NCT02704364CompletedPhase 2
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 enrollmentStarted: March 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 62
- Locations
- 38
- Primary Endpoint
- Mean Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis
Study Overview
Brief Summary
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Sclerosing Cholangitis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Experimental
NGM282 Dose 1
Intervention: NGM282 (Biological)
NGM282 Dose 2
Experimental
NGM282 Dose 2
Intervention: NGM282 (Biological)
Placebo
Active Comparator
Placebo
Intervention: Placebo (Other)
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)
Investigators
Study Sites (38)
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