OP-1 LONG-TERM EFFICACY AND SAFETY OF OPEN-LABEL SELADELPAR TREATMENT IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS: INTERIM 2-YEAR RESULTS FROM THE ASSURE STUDY

Yes, Full disclosures sent separately. Seladelpar reduces biochemical markers of cholestasis and pruritus in patients with primary biliary cholangitis. ASSURE (NCT03301506) is an ongoing, open-label, long-term Phase 3 trial of seladelpar in patients rolling over from Phase 3 RESPONSE (NCT04620733) o...

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Published in:Annals of hepatology 2024-12, Vol.29, p.101599
Main Authors: Trivedi, Palak J., Levy, Cynthia, Kowdley, Kris V., Gordon, Stuart C., Bowlus, Christopher L., Hurtado, Maria Carlota Londoño, Hirschfield, Gideon M., Gulamhusien, Aliya F., Lawitz, Eric J., Villamil, Alejandra, Cetina, Alma Ladron de Guevara, Mayo, Marlyn J., Younes, Ziad H., Shibolet, Oren, Yimam, Kidist K., Pratt, Daniel S., Heo, Jeong, Morgera, Ulrike, Andreone, Pietro, Kremer, Andreas E., Corpechot, Christophe, Goel, Aparna, Peyton, Adam, Elbeshbeshy, Hany, Crittenden, Daria B., Heusner, Carrie, Proehl, Sarah, Zhou, Shuqiong, McWherter, Charles A.
Format: Article
Language:English
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Summary:Yes, Full disclosures sent separately. Seladelpar reduces biochemical markers of cholestasis and pruritus in patients with primary biliary cholangitis. ASSURE (NCT03301506) is an ongoing, open-label, long-term Phase 3 trial of seladelpar in patients rolling over from Phase 3 RESPONSE (NCT04620733) or legacy studies (NCT03602560, NCT02955602, NCT03301506, and NCT04950764). We report interim 2-year efficacy and safety results. Patients with insufficient response/intolerance to ursodeoxycholic acid could enroll in ASSURE. Key endpoints were composite biochemical response (alkaline phosphatase [ALP]
ISSN:1665-2681
DOI:10.1016/j.aohep.2024.101599