A Study of NGM282 in Patients With Primary Sclerosing Cholangitis
NCT ID: NCT02704364
Last Updated: 2025-06-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
62 participants
INTERVENTIONAL
2016-03-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NGM282 Dose 1
NGM282 Dose 1
NGM282
NGM282 Dose 2
NGM282 Dose 2
NGM282
Placebo
Placebo
Placebo
Interventions
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NGM282
Placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Secondary or IgG4 related sclerosing cholangitis
18 Years
75 Years
ALL
No
Sponsors
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NGM Biopharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen J Rossi, PharmD
Role: STUDY_DIRECTOR
NGM Biopharmaceuticals, Inc
Locations
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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
NGM Clinical Study Site 102
Kansas City, Missouri, United States
NGM Clinical Study Site 107
St Louis, Missouri, United States
NGM Clinical Study Site 103
New York, New York, United States
NGM Clinical Study Site 116
Durham, North Carolina, United States
NGM Clinical Study Site 120
Cincinnati, Ohio, United States
NGM Clinical Study Site 114
Nashville, Tennessee, United States
NGM Clinical Study Site 113
Dallas, Texas, United States
NGM Clinical Study Site 117
Dallas, Texas, United States
NGM Clinical Study Site 119
Houston, Texas, United States
NGM Clinical Study Site 125
Southlake, Texas, United States
NGM Clinical Study Site 111
Charlottesville, Virginia, 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 108
Seattle, Washington, United States
NGM Clinical Study Site 126
Seattle, Washington, United States
NGM Clinical Study Site 301
Paris, , France
NGM Clinical Study Site 402
Amsterdam, , Netherlands
NGM Clinical Study Site 407
Amsterdam, , Netherlands
NGM Clinical Study Site 406
Leiden, , 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 505
Birmingham, , United Kingdom
NGM Clinical Study Site 504
Liverpool, , United Kingdom
NGM Clinical Study Site 502
London, , United Kingdom
NGM Clinical Study Site 501
Newcastle, , United Kingdom
NGM Clinical Study Site 503
Norwich, , United Kingdom
Countries
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References
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Sanyal AJ, Ling L, Beuers U, DePaoli AM, Lieu HD, Harrison SA, Hirschfield GM. Potent suppression of hydrophobic bile acids by aldafermin, an FGF19 analogue, across metabolic and cholestatic liver diseases. JHEP Rep. 2021 Feb 19;3(3):100255. doi: 10.1016/j.jhepr.2021.100255. eCollection 2021 Jun.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-003392-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15-0106
Identifier Type: -
Identifier Source: org_study_id
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