drugset / Trial / NCT04620733
RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)
RandomizedParallel-groupDouble-blindTreatment
Summary
The purposes of this study are to evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo. The study also checked the effect of treatment on the symptoms of PBC, including pruritus.
Timeline
- Start
- 2021-04-21
- Primary completion
- 2023-08-11
- Completion
- 2023-08-11
Publications
- Levy C, Jones DEJ, Mayo MJ, Bowlus CL, Kowdley KV, Hirschfield GM, Liu J, Burk C, Carroll S, Crittenden DB, Kremer AE. Seladelpar Improved Itch, Itch-Related Sleep Disturbance and Measures of Fatigue in Patients With Primary Biliary Cholangitis and Pruritus in the Phase 3 RESPONSE Trial. Aliment Pharmacol Ther. 2026 Jul;64(1):23-35. doi: 10.1111/apt.70630. Epub 2026 Apr 3.
- Hirschfield GM, Bowlus CL, Mayo MJ, Kremer AE, Vierling JM, Kowdley KV, Levy C, Villamil A, Ladron de Guevara Cetina AL, Janczewska E, Zigmond E, Jeong SH, Yilmaz Y, Kallis Y, Corpechot C, Buggisch P, Invernizzi P, Londono Hurtado MC, Bergheanu S, Yang K, Choi YJ, Crittenden DB, McWherter CA; RESPONSE Study Group. A Phase 3 Trial of Seladelpar in Primary Biliary Cholangitis. N Engl J Med. 2024 Feb 29;390(9):783-794. doi: 10.1056/NEJMoa2312100. Epub 2024 Feb 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Seladelpar | Small molecule | 5 mg | Oral |
| Subject | Seladelpar | Small molecule | 10 mg | Oral |