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

Primary Purpose

Primary Biliary Cirrhosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NGM282
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:

  • 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

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 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 613
  • NGM Clinical Study Site 401
  • NGM Clinical Study Site 402

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

NGM282 Dose 1

NGM282 Dose 2

NGM282 Dose 3

Arm Description

NGM282 Dose 1

NGM282 Dose 2

NGM282 Dose 3

Outcomes

Primary Outcome Measures

Absolute change in plasma ALP from Baseline to Week 12

Secondary Outcome Measures

Percentage change in bilirubin, ALT, AST, and GGT from Baseline to Week 12 and Week 24

Full Information

First Posted
May 8, 2014
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
NCT02135536
Brief Title
Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (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 extended treatment with 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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (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
NGM282 Dose 3
Arm Type
Experimental
Arm Description
NGM282 Dose 3
Intervention Type
Biological
Intervention Name(s)
NGM282
Intervention Description
NGM282
Primary Outcome Measure Information:
Title
Absolute change in plasma ALP from Baseline to Week 12
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percentage change in bilirubin, ALT, AST, and GGT from Baseline to Week 12 and Week 24
Time Frame
12 weeks and 24 weeks

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: 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
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 Antonia
State/Province
Texas
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 613
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
NGM Clinical Study Site 401
City
Auckland
Country
New Zealand
Facility Name
NGM Clinical Study Site 402
City
Christchurch
Country
New Zealand

12. IPD Sharing Statement

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

Learn more about this trial

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

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