Induction Study #1 of Oral Ozanimod as Induction 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 explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.

Key facts

Study ID

NCT03440372

Run by

Celgene

People needed

625

Starts

2018-02-27

Expected to finish

2024-10-01

Last updated by the study team

2025-11-04

Who can join

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

You may qualify if…

• Crohn's disease for ≥ 3 months on endoscopy and on histological exam
• Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapies
• Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
• An average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
• Has Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)

You may not qualify if…

• Has a diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
• Has extensive small bowel resection (>100cm) or known diagnosis of short bowel syndrome, or requires total parenteral nutrition
• Current stoma, ileal-anal pouch anastomosis, or fistula
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 026 — North Little Rock, Arkansas, United States
• Local Institution - 284 — Camarillo, California, United States
• Local Institution - 165 — Chula Vista, California, United States
• Local Institution - 039 — Garden Grove, California, United States
• San Diego Clinical Trials — La Mesa, California, United States
• Local Institution - 061 — Los Angeles, California, United States
• Local Institution - 110 — Los Angeles, California, United States
• Local Institution - 140 — 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
• Local Institution - 006 — Rialto, California, United States
• Local Institution - 003 — San Diego, California, United States
• Local Institution - 297 — Lakewood, Colorado, United States
• Local Institution - 225 — Bristol, Connecticut, United States
• Local Institution - 091 — New Haven, Connecticut, United States
• Local Institution - 062 — Clearwater, Florida, United States
• Local Institution - 218 — Gainesville, Florida, United States
• Local Institution - 203 — Hialeah, Florida, United States
• Harmony Medical Research Institute — Hialeah, Florida, United States
• Local Institution - 078 — Hialeah, Florida, United States
• Local Institution - 179 — Hollywood, Florida, United States
• Local Institution - 101 — Homestead, Florida, United States
• Local Institution - 016 — Largo, Florida, United States
• Holland Center for Family Health — Peoria, Arizona, United States

Full record on ClinicalTrials.gov

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