An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
- Registration Number
- NCT02531126
- Lead Sponsor
- Celgene
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 878
• Previously participated in a trial of RPC1063 and meets the criteria for participation in the open-label extension as outlined in the prior trial
- Receiving treatment with breast cancer resistance protein inhibitors
- Clinically relevant cardiovascular conditions
- Liver function impairment
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RPC0163 (Ozanimod) RPC1063 -
- Primary Outcome Measures
Name Time Method Number of Participants with TEAEs Leading to Discontinuation of Investigational Drug From enrollment until at least 90 days after completion of study treatment Number of Participants with Adverse Events of Special Interest From enrollment until at least 90 days after completion of study treatment Number of Participants with Adverse Events (AEs) From enrollment until at least 90 days after completion of study treatment Number of Participants with Serious Adverse Events (SAEs) From enrollment until at least 90 days after completion of study treatment Number of Participants with Treatment Emergent Adverse Events (TEAEs) From enrollment until at least 90 days after completion of study treatment
- Secondary Outcome Measures
Name Time Method Proportion of participants with mucosal healing Up to 6 years Proportion of participants with clinical remission Up to 6 years Proportion of participants with corticosteroid-free remission Up to 6 years Proportion of participants with endoscopic improvement Up to 6 years Proportion of participants with a clinical response Up to 6 years Change from Baseline in complete Mayo score Up to 6 years Change from Baseline in partial Mayo score Up to 6 years Change from Baseline in 9-point Mayo score Up to 6 years Proportion of participants with histologic remission Up to 6 years Proportion of participants with clinical response in participants who had previously received anti-TNF therapy Up to 6 years Proportion of participants with clinical remission in participants who had previously received anti-TNF therapy Up to 6 years Proportion of participants with endoscopic improvement in participants who had previously received anti-TNF therapy Up to 6 years
Trial Locations
- Locations (28)
Local Institution - 102
🇺🇸Anaheim, California, United States
Local Institution - 179
🇺🇸Germantown, Tennessee, United States
Local Institution - 143
🇺🇸Portland, Oregon, United States
Local Institution - 954
🇺🇦Kharkiv, Ukraine
Local Institution - 451
🇧🇬Sofia, Bulgaria
Local Institution - 816
ðŸ‡ðŸ‡ºBalatonfured, Hungary
Local Institution - 535
🇩🇪Berlin, Germany
Local Institution - 127
🇺🇸Jacksonville, North Carolina, United States
Local Institution - 144
🇺🇸Tucson, Arizona, United States
Local Institution - 910
🇸🇰Bardejov, Slovakia
Local Institution - 243
🇬🇧London, United Kingdom
Local Institution - 450
🇧🇬Sofia, Bulgaria
Local Institution - 525
🇩🇪Berlin, Germany
Local Institution - 119
🇺🇸Baton Rouge, Louisiana, United States
Local Institution - 751
🇧🇾Vitebsk, Belarus
Local Institution - 459
🇧🇬Sofia, Bulgaria
Local Institution - 505
🇮🇱Rechovot, Israel
Local Institution - 545
🇩🇪Frankfurt, Germany
Local Institution - 236
🇬🇧London, Greater London, United Kingdom
Local Institution - 643
🇬🇷Athens, Greece
Local Institution - 808
ðŸ‡ðŸ‡ºDebrecen, Hungary
Local Institution - 290
🇺🇸Oklahoma City, Oklahoma, United States
Local Institution - 112
🇺🇸Oak Lawn, Illinois, United States
Local Institution - 122
🇺🇸Dallas, Texas, United States
Local Institution - 152
🇦🇺Camperdown, New South Wales, Australia
Local Institution - 567
🇮🇹Firenze, Toscana, Italy
Local Institution - 677
🇷🇴Bucharest, Romania
Local Institution - 601
🇧🇪Leuven, Belgium