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Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis

NCT03760003 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 355

Last updated 2025-11-28

Study results available
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Summary

Phase 2b study to evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily in patients with moderate to severe Ulcerative Colitis.

Conditions

Interventions

DRUG

ABX464 25 mg

ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks

DRUG

Placebo

Two capsules of placebo once daily for 16 weeks

DRUG

ABX464 100 mg

ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks

DRUG

ABX464 50 mg

ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks

Sponsors & Collaborators

  • Abivax S.A.

    lead INDUSTRY

Principal Investigators

  • Séverine VERMEIRE, MD · Universitaire Ziekenhuizen KU Leuven

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
2019-08-13
Primary Completion
2021-04-01
Completion
2021-04-16
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belarus
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • Serbia
  • Slovakia
  • Slovenia
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

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 NCT03760003 on ClinicalTrials.gov