The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Sclerosing Cholangitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
62
Mean Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis
Blood samples were collected to assess changes in alkaline phosphatase levels.
Time frame: Baseline to Week 12
Mean Percent Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis
Blood samples were collected to assess changes in alkaline phosphatase levels.
Time frame: Baseline to Week 12
Mean Rate of Change in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis
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.
Time frame: Baseline to Week 12
Mean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis
Blood samples were collected to assess changes in aspartate aminotransferase and alanine aminotransferase levels.
Time frame: Baseline to Week 12
Mean Percent Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis
Blood samples were collected to assess changes in aspartate aminotransferase and alanine aminotransferase levels.
Time frame: Baseline to Week 12
Mean Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis
Blood samples were collected to assess changes in bilirubin (direct and total) levels.
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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 D.C., District of Columbia, United States
NGM Clinical Study Site 110
Gainesville, Florida, United States
NGM Clinical Study Site 124
Lakewood Rch, 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
...and 28 more locations
Time frame: Baseline to Week 12
Mean Percent Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis
Blood samples were collected to assess changes in bilirubin (direct and total) levels.
Time frame: Baseline to Week 12
Mean Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis
Blood samples were collected to assess changes in gamma glutamyl transferase levels.
Time frame: Baseline to Week 12
Mean Percent Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis
Blood samples were collected to assess changes in gamma glutamyl transferase levels.
Time frame: Baseline to Week 12
Mean Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis
Blood samples were collected to assess changes in cholesterol levels.
Time frame: Baseline to Week 12
Mean Percent Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis
Blood samples were collected to assess changes in cholesterol levels.
Time frame: Baseline to Week 12
Mean Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis
Blood samples were collected to assess changes in 25-Hydroxyvitamin D levels.
Time frame: Baseline to Week 12
Mean Percent Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis
Blood samples were collected to assess changes in 25-Hydroxyvitamin D levels.
Time frame: Baseline to Week 12
Mean Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis
Blood samples were collected to assess changes in Prothrombin levels.
Time frame: Baseline to Week 12
Mean Percent Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis
Blood samples were collected to assess changes in Prothrombin levels.
Time frame: Baseline to Week 12
Mean Change From Baseline in Calprotectin in Patients With Primary Sclerosing Cholangitis
Blood samples were collected to assess changes in Calprotectin levels.
Time frame: Baseline to Week 12
Mean Change From Baseline in Enhanced Liver Fibrosis Score in Patients With Primary Sclerosing Cholangitis
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.
Time frame: Baseline to Week 12
Severity of Inflammatory Bowel Disease-Associated Intestinal Symptoms in Patients With Primary Sclerosing Cholangitis
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.
Time frame: Baseline to Week 12