Study of OSE-127 vs Placebo in Patients With Moderate to Severe Active Ulcerative Colitis (CoTikiS)
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ClinicalTrials.gov Identifier: NCT04882007 |
Recruitment Status : Unknown
Verified June 2021 by OSE Immunotherapeutics.
Recruitment status was: Recruiting
First Posted : May 11, 2021
Last Update Posted : June 28, 2021
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Tracking Information | |||||
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First Submitted Date ICMJE | April 13, 2021 | ||||
First Posted Date ICMJE | May 11, 2021 | ||||
Last Update Posted Date | June 28, 2021 | ||||
Actual Study Start Date ICMJE | October 2, 2020 | ||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change in modified Mayo Score [ Time Frame: Baseline and Week 10 ] Change in modified Mayo Score between baseline and Week 10 clinical symptoms (stool frequency and rectal bleeding sub-scores) additionally to the endoscopic sub-score
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study of OSE-127 vs Placebo in Patients With Moderate to Severe Active Ulcerative Colitis | ||||
Official Title ICMJE | Randomized, Double-blind, Phase 2 Study to Evaluate the Efficacy and the Safety of OSE-127 Versus Placebo in Subjects With Moderate to Severe Active Ulcerative Colitis Who Have Failed or Are Intolerant to Previous Treatment(s) | ||||
Brief Summary | This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in patients with moderate to severe active ulcerative colitis. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: During the Double-blind phase all participants will be blinded to treatment assignment. 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 | Unknown status | ||||
Estimated Enrollment ICMJE |
150 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | March 2023 | ||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
OR Previous or current biologic therapy Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | Belarus, Belgium, Bulgaria, Croatia, Georgia, Hungary, Latvia, Poland, Russian Federation, South Africa, Ukraine | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04882007 | ||||
Other Study ID Numbers ICMJE | OSE-127-C201 2020-001398-59 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | OSE Immunotherapeutics | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | OSE Immunotherapeutics | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | OSE Immunotherapeutics | ||||
Verification Date | June 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |