The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,012
Percentage of Participants in Clinical Remission at 10 Weeks
Percentage of participants that are in Clinical remission at 10 weeks
Time frame: At 10 Weeks
Percentage of Participants in Clinical Remission at 52 Weeks
Percentage of participants that are in Clinical remission at 52 weeks
Time frame: At 52 Weeks
Percentage of Participants With Clinical Response at 10 Weeks
Percentage of participants that are in Clinical response at 10 weeks
Time frame: At 10 Weeks
Percentage of Participants With Endoscopic Improvement at 10 Weeks
Percentage of participants with endoscopic improvement at 10 weeks
Time frame: At 10 Weeks
Percentage of Participants With Mucosal Healing at 10 Weeks
Percentage of participants with mucosal healing at 10 weeks
Time frame: At 10 Weeks
Percentage of Participants in Clinical Response at 52 Weeks
Percentage of participants that are in Clinical response at 52 weeks
Time frame: At 52 Weeks
Percentage of Participants With Endoscopic Improvement at 52 Weeks
Percentage of participants with endoscopic improvement at 52 weeks
Time frame: At 52 Weeks
Percentage of Participants in Clinical Remission at Week 52 Who Were in Remission at Week 10
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Arizona Digestive Health
Sun City, Arizona, United States
Adobe Clinical Research LLC
Tucson, Arizona, United States
Arkansas Gastroenterology, P.A.
North Little Rock, Arkansas, United States
Anaheim Clinical Trials
Anaheim, California, United States
Aurora Care Clinic
Costa Mesa, California, United States
Valley View Internal Medicine
Garden Grove, California, United States
Davita Clinical Trials, LLC
Huntington Beach, California, United States
University of California San Diego Medical Center
La Jolla, California, United States
OM Research
Lancaster, California, United States
University of Southern California - Keck School of Medicine
Los Angeles, California, United States
...and 362 more locations
Percentage of participants in clinical remission at week 52 who were in clinical remission at week 10
Time frame: At 52 Weeks
Percentage of Participants With Corticosteroid Free Remission at 52 Weeks
Percentage of participants with corticosteroid free remission at 52 weeks
Time frame: At 52 Weeks
Percentage of Participants With Mucosal Healing at 52 Weeks
Percentage of participants with Mucosal Healing at 52 weeks
Time frame: At 52 Weeks
Percentage of Participants With Durable Clinical Remission at 52 Weeks
Percentage of participants with durable clinical remission at 52 weeks
Time frame: At 52 Weeks