NCT03602560

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

A 52-week, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Safety and Efficacy of Seladelpar in Subjects 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: 265 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) The participants might enter the ongoing open-label safety study (NCT03301506) following this double-blind study.

Detailed description

Primary: * To evaluate the safety and effect on cholestasis of two seladelpar regimens (5 mg/day titrated to 10 mg/day and 10 mg/day) over 52 weeks of treatment compared to placebo Key Secondary: * To evaluate the effect of seladelpar on normalization of alkaline phosphatase (AP) levels * To evaluate the effect of seladelpar on pruritus

Conditions

• Primary Biliary Cholangitis

Interventions

Type	Name	Description
DRUG	seladelpar 5-10 mg	Seladelpar 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety study. Subjects will continue the seladelpar dose (5 or 10 mg) received during the double-blinded study
DRUG	seladelpar 10 mg	Seladelpar 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label safety study. Subjects will continue the seladelpar dose (10 mg) received during the double-blinded study
DRUG	Placebo	One capsule daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety study. Subjects on placebo will be re-randomized to initiate seladelpar at 5 or 10 mg once daily

Timeline

• Start date: 2018-10-01
• Primary completion: 2020-02-16
• Completion: 2020-02-16
• First posted: 2018-07-27
• Last updated: 2022-08-02
• Results posted: 2022-05-31

Locations

156 sites across 23 countries: United States, Argentina, Australia, Austria, Belgium, Canada, Chile, France, Germany, Greece, Hungary, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Romania, Russia, Serbia, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study