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NCT06456593 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease
A Phase 2 study of Moderately to Severely Active Crohn Disease, sponsored by Abivax S.A..
- Recruiting
- Registry status
- Phase 2
- Development phase
- 212
- Enrollment target
- 20
- Study locations
NCT06456593 is a Phase 2 study of Moderately to Severely Active Crohn Disease that is actively recruiting participants, run by Abivax S.A.. The registered enrollment target is 212 participants. The trial reports 20 study locations across 8 states.
The verdict
NCT06456593, a Phase 2 study of Moderately to Severely Active Crohn Disease, is actively recruiting participants, sponsored by Abivax S.A..
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 212 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study has 3 treatment phases, a 12-Week Induction Phase, a 40-Week Maintenance Phase, and a 48-Week Extension Phase. The objective is to evaluate the efficacy and safety of obefazimod compared to placebo as induction and maintenance therapy in subjects with moderately to severely active CD after inadequate response (no response, loss of response, or intolerance) to conventional therapies and/or advanced therapies. The primary objective for the 48-Week Extension Phase is to evaluate the safety and tolerability of obefazimod compared with placebo in subjects who are enrolled in the Extension Phase.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Obefazimod
Study Locations (20)
Florida
- Clinical Research Of Brandon, LLC - Brandon
- West Central Gastroenterology d/b/a Gastro Florida - Clearwater
- Auzmer Research - Lakeland
- Research Associates of South Florida, LLC - Miami
- Wellness Clinical Research - Miami Lakes
- Advanced Research Institute, Inc. - New Port Richey
- Sarkis Clinical Trials - Parent - Ocala
- Orlando Health, Inc. - Orlando
- GCP Clinical Research, LLC - Tampa
- Theia Clinical Research Centers, LLC - Temple Terrace
Arizona
- Scottsdale Gastroenterology Specialists - Scottsdale
- GI Alliance -Gurnee - Sun City
California
- Hoag Hospital - Irvine
- United Medical Doctors - Murrieta
Massachusetts
- Lucida Clinical Trials, LLC - New Bedford
- University of Massachusetts, Worcester - Worcester
Alabama
- IMC Gulf Coast Gastroenterology, PC - Fairhope
Colorado
- Peak Gastroenterology Associates - Colorado Springs
Illinois
- Northwestern University - Evanston
Iowa
- University of Iowa Health Care - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 212 participants |
| Start Date | 2024-10-30 |
| Est. Completion | 2028-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06456593
The ClinicalTrials.gov registry entry for NCT06456593 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 212 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abivax S.A., which has 6 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Moderately to Severely Active Crohn Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06456593 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT06456593 about?
NCT06456593 is a clinical study titled "Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease". This study has 3 treatment phases, a 12-Week Induction Phase, a 40-Week Maintenance Phase, and a 48-Week Extension Phase. The objective is to evaluate the efficacy and safety of obefazimod compared to placebo as induction and maintenance therapy in subjects with moderately to severely active CD aft...
What is the current status of trial NCT06456593?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 212 participants. The study started on 2024-10-30. Estimated completion is 2028-04.
What conditions does trial NCT06456593 study?
This clinical trial studies the following conditions: Moderately to Severely Active Crohn Disease.
What interventions are being tested in trial NCT06456593?
The interventions under investigation include: Placebo (OTHER), Obefazimod (DRUG).
Who is sponsoring clinical trial NCT06456593?
This trial is sponsored by Abivax S.A., which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06456593 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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