To Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA). The primary objective is to evaluate the effect of seladelpar treatment at Week 52 compared to placebo based on normalization of alkaline phosphatase (ALP) defined by a composite endpoint of ALP ≤ 1.0× upper limit of normal (ULN) and ≥ 15% decrease from baseline in PBC participants with an ALP value greater than ULN but less than 1.67× ULN.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
Administered orally
Administered orally
The Institute for Liver Health II LLC dba Arizona Clinical Trials; Arizona Liver Health
Chandler, Arizona, United States
California Liver Research Institute
Pasadena, California, United States
University of California (UC) Davis Medical Center
Sacramento, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of Colorado Denver - School of Medicine - Anschutz Medical Campus
Aurora, Colorado, United States
Percentage of Participants Response defined as Alkaline phosphatase (ALP) ≤ 1.0× Upper Limit of Normal (ULN) AND ≥ 15% Decrease in ALP at Week 52.
Time frame: 52 weeks
Type, Frequency, and Severity of Treatment-emergent Adverse Events.
Time frame: 52 weeks
Percentage of Participant Response Defined as ALP ≤ 1.0× ULN.
Time frame: 52 weeks
Percentage of Participant Response Defined as ALP ≤ 1.0× ULN AND ≥ 15% Decrease in ALP at 4 Weeks.
Time frame: 4 weeks
Percentage of Participant Response Defined as ALP ≤ 1.0× ULN AND ≥ 15% Decrease in ALP at 12 Weeks.
Time frame: 12 weeks
Percentage of Participant Response Defined as ALP ≤ 1.0× ULN AND ≥ 15% Decrease in ALP at 26 Weeks.
Time frame: 26 weeks
Percentage of Participant Response Defined as ALP ≤ 1.0× ULN AND ≥ 15% Decrease in ALP at 39 Weeks.
Time frame: 39 weeks
Absolute and Percent Change From Baseline in ALP.
Time frame: 52 weeks
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