A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis
The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).
18 Years to 75 Years
Accepting Healthy Volunteers?
- Ulcerative Colitis (UC) confirmed on endoscopy
- Moderately to severely active UC (Mayo score 6-12)
- Currently receiving treatment with aminosalisylate, prednisone, or budesonide
Key Exclusion Criteria:
- Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease or microscopic colitis or 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 macular edema
- Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during Screening