An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
- Registration Number
- NCT03467958
- Lead Sponsor
- Celgene
- Brief Summary
This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 854
- Is not in clinical response or clinical remission after completing 12 weeks in the Induction Studies
- Experience relapse or who complete the Maintenance Study
- Complete a study of ozanimod for Crohn's Disease and meet the criteria for participation
- Has any 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 subject at risk by participating in the study
- Has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated
- Is receiving treatment with any of the following drugs or interventions: CYP2C8 inducers; Monoamine oxidase inhibitors
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Administration of oral Ozanimod Ozanimod -
- Primary Outcome Measures
Name Time Method Incidence of adverse events (AEs) Up to 264 weeks Incidence of adverse events leading to discontinuation Up to 264 weeks Proportion of participants with a CDAI score of < 150 Up to 264 Weeks The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinicalactivity of CD
Incidence of serious adverse events (SAEs) Up to 264 weeks
- Secondary Outcome Measures
Name Time Method Proportion of participants with average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than baseline Up to 264 Weeks Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150 Up to 264 Weeks
Trial Locations
- Locations (763)
Holland Center for Family Health
🇺🇸Peoria, Arizona, United States
Local Institution - 202
🇺🇸Scottsdale, Arizona, United States
Local Institution - 026
🇺🇸North Little Rock, Arkansas, United States
Local Institution - 284
🇺🇸Camarillo, California, United States
Sharp Chula Vista Medical Center
🇺🇸Chula Vista, California, United States
Local Institution - 039
🇺🇸Garden Grove, California, United States
Ucsd Medical Center
🇺🇸La Jolla, California, United States
San Diego Clinical Trials
🇺🇸La Mesa, California, United States
Local Institution - 010
🇺🇸Lancaster, California, United States
Local Institution - 061
🇺🇸Los Angeles, California, United States
Scroll for more (753 remaining)Holland Center for Family Health🇺🇸Peoria, Arizona, United States