A Study of NGM282 in Patients With Primary Sclerosing Cholangitis

June 13, 2025 updated by: NGM Biopharmaceuticals, Inc

A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of NGM282 Administered for 12 Weeks in Patients With Primary Sclerosing Cholangitis

The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Sclerosing Cholangitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

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

  • France
      • Paris, France
        • NGM Clinical Study Site 301
  • Netherlands
      • Amsterdam, Netherlands
        • NGM Clinical Study Site 402
      • Amsterdam, Netherlands
        • NGM Clinical Study Site 407
      • Leiden, Netherlands
        • NGM Clinical Study Site 406
      • Nijmegen, Netherlands
        • NGM Clinical Study Site 401
      • Rotterdam, Netherlands
        • NGM Clinical Study Site 404
      • Utrecht, Netherlands
        • NGM Clinical Study Site 405
  • United Kingdom
      • Birmingham, United Kingdom
        • NGM Clinical Study Site 505
      • Liverpool, United Kingdom
        • NGM Clinical Study Site 504
      • London, United Kingdom
        • NGM Clinical Study Site 502
      • Newcastle, United Kingdom
        • NGM Clinical Study Site 501
      • Norwich, United Kingdom
        • NGM Clinical Study Site 503
  • United States
    • California
      • Sacramento, California, United States
        • NGM Clinical Study Site 118
      • San Clemente, California, United States
        • NGM Clinical Study Site 112
      • San Francisco, California, United States
        • NGM Clinical Study Site 127
    • Colorado
      • Aurora, Colorado, United States
        • NGM Clinical Study Site 106
    • District of Columbia
      • Washington, District of Columbia, United States
        • NGM Clinical Study Site 115
    • Florida
      • Gainesville, Florida, United States
        • NGM Clinical Study Site 110
      • Lakewood Ranch, Florida, United States
        • NGM Clinical Study Site 124
      • Miami, Florida, United States
        • NGM Clinical Study Site 105
    • Indiana
      • Indianapolis, Indiana, United States
        • NGM Clinical Study Site 109
    • Michigan
      • Detroit, Michigan, United States
        • NGM Clinical Study Site 104
    • Missouri
      • Kansas City, Missouri, United States
        • NGM Clinical Study Site 102
      • Saint Louis, Missouri, United States
        • NGM Clinical Study Site 107
    • New York
      • New York, New York, United States
        • NGM Clinical Study Site 103
    • North Carolina
      • Durham, North Carolina, United States
        • NGM Clinical Study Site 116
    • Ohio
      • Cincinnati, Ohio, United States
        • NGM Clinical Study Site 120
    • Tennessee
      • Nashville, Tennessee, United States
        • NGM Clinical Study Site 114
    • Texas
      • Dallas, Texas, United States
        • NGM Clinical Study Site 113
      • Dallas, Texas, United States
        • NGM Clinical Study Site 117
      • Houston, Texas, United States
        • NGM Clinical Study Site 119
      • Southlake, Texas, United States
        • NGM Clinical Study Site 125
    • Virginia
      • Charlottesville, Virginia, United States
        • NGM Clinical Study Site 111
      • Newport News, Virginia, United States
        • NGM Clinical Study Site 122
      • Norfolk, Virginia, United States
        • NGM Clinical Study Site 101
      • Richmond, Virginia, United States
        • NGM Clinical Study Site 121
    • Washington
      • Seattle, Washington, United States
        • NGM Clinical Study Site 108
      • Seattle, Washington, United States
        • NGM Clinical Study Site 126

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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Confirmed diagnosis of PSC

Exclusion Criteria:

  • Clinically significant acute or chronic liver disease of an etiology other than PSC
  • Secondary or IgG4 related sclerosing cholangitis

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NGM282 Dose 1
Biological: NGM282
Experimental: NGM282 Dose 2
Biological: NGM282
Active Comparator: Placebo
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis
Time Frame: Baseline to Week 12
Blood samples were collected to assess changes in alkaline phosphatase levels.
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Percent Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis
Time Frame: Baseline to Week 12
Blood samples were collected to assess changes in alkaline phosphatase levels.
Baseline to Week 12
Mean Rate of Change in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis
Time Frame: Baseline to Week 12
Blood samples were collected to assess rate of change in alkaline phosphatase levels. Serum levels of alkaline phosphatase was measured in a central laboratory using standard enzymatic method. The unit of measure is U/L.
Baseline to Week 12
Mean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis
Time Frame: Baseline to Week 12
Blood samples were collected to assess changes in aspartate aminotransferase and alanine aminotransferase levels.
Baseline to Week 12
Mean Percent Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis
Time Frame: Baseline to Week 12
Blood samples were collected to assess changes in aspartate aminotransferase and alanine aminotransferase levels.
Baseline to Week 12
Mean Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis
Time Frame: Baseline to Week 12
Blood samples were collected to assess changes in bilirubin (direct and total) levels.
Baseline to Week 12
Mean Percent Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis
Time Frame: Baseline to Week 12
Blood samples were collected to assess changes in bilirubin (direct and total) levels.
Baseline to Week 12
Mean Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis
Time Frame: Baseline to Week 12
Blood samples were collected to assess changes in gamma glutamyl transferase levels.
Baseline to Week 12
Mean Percent Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis
Time Frame: Baseline to Week 12
Blood samples were collected to assess changes in gamma glutamyl transferase levels.
Baseline to Week 12
Mean Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis
Time Frame: Baseline to Week 12
Blood samples were collected to assess changes in cholesterol levels.
Baseline to Week 12
Mean Percent Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis
Time Frame: Baseline to Week 12
Blood samples were collected to assess changes in cholesterol levels.
Baseline to Week 12
Mean Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis
Time Frame: Baseline to Week 12
Blood samples were collected to assess changes in 25-Hydroxyvitamin D levels.
Baseline to Week 12
Mean Percent Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis
Time Frame: Baseline to Week 12
Blood samples were collected to assess changes in 25-Hydroxyvitamin D levels.
Baseline to Week 12
Mean Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis
Time Frame: Baseline to Week 12
Blood samples were collected to assess changes in Prothrombin levels.
Baseline to Week 12
Mean Percent Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis
Time Frame: Baseline to Week 12
Blood samples were collected to assess changes in Prothrombin levels.
Baseline to Week 12
Mean Change From Baseline in Calprotectin in Patients With Primary Sclerosing Cholangitis
Time Frame: Baseline to Week 12
Blood samples were collected to assess changes in Calprotectin levels.
Baseline to Week 12
Mean Change From Baseline in Enhanced Liver Fibrosis Score in Patients With Primary Sclerosing Cholangitis
Time Frame: Baseline to Week 12

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.
Baseline to Week 12
Severity of Inflammatory Bowel Disease-Associated Intestinal Symptoms in Patients With Primary Sclerosing Cholangitis
Time Frame: Baseline to Week 12
Severity of inflammatory bowel disease (IBD)-associated symptoms and acute cholangitis are summarized with number and percentage. The partial Mayo IBD scale assesses stool frequency, rectal bleeding, and there is a Physician's global assessment. Each section is summed and remission is defined as a total score of 0-1, mild disease 2-4, moderate disease 5-6, and severe disease 7-9. Higher total scores indicate more severe disease. The number of participants are being presented based on the severity of their IBD symptoms.
Baseline to Week 12

Collaborators and Investigators

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

Sponsor

NGM Biopharmaceuticals, Inc

Investigators

  • Study Director: Stephen J Rossi, PharmD, NGM Biopharmaceuticals, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

February 29, 2016

First Submitted That Met QC Criteria

March 4, 2016

First Posted (Estimated)

March 10, 2016

Study Record Updates

Last Update Posted (Actual)

June 17, 2025

Last Update Submitted That Met QC Criteria

June 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-0106
  • 2015-003392-30 (EudraCT Number)

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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