ABTECT-1 Study on Ulcerative Colitis

ABTECT-1 – Evaluation of Treatment with ABX464 for Ulcerative Colitis – 1

ClinicalTrials.gov ID: NCT05507203
Sponsor: Abivax S.A. (Information provided by Abivax S.A. (responsible party))

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464, Administered Once Daily, for Induction Therapy in Patients with Moderately to Severely Active Ulcerative Colitis.

Study overview

This is a multicenter, randomized, placebo-controlled study to investigate the efficacy and safety of ABX464 at a dosage of 25 mg or 50 mg once daily for the induction of clinical remission in patients with moderately to severely active ulcerative colitis.

Patients who have had an inadequate response, no response, loss of response, or intolerance to conventional therapies – including corticosteroids and immunosuppressants (e.g., azathioprine, 6-mercaptopurine, methotrexate) – will be included.

In addition, patients may also be included who have had an inadequate response, loss of effect, or intolerance to advanced therapies, including:

• Biologics (TNF inhibitors, anti-integrins, anti-IL-23 antibodies),
• S1P receptor modulators,
• JAK inhibitors.

The aim of the study is to assess whether ABX464 is effective and safe at the stated dosages in achieving clinical remission in this patient group.