Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Completed · 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

NCT03440385

Run by

Celgene

People needed

606

Starts

2018-03-07

Expected to finish

2023-11-21

Last updated by the study team

2024-12-05

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 therapy
• Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
• Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
• 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…

• Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
• 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

• Ucsd Medical Center — La Jolla, California, United States
• Local Institution - 010 — Lancaster, California, United States
• Southern California Research Institute Medical Group, Inc. — Los Angeles, California, United States
• Matrix Clinical Research Inc — Los Angeles, California, United States
• Facey Medical Foundation (Parent) — Mission Hills, California, United States
• Local Institution - 093 — Pasadena, California, United States
• Sutter Medical Group — Roseville, California, United States
• Local Institution - 280 — Sacramento, California, United States
• Local Institution - 281 — San Francisco, California, United States
• Local Institution - 124 — West Covina, California, United States
• Local Institution - 065 — Colorado Springs, Colorado, United States
• Local Institution - 182 — Bristol, Connecticut, United States
• Local Institution - 166 — Clearwater, Florida, United States
• Local Institution - 084 — Clermont, Florida, United States
• American Research Institute Inc — Cutler Bay, Florida, United States
• Local Institution - 112 — Doral, Florida, United States
• Riverside Clinical Research — Edgewater, Florida, United States
• SIH Research — Kissimmee, Florida, United States
• Local Institution - 067 — Lighthouse PT, Florida, United States
• Center For Advanced Gastroenterology — Maitland, Florida, United States
• LMG Research — Miami, Florida, United States
• Local Institution - 175 — Miami, Florida, United States
• Local Institution - 081 — Miami, Florida, United States
• Local Institution - 044 — Miami Springs, Florida, United States
• Local Institution - 202 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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