Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

Open to people ages 12 years and up

• Aged 18 to 75 years (at screening for Cohorts 1 and 2)
• Male of Female adolescent patients aged 12 to < 18 years (at screening) with a body weight > or = 45kg (Cohort 3)
• Ulcerative colitis confirmed on endoscopy
• Moderately to severely active ulcerative colitis (Mayo score 6-12)
• Currently receiving treatment with aminosalicylates, prednisone or budesonide
• Can be receiving azathioprine, mercaptopurine, or methotrexate but treatment will be stopped prior to randomization

• Have severe extensive colitis as evidenced by:
• Physician judgement 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 Crohn's disease, indeterminate colitis, or the presence of a fistula consistent with Crohn's disease 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 known macular edema
• Pregnancy, lactation, or a positive serum B-hCG measured during screening