A Study of NGM282 in Patients With Primary Sclerosing Cholangitis
- Conditions
- Primary Sclerosing Cholangitis
- Interventions
- Other: Placebo
- Registration Number
- NCT02704364
- Lead Sponsor
- NGM Biopharmaceuticals, Inc
- Brief Summary
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Sclerosing Cholangitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- Confirmed diagnosis of PSC
- Clinically significant acute or chronic liver disease of an etiology other than PSC
- Secondary or IgG4 related sclerosing cholangitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NGM282 Dose 1 NGM282 NGM282 Dose 1 Placebo Placebo Placebo NGM282 Dose 2 NGM282 NGM282 Dose 2
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis Baseline to Week 12 Blood samples were collected to assess changes in alkaline phosphatase levels.
- Secondary Outcome Measures
Name Time Method Mean Percent Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis Baseline to Week 12 Blood samples were collected to assess changes in aspartate aminotransferase and alanine aminotransferase levels.
Mean Percent Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis Baseline to Week 12 Blood samples were collected to assess changes in alkaline phosphatase levels.
Mean Rate of Change in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis 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.
Mean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis Baseline to Week 12 Blood samples were collected to assess changes in aspartate aminotransferase and alanine aminotransferase levels.
Mean Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis Baseline to Week 12 Blood samples were collected to assess changes in bilirubin (direct and total) levels.
Mean Percent Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis Baseline to Week 12 Blood samples were collected to assess changes in bilirubin (direct and total) levels.
Mean Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis Baseline to Week 12 Blood samples were collected to assess changes in gamma glutamyl transferase levels.
Mean Percent Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis Baseline to Week 12 Blood samples were collected to assess changes in cholesterol levels.
Mean Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis Baseline to Week 12 Blood samples were collected to assess changes in 25-Hydroxyvitamin D levels.
Mean Percent Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis Baseline to Week 12 Blood samples were collected to assess changes in 25-Hydroxyvitamin D levels.
Mean Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis Baseline to Week 12 Blood samples were collected to assess changes in Prothrombin levels.
Mean Percent Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis Baseline to Week 12 Blood samples were collected to assess changes in Prothrombin levels.
Mean Change From Baseline in Calprotectin in Patients With Primary Sclerosing Cholangitis Baseline to Week 12 Blood samples were collected to assess changes in Calprotectin levels.
Mean Change From Baseline in Enhanced Liver Fibrosis Score in Patients With Primary Sclerosing Cholangitis 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.Severity of Inflammatory Bowel Disease-Associated Intestinal Symptoms in Patients With Primary Sclerosing Cholangitis 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.
Mean Percent Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis Baseline to Week 12 Blood samples were collected to assess changes in gamma glutamyl transferase levels.
Mean Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis Baseline to Week 12 Blood samples were collected to assess changes in cholesterol levels.
Trial Locations
- Locations (38)
NGM Clinical Study Site 118
🇺🇸Sacramento, California, United States
NGM Clinical Study Site 112
🇺🇸San Clemente, California, United States
NGM Clinical Study Site 127
🇺🇸San Francisco, California, United States
NGM Clinical Study Site 106
🇺🇸Aurora, Colorado, United States
NGM Clinical Study Site 115
🇺🇸Washington, District of Columbia, United States
NGM Clinical Study Site 110
🇺🇸Gainesville, Florida, United States
NGM Clinical Study Site 124
🇺🇸Lakewood Ranch, Florida, United States
NGM Clinical Study Site 105
🇺🇸Miami, Florida, United States
NGM Clinical Study Site 109
🇺🇸Indianapolis, Indiana, United States
NGM Clinical Study Site 104
🇺🇸Detroit, Michigan, United States
Scroll for more (28 remaining)NGM Clinical Study Site 118🇺🇸Sacramento, California, United States