Long-term Safety and Efficacy Profile of ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis
Market
0.0%
Details
- Resolved Date
- 10/3/24
- Study Completion
- 4/1/26
- Company
- Abivax S.A.
- Ticker
- ABVX
- Type
- Trial Status
- Active Not Recruiting
- Trial Size
- 203
- Volume
- $0
- NCT
- NCT05177835
- Drug 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 (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.
Resolution Evidence
- Outcome
- YES
- Status
- Resolved
- Settlement Date
- 4/1/26 UTC
- Executive Summary
The exact Phase 2 long-term maintenance study appears to have had a positive interim public readout. Abivax explicitly called it a “positive interim efficacy and safety analysis,” and Abivax had previously identified NCT05177835 as the merged Phase 2a/2b maintenance trial this readout describes.
Sources
Sponsorir.abivax.com10/3/24
Abivax Reports Positive Interim Efficacy and Safety Analysis of Once-Daily 25mg Obefazimod in Moderate to Severe Ulcerative Colitis Patients After 2-Years of Open-Label Maintenance
Abivax announced results of a positive interim efficacy and safety analysis from an open-label maintenance study enrolling UC patients after the Phase 2a and Phase 2b OLM studies.
View source
Sponsorir.abivax.com1/6/22
Abivax phase 3 program with obefazimod in ulcerative colitis progresses with US IRB approval
Abivax said the Phase 2a and Phase 2b maintenance studies were merged into one single maintenance trial, NCT05177835.
View source
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