An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice
- Registration Number
- NCT05369832
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 139
-
A diagnosis of ulcerative colitis (UC), with signs and symptoms consistent with UC for 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 (endoscopy performed within 60 days of the first study intervention administration).
-
Report of a previous colonoscopy that documents extent of disease
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2 - Advanced therapy-exposed Ozanimod - Cohort 1 - Advanced therapy-naive Ozanimod -
- Primary Outcome Measures
Name Time Method Clinical response as measured by modified Mayo score Up to approximately 26 weeks Cohort 1 and 2
- Secondary Outcome Measures
Name Time Method Proportion of participants with Adverse Events (AEs) Up to approximately 2 years Cohort 1 and 2
Proportion of participants with Serious Adverse Events (SAEs) Up to approximately 2 years Cohort 1 and 2
Clinical remission by partial Mayo score Up to approximately 104 weeks Cohort 1 and 2
Clinical remission as measured by modified Mayo score Up to approximately 26 weeks Cohort 1 and 2
Proportion of participants with change in the Inflammatory Bowel Disease Questionnaire (IBDQ) total score from baseline Up to approximately 26 weeks Cohort 1 and 2
Proportion of participants who achieve endoscopic response Up to approximately 26 weeks Cohort 1 and 2
Proportion of participants who achieve endoscopic improvement Up to approximately 26 weeks Cohort 1 and 2
Proportion of participants with histo-endoscopic mucosal improvement Up to approximately 26 weeks Cohort 2 only
Proportion of participants with AEs of interest (AEI) Up to approximately 2 years Cohort 1 and 2
Clinical response by partial Mayo score Up to approximately 104 weeks Cohort 1 and 2
Proportion of participants with change in total score (≥ 16 points) of IBDQ response from baseline Up to approximately 26 weeks Cohort 1 and 2
Proportion of participants who achieve histological remission Up to approximately 26 weeks Cohort 2 only
Corticosteroid-free clinical remission by partial Mayo Up to approximately 104 weeks Cohort 1 and 2
Proportion of participants who achieve histological improvement Up to approximately 26 weeks Cohort 1 and 2
Proportion of participants with IBDQ remission with total score of ≥ 170 points Up to approximately 26 weeks Cohort 1 and 2
Proportion of participants who achieve endoscopic remission Up to approximately 26 weeks Cohort 2 only
Corticosteroid-free clinical remission as measured by modified Mayo score Up to approximately 26 weeks Cohort 2 only
Proportion of participants with clinical laboratory abnormalities Up to approximately 2 years Cohort 1 and 2
Proportion of participants with AEs leading to discontinuation Up to approximately 2 years Cohort 1 and 2
Trial Locations
- Locations (85)
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 - 0162
🇺🇸Camarillo, California, United States
Local Institution - 0014
🇺🇸Lancaster, 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
Local Institution - 0018
🇺🇸Clearwater, Florida, United States
Local Institution - 0050
🇺🇸Homestead, Florida, United States
Local Institution - 0026
🇺🇸Lighthouse Point, Florida, United States
Local Institution - 0167
🇺🇸Miami, 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 - 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 - 0084
🇺🇸Brooklyn, New York, United States
Local Institution - 0184
🇺🇸Ocean Springs, Mississippi, United States
Local Institution - 0024
🇺🇸Chesterfield, Missouri, United States
Local Institution - 0180
🇺🇸Englewood, New Jersey, United States
Local Institution - 0187
🇺🇸New York, New York, United States
Local Institution - 0059
🇺🇸New York, New York, United States
Local Institution - 0176
🇺🇸New York, New York, United States
Local Institution - 0170
🇺🇸Utica, New York, United States
Local Institution - 0005
🇺🇸Cincinnati, 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
Local Institution - 0138
🇺🇸Dallas, Texas, United States
Local Institution - 0036
🇺🇸Houston, Texas, United States
Local Institution - 0163
🇺🇸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
Local Institution - 0039
🇺🇸Mansfield, Texas, United States
Local Institution - 0201
🇺🇸San Antonio, Texas, United States
Local Institution - 0043
🇺🇸San Antonio, Texas, United States
Local Institution - 0166
🇺🇸San Marcos, Texas, United States
Local Institution - 0046
🇺🇸Tyler, Texas, United States
Local Institution - 0091
🇺🇸Webster, Texas, United States
Local Institution - 0193
🇺🇸Ogden, Utah, United States
Local Institution - 0189
🇺🇸Tacoma, Washington, 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 - 0017
🇺🇸Madison, Wisconsin, United States
Local Institution - 0165
🇺🇸Apple Valley, California, United States
OM Research LLC - Lancaster - ClinEdge - PPDS
🇺🇸Lancaster, California, United States
Local Institution - 0209
🇺🇸Los Angeles, California, United States
Gastro Florida
🇺🇸Clearwater, Florida, United States
Gastroenterology Group of Naples
🇺🇸Naples, Florida, United States
Local Institution - 0183
🇺🇸Louisville, Kentucky, United States
Local Institution - 0049
🇺🇸Miami Lakes, Florida, United States
Wellness Clinical Research-Miami Florida
🇺🇸Miami Lakes, Florida, United States
Local Institution - 0213
🇺🇸Weldon Spring, Missouri, United States
NYU Langone Health -Inflammatory Bowel Disease Center
🇺🇸New York, New York, United States
Carolina Digestive Diseases
🇺🇸Greenville, North Carolina, United States
University of Cincinnati Physicians Company
🇺🇸Cincinnati, Ohio, United States
Local Institution - 0188
🇺🇸Columbus, Ohio, United States
Novel Research LLC
🇺🇸Bellaire, Texas, United States
Ace Clinical Research Group: Digestive Health Associates
🇺🇸Houston, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
GI Alliance: Mansfield - TDDC
🇺🇸Mansfield, Texas, United States
San Antonio Gastroenterology
🇺🇸San Antonio, Texas, United States
Tyler Research Institute, LLC
🇺🇸Tyler, Texas, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States