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INDUCTION STUDY #1 - A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ORAL OZANIMOD AS INDUCTION THERAPY FOR MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE

This study is for patients who have been diagnosed with or have signs and symptoms of moderately to severely active Crohn's disease (CD) which is a chronic inflammatory disorder of the bowels. People with CD often suffer from diarrhea, abdominal pain, rectal bleeding, weight loss, and fever. This study is being done to see whether an experimental medication that is not approved by the Food and Drug Administration, is safe and effective for the possible treatment of CD. To do this, a comparison will be made between people who receive active drug and people who receive placebo (a ‘dummy treatment’ that looks like the active drug but contains no active ingredient). The purpose of this study is to confirm preliminary results from a phase II study that suggests that the active drug may be safe and effective in treating patients with CD.
Laurie Peiffer at lpeiffer@pennstatehealth.psu.edu or 717-531-5226
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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03440372
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Inclusion Criteria:
Ages 18-75, inclusive
Diagnosis of Crohn's Disease for at least 3 months
Failed prior treatment
Exclusion Criteria:
Will need surgery in 3 months
Stricture or obstruction symptoms
Prior cancers
Drug or alcohol abuse within 1 year
Diagnosis of colitis
Digestive Systems & Liver Disease
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Location
Hershey, PA