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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02531126
Recruitment Status : Active, not recruiting
First Posted : August 24, 2015
Last Update Posted : May 23, 2023
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date  ICMJE August 20, 2015
First Posted Date  ICMJE August 24, 2015
Last Update Posted Date May 23, 2023
Actual Study Start Date  ICMJE December 2, 2015
Estimated Primary Completion Date February 27, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2021)
  • Number of Participants with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From enrollment until at least 90 days after completion of study treatment ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: From enrollment until at least 90 days after completion of study treatment ]
  • Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: From enrollment until at least 90 days after completion of study treatment ]
  • Number of Participants with TEAEs Leading to Discontinuation of Investigational Drug [ Time Frame: From enrollment until at least 90 days after completion of study treatment ]
  • Number of Participants with Adverse Events of Special Interest [ Time Frame: From enrollment until at least 90 days after completion of study treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 21, 2015)
  • Safety as assessed by the evaluation of adverse events [ Time Frame: Up to 5 years ]
  • Efficacy as assed by Mayo component sub-scores [ Time Frame: Up to 5 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2021)
  • Proportion of participants with clinical remission [ Time Frame: Up to 6 years ]
  • Proportion of participants with a clinical response [ Time Frame: Up to 6 years ]
  • Proportion of participants with endoscopic improvement [ Time Frame: Up to 6 years ]
  • Proportion of participants with mucosal healing [ Time Frame: Up to 6 years ]
  • Proportion of participants with corticosteroid-free remission [ Time Frame: Up to 6 years ]
  • Change from Baseline in complete Mayo score [ Time Frame: Up to 6 years ]
  • Change from Baseline in partial Mayo score [ Time Frame: Up to 6 years ]
  • Change from Baseline in 9-point Mayo score [ Time Frame: Up to 6 years ]
  • Proportion of participants with histologic remission [ Time Frame: Up to 6 years ]
  • Proportion of participants with clinical response in participants who had previously received anti-TNF therapy [ Time Frame: Up to 6 years ]
  • Proportion of participants with clinical remission in participants who had previously received anti-TNF therapy [ Time Frame: Up to 6 years ]
  • Proportion of participants with endoscopic improvement in participants who had previously received anti-TNF therapy [ Time Frame: Up to 6 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
Official Title  ICMJE A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE Drug: RPC1063
Other Name: Ozanimod
Study Arms  ICMJE Experimental: RPC0163 (Ozanimod)
Intervention: Drug: RPC1063
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 20, 2021)		 878
Original Estimated Enrollment  ICMJE
 (submitted: August 21, 2015)		 1200
Estimated Study Completion Date  ICMJE February 27, 2025
Estimated Primary Completion Date February 27, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Bulgaria,   Germany,   Greece,   Slovakia,   United Kingdom,   United States
Removed Location Countries Argentina,   Australia,   Austria,   Belarus,   Canada,   Croatia,   Czech Republic,   Czechia,   Georgia,   Hungary,   Israel,   Italy,   Korea, Republic of,   Latvia,   Moldova, Republic of,   Netherlands,   New Zealand,   Poland,   Romania,   Russian Federation,   Serbia,   South Africa,   Spain,   Ukraine
 
Administrative Information
NCT Number  ICMJE NCT02531126
Other Study ID Numbers  ICMJE RPC01-3102
2015-001600-64 ( EudraCT Number )
U1111-1218-0284 ( Registry Identifier: WHO )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Celgene
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Celgene
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Celgene
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP