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RPC01-3203: A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Chron's Disease

Recruiting

This is a Phase 3, randomized, double-blind, placebo-controlled study to demonstrate the effect of oral ozanimod as maintenance therapy in subjects with moderately to severely active CD, defined as a CDAI score of ≥ 220 to ≤ 450. Subjects who complete the initial 12 weeks of treatment (Induction Studies RPC01-3201 or RPC01-3202) and are in clinical response (CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150) and/or clinical remission (CDAI score < 150 and/or average stool frequency score ≤ 3 with a stool frequency no worse than baseline and an average abdominal pain score ≤ 1) will be eligible to participate in the Maintenance Study.

I'm interested

All
18 Years to 75 Years old
This study is NOT accepting healthy volunteers
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com
Inclusion Criteria:

• 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
Exclusion Criteria:

• 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

Drug: Ozanimod, Other: Placebo

Crohn Disease, Digestive & Liver Health

Crohn's Disease, Crohn Disease, Oral, Ozanimod, Moderately active, Severely active, RPC01, RPC01-3203, Clinics and Surgery Center (CSC), inflammatory bowel disease

Mary McDonald - mcdo0664@umn.edu
Eugenia Shmidt
Phase 3
STUDY00003228
NCT03464097
See this study on ClinicalTrials.gov

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