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Phase 2 Study of NGM282 in Patients With Primary Sclerosing Cholangitis

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ClinicalTrials.gov Identifier: NCT02704364
Recruitment Status : Completed
First Posted : March 10, 2016
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Biological: NGM282 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017


Arm Intervention/treatment
Experimental: NGM282 Dose 1
NGM282 Dose 1
Biological: NGM282
Experimental: NGM282 Dose 2
NGM282 Dose 2
Biological: NGM282
Active Comparator: Placebo
Placebo
Other: Placebo



Primary Outcome Measures :
  1. The mean and percent change in ALP from Baseline to Week 12 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. The mean and percent change in ALT from Baseline to Week 12 [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704364


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Locations
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United States, California
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
United States, Colorado
NGM Clinical Study Site 106
Aurora, Colorado, United States
United States, District of Columbia
NGM Clinical Study Site 115
Washington, District of Columbia, United States
United States, Florida
NGM Clinical Study Site 110
Gainesville, Florida, United States
NGM Clinical Study Site 124
Lakewood Ranch, Florida, United States
NGM Clinical Study Site 105
Miami, Florida, United States
United States, Indiana
NGM Clinical Study Site 109
Indianapolis, Indiana, United States
United States, Michigan
NGM Clinical Study Site 104
Detroit, Michigan, United States
United States, Missouri
NGM Clinical Study Site 102
Kansas City, Missouri, United States
NGM Clinical Study Site 107
Saint Louis, Missouri, United States
United States, New York
NGM Clinical Study Site 103
New York, New York, United States
United States, North Carolina
NGM Clinical Study Site 116
Durham, North Carolina, United States
United States, Ohio
NGM Clinical Study Site 120
Cincinnati, Ohio, United States
United States, Tennessee
NGM Clinical Study Site 114
Nashville, Tennessee, United States
United States, Texas
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
United States, Virginia
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
United States, Washington
NGM Clinical Study Site 108
Seattle, Washington, United States
NGM Clinical Study Site 126
Seattle, Washington, United States
France
NGM Clinical Study Site 301
Paris, France
Netherlands
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
United Kingdom
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
Sponsors and Collaborators
NGM Biopharmaceuticals, Inc
Investigators
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Study Director: Stephen J Rossi, PharmD NGM Biopharmaceuticals, Inc

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Responsible Party: NGM Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02704364     History of Changes
Other Study ID Numbers: 15-0106
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases