MedTrace Logo

ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis

NCT03093259 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-06-03

Study results available
· View outcomes & findings →

Summary

This Phase IIa study is an 8-week, double-blind, placebo-controlled, randomized study aiming at evaluating the safety and the efficacy of ABX464 given once a day (o.d) at 50 mg in subjects with moderate to severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFα, vedolizumab and/or corticosteroids followed by a one-month follow-up period.

Conditions

Interventions

DRUG

ABX464

ABX464 is a new Anti-inflammatory drug

DRUG

Placebo oral capsule

Placebo matching with ABX464

Sponsors & Collaborators

  • Abivax S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-11-16
Primary Completion
2018-07-25
Completion
2019-02-04

Countries

  • Austria
  • Belgium
  • Czechia
  • France
  • Germany
  • Hungary
  • Poland
  • Spain

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 NCT03093259 on ClinicalTrials.gov