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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: Recruiting Phase 2 study of Moderately to Severely Active Crohn Disease, sponsored by Abivax S.A..
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change from baseline in Crohn's Disease Activity Index (CDAI) score at Week 12 and Week 52 The CDAI total score ranges from 0 to over 600. Higher scores mean a worse outcome.
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 |
What NCT06456593 shows while recruiting
NCT06456593 is an interventional study that assigns participants to a tested intervention. The registered 212 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% higher).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06456593's enrollment target sits among peer trials
212 290th of 2000 higher than 1,711 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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