ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1
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ClinicalTrials.gov Identifier: NCT05507203 |
Recruitment Status :
Recruiting
First Posted : August 18, 2022
Last Update Posted : May 20, 2024
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Sponsor:
Abivax S.A.
Information provided by (Responsible Party):
Abivax S.A.
Tracking Information | |||||
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First Submitted Date ICMJE | August 17, 2022 | ||||
First Posted Date ICMJE | August 18, 2022 | ||||
Last Update Posted Date | May 20, 2024 | ||||
Actual Study Start Date ICMJE | October 10, 2022 | ||||
Estimated Primary Completion Date | December 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Proportion of subjects who achieve clinical remission per Modified Mayo Score at week 8 [ Time Frame: 8 weeks ] To compare the efficacy of ABX464 versus placebo on clinical remission
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Original Primary Outcome Measures ICMJE |
To compare the efficacy of ABX464 versus placebo on clinical remission [ Time Frame: 8 weeks ] Proportion of subjects who achieve clinical remission per Modified Mayo Score at week 8
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1 | ||||
Official Title ICMJE | A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis | ||||
Brief Summary | This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors]. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) 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 | Recruiting | ||||
Estimated Enrollment ICMJE |
612 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | February 2025 | ||||
Estimated Primary Completion Date | December 2024 (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 | 16 Years and older (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China, Czechia, France, Germany, Greece, Hungary, India, Italy, Korea, Republic of, Netherlands, Poland, Portugal, Spain, Switzerland, Turkey, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05507203 | ||||
Other Study ID Numbers ICMJE | ABX464-105 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Abivax S.A. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Abivax S.A. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Abivax S.A. | ||||
Verification Date | April 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |