A Phase 3 Trial of Seladelpar in Primary Biliary Cholangitis.
Gideon M HirschfieldChristopher L BowlusMarlyn J MayoAndreas E KremerJohn M VierlingKris V KowdleyCynthia LevyAlejandra VillamilAlma L Ladrón de Guevara CetinaEwa JanczewskaEhud ZigmondSook-Hyang JeongYusuf YilmazYiannis KallisChristophe CorpechotPeter BuggischPietro InvernizziMaria Carlota Londoño HurtadoSandrin BergheanuKe YangYun-Jung ChoiDaria B CrittendenCharles A McWherternull nullPublished in: The New England journal of medicine (2024)
In this trial involving patients with primary biliary cholangitis, the percentage of patients who had a biochemical response and alkaline phosphatase normalization was significantly greater with seladelpar than with placebo. Seladelpar also significantly reduced pruritus among patients who had moderate-to-severe pruritus at baseline. The incidence and severity of adverse events were similar in the two groups. (Funded by CymaBay Therapeutics; RESPONSE ClinicalTrials.gov number, NCT04620733; EudraCT number, 2020-004348-27.).