Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

• Status: Completed
• Trial end date: 2020-06-17
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene
• Treatments: Ozanimod

Criteria

Inclusion Criteria:

• Aged 18 to 75 years (at screening for Cohort 1 and 2)

• UC confirmed on endoscopy

• Moderately to severely active UC (May score 6-12)

• Currently receiving treatment with aminosalisylate, prednisone, or budesonide

• Can be receiving azathioprine, mercaptopurine, or methotrexate, but treatment will be stopped prior to randomization

Exclusion Criteria:

• Have severe extensive colitis as evidence by:

• Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline.

• Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or bowel perforation.

• Diagnosis of CD, indeterminate colitis, or the presence of fistula consistent with CD or microscopic colitis, radiation colitis, or ischemic colitis

• 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 unknown macular edema

• Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during screening