Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis

March 27, 2017 updated by: NGM Biopharmaceuticals, Inc

A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Pharmacodynamic Activity of NGM282 in Combination With Ursodeoxycholic Acid (UDCA) Administered for 28 Days in Patients With Primary Biliary Cirrhosis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

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 604
      • Melbourne, Victoria, Australia
        • NGM Clinical Study Site 613
  • 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 Antonio, Texas, United States
        • NGM Clinical Study Site 113
    • Virginia
      • Richmond, Virginia, United States
        • NGM Clinical Study Site 104

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:

  • 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: FACTORIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Biological: Placebo
EXPERIMENTAL: NGM282 Dose 1
Biological: NGM282
EXPERIMENTAL: NGM282 Dose 2
Biological: NGM282

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute change in plasma ALP from Baseline to Day 28
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Absolute change in bilirubin from Baseline to Day 28
Time Frame: 28 days
28 days

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

February 1, 2014

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

December 30, 2013

First Submitted That Met QC Criteria

January 2, 2014

First Posted (ESTIMATE)

January 3, 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

  • 13-0103

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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