NCT05177835

Long-term Safety and Efficacy Profile of ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis

A Follow-up Phase II Open-label Study to Evaluate the Long-term Safety and Efficacy Profile of ABX464 Given at 25 mg Once Daily in Subjects With Moderate to Severe Active Ulcerative Colitis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 203 (estimated)
• Sponsor: Abivax S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label study aiming at evaluating the long-term safety and the efficacy profile of ABX464 given once a day (QD) at 25 mg in subjects who have been previously enrolled in the ABX464-102 or ABX464-104 studies (OLE and maintenance studies) and who are willing to continue their treatment. All subjects will receive ABX464 given at 25 mg QD. The enrolment in this long-term study will be based on the endoscopic improvement, the willingness of the subject to carry on his/her participation and also based on investigator's judgement. Subjects will be treated with ABX464 for a maximum period of 54 months. Subjects will be followed up quarterly. After the treatment period, subjects will be followed for 4 additional weeks for safety purposes.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	ABX464	All subjects will receive ABX464 given at 25 mg QD.

Timeline

• Start date: 2021-12-03
• Primary completion: 2026-03-01
• Completion: 2026-04-01
• First posted: 2022-01-05
• Last updated: 2025-09-04

Locations

46 sites across 14 countries: Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Poland, Serbia, Slovakia, Slovenia, Spain, Ukraine