Clinical trial NCT05369832: An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Colitis, Ulcerative
Keywords: Ulcerative Colitis
Ozanimod
RPC-1063
Zeposia®
Inflammatory bowel disease
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-05-11
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical response as measured by modified Mayo score
timeFrame: Up to approximately 26 weeks
Secondary outcomes:
measure: Clinical remission as measured by modified Mayo score
timeFrame: Up to approximately 26 weeks
measure: Proportion of participants who achieve endoscopic response
timeFrame: Up to approximately 26 weeks
measure: Proportion of participants who achieve endoscopic improvement
timeFrame: Up to approximately 26 weeks
measure: Proportion of participants who achieve histological improvement
timeFrame: Up to approximately 26 weeks
measure: Proportion of participants with change in the Inflammatory Bowel Disease Questionnaire (IBDQ) total score from baseline
timeFrame: Up to approximately 26 weeks
measure: Proportion of participants with change in total score (≥ 16 points) of IBDQ response from baseline
timeFrame: Up to approximately 26 weeks
measure: Proportion of participants with IBDQ remission with total score of ≥ 170 points
timeFrame: Up to approximately 26 weeks
measure: Proportion of participants who achieve endoscopic remission
timeFrame: Up to approximately 26 weeks
measure: Proportion of participants who achieve histological remission
timeFrame: Up to approximately 26 weeks
measure: Corticosteroid-free clinical remission as measured by modified Mayo score
timeFrame: Up to approximately 26 weeks
measure: Proportion of participants with histo-endoscopic mucosal improvement
timeFrame: Up to approximately 26 weeks
measure: Proportion of participants with Adverse Events (AEs)
timeFrame: Up to approximately 2 years
measure: Proportion of participants with Serious Adverse Events (SAEs)
timeFrame: Up to approximately 2 years
measure: Proportion of participants with AEs of interest (AEI)
timeFrame: Up to approximately 2 years
measure: Proportion of participants with AEs leading to discontinuation
timeFrame: Up to approximately 2 years
measure: Proportion of participants with clinical laboratory abnormalities
timeFrame: Up to approximately 2 years
measure: Clinical remission by partial Mayo score
timeFrame: Up to approximately 104 weeks
measure: Corticosteroid-free clinical remission by partial Mayo
timeFrame: Up to approximately 104 weeks
measure: Clinical response by partial Mayo score
timeFrame: Up to approximately 104 weeks
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Local Institution - 0048
state: Alabama
city: Chandler
country: United States
facility: Local Institution - 0206
state: Arizona
city: Gilbert
country: United States
facility: Local Institution - 0216
state: Arizona
city: Sun City
country: United States
facility: Local Institution - 0125
state: Arizona
city: Tucson
country: United States
facility: Local Institution - 0195
state: Arizona
city: North Little Rock
country: United States
facility: Local Institution - 0045
state: Arkansas
city: Apple Valley
country: United States
facility: Local Institution - 0165
state: California
city: Camarillo
country: United States
facility: Local Institution - 0162
state: California
city: Lancaster
country: United States
facility: Local Institution - 0014
state: California
city: Lancaster
country: United States
facility: OM Research LLC - Lancaster - ClinEdge - PPDS
state: California
city: Los Angeles
country: United States
facility: Local Institution - 0209
state: California
city: San Diego
country: United States
facility: Local Institution - 0002
state: California
city: San Diego
country: United States
facility: Local Institution - 0208
state: California
city: San Jose
country: United States
facility: Local Institution - 0185
state: California
city: Littleton
country: United States
facility: Local Institution - 0178
state: Colorado
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Clearwater
country: United States
facility: Local Institution - 0018
state: Florida
city: Homestead
country: United States
facility: Local Institution - 0050
state: Florida
city: Lighthouse Point
country: United States
facility: Local Institution - 0026
state: Florida
city: Miami Lakes
country: United States
facility: Local Institution - 0049
state: Florida
city: Miami Lakes
country: United States
facility: Wellness Clinical Research-Miami Florida
state: Florida
city: Miami
country: United States
facility: Local Institution - 0167
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Naples
country: United States
facility: Local Institution - 0003
state: Florida
city: Orange Park
country: United States
facility: Local Institution - 0058
state: Florida
city: Orlando
country: United States
facility: Local Institution - 0205
state: Florida
city: Palm Harbor
country: United States
facility: Local Institution - 0037
state: Florida
city: Wellington
country: United States
facility: Local Institution - 0179
state: Florida
city: Roswell
country: United States
facility: Local Institution - 0027
state: Georgia
city: Arlington Heights
country: United States
facility: Local Institution - 0198
state: Illinois
city: Chicago
country: United States
facility: Local Institution - 0051
state: Illinois
city: Gurnee
country: United States
facility: Local Institution - 0098
state: Illinois
city: Kansas City
country: United States
facility: Local Institution - 0192
state: Kansas
city: Topeka
country: United States
facility: Local Institution - 0181
state: Kansas
city: Louisville
country: United States
facility: Local Institution - 0183
state: Kentucky
city: Baton Rouge
country: United States
facility: Local Institution - 0200
state: Louisiana
city: Chevy Chase
country: United States
facility: Local Institution - 0171
state: Maryland
city: Glen Burnie
country: United States
facility: Local Institution - 0191
state: Maryland
city: Boston
country: United States
facility: Local Institution - 0199
state: Massachusetts
city: Worcester
country: United States
facility: Local Institution - 0196
state: Massachusetts
city: Plymouth
country: United States
facility: Local Institution - 0174
state: Minnesota
city: Ocean Springs
country: United States
facility: Local Institution - 0184
state: Mississippi
city: Chesterfield
country: United States
facility: Local Institution - 0024
state: Missouri
city: Weldon Spring
country: United States
facility: Local Institution - 0213
state: Missouri
city: Englewood
country: United States
facility: Local Institution - 0180
state: New Jersey
city: Brooklyn
country: United States
facility: Local Institution - 0084
state: New York
city: New York
country: United States
facility: Local Institution - 0187
state: New York
city: New York
country: United States
facility: Local Institution - 0059
state: New York
city: New York
country: United States
facility: NYU Langone Health -Inflammatory Bowel Disease Center
state: New York
city: New York
country: United States
facility: Local Institution - 0176
state: New York
city: Utica
country: United States
facility: Local Institution - 0170
state: New York
city: Greenville
country: United States
facility: Carolina Digestive Diseases
state: North Carolina
city: Cincinnati
country: United States
facility: Local Institution - 0005
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Physicians Company
state: Ohio
city: Columbus
country: United States
facility: Local Institution - 0188
state: Ohio
city: Mentor
country: United States
facility: Local Institution - 0061
state: Ohio
city: Providence
country: United States
facility: Local Institution - 0060
state: Rhode Island
city: Cordova
country: United States
facility: Local Institution - 0177
state: Tennessee
city: Nashville
country: United States
facility: Local Institution - 0168
state: Tennessee
city: Bellaire
country: United States
facility: Local Institution - 0038
state: Texas
city: Bellaire
country: United States
facility: Novel Research LLC
state: Texas
city: Dallas
country: United States
facility: Local Institution - 0138
state: Texas
city: Houston
country: United States
facility: Local Institution - 0036
state: Texas
city: Houston
country: United States
facility: Local Institution - 0163
state: Texas
city: Houston
country: United States
facility: Ace Clinical Research Group: Digestive Health Associates
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: Local Institution - 0052
state: Texas
city: Katy
country: United States
facility: Local Institution - 0129
state: Texas
city: Lubbock
country: United States
facility: Local Institution - 0161
state: Texas
city: Mansfield
country: United States
facility: GI Alliance: Mansfield - TDDC
state: Texas
city: Mansfield
country: United States
facility: Local Institution - 0039
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 0201
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 0043
state: Texas
city: San Antonio
country: United States
facility: San Antonio Gastroenterology
state: Texas
city: San Marcos
country: United States
facility: Local Institution - 0166
state: Texas
city: Tyler
country: United States
facility: Local Institution - 0046
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Webster
country: United States
facility: Local Institution - 0091
state: Texas
city: Ogden
country: United States
facility: Local Institution - 0193
state: Utah
city: Salt Lake City
country: United States
facility: Local Institution - 0169
state: Utah
city: Lynchburg
country: United States
facility: Local Institution - 0197
state: Virginia
city: Seattle
country: United States
facility: Local Institution - 0130
state: Washington
city: Tacoma
country: United States
facility: Local Institution - 0189
state: Washington
city: Madison
country: United States
facility: Local Institution - 0017
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: