MedTrace Logo

ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2

NCT05507216 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 636

Last updated 2025-10-24

No results posted yet for this study

Summary

This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies \[corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)\] and/or advanced therapies \[biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors\].

Conditions

Interventions

DRUG

ABX464

Administered once daily in the morning with food

DRUG

Placebo

Administered once daily in the morning with food

Sponsors & Collaborators

  • Abivax S.A.

    lead INDUSTRY

Principal Investigators

  • Severine Vermeire, MD, PhD · UZ Leuven, Belgium

  • Bruce Sands, MD, PhD · Mount Sinai Health System Digestive Disease Institute, New York USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-21
Primary Completion
2025-06-24
Completion
2025-07-15
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Croatia
  • Czechia
  • France
  • Germany
  • Hungary
  • India
  • Ireland
  • Israel
  • Italy
  • Japan
  • Lithuania
  • Mexico
  • New Zealand
  • Poland
  • Romania
  • Serbia
  • Slovakia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT05507216 on ClinicalTrials.gov