NCT03368118

Study Evaluating the Long-term Safety and Efficacy of ABX464 in Active Ulcerative Colitis

A Follow-up Phase IIa Study to Evaluate the Long-term Safety and Efficacy Profile of ABX464 Given at 50 mg Once Daily in Subjects With Moderate to Severe Active Ulcerative Colitis.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Abivax S.A. · Industry
• Sex: All
• Age: 18 Years – 70 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 (o.d) at 50 mg in subjects who have been previously enrolled in the ABX464-101 clinical study (induction study) and who are willing to continue their treatment.

Detailed description

This study is an open-label study aiming at evaluating the long-term safety and the efficacy profile of ABX464 given once a day (o.d) at 50 mg in subjects who have been previously enrolled in the ABX464-101 clinical study (induction study) and who are willing to continue their treatment. All subjects will receive ABX464 given at 50 mg o.d irrespective of their previous treatment received in the ABX464-101 study (i.e. ABX464 or Placebo). The actual treatment received by a subject throughout the previous study (ABX464-101) will not be known at the time the subjects enter this follow-up study. This treatment group will be communicated (throughout the investigators) to the subjects at the end of the ABX464-101 study (planned in Q3/2018). The enrolment in this follow-up study will be based on 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 an overall period of 48 months. Subjects will be followed up weekly during the first month, every two weeks during the second month and then on a monthly basis until M24, then quaterly from M24 to M48.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	ABX464	All subjects will receive ABX464 given at 50 mg o.d for an overall period of 48 months.

Timeline

• Start date: 2018-01-20
• Primary completion: 2022-07-12
• Completion: 2022-08-15
• First posted: 2017-12-11
• Last updated: 2025-05-29
• Results posted: 2025-03-05

Locations

1 site across 1 country: Belgium