NCT04620733

RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)

RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Biliary Cholangitis

Interventions

Type	Name	Description
DRUG	Seladelpar 10 mg	Seladelpar 10 mg one capsule daily for double-blind period, for a duration of up to 12 months
DRUG	Placebo	One capsule daily for double-blind period, for a duration of up to 12 months
DRUG	Seladelpar 5 mg	If down-titration needed, one capsule daily for double-blind period, for a duration of up to 12 months

Timeline

• Start date: 2021-04-21
• Primary completion: 2023-08-11
• Completion: 2023-08-11
• First posted: 2020-11-09
• Last updated: 2024-09-05
• Results posted: 2024-07-25

Locations

134 sites across 26 countries: United States, Argentina, Australia, Austria, Belgium, Canada, Chile, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Mexico, New Zealand, Poland, Romania, Russia, South Korea, Spain, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study