The purpose of this open-label, pilot, proof of concept study is to evaluate the safety, tolerability, and efficacy of oral etrasimod (APD334) in participants with primary biliary cholangitis (PBC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
APD334 active treatment for 24 weeks.
Gastroenterology and Hepatology, UC Davis Medical Center
Sacramento, California, United States
Baylor College of Medicine
Houston, Texas, United States
Texas Liver Institute
San Antonio, Texas, United States
Swedish Medical Center
Change in Serum Alkaline Phosphatase (ALP) Concentration
Reduction in ALP concentration is a surrogate marker of slower disease progression.
Time frame: Baseline, Week 24
Number of Participants With Adverse Events
Safety was assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
Time frame: Up to Week 26
Change in Serum ALP Concentration
Reduction in ALP concentration is a surrogate marker of slower disease progression.
Time frame: Baseline, Week 12
Pharmacokinetic Parameters of Etrasimod, and Its Metabolites
Time frame: Up to Week 24
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Seattle, Washington, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Alfred Health
Melbourne, Victoria, Australia
Auckland City Hospital
Grafton, Auckland, New Zealand
Christchurch Clinical Studies Trust
Christchurch, New Zealand