Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by NGM Biopharmaceuticals, Inc
Sponsor:
Collaborator:
NGM Biopharmaceuticals Australia Pty Ltd
Information provided by (Responsible Party):
NGM Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT02026401
First received: December 30, 2013
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Primary Biliary Cirrhosis
Biological: NGM282
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, 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 Pharmacodynamic Activity of NGM282 in Combination With Ursodeoxycholic Acid (UDCA) Administered for 28 Days in Patients With Primary Biliary Cirrhosis

Resource links provided by NLM:


Further study details as provided by NGM Biopharmaceuticals, Inc:

Primary Outcome Measures:
  • Absolute change in plasma ALP from Baseline to Day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute change in bilirubin from Baseline to Day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: February 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NGM282 Dose 1
NGM282 Dose 1
Biological: NGM282
Experimental: NGM282 Dose 2
NGM282 Dose 2
Biological: NGM282
Placebo Comparator: Placebo
Placebo
Biological: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02026401

Contacts
Contact: Michael Elliott 650-243-5571 melliott@ngmbio.com

Locations
United States, Michigan
NGM Clinical Study Site 101 Recruiting
Detroit, Michigan, United States
Australia, New South Wales
NGM Clinical Study Site 602 Recruiting
Sydney, New South Wales, Australia
NGM Clinical Study Site 603 Recruiting
Sydney, New South Wales, Australia
NGM Clinical Study Site 606 Recruiting
Sydney, New South Wales, Australia
NGM Clinical Study Site 609 Recruiting
Sydney, New South Wales, Australia
NGM Clinical Study Site 611 Recruiting
Sydney, New South Wales, Australia
Australia, Queensland
NGM Clinical Study Site 614 Recruiting
Brisbane, Queensland, Australia
Australia, South Australia
NGM Clinical Study Site 607 Recruiting
Adelaide, South Australia, Australia
NGM Clinical Study Site 608 Recruiting
Adelaide, South Australia, Australia
Australia, Victoria
NGM Clinical Study Site 601 Recruiting
Melbourne, Victoria, Australia
NGM Clinical Study Site 604 Recruiting
Melbourne, Victoria, Australia
NGM Clinical Study Site 605 Recruiting
Melbourne, Victoria, Australia
NGM Clinical Study Site 613 Recruiting
Melbourne, Victoria, Australia
Sponsors and Collaborators
NGM Biopharmaceuticals, Inc
NGM Biopharmaceuticals Australia Pty Ltd
Investigators
Study Director: Stephen J Rossi, PharmD NGM Biopharmaceuticals, Inc
  More Information

Additional Information:
No publications provided

Responsible Party: NGM Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02026401     History of Changes
Other Study ID Numbers: 13-0103
Study First Received: December 30, 2013
Last Updated: March 20, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Liver Cirrhosis
Liver Cirrhosis, Biliary
Liver Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014