Phase 2 Study of NGM282 in Patients With Primary Sclerosing Cholangitis

July 16, 2018 updated by: NGM Biopharmaceuticals, Inc

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

The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Sclerosing Cholangitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • NGM Clinical Study Site 301
  • Netherlands
      • Amsterdam, Netherlands
        • NGM Clinical Study Site 402
      • Amsterdam, Netherlands
        • NGM Clinical Study Site 407
      • Leiden, Netherlands
        • NGM Clinical Study Site 406
      • Nijmegen, Netherlands
        • NGM Clinical Study Site 401
      • Rotterdam, Netherlands
        • NGM Clinical Study Site 404
      • Utrecht, Netherlands
        • NGM Clinical Study Site 405
  • United Kingdom
      • Birmingham, United Kingdom
        • NGM Clinical Study Site 505
      • Liverpool, United Kingdom
        • NGM Clinical Study Site 504
      • London, United Kingdom
        • NGM Clinical Study Site 502
      • Newcastle, United Kingdom
        • NGM Clinical Study Site 501
      • Norwich, United Kingdom
        • NGM Clinical Study Site 503
  • United States
    • California
      • Sacramento, California, United States
        • NGM Clinical Study Site 118
      • San Clemente, California, United States
        • NGM Clinical Study Site 112
      • San Francisco, California, United States
        • NGM Clinical Study Site 127
    • Colorado
      • Aurora, Colorado, United States
        • NGM Clinical Study Site 106
    • District of Columbia
      • Washington, District of Columbia, United States
        • NGM Clinical Study Site 115
    • Florida
      • Gainesville, Florida, United States
        • NGM Clinical Study Site 110
      • Lakewood Ranch, Florida, United States
        • NGM Clinical Study Site 124
      • Miami, Florida, United States
        • NGM Clinical Study Site 105
    • Indiana
      • Indianapolis, Indiana, United States
        • NGM Clinical Study Site 109
    • Michigan
      • Detroit, Michigan, United States
        • NGM Clinical Study Site 104
    • Missouri
      • Kansas City, Missouri, United States
        • NGM Clinical Study Site 102
      • Saint Louis, Missouri, United States
        • NGM Clinical Study Site 107
    • New York
      • New York, New York, United States
        • NGM Clinical Study Site 103
    • North Carolina
      • Durham, North Carolina, United States
        • NGM Clinical Study Site 116
    • Ohio
      • Cincinnati, Ohio, United States
        • NGM Clinical Study Site 120
    • Tennessee
      • Nashville, Tennessee, United States
        • NGM Clinical Study Site 114
    • Texas
      • Dallas, Texas, United States
        • NGM Clinical Study Site 113
      • Dallas, Texas, United States
        • NGM Clinical Study Site 117
      • Houston, Texas, United States
        • NGM Clinical Study Site 119
      • Southlake, Texas, United States
        • NGM Clinical Study Site 125
    • Virginia
      • Charlottesville, Virginia, United States
        • NGM Clinical Study Site 111
      • Newport News, Virginia, United States
        • NGM Clinical Study Site 122
      • Norfolk, Virginia, United States
        • NGM Clinical Study Site 101
      • Richmond, Virginia, United States
        • NGM Clinical Study Site 121
    • Washington
      • Seattle, Washington, United States
        • NGM Clinical Study Site 108
      • Seattle, Washington, United States
        • NGM Clinical Study Site 126

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NGM282 Dose 1
Biological: NGM282
Experimental: NGM282 Dose 2
Biological: NGM282
Active Comparator: Placebo
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The mean and percent change in ALP from Baseline to Week 12
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The mean and percent change in ALT from Baseline to Week 12
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NGM Biopharmaceuticals, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

February 29, 2016

First Submitted That Met QC Criteria

March 4, 2016

First Posted (Estimate)

March 10, 2016

Study Record Updates

Last Update Posted (Actual)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-0106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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