A Phase 2 Proof-of-Concept Study With a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Active Treatment Extension Period to Assess the Safety and Efficacy of Seladelpar and Cilofexor in Combination for Primary Biliary Cholangitis

Gilead Sciences

Summary

The goal of this clinical study is to learn more about the combination of study drugs seladelpar and cilofexor. The study will assess, the safety, tolerability, and effectiveness of the combination drugs versus both seladelpar alone and placebo, in participants with primary biliary cholangitis (PBC). The primary objective of this study is to determine whether the combination of seladelpar + cilofexor leads to greater alkaline phosphatase (ALP) reduction than seladelpar alone and describe the safety and tolerability of seladelpar + cilofexor.

Eligibility

Age range: 18–75 years
Sex: All
Healthy volunteers: No

Detailed criteria

Key Inclusion Criteria: * Have a diagnosis of primary biliary cholangitis (PBC) as defined by a history of any 2 of the following criteria: 1. ALP above 1.0 × the ULN for at least 6 months 2. Positive antimitochondrial antibody titer (\> 1:40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay) or positive PBC-specific antinuclear antibodies 3. Documented liver biopsy results consistent with PBC * Used ursodeoxycholic acid (UDCA) for the past 12 months (stable dose for \> 6 months prior to screening), or intolerant to UDCA (last dose of UDCA \> 90 days prior to sc…

Interventions

Drug
Seladelpar
Capsule administered orally
Drug
PTM Seladelpar
Capsule administered orally
Drug
Cilofexor Dose B
Tablet administered orally
Drug
PTM Cilofexor Dose A
Tablet administered orally
Drug
PTM Cilofexor Dose B
Tablet administered orally
Drug
Cilofexor Dose A
Tablet administered orally

Summary

Eligibility

Interventions

Locations (4)