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Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis

Primary Purpose

Primary Biliary Cirrhosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NGM282
Placebo
Sponsored by
NGM Biopharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Biliary Cirrhosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NGM Clinical Study Site 103
  • NGM Clinical Study Site 108
  • NGM Clinical Study Site 101
  • NGM Clinical Study Site 105
  • NGM Clinical Study Site 102
  • NGM Clinical Study Site 113
  • NGM Clinical Study Site 104
  • NGM Clinical Study Site 602
  • NGM Clinical Study Site 606
  • NGM Clinical Study Site 609
  • NGM Clinical Study Site 611
  • NGM Clinical Study Site 614
  • NGM Clinical Study Site 607
  • NGM Clinical Study Site 608
  • NGM Clinical Study Site 601
  • NGM Clinical Study Site 604
  • NGM Clinical Study Site 613

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

NGM282 Dose 1

NGM282 Dose 2

Placebo

Arm Description

NGM282 Dose 1

NGM282 Dose 2

Placebo

Outcomes

Primary Outcome Measures

Absolute change in plasma ALP from Baseline to Day 28

Secondary Outcome Measures

Absolute change in bilirubin from Baseline to Day 28

Full Information

First Posted
December 30, 2013
Last Updated
March 27, 2017
Sponsor
NGM Biopharmaceuticals, Inc
Collaborators
NGM Biopharmaceuticals Australia Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02026401
Brief Title
Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NGM Biopharmaceuticals, Inc
Collaborators
NGM Biopharmaceuticals Australia Pty Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NGM282 Dose 1
Arm Type
Experimental
Arm Description
NGM282 Dose 1
Arm Title
NGM282 Dose 2
Arm Type
Experimental
Arm Description
NGM282 Dose 2
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Biological
Intervention Name(s)
NGM282
Intervention Type
Biological
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Absolute change in plasma ALP from Baseline to Day 28
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Absolute change in bilirubin from Baseline to Day 28
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen J Rossi, PharmD
Organizational Affiliation
NGM Biopharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
NGM Clinical Study Site 103
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
NGM Clinical Study Site 108
City
Coronado
State/Province
California
Country
United States
Facility Name
NGM Clinical Study Site 101
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
NGM Clinical Study Site 105
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
NGM Clinical Study Site 102
City
Dallas
State/Province
Texas
Country
United States
Facility Name
NGM Clinical Study Site 113
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
NGM Clinical Study Site 104
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
NGM Clinical Study Site 602
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
NGM Clinical Study Site 606
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
NGM Clinical Study Site 609
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
NGM Clinical Study Site 611
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
NGM Clinical Study Site 614
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
NGM Clinical Study Site 607
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
NGM Clinical Study Site 608
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
NGM Clinical Study Site 601
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
NGM Clinical Study Site 604
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
NGM Clinical Study Site 613
City
Melbourne
State/Province
Victoria
Country
Australia

12. IPD Sharing Statement

Links:
URL
http://www.ngmbio.com
Description
Related Info

Learn more about this trial

Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis

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