Clinical trial NCT02531126: An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
Official title: A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2015-08-24
Enrollment: 878
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs)
timeFrame: From enrollment until at least 90 days after completion of study treatment
measure: Number of Participants with Adverse Events (AEs)
timeFrame: From enrollment until at least 90 days after completion of study treatment
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: From enrollment until at least 90 days after completion of study treatment
measure: Number of Participants with TEAEs Leading to Discontinuation of Investigational Drug
timeFrame: From enrollment until at least 90 days after completion of study treatment
measure: Number of Participants with Adverse Events of Special Interest
timeFrame: From enrollment until at least 90 days after completion of study treatment
Secondary outcomes:
measure: Proportion of participants with clinical remission
timeFrame: Up to 6 years
measure: Proportion of participants with a clinical response
timeFrame: Up to 6 years
measure: Proportion of participants with endoscopic improvement
timeFrame: Up to 6 years
measure: Proportion of participants with mucosal healing
timeFrame: Up to 6 years
measure: Proportion of participants with corticosteroid-free remission
timeFrame: Up to 6 years
measure: Change from Baseline in complete Mayo score
timeFrame: Up to 6 years
measure: Change from Baseline in partial Mayo score
timeFrame: Up to 6 years
measure: Change from Baseline in 9-point Mayo score
timeFrame: Up to 6 years
measure: Proportion of participants with histologic remission
timeFrame: Up to 6 years
measure: Proportion of participants with clinical response in participants who had previously received anti-TNF therapy
timeFrame: Up to 6 years
measure: Proportion of participants with clinical remission in participants who had previously received anti-TNF therapy
timeFrame: Up to 6 years
measure: Proportion of participants with endoscopic improvement in participants who had previously received anti-TNF therapy
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Local Institution - 144
state: Arizona
city: Anaheim
country: United States
facility: Local Institution - 102
state: California
city: Oak Lawn
country: United States
facility: Local Institution - 112
state: Illinois
city: Baton Rouge
country: United States
facility: Local Institution - 119
state: Louisiana
city: Jacksonville
country: United States
facility: Local Institution - 127
state: North Carolina
city: Oklahoma City
country: United States
facility: Local Institution - 290
state: Oklahoma
city: Portland
country: United States
facility: Local Institution - 143
state: Oregon
city: Germantown
country: United States
facility: Local Institution - 179
state: Tennessee
city: Dallas
country: United States
facility: Local Institution - 122
state: Texas
city: Camperdown
country: Australia
facility: Local Institution - 152
state: New South Wales
city: Vitebsk
country: Belarus
facility: Local Institution - 751
city: Leuven
country: Belgium
facility: Local Institution - 601
city: Sofia
country: Bulgaria
facility: Local Institution - 450
city: Sofia
country: Bulgaria
facility: Local Institution - 459
city: Sofia
country: Bulgaria
facility: Local Institution - 451
city: Berlin
country: Germany
facility: Local Institution - 535
city: Berlin
country: Germany
facility: Local Institution - 525
city: Frankfurt
country: Germany
facility: Local Institution - 545
city: Athens
country: Greece
facility: Local Institution - 643
city: Balatonfured
country: Hungary
facility: Local Institution - 816
city: Debrecen
country: Hungary
facility: Local Institution - 808
city: Rechovot
country: Israel
facility: Local Institution - 505
city: Firenze
country: Italy
facility: Local Institution - 567
state: Toscana
city: Bucharest
country: Romania
facility: Local Institution - 677
city: Bardejov
country: Slovakia
facility: Local Institution - 910
city: Kharkiv
country: Ukraine
facility: Local Institution - 954
city: London
country: United Kingdom
facility: Local Institution - 236
state: Greater London
city: London
country: United Kingdom
facility: Local Institution - 243
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Sandborn WJ, Feagan BG, Hanauer S, Vermeire S, Ghosh S, Liu WJ, Petersen A, Charles L, Huang V, Usiskin K, Wolf DC, D'Haens G. Long-Term Efficacy and Safety of Ozanimod in Moderately to Severely Active Ulcerative Colitis: Results From the Open-Label Extension of the Randomized, Phase 2 TOUCHSTONE Study. J Crohns Colitis. 2021 Jul 5;15(7):1120-1129. doi: 10.1093/ecco-jcc/jjab012.