri, United States
Local Institution - 0180
Englewood, New Jersey, United States
Local Institution - 0084
Brooklyn, New York, United States
Local Institution - 0187
New York, New York, United States
Local Institution - 0059
New York, New York, United States
NYU Langone Health -Inflammatory Bowel Disease Center
New York, New York, United States
Local Institution - 0176
New York, New York, United States
Local Institution - 0170
Utica, New York, United States
Carolina Digestive Diseases
Greenville, North Carolina, United States
Local Institution - 0005
Cincinnati, Ohio, United States
University of Cincinnati Physicians Company
Cincinnati, Ohio, United States
Local Institution - 0188
Columbus, Ohio, United States
Local Institution - 0061
Mentor, Ohio, United States
Local Institution - 0060
Providence, Rhode Island, United States
Local Institution - 0177
Cordova, Tennessee, United States
Local Institution - 0168
Nashville, Tennessee, United States
Local Institution - 0038
Bellaire, Texas, United States
Novel Research LLC
Bellaire, Texas, United States
Local Institution - 0138
Dallas, Texas, United States
Local Institution - 0036
Houston, Texas, United States
Local Institution - 0163
Houston, Texas, United States
Ace Clinical Research Group: Digestive Health Associates
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Local Institution - 0052
Houston, Texas, United States
Local Institution - 0129
Katy, Texas, United States
Local Institution - 0161
Lubbock, Texas, United States
GI Alliance: Mansfield - TDDC
Mansfield, Texas, United States
Local Institution - 0039
Mansfield, Texas, United States
Local Institution - 0201
San Antonio, Texas, United States
Local Institution - 0043
San Antonio, Texas, United States
San Antonio Gastroenterology
San Antonio, Texas, United States
Local Institution - 0166
San Marcos, Texas, United States
Local Institution - 0046
Tyler, Texas, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
Local Institution - 0091
Webster, Texas, United States
Local Institution - 0193
Ogden, Utah, United States
Local Institution - 0169
Salt Lake City, Utah, United States
Local Institution - 0197
Lynchburg, Virginia, United States
Local Institution - 0130
Seattle, Washington, United States
Local Institution - 0189
Tacoma, Washington, United States
Local Institution - 0017
Madison, Wisconsin, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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IM047-029
Identifier Type: -
Identifier Source: org_study_id
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