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Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease

NCT06456593 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2026-04-27

No results posted yet for this 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

  • Moderately to Severely Active Crohn Disease

Interventions

DRUG

Obefazimod

Obefazimod is administered once-daily in fed condition (ideally at the same time in the morning).

OTHER

Placebo

Matching placebo will be administered QD in fed condition (ideally at the same time in the morning).

Sponsors & Collaborators

  • Abivax S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-30
Primary Completion
2026-12-31
Completion
2028-04-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Romania
  • Slovakia
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06456593 on ClinicalTrials.gov