Phase 2 Study of NGM282 in Patients With Primary Sclerosing Cholangitis
- Conditions
- Primary Sclerosing Cholangitis
- Interventions
- Biological: NGM282Other: 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 The mean and percent change in ALP from Baseline to Week 12 12 weeks
- Secondary Outcome Measures
Name Time Method The mean and percent change in ALT from Baseline to Week 12 12 weeks
Trial Locations
- Locations (38)
NGM Clinical Study Site 406
🇳🇱Leiden, Netherlands
NGM Clinical Study Site 502
🇬🇧London, United Kingdom
NGM Clinical Study Site 505
🇬🇧Birmingham, United Kingdom
NGM Clinical Study Site 112
🇺🇸San Clemente, California, United States
NGM Clinical Study Site 110
🇺🇸Gainesville, Florida, United States
NGM Clinical Study Site 103
🇺🇸New York, New York, United States
NGM Clinical Study Site 127
🇺🇸San Francisco, California, United States
NGM Clinical Study Site 115
🇺🇸Washington, District of Columbia, United States
NGM Clinical Study Site 118
🇺🇸Sacramento, California, 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
NGM Clinical Study Site 107
🇺🇸Saint Louis, Missouri, United States
NGM Clinical Study Site 102
🇺🇸Kansas City, Missouri, United States
NGM Clinical Study Site 116
🇺🇸Durham, North Carolina, United States
NGM Clinical Study Site 114
🇺🇸Nashville, Tennessee, United States
NGM Clinical Study Site 120
🇺🇸Cincinnati, Ohio, United States
NGM Clinical Study Site 301
🇫🇷Paris, France
NGM Clinical Study Site 113
🇺🇸Dallas, Texas, United States
NGM Clinical Study Site 117
🇺🇸Dallas, Texas, United States
NGM Clinical Study Site 402
🇳🇱Amsterdam, Netherlands
NGM Clinical Study Site 111
🇺🇸Charlottesville, Virginia, United States
NGM Clinical Study Site 119
🇺🇸Houston, Texas, United States
NGM Clinical Study Site 125
🇺🇸Southlake, Texas, United States
NGM Clinical Study Site 122
🇺🇸Newport News, Virginia, United States
NGM Clinical Study Site 101
🇺🇸Norfolk, Virginia, United States
NGM Clinical Study Site 121
🇺🇸Richmond, Virginia, United States
NGM Clinical Study Site 126
🇺🇸Seattle, Washington, United States
NGM Clinical Study Site 108
🇺🇸Seattle, Washington, United States
NGM Clinical Study Site 407
🇳🇱Amsterdam, Netherlands
NGM Clinical Study Site 401
🇳🇱Nijmegen, Netherlands
NGM Clinical Study Site 404
🇳🇱Rotterdam, Netherlands
NGM Clinical Study Site 405
🇳🇱Utrecht, Netherlands
NGM Clinical Study Site 504
🇬🇧Liverpool, United Kingdom
NGM Clinical Study Site 501
🇬🇧Newcastle, United Kingdom
NGM Clinical Study Site 503
🇬🇧Norwich, United Kingdom
NGM Clinical Study Site 106
🇺🇸Aurora, Colorado, United States