Colitis, Ulcerative Clinical Trial
Official title:
A Phase 4, Prospective, Open-label Study of Ozanimod to Explore the Safety, Efficacy, Quality of Life, and Biomarker Response in Participants With Moderate to Severe Ulcerative Colitis in Clinical Practice
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.
| Status | Recruiting |
| Enrollment | 415 |
| Est. completion date | April 28, 2027 |
| Est. primary completion date | November 29, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Local Institution - 0150 | London | Greater London |
| United States | Om Research, LLC Apple Valley | Apple Valley | California |
| United States | Northwest Gastroenterologists | Arlington Heights | Illinois |
| United States | Texas Digestive Disease Consultants - PPDS | Baton Rouge | Louisiana |
| United States | Novel Research LLC | Bellaire | Texas |
| United States | Novel Research LLC | Bellaire | Texas |
| United States | Boston Specialists | Boston | Massachusetts |
| United States | NYC Health and Hospitals/Kings County Hospital - BRANY - PPDS | Brooklyn | New York |
| United States | OM Research LLC - Camarillo - ClinEdge - PPDS | Camarillo | California |
| United States | Arizona Gastrointestinal Associates, PLC - Chandler - Advanced Gastroenterology | Chandler | Arizona |
| United States | Chevy Chase Clinical Research | Chevy Chase | Maryland |
| United States | Feinberg School of Medicine Northwestern University | Chicago | Illinois |
| United States | University of Chicago Medical Center | Chicago | Illinois |
| United States | University of Cincinnati Physicians Company | Cincinnati | Ohio |
| United States | University of Cincinnati Physicians Company | Cincinnati | Ohio |
| United States | Gastro Florida | Clearwater | Florida |
| United States | Gastro Florida | Clearwater | Florida |
| United States | Optimed Research Ltd - Clinedge - PPDS | Columbus | Ohio |
| United States | Gastro One-8110 Walnut Run Rd | Cordova | Tennessee |
| United States | Clinical Research Professionals | Creve Coeur | Missouri |
| United States | Baylor Research Institute | Dallas | Texas |
| United States | GUT P.C., dba Digestive Health Specialists | Dothan | Alabama |
| United States | The Gastroenterology Group of Northern New Jersey, LLC | Englewood | New Jersey |
| United States | Arizona Arthritis & Rheumatology Research, PLLC | Gilbert | Arizona |
| United States | Woodholme Gastroenterology Associates | Glen Burnie | Maryland |
| United States | Carolina Digestive Diseases | Greenville | North Carolina |
| United States | Illinois Gastroenterology Group- Gurnee (GI Alliance) | Gurnee | Illinois |
| United States | Ace Clinical Research Group: Digestive Health Associates | Houston | Texas |
| United States | Digestive Health Associates of Texas | Houston | Texas |
| United States | Digestive Health Associates of Texas | Houston | Texas |
| United States | Houston Methodist Hospital | Houston | Texas |
| United States | Houston Methodist Hospital | Houston | Texas |
| United States | University of Kansas Medical Center | Kansas City | Kansas |
| United States | Katy Integrative Gastroenterology | Katy | Texas |
| United States | OM Research LLC - Lancaster - ClinEdge - PPDS | Lancaster | California |
| United States | OM Research LLC - Lancaster - ClinEdge - PPDS | Lancaster | California |
| United States | Alliance Medical Research LLC | Lighthouse Point | Florida |
| United States | Rocky Mountain Gastroenterology (RMG) - Littleton | Littleton | Colorado |
| United States | Southern California Research Institute Medical Group, Inc. | Los Angeles | California |
| United States | Local Institution - 0183 | Louisville | Kentucky |
| United States | Lubbock Digestive Disease Associates | Lubbock | Texas |
| United States | Blue Ridge Medical Research | Lynchburg | Virginia |
| United States | University of Wisconsin Hospital and Clinics | Madison | Wisconsin |
| United States | University of Wisconsin Hospital and Clinics | Madison | Wisconsin |
| United States | GI Alliance: Mansfield - TDDC | Mansfield | Texas |
| United States | GI Alliance: Mansfield - TDDC | Mansfield | Texas |
| United States | The Endoscopy Center of Lake County | Mentor | Ohio |
| United States | Homestead Associates in Research Inc | Miami | Florida |
| United States | University of Miami Hospitals and Clinics | Miami | Florida |
| United States | Wellness Clinical Research-Miami Florida | Miami Lakes | Florida |
| United States | Gastroenterology Group of Naples | Naples | Florida |
| United States | Gastroenterology Group of Naples | Naples | Florida |
| United States | Nashville Gastrointestinal Specialists Inc | Nashville | Tennessee |
| United States | NYU Langone Health -Inflammatory Bowel Disease Center | New York | New York |
| United States | NYU Langone Health -Inflammatory Bowel Disease Center | New York | New York |
| United States | Vanguard Gastroenterology LLP (Midtown) | New York | New York |
| United States | Weill Cornell Medical College | New York | New York |
| United States | Arkansas Gastroenterology | North Little Rock | Arkansas |
| United States | Digestive Health Center - Ocean Springs | Ocean Springs | Mississippi |
| United States | Ogden Clinic Gastrenterology - CAR | Ogden | Utah |
| United States | Digestive Disease Consultants, PA | Orange Park | Florida |
| United States | Orlando Health Digestive Health Institute - 22 W Underwood St | Orlando | Florida |
| United States | Advanced Gastroenterology Associates, LLC | Palm Harbor | Florida |
| United States | MNGI Digestive Health PA-Plymouth | Plymouth | Minnesota |
| United States | University Gastroenterology | Providence | Rhode Island |
| United States | Gastroenterology Consultants, PC | Roswell | Georgia |
| United States | University of Utah - PPDS | Salt Lake City | Utah |
| United States | Gastroenterology Research of San Antonio (GERSA) | San Antonio | Texas |
| United States | San Antonio Gastroenterology | San Antonio | Texas |
| United States | San Antonio Gastroenterology | San Antonio | Texas |
| United States | Clinical Applications Laboratories Inc | San Diego | California |
| United States | Medical Associates Research Group, Inc. | San Diego | California |
| United States | San Jose Gastroenterology - 2340 Montpelier Dr | San Jose | California |
| United States | Texas Digestive Disease Consultants - San Marcos - PPDS | San Marcos | Texas |
| United States | Swedish Gastroenterology - First Hill | Seattle | Washington |
| United States | Texas Digestive Disease Consultants - Sun City - TDDC - PPDS | Sun City | Arizona |
| United States | Washington Gastroenterology - Tacoma | Tacoma | Washington |
| United States | Stormont Vail Health Care | Topeka | Kansas |
| United States | University of Arizona | Tucson | Arizona |
| United States | Tyler Research Institute, LLC | Tyler | Texas |
| United States | Tyler Research Institute, LLC | Tyler | Texas |
| United States | Digestive Disease Medicine of Central New York | Utica | New York |
| United States | Texas Digestive Disease Consultants - TDDC - PPDS | Webster | Texas |
| United States | St. Charles Clinical Research, LLC | Weldon Spring | Missouri |
| United States | Gastroenterology Associates of Florida (GI Allianc | Wellington | Florida |
| United States | UMass Memorial Medical Center | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical response as measured by modified Mayo score at Week 12 | Cohort 1 and 2 | Up to approximately 26 weeks | |
| Secondary | Clinical remission as measured by modified Mayo score | Cohort 1 and 2 | Up to approximately 26 weeks | |
| Secondary | Proportion of participants who achieve endoscopic response | Cohort 1 and 2 | Up to approximately 26 weeks | |
| Secondary | Proportion of participants who achieve endoscopic improvement | Cohort 1 and 2 | Up to approximately 26 weeks | |
| Secondary | Proportion of participants who achieve histological improvement | Cohort 1 and 2 | Up to approximately 26 weeks | |
| Secondary | Proportion of participants with change in the Inflammatory Bowel Disease Questionnaire (IBDQ) total score from baseline | Cohort 1 and 2 | Up to approximately 26 weeks | |
| Secondary | Proportion of participants with change in total score (= 16 points) of IBDQ response from baseline | Cohort 1 and 2 | Up to approximately 26 weeks | |
| Secondary | Proportion of participants with IBDQ remission with total score of = 170 points | Cohort 1 and 2 | Up to approximately 26 weeks | |
| Secondary | Proportion of participants who achieve endoscopic remission | Cohort 2 only | Up to approximately 26 weeks | |
| Secondary | Proportion of participants who achieve histological remission | Cohort 2 only | Up to approximately 26 weeks | |
| Secondary | Corticosteroid-free clinical remission as measured by modified Mayo score | Cohort 2 only | Up to approximately 26 weeks | |
| Secondary | Proportion of participants with histo-endoscopic mucosal improvement | Cohort 2 only | Up to approximately 26 weeks | |
| Secondary | Proportion of participants with Adverse Events (AEs) | Cohort 1 and 2 | Up to approximately 2 years | |
| Secondary | Proportion of participants with Serious Adverse Events (SAEs) | Cohort 1 and 2 | Up to approximately 2 years | |
| Secondary | Proportion of participants with AEs of interest (AEI) | Cohort 1 and 2 | Up to approximately 2 years | |
| Secondary | Proportion of participants with AEs leading to discontinuation | Cohort 1 and 2 | Up to approximately 2 years | |
| Secondary | Proportion of participants with clinical laboratory abnormalities | Cohort 1 and 2 | Up to approximately 2 years | |
| Secondary | Clinical remission by partial Mayo score | Cohort 1 and 2 | Up to approximately 104 weeks | |
| Secondary | Corticosteroid-free clinical remission by partial Mayo | Cohort 1 and 2 | Up to approximately 104 weeks | |
| Secondary | Clinical response by partial Mayo score | Cohort 1 and 2 | Up to approximately 104 weeks |
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