Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Arena Pharmaceuticals
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Males or females aged 18 to 80 years (inclusive) at the time of screening, with confirmed Primary Biliary Cholangitis (PBC) diagnosis based upon at least 2 of 3 criteria:
* Anti-mitochondrial antibodies (AMA) titer \>1:40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies (anti-GP210 and/or anti-SP100)
* Alkaline phosphatase (ALP) \>1.5 x upper limit of normal (ULN) for at least 6 months
* Liver biopsy findings consistent with PBC
Use of ursodeoxycholic acid (UDCA) for at least 6 months prior to screening (stable dose for at least 3 months immediately prior to screening)
Participants must have ALP \>1.5 x ULN but \<10 x ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<5 x ULN, and total bilirubin \<ULN, at all screening visits
AST, ALT, ALP, and total bilirubin must have 2 values at least 4 weeks apart that are within 20% of each other
You may not be if
Chronic liver disease of a non-PBC etiology. However, PBC participants accompanied with primary Sjögren's syndrome (pSS) are eligible to be enrolled.
History or evidence of clinically significant hepatic decompensation
Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease)
Clinically significant infections within 6 weeks prior to treatment start, or infection with hepatitis C virus anytime in the past
Immunosuppressive, immunomodulating, or investigational agents within 30 days prior to treatment start
Treatment with obeticholic acid (OCA) within 30 days prior to Day 1
Clareo Health | Safety, Tolerability, and Efficacy of Etrasimod (APD334) in Participants With Primary Biliary Cholangitis
