A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Crohn Disease

In brief

This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.

Key facts

Study ID

NCT03464097

Run by

Celgene

People needed

550

Starts

2018-06-27

Expected to finish

2024-10-03

Last updated by the study team

2025-10-09

Who can join

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

You may qualify if…

• Fulfilled the inclusion criteria at time of entry into the induction study and completed the week 12 efficacy assessments of the induction study
• In clinical response and/or clinical remission and/or an average daily stool frequency score ≤ 3 and an average abdominal pain score ≤ 1 with abdominal pain and stool frequency no worse than baseline at Week 12 of the Induction Study

You may not qualify if…

• Partial or total colectomy, small bowel resection, or an ostomy since day 1 of the induction studies or has developed a symptomatic fistula
• Had a rectal steroid therapy, rectal 5-aminosalicylates, parenteral corticosteroids, immunomodulatory agents, investigational agents or apheresis
• 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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