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.
Brief Title
An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Ulcerative Colitis
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com
Inclusion Criteria:
• Previously participated in a trial of RPC1063 and meets the criteria for participation in the open-label extension as outlined in the prior trial
Exclusion Criteria:
* Receiving treatment with breast cancer resistance protein inhibitors
* Clinically relevant cardiovascular conditions
* Liver function impairment
Other protocol-defined inclusion/exclusion criteria apply
Inclusion Criteria:
• Previously participated in a trial of RPC1063 and meets the criteria for participation in the open-label extension as outlined in the prior trial
Exclusion Criteria:
* Receiving treatment with breast cancer resistance protein inhibitors
* Clinically relevant cardiovascular conditions
* Liver function impairment
Other protocol-defined inclusion/exclusion criteria apply
Inclusion Criteria
Inclusion Criteria:
• Previously participated in a trial of RPC1063 and meets the criteria for participation in the open-label extension as outlined in the prior trial
inclusion/
• Previously participated in a trial of RPC1063 and meets the criteria for participation in the open-label extension as outlined in the prior trial
inclusion/
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
75 Years
Minimum Age
18 Years
NCT Id
NCT02531126
Org Class
Industry
Org Full Name
Celgene
Org Study Id
RPC01-3102
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
Primary Outcomes
Outcome Measure
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Outcome Time Frame
From enrollment until at least 90 days after completion of study treatment
Outcome Measure
Number of Participants with Adverse Events (AEs)
Outcome Time Frame
From enrollment until at least 90 days after completion of study treatment
Outcome Measure
Number of Participants with Serious Adverse Events (SAEs)
Outcome Time Frame
From enrollment until at least 90 days after completion of study treatment
Outcome Measure
Number of Participants with TEAEs Leading to Discontinuation of Investigational Drug
Outcome Time Frame
From enrollment until at least 90 days after completion of study treatment
Outcome Measure
Number of Participants with Adverse Events of Special Interest
Outcome Time Frame
From enrollment until at least 90 days after completion of study treatment
Secondary Ids
Secondary Id
2015-001600-64
Secondary Id
U1111-1218-0284
Secondary Outcomes
Outcome Time Frame
Up to 6 years
Outcome Measure
Proportion of participants with clinical remission
Outcome Time Frame
Up to 6 years
Outcome Measure
Proportion of participants with a clinical response
Outcome Time Frame
Up to 6 years
Outcome Measure
Proportion of participants with endoscopic improvement
Outcome Time Frame
Up to 6 years
Outcome Measure
Proportion of participants with mucosal healing
Outcome Time Frame
Up to 6 years
Outcome Measure
Proportion of participants with corticosteroid-free remission
Outcome Time Frame
Up to 6 years
Outcome Measure
Change from Baseline in complete Mayo score
Outcome Time Frame
Up to 6 years
Outcome Measure
Change from Baseline in partial Mayo score
Outcome Time Frame
Up to 6 years
Outcome Measure
Change from Baseline in 9-point Mayo score
Outcome Time Frame
Up to 6 years
Outcome Measure
Proportion of participants with histologic remission
Outcome Time Frame
Up to 6 years
Outcome Measure
Proportion of participants with clinical response in participants who had previously received anti-TNF therapy
Outcome Time Frame
Up to 6 years
Outcome Measure
Proportion of participants with clinical remission in participants who had previously received anti-TNF therapy
Outcome Time Frame
Up to 6 years
Outcome Measure
Proportion of participants with endoscopic improvement in participants who had previously received anti-TNF therapy
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
75
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Thomas Ullman
Investigator Email
tullman@montefiore.org
Investigator Phone
347-671-8211