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

NGM Biopharmaceuticals

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Primary Sclerosing Cholangitis

Treatments: Drug: aldafermin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06654726

282-PS-231

Details and patient eligibility

About

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

Full description

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)

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

aldafermin

Experimental group

Description:

Aldafermin 3mg given subcutaneously, daily, for up to 6 years

Treatment:

Drug: aldafermin

placebo

Placebo Comparator group

Description:

Placebo given subcutaneously, daily, for up to 6 years

Treatment:

Drug: Placebo