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A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
The purpose of this study is to evaluate the long-term safety and efficacy of RPC1063 in participants with moderately to severely active ulcerative colitis. Only those participants who have previously participated in a trial of RPC1063, being either RPC01-3101 or completed at least 1 year of the open-label period of RPC01-202 will be eligible.
This is an extension study trial. Eligible participants from the RPC01-3101 and RPC01-202 trials were able to roll-over in this trial to receive study medication until March 2023 or until the Sponsor discontinues the development program, whichever comes first.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Local Institution - 144
Tucson, Arizona, United States
Local Institution - 102
Anaheim, California, United States
Local Institution - 117
Mission Hills, California, United States
Local Institution - 112
Oak Lawn, Illinois, United States
Local Institution - 119
Baton Rouge, Louisiana, United States
Local Institution - 127
Jacksonville, North Carolina, United States
Local Institution - 290
Oklahoma City, Oklahoma, United States
Local Institution - 143
Portland, Oregon, United States
Local Institution - 179
Germantown, Tennessee, United States
Local Institution - 122
Dallas, Texas, United States
Start Date
December 2, 2015
Primary Completion Date
December 19, 2024
Completion Date
December 19, 2024
Last Updated
December 31, 2025
877
ACTUAL participants
RPC1063
DRUG
Lead Sponsor
Celgene
NCT07271069
NCT06975722
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07185009