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Ozanimod is a novel, oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator.  This is a Phase 3, randomized, double-blind, placebo-controlled study to determine the effect of oral ozanimod as an induction treatment for subjects with moderately to severely active CD, defined as a CDAI (Crohn’s Disease Activity Index) score ≥ 220 to ≤ 450. Approximately 600 subjects with active clinical symptoms and mucosal inflammation will be randomized in a 2:1 ratio to receive either ozanimod or placebo. Subjects will be stratified by prior biologic use (yes/no) and corticosteroid use at baseline (yes/no). Approximately 50% of subjects with a history of treatment with marketed biologic agents (eg, TNF antagonists, anti-IL-12/23 and anti-integrin therapy) will be recruited. This limit will ensure the enrollment of subjects who have failed or been intolerant to corticosteroids or immunomodulators but never failed a TNF antagonist.
The primary endpoint of the study is the proportion of subjects in clinical remission (CDAI score < 150) at Week 12.

For more information on this study, you may go to the ClinicalTrials.gov website.  If you have further questions or are interested in participating in this trial, please Contact Us.

Meet the Doctors

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Christina L. Errichiello

PA-C
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Michael J. DiGiovanna

D.O, CPI.
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Dr. Omer K. Masood, M.D.

Gastroenterologist