A Multi-center Evaluation of Aldafermin in a Randomized, Double-blind, Placebo-controlled Study in Subjects With Primary Sclerosing Cholangitis.

A Phase 2b/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of Aldafermin in Subjects With Primary Sclerosing Cholangitis (ALPINE-PSC).

A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with Primary Sclerosing Cholangitis.

Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects with Primary Sclerosing Cholangitis (ALPINE-PSC)

Inclusion Criteria:

1. Able and willing to give informed consent

2. Confirmed diagnosis of PSC based on either:

   1. Abnormal cholangiography consistent with PSC as measured by MRCP with contrast
   2. Liver biopsy consistent with PSC

3. LSM by VCTE, indicative of at least F2 liver fibrosis stage

4. Laboratory parameters:

   1. TBL ≤2.5 mg/dL unless known for Gilbert's Syndrome
   2. ALT and ALT <5x ULN
   3. MELD score ≤12

Exclusion Criteria:

1. Clinically significant acute or chronic liver disease of an etiology other than PSC
2. Alternate causes of sclerosing cholangitis including IgG4 related sclerosing cholangitis
3. Subjects with moderate to severe hepatic impairment
4. Subjects with moderate to severe renal impairment
5. Placement of bile duct stent or percutaneous bile duct drain within 12 weeks of Screening