Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
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The purpose of this study is to determine the long-term safety of RPC1063 for the treatment of all patients with moderate to severe Ulcerative Colitis (UC) as well as the long-term efficacy of RPC1063 for the treatment of adult patients with moderate to severe UC. Additionally, to determine the long-term efficacy of RPC1063 for the treatment of adolescent patients with moderate to severe UC.
Condition or disease
The trial is an open label extension study. Eligible patients from the RPC01-3101 and RPC01-202 trials will have the option to enroll in this trial to receive study medication until the end of 2021 or until marketing approval of RPC1063 for UC is obtained in their country, or until the Sponsor discontinues the development program, whichever comes first.
Evaluate the long-term safety of RPC1063 for the treatment of all patients with moderate to severe UC. [ Time Frame: Up to 6 years ]
Number of participants with adverse events
Evaluate the long-term efficacy of RPC1063 for the treatment of adult patients with moderate to severe UC. [ Time Frame: Up to 6 years ]
Assessed by Mayo component sub scores which are the rectal bleeding subscore, stool frequency subscore, physician global assessment subscore, and the endoscopy subscore. Each subscore has a range of 0-3 points. The primary endpoint analysis will be based on the 9-point Mayo score consisting of RBS, SFS, and endoscopy score with a range of 0-9 points
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Layout table for eligibility information
Ages Eligible for Study:
12 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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