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
Status: Terminated
Location: See all (85) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
Local Institution - 0048
Dothan
Arkansas
Local Institution - 0045
North Little Rock
Arizona
Local Institution - 0206
Chandler
Local Institution - 0216
Gilbert
Local Institution - 0125
Sun City
Local Institution - 0195
Tucson
California
Local Institution - 0165
Apple Valley
Local Institution - 0162
Camarillo
Local Institution - 0014
Lancaster
OM Research LLC - Lancaster - ClinEdge - PPDS
Lancaster
Local Institution - 0209
Los Angeles
Local Institution - 0002
San Diego
Local Institution - 0208
San Diego
Local Institution - 0185
San Jose
Colorado
Local Institution - 0178
Littleton
Florida
Gastro Florida
Clearwater
Local Institution - 0018
Clearwater
Local Institution - 0050
Homestead
Local Institution - 0026
Lighthouse Pt
Local Institution - 0167
Miami
Local Institution - 0049
Miami Lakes
Wellness Clinical Research-Miami Florida
Miami Lakes
Gastroenterology Group of Naples
Naples
Local Institution - 0003
Naples
Local Institution - 0058
Orange Park
Local Institution - 0205
Orlando
Local Institution - 0037
Palm Harbor
Local Institution - 0179
Wellington
Georgia
Local Institution - 0027
Roswell
Illinois
Local Institution - 0198
Arlington Heights
Local Institution - 0051
Chicago
Local Institution - 0098
Gurnee
Kansas
Local Institution - 0192
Kansas City
Local Institution - 0181
Topeka
Kentucky
Local Institution - 0183
Louisville
Louisiana
Local Institution - 0200
Baton Rouge
Massachusetts
Local Institution - 0199
Boston
Local Institution - 0196
Worcester
Maryland
Local Institution - 0171
Chevy Chase
Local Institution - 0191
Glen Burnie
Minnesota
Local Institution - 0174
Plymouth
Missouri
Local Institution - 0024
Chesterfield
Local Institution - 0213
Weldon Spring
Mississippi
Local Institution - 0184
Ocean Springs
North Carolina
Carolina Digestive Diseases
Greenville
New Jersey
Local Institution - 0180
Englewood
New York
Local Institution - 0084
Brooklyn
Local Institution - 0059
New York
Local Institution - 0176
New York
Local Institution - 0187
New York
NYU Langone Health -Inflammatory Bowel Disease Center
New York
Local Institution - 0170
Utica
Ohio
Local Institution - 0005
Cincinnati
University of Cincinnati Physicians Company
Cincinnati
Local Institution - 0188
Columbus
Local Institution - 0061
Mentor
Rhode Island
Local Institution - 0060
Providence
Tennessee
Local Institution - 0177
Cordova
Local Institution - 0168
Nashville
Texas
Local Institution - 0038
Bellaire
Novel Research LLC
Bellaire
Local Institution - 0138
Dallas
Ace Clinical Research Group: Digestive Health Associates
Houston
Houston Methodist Hospital
Houston
Local Institution - 0036
Houston
Local Institution - 0052
Houston
Local Institution - 0163
Houston
Local Institution - 0129
Katy
Local Institution - 0161
Lubbock
GI Alliance: Mansfield - TDDC
Mansfield
Local Institution - 0039
Mansfield
Local Institution - 0043
San Antonio
Local Institution - 0201
San Antonio
San Antonio Gastroenterology
San Antonio
Local Institution - 0166
San Marcos
Local Institution - 0046
Tyler
Tyler Research Institute, LLC
Tyler
Local Institution - 0091
Webster
Utah
Local Institution - 0193
Ogden
Local Institution - 0169
Salt Lake City
Virginia
Local Institution - 0197
Lynchburg
Washington
Local Institution - 0130
Seattle
Local Institution - 0189
Tacoma
Wisconsin
Local Institution - 0017
Madison
University of Wisconsin Hospital and Clinics
Madison
Time Frame
Start Date: 2022-12-16
Completion Date: 2025-04-11
Participants
Target number of participants: 139
Treatments
Experimental: Cohort 1 - Advanced therapy-naive
Experimental: Cohort 2 - Advanced therapy-exposed
Related Therapeutic Areas
Sponsors
Leads: Bristol-Myers Squibb