Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease
← catalyst calendarNCT06456593 · readout ≤ 134 d
Sponsored by Abivax S.A. (industry) · ABVX — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
212estimated
Sites
149
Countries
Belgium, Czechia, France +9
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-10-30 | actual | When the study began enrolling |
| Primary completion | Dec 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Apr 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2024-06-13 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Moderately to Severely Active Crohn Disease
Interventions
- Drug: Obefazimod
- Other: Placebo
Primary outcomes
what the primary-completion date above is the date OFInduction and maintenance Phase Efficacy- Crohn's Disease Activity Index (CDAI)
measured Week 12 and week 52
Maintenance Phase Efficacy - Simple Endoscopic Score for Crohn's disease (SES-CD)
measured Week 52
Maintenance Phase Efficacy - Endoscopic response
measured Week 52
Maintenance Phase Efficacy - SES-CD ulcer subscore > 1
measured Week 52
Maintenance Phase Efficacy - CDAI clinical remission
measured Week 52
Maintenance Phase Efficacy - PRO-2 clinical remission
measured Week 52
Maintenance Phase Efficacy - CDAI clinical response
measured Week 52
Maintenance Phase Efficacy - PRO-2 clinical response
measured Week 52
Maintenance Phase Efficacy - CDAI clinical response and endoscopic response
measured Week 52
Maintenance Phase Efficacy - endoscopic remission
measured Week 52
Extension Phase Safety- Adverse events
measured Weeks 64, 76, 88,100 and EOS
Extension Phase Safety - Hematology and coagulation
measured Weeks 64, 76, 88,100 and EOS
Extension Phase Safety - Biochemistry
measured Weeks 64, 76, 88,100 and EOS
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