NCT05507216

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

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 636 (actual)
• Sponsor: Abivax S.A. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	ABX464	Administered once daily in the morning with food
DRUG	Placebo	Administered once daily in the morning with food

Timeline

• Start date: 2022-12-21
• Primary completion: 2025-06-24
• Completion: 2025-07-15
• First posted: 2022-08-18
• Last updated: 2025-10-24

Locations

273 sites across 25 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

Regulatory

• FDA-regulated drug study