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

May 3, 2025 updated by: NGM Biopharmaceuticals, Inc

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78757
        • NGM Clinical Study Site
      • San Antonio, Texas, United States, 78215
        • NGM Clinical Study Site
    • Washington
      • Seattle, Washington, United States, 98105
        • NGM Clinical Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: aldafermin
Aldafermin 3mg given subcutaneously, daily, for up to 6 years
Drug: aldafermin
aldafermin
Placebo Comparator: placebo
Placebo given subcutaneously, daily, for up to 6 years
Drug: Placebo
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Enhanced Liver Fibrosis Score at Week 96
Time Frame: 96 Weeks

Enhanced Liver Fibrosis (ELF) score is a non-invasive blood test derived from the measurement of hyaluronic acid (HA), amino terminal propeptide of type III procollagen (PIIINP), and tissue inhibitor of metalloprotease 1 (TIMP1) using a proprietary algorithm (Siemens). ELF score is a laboratory test, is unitless, and is used as a continuous variable. The minimal ELF score is zero, the maximal ELF score is unknown. The higher the ELF score, the worse the disease outcome.

ELF is a score on a scale of severity assessment against biopsy-proven fibrosis. A score of <7.7 is none to mild, > 7.7-9.8 is moderate, > 9.8 is severe.
96 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NGM Biopharmaceuticals, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2024

Primary Completion (Actual)

December 5, 2024

Study Completion (Actual)

March 18, 2025

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

October 22, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2025

Last Update Submitted That Met QC Criteria

May 3, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 282-PS-231

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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