An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02531126
• Other study ID #: RPC01-3102
• Secondary ID: 2015-001600-64U1
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 2, 2015
• Est. completion date: February 27, 2025

Study information

• Verified date: September 2023
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 878
• Est. completion date: February 27, 2025
• Est. primary completion date: February 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• RPC1063

Locations

Country	Name	City	State
Australia	Local Institution - 152	Camperdown	New South Wales
Belarus	Local Institution - 751	Vitebsk
Belgium	Local Institution - 601	Leuven
Bulgaria	Local Institution - 450	Sofia
Bulgaria	Local Institution - 451	Sofia
Bulgaria	Local Institution - 459	Sofia
Germany	Local Institution - 525	Berlin
Germany	Local Institution - 535	Berlin
Germany	Local Institution - 545	Frankfurt
Greece	Local Institution - 643	Athens
Hungary	Local Institution - 816	Balatonfured
Hungary	Local Institution - 808	Debrecen
Israel	Local Institution - 505	Rechovot
Italy	Local Institution - 567	Firenze	Toscana
Romania	Local Institution - 677	Bucharest
Slovakia	Local Institution - 910	Bardejov
Ukraine	Local Institution - 954	Kharkiv
United Kingdom	Local Institution - 236	London	Greater London
United Kingdom	Local Institution - 243	London
United States	Local Institution - 102	Anaheim	California
United States	Local Institution - 119	Baton Rouge	Louisiana
United States	Local Institution - 122	Dallas	Texas
United States	Local Institution - 179	Germantown	Tennessee
United States	Local Institution - 127	Jacksonville	North Carolina
United States	Local Institution - 112	Oak Lawn	Illinois
United States	Local Institution - 290	Oklahoma City	Oklahoma
United States	Local Institution - 143	Portland	Oregon
United States	Local Institution - 144	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Australia,  Belarus,  Belgium,  Bulgaria,  Germany,  Greece,  Hungary,  Israel,  Italy,  Romania,  Slovakia,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Treatment Emergent Adverse Events (TEAEs)		From enrollment until at least 90 days after completion of study treatment
Primary	Number of Participants with Adverse Events (AEs)		From enrollment until at least 90 days after completion of study treatment
Primary	Number of Participants with Serious Adverse Events (SAEs)		From enrollment until at least 90 days after completion of study treatment
Primary	Number of Participants with TEAEs Leading to Discontinuation of Investigational Drug		From enrollment until at least 90 days after completion of study treatment
Primary	Number of Participants with Adverse Events of Special Interest		From enrollment until at least 90 days after completion of study treatment
Secondary	Proportion of participants with clinical remission		Up to 6 years
Secondary	Proportion of participants with a clinical response		Up to 6 years
Secondary	Proportion of participants with endoscopic improvement		Up to 6 years
Secondary	Proportion of participants with mucosal healing		Up to 6 years
Secondary	Proportion of participants with corticosteroid-free remission		Up to 6 years
Secondary	Change from Baseline in complete Mayo score		Up to 6 years
Secondary	Change from Baseline in partial Mayo score		Up to 6 years
Secondary	Change from Baseline in 9-point Mayo score		Up to 6 years
Secondary	Proportion of participants with histologic remission		Up to 6 years
Secondary	Proportion of participants with clinical response in participants who had previously received anti-TNF therapy		Up to 6 years
Secondary	Proportion of participants with clinical remission in participants who had previously received anti-TNF therapy		Up to 6 years
Secondary	Proportion of participants with endoscopic improvement in participants who had previously received anti-TNF therapy		Up to 6 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting