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

NGM Biopharmaceuticals, Inc38 sites in 4 countries62 target enrollmentMarch 2016

ConditionsPrimary Sclerosing Cholangitis

InterventionsNGM282 Placebo

DrugsNGM282

Overview

Phase: Phase 2
Intervention: NGM282
Conditions: Primary Sclerosing Cholangitis
Sponsor: NGM Biopharmaceuticals, Inc
Enrollment: 62
Locations: 38
Primary Endpoint: Mean Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

June 2017

Last Updated

10 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

NGM Biopharmaceuticals, Inc

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

NGM282 Dose 1

Intervention: NGM282

NGM282 Dose 2

Intervention: NGM282

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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

Mean Percent Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis(Baseline to Week 12)
Mean Percent Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis(Baseline to Week 12)
Mean Rate of Change in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis(Baseline to Week 12)
Mean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis(Baseline to Week 12)
Mean Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis(Baseline to Week 12)
Mean Percent Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis(Baseline to Week 12)
Mean Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis(Baseline to Week 12)
Mean Percent Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis(Baseline to Week 12)
Mean Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis(Baseline to Week 12)
Mean Percent Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis(Baseline to Week 12)
Mean Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis(Baseline to Week 12)
Mean Percent Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis(Baseline to Week 12)
Mean Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis(Baseline to Week 12)
Mean Percent Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis(Baseline to Week 12)
Mean Change From Baseline in Calprotectin in Patients With Primary Sclerosing Cholangitis(Baseline to Week 12)
Mean Change From Baseline in Enhanced Liver Fibrosis Score in Patients With Primary Sclerosing Cholangitis(Baseline to Week 12)
Severity of Inflammatory Bowel Disease-Associated Intestinal Symptoms in Patients With Primary Sclerosing Cholangitis(Baseline to Week 12)