Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease

• Status: Completed
• Trial end date: 2019-11-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose is to determine whether RPC1063 is effective in the treatment of Crohn's disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene
• Treatments: Ozanimod

Criteria

Key Inclusion Criteria:

• Crohn's disease (CD) confirmed by endoscopy and histology

• Active disease as evaluated by Crohn's Disease Activity Index Score and Simple Endoscopic Score for CD

• Inadequate response to aminosalicylates, corticosteroids, immunomodulators or biologic therapy

Key Exclusion Criteria:

• Diagnosis of ulcerative colitis or indeterminate colitis

• Known strictures/stenosis leading to symptoms of obstruction

• Current stoma or need for ileostomy or colostomy

• Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk

• History of uveitis or known macular edema

• History of colonic dysplasia