NCT03301506

Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)

ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

Detailed description

Primary: To evaluate the long-term safety and tolerability of seladelpar Secondary: * To evaluate the long-term efficacy of seladelpar * To evaluate the effect of seladelpar on patient-reported outcomes (pruritus)

Conditions

• Primary Biliary Cirrhosis

Interventions

Type	Name	Description
DRUG	Seladelpar 5 mg Capsule	Participants will be assigned to a treatment group if tolerability issues noted in the previous study.
DRUG	Seladelpar 10 mg Capsule	Participants will be assigned to a treatment group unless there are tolerability issues.

Timeline

• Start date: 2017-12-12
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2017-10-04
• Last updated: 2025-12-23

Locations

108 sites across 24 countries: United States, Argentina, Australia, Austria, Belgium, Canada, Chile, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Romania, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study