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Phase 2b/3 Study of ABX464 in Moderate to Severe Active Crohn's Disease Patients

NCT03905109 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2024-07-31

No results posted yet for this study

Summary

This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464, administered once daily (QD), in inducing clinical remission and endoscopic response in patients with moderate to severe active Crohn's disease (CD) who have inadequate response, loss of response, or intolerance to prior corticosteroid and/or immunosuppressant treatment and/or biologics. This study consists of a 28 day Screening Period, a 52 week Treatment Period; including a 12 week double blinded (Cohort 1) or open label (Cohort 2) Induction Phase and a 40 week double blinded (responders) or open label (nonresponders) Maintenance Phase; and a 4 week Follow up Period, which will consist of an End of Study (EOS) visit

Conditions

  • Crohn Disease

Interventions

DRUG

ABX464

ABX464 is a new anti-inflammatory drug. In the treatment arm, patients will receive dose A or Dose B of ABX464 orally once daily for 52 weeks.

DRUG

Placebo

In the placebo group, patients will receive dose A or B ABX464-matching-placebo orally once daily for 52 weeks.

Sponsors & Collaborators

  • Abivax S.A.

    lead INDUSTRY

Principal Investigators

  • Paul GINESTE, PharmD · Abivax S.A.

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
2022-09-19
Primary Completion
2022-09-19
Completion
2022-09-19

Countries

  • Belgium

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 NCT03905109 on ClinicalTrials.gov