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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 : September 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

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
Study Start Date : February 2016
Primary Completion Date : June 2017
Study Completion Date : June 2017


Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
Contacts and Locations

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


  Show 38 Study Locations
Sponsors and Collaborators
NGM Biopharmaceuticals, Inc
Investigators
Study Director: Stephen J Rossi, PharmD NGM Biopharmaceuticals, Inc
More Information

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: September 14, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases