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Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis

NCT04023396 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2026-05-06

Study results available
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Summary

A phase 2b study to evaluate the long-term efficacy and safety study of ABX464 50mg as maintenance therapy in patients with moderate to severe Ulcerative Colitis.

Conditions

Interventions

DRUG

ABX464

ABX464 All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.

Sponsors & Collaborators

  • Abivax S.A.

    lead INDUSTRY

Principal Investigators

  • Severine VERMEIRE, MD · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-01-13
Primary Completion
2023-02-23
Completion
2023-02-23

Countries

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

Study Locations

More Related Trials

Entities

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 NCT04023396 on ClinicalTrials.gov