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NCT05535946

Sponsored by Abivax S.A. (industry) · ABVX — their whole pipeline →.

Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
1,116actual
Sites
413
Countries
Argentina, Australia, Austria +31

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
DateFiledBasisWhat it is
Start2023-01-16actualWhen the study began enrolling
Primary completion2026-04-28actualThe date the last participant is measured for the primary outcome — the readout window
Study completionMay 2030estimatedThe whole study's end, after follow-up
First posted2022-09-10actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-07-07actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Ulcerative Colitis

Interventions

  • Drug: ABX464 — also filed as Obefazimod
  • Drug: Placebo

Primary outcomes

what the primary-completion date above is the date OF
Rate of subjects in clinical remission at Week 44
measured Week 44
Number and percentage of all treatment-emergent adverse events (TEAEs)
measured Week 44
Number and percentage of all serious adverse events (SAEs)
measured Week 44
Number and percentage of all causally related TEAEs/SAEs
measured Week 44

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