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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 May 2021 |
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Main ID: |
NCT01647516 |
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Date of registration:
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19/07/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and Safety Study of Ozanimod in Ulcerative Colitis
Touchstone |
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Scientific title:
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A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo Controlled Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of Induction Therapy With RPC1063 in Patients With Moderately to Severely Active Ulcerative Colitis |
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Date of first enrolment:
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December 26, 2012 |
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Target sample size:
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199 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01647516 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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Belgium
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Bulgaria
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Canada
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Greece
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Hungary
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Israel
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Korea, Republic of
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Netherlands
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New Zealand
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Poland
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Russian Federation
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Slovakia
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Ukraine
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United States
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Contacts
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Name:
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AnnKatrin Petersen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Ulcerative colitis (UC) confirmed on endoscopy
- Moderately to severely active UC (Mayo score 6-12)
Exclusion Criteria:
- Current use of anti-TNF agents
Age minimum:
18 Years
Age maximum:
73 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: Placebo
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Drug: Ozanimod
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Primary Outcome(s)
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Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8
[Time Frame: Week 8]
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Secondary Outcome(s)
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Change From Baseline in Mayo Score at Week 8
[Time Frame: Baseline to Week 8]
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Percentage of Participants Who Achieved Clinical Remission in the Mayo Score at Week 32
[Time Frame: Week 32]
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Percentage of Participants With Mucosal Healing at Week 32
[Time Frame: Week 32]
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Number of Participants With TEAE During the Open-Label Treatment Period (OLP)
[Time Frame: From the first dose of IP until 90 days after the last dose of IP or at follow-up visit; the mean total duration of study drug exposure in the OLP was 2.42 years]
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Percentage of Participants With Mucosal Healing at Week 8
[Time Frame: Week 8]
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Percentage of Participants Who Achieved Clinical Response at Week 32
[Time Frame: Week 32]
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Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction Period
[Time Frame: From the first dose of investigational product (IP) up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 52.8 days, 56.1 days and 50.8 days respectively for 0.5 mg, 1 mg ozanimod and placebo]
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Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Maintenance Period
[Time Frame: From the first dose of IP up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 156.3 days, 171.1 days and 154.5 days respectively for 0.5 mg, 1 mg ozanimod and placebo.]
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Percentage of Participants Who Achieved a Clinical Response in the Mayo Score (MS) at Week 8
[Time Frame: Week 8]
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Secondary ID(s)
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RPC01-202
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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