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

The trial is composed of 2 periods: Induction and Maintenance. In the Induction Period (IP), patients will be entered into the trial in 2 separate cohorts (Cohort 1 and Cohort 2).Patients from Cohort 1 and 2 in clinical response at the end of the IP will proceed through to the Maintenance Period (MP). Patients from Cohort 1 and 2 who participate in this trial may also qualify to participate in an optional Open-Label Extension (OLE) trial.

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