Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis

March 27, 2017 updated by: NGM Biopharmaceuticals, Inc

A Phase 2, Multi-Center Study to Evaluate Three Doses of NGM282 Administered for 24 Weeks in Patients With Primary Biliary Cirrhosis (PBC) Who Have Completed Study 13-0103

The purpose of this study is to determine the safety, tolerability, and activity of extended treatment with NGM282 in patients with Primary Biliary Cirrhosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

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

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia
        • NGM Clinical Study Site 602
      • Sydney, New South Wales, Australia
        • NGM Clinical Study Site 606
      • Sydney, New South Wales, Australia
        • NGM Clinical Study Site 609
      • Sydney, New South Wales, Australia
        • NGM Clinical Study Site 611
    • Queensland
      • Brisbane, Queensland, Australia
        • NGM Clinical Study Site 614
    • South Australia
      • Adelaide, South Australia, Australia
        • NGM Clinical Study Site 607
      • Adelaide, South Australia, Australia
        • NGM Clinical Study Site 608
    • Victoria
      • Melbourne, Victoria, Australia
        • NGM Clinical Study Site 601
      • Melbourne, Victoria, Australia
        • NGM Clinical Study Site 613
  • New Zealand
      • Auckland, New Zealand
        • NGM Clinical Study Site 401
      • Christchurch, New Zealand
        • NGM Clinical Study Site 402
  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • NGM Clinical Study Site 103
    • California
      • Coronado, California, United States
        • NGM Clinical Study Site 108
    • Michigan
      • Detroit, Michigan, United States
        • NGM Clinical Study Site 101
    • North Carolina
      • Durham, North Carolina, United States
        • NGM Clinical Study Site 105
    • Texas
      • Dallas, Texas, United States
        • NGM Clinical Study Site 102
      • San Antonia, Texas, United States
        • NGM Clinical Study Site 113

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Completion of NGM 13-0103
  • Males or females, between 18 and 75 years of age, inclusive
  • PBC Diagnosis consistent with AASLD and EASL guidelines
  • Stable dose of UDCA

Exclusion Criteria:

  • Chronic liver disease of a non-PBC etiology
  • Evidence of clinically significant hepatic decompensation

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NGM282 Dose 1
Biological: NGM282
NGM282
Experimental: NGM282 Dose 2
Biological: NGM282
NGM282
Experimental: NGM282 Dose 3
Biological: NGM282
NGM282

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute change in plasma ALP from Baseline to Week 12
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage change in bilirubin, ALT, AST, and GGT from Baseline to Week 12 and Week 24
Time Frame: 12 weeks and 24 weeks
12 weeks and 24 weeks

Collaborators and Investigators

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

Sponsor

NGM Biopharmaceuticals, Inc

Collaborators

NGM Biopharmaceuticals Australia Pty Ltd

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.

Helpful Links

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

May 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

May 8, 2014

First Submitted That Met QC Criteria

May 8, 2014

First Posted (Estimate)

May 12, 2014

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-0104

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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