Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
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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: NCT02435992 |
Recruitment Status :
Completed
First Posted : May 6, 2015
Last Update Posted : July 9, 2020
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Sponsor:
Celgene
Information provided by (Responsible Party):
Celgene
Tracking Information | ||||
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First Submitted Date ICMJE | April 24, 2015 | |||
First Posted Date ICMJE | May 6, 2015 | |||
Last Update Posted Date | July 9, 2020 | |||
Actual Study Start Date ICMJE | June 17, 2015 | |||
Actual Primary Completion Date | March 27, 2020 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
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 | Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis | |||
Official Title ICMJE | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis | |||
Brief Summary | The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC). | |||
Detailed Description | The trial is composed of 2 periods: Induction and Maintenance. In the Induction Period (IP), patients will be entered into the trial in 3 separate cohorts (Cohort 1 and Cohort 2 for adults, Cohort 3 for adolescents). Patients from Cohort 1, 2, and 3 in clinical response at the end of the IP will proceed through to the Maintenance Period (MP). Patients from Cohort 1, 2, and 3 who participate in this trial may also qualify to participate in an optional Open-Label Extension (OLE) trial. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Ulcerative Colitis | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
1012 | |||
Original Estimated Enrollment ICMJE |
900 | |||
Actual Study Completion Date ICMJE | June 17, 2020 | |||
Actual Primary Completion Date | March 27, 2020 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 12 Years to 75 Years (Child, 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 | Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Croatia, Czechia, Georgia, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Latvia, Moldova, Republic of, Netherlands, New Zealand, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Ukraine, United Kingdom, United States | |||
Removed Location Countries | Czech Republic | |||
Administrative Information | ||||
NCT Number ICMJE | NCT02435992 | |||
Other Study ID Numbers ICMJE | RPC01-3101 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Celgene | |||
Study Sponsor ICMJE | Celgene | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Celgene | |||
Verification Date | July 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |