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Completed

NCT Number: NCT02704364

A Study of NGM282 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.

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Key information

Conditions

Primary Sclerosing Cholangitis Bile Duct Diseases Biliary Tract Diseases Cholangitis Cholangitis, Sclerosing Digestive System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NGM Clinical Study Site 301, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NGM282

Biological

Placebo

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

Sponsors and collaborators

Lead sponsor

NGM Biopharmaceuticals, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 10, 2016
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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