An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

Stopped early · Phase 3

Conditions studied: Crohn Disease

In brief

This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.

Key facts

Study ID

NCT03467958

Run by

Celgene

People needed

854

Starts

2018-08-24

Expected to finish

2024-10-31

Last updated by the study team

2025-09-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Southern California Research Institute Medical Group, Inc. — Los Angeles, California, United States
• Matrix Clinical Research Inc — Los Angeles, California, United States
• Local Institution - 110 — Los Angeles, California, United States
• Facey Medical Foundation (Parent) — Mission Hills, California, United States
• ABS Health, LLC — Mission Viejo, California, United States
• Alliance Clinical Research — Oceanside, California, United States
• Local Institution - 027 — Orange, California, United States
• Palo Alto Center-Palo Alto Medical Foundation Research Institute — Palo Alto, California, United States
• Havana Research Institute LLC — Pasadena, California, United States
• Local Institution - 006 — Rialto, California, United States
• Sutter Medical Group — Roseville, California, United States
• Local Institution - 280 — Sacramento, California, United States
• Local Institution - 003 — San Diego, California, United States
• Local Institution - 281 — San Francisco, California, United States
• New Hope Research Development — West Covina, California, United States
• Holland Center for Family Health — Peoria, Arizona, United States

Full record on ClinicalTrials.gov

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