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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
132
Capsule administered orally
Capsule administered orally
Tablet administered orally
Change From Baseline in Serum Concentration of Alkaline Phosphate (ALP) at Week 24
Time frame: Baseline, Week 24
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Time frame: First dose up to 30 days post last dose (up to 318 weeks)
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: First dose up to 30 days post last dose (up to 318 weeks)
Proportion of Participants Achieving the Biochemistry Composite Endpoint at Week 24
Defined as the percentage of participants with ALP \< 1.67 × upper limit of normal (ULN), ALP decrease of ≥ 15%, and total bilirubin ≤ 1 × ULN.
Time frame: Week 24
Proportion of Participants Achieving ALP Normalization at Week 24
ALP Normalization is defined as ALP ≤ 1.0 × ULN.
Time frame: Week 24
Change From Baseline to Week 24 in Weekly Average Pruritus Numerical Rating Scale (NRS)
Time frame: Baseline, Week 24
Gilead Clinical Study Information Center
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Tablet administered orally
Tablet administered orally
Tablet administered orally