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NCT06654726 | NOT YET RECRUITING | Primary Sclerosing Cholangitis

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

NGM Biopharmaceuticals, Inc

Brief Summary:

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

Condition or disease

Primary Sclerosing Cholangitis

Intervention/treatment

aldafermin

Placebo

Phase

PHASE2

PHASE3

Detailed 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)

Study Type : INTERVENTIONAL
Estimated Enrollment : 300 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : 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).
Actual Study Start Date : 2025-05
Estimated Primary Completion Date : 2030-12
Estimated Study Completion Date : 2032-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
A Multi-center Evaluation of Aldafermin in a Randomized, Double-blind, Placebo-controlled Study in Subjects With Primary Sclerosing Cholangitis.

Location Details

NCT06654726

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Texas

NGM Clinical Study Site

Austin, Texas, United States, 78757

Not yet recruiting

United States, Texas

NGM Clinical Study Site

San Antonio, Texas, United States, 78215

Not yet recruiting

United States, Washington

NGM Clinical Study Site

Seattle, Washington, United States, 98105