Safety, Tolerability, and Efficacy of Etrasimod (APD334) in Patients With Primary Biliary Cholangitis

Key Inclusion Criteria:

- Males or females aged 18 to 80 years (inclusive) at the time of screening, with
confirmed PBC diagnosis based upon at least 2 of 3 criteria:

- 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)

- ALP >1.5 x ULN for at least 6 months

- Liver biopsy findings consistent with PBC

- Use of UDCA for at least 6 months prior to screening (stable dose for at least 3
months immediately prior to screening)

- Patients must have ALP >1.5 x ULN but <10 x ULN, ALT and AST <5 x ULN, and total
bilirubin
- AST, ALT, ALP, and total bilirubin must have 2 values at least 4 weeks apart that are
within 20% of each other

Key Exclusion Criteria:

- Chronic liver disease of a non-PBC etiology. However, PBC patients 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 OCA within 30 days prior to Day 1

Note: Other protocol defined Inclusion/Exclusion criteria may apply