Long-term Safety and Efficacy Profile of ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis
Status:
Recruiting
Trial end date:
2026-04-01
Target enrollment:
Participant gender:
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.