Ulcerative Colitis
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of ozanimod compared with placebo in participants with ulcerative colitis (UC) in mainland China and Taiwan. The main study is composed of an induction period, maintenance period, safety follow-up, and participants meeting certain criteria will be given the opportunity to participate in an optional open label extension.
Interventions
DRUGOzanimod
Specified dose on specified days
DRUGPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Main Study: * Eligible participants must be Chinese. * Participant has had moderately to severely active UC diagnosed at least 3 months prior to first investigational product administration. Open-label Extension Period: * Participants who have completed the Week 10 Visit and are non-responders at Week 10. * Participants who have completed the Induction Period and entered the Maintenance Period experienced disease relapse during the Maintenance Period, or who have completed the Maintenance Period at Week 52.
Exclusion criteria
Main Study and Open-label Extension Period: * Participant has severe extensive colitis, diagnosis of CD, indeterminate colitis, presence or history of a fistula consistent with CD, microscopic colitis, radiation colitis, or ischemic colitis. Open-label Extension Period: * Participant has clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the participant at risk by continuing the study or that would have required a participant to discontinue treatment were observed during the Induction Period or Maintenance Period. * Participant has clinically relevant cardiovascular conditions, including history or presence of recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, Class III/IV heart failure, sick sinus syndrome, or severe untreated sleep apnea were observed during the Induction Period or Maintenance Period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with clinical remission as measured by the 3-component Mayo Score | At week 10 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with clinical response as measured by the 3-component Mayo Score | At week 10 and at week 52 |
| Proportion of participants with endoscopic improvement | At week 10 and at week 52 |
| Proportion of participants achieving histologic remission | At week 10 and at week 52 |
| Proportion of participants with mucosal healing | At week 10 and at week 52 |
| Proportion of participants in remission as measured by the 3-component Mayo Score while off corticosteroids for ≥ 12 weeks | At week 52 |
| Proportion of participants with Treatment Emergent Adverse Events (TEAEs) | Up to 78 weeks |
| Proportion of participants with clinical remission as measured by the 3-component Mayo Score | At week 52 |
| Proportion of participants with TEAEs leading to discontinuation of investigational product | Up to 78 weeks |
| Proportion of participants with TEAEs of special interest | Up to 78 weeks |
| Proportion of participants with clinical laboratory abnormalities | Up to 78 weeks |
| Proportion of participants with vital sign abnormalities | Up to 78 weeks |
| Proportion of participants with electrocardiogram (ECG) abnormalities | Up to 78 weeks |
| Proportion of participants with pulmonary function test abnormalities | Up to 78 weeks |
| Proportion of participants with Serious Adverse Events (SAEs) | Up to 78 weeks |
Countries
China, Taiwan
Outcome results
None listed