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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 : March 16, 2023
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: RPC1063 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 878 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
Actual Study Start Date : December 2, 2015
Estimated Primary Completion Date : February 27, 2025
Estimated Study Completion Date : February 27, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: RPC0163 (Ozanimod) Drug: RPC1063
Other Name: Ozanimod


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From enrollment until at least 90 days after completion of study treatment ]
  2. Number of Participants with Adverse Events (AEs) [ Time Frame: From enrollment until at least 90 days after completion of study treatment ]
  3. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: From enrollment until at least 90 days after completion of study treatment ]
  4. 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 ]
  5. Number of Participants with Adverse Events of Special Interest [ Time Frame: From enrollment until at least 90 days after completion of study treatment ]

Secondary Outcome Measures :
  1. Proportion of participants with clinical remission [ Time Frame: Up to 6 years ]
  2. Proportion of participants with a clinical response [ Time Frame: Up to 6 years ]
  3. Proportion of participants with endoscopic improvement [ Time Frame: Up to 6 years ]
  4. Proportion of participants with mucosal healing [ Time Frame: Up to 6 years ]
  5. Proportion of participants with corticosteroid-free remission [ Time Frame: Up to 6 years ]
  6. Change from Baseline in complete Mayo score [ Time Frame: Up to 6 years ]
  7. Change from Baseline in partial Mayo score [ Time Frame: Up to 6 years ]
  8. Change from Baseline in 9-point Mayo score [ Time Frame: Up to 6 years ]
  9. Proportion of participants with histologic remission [ Time Frame: Up to 6 years ]
  10. Proportion of participants with clinical response in participants who had previously received anti-TNF therapy [ Time Frame: Up to 6 years ]
  11. Proportion of participants with clinical remission in participants who had previously received anti-TNF therapy [ Time Frame: Up to 6 years ]
  12. Proportion of participants with endoscopic improvement in participants who had previously received anti-TNF therapy [ Time Frame: Up to 6 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531126


Locations
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United States, California
Local Institution - 102
Anaheim, California, United States, 92801
United States, Illinois
Local Institution - 112
Oak Lawn, Illinois, United States, 60453
United States, North Carolina
Local Institution - 127
Jacksonville, North Carolina, United States, 28546
United States, Tennessee
Local Institution - 179
Germantown, Tennessee, United States, 38138
United States, Texas
Local Institution - 122
Dallas, Texas, United States, 75246
Belgium
Local Institution - 601
Leuven, Belgium, 3000
Greece
Local Institution - 643
Athens, Greece, 10676
Slovakia
Local Institution - 910
Bardejov, Slovakia, 08501
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02531126    
Other Study ID Numbers: RPC01-3102
2015-001600-64 ( EudraCT Number )
U1111-1218-0284 ( Registry Identifier: WHO )
First Posted: August 24, 2015    Key Record Dates
Last Update Posted: March 16, 2023
Last Verified: March 2023
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
 Pathologic Processes
Inflammatory Bowel Diseases
Ozanimod
Sphingosine 1 Phosphate Receptor Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs