Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis
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
1 other identifier
interventional
36
3 countries
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2014
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 8, 2014
CompletedFirst Posted
Study publicly available on registry
May 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMarch 28, 2017
March 1, 2017
1.8 years
May 8, 2014
March 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute change in plasma ALP from Baseline to Week 12
12 weeks
Secondary Outcomes (1)
Percentage change in bilirubin, ALT, AST, and GGT from Baseline to Week 12 and Week 24
12 weeks and 24 weeks
Study Arms (3)
NGM282 Dose 1
EXPERIMENTALNGM282 Dose 1
NGM282 Dose 2
EXPERIMENTALNGM282 Dose 2
NGM282 Dose 3
EXPERIMENTALNGM282 Dose 3
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Chronic liver disease of a non-PBC etiology
- Evidence of clinically significant hepatic decompensation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
NGM Clinical Study Site 103
Phoenix, Arizona, United States
NGM Clinical Study Site 108
Coronado, California, United States
NGM Clinical Study Site 101
Detroit, Michigan, United States
NGM Clinical Study Site 105
Durham, North Carolina, United States
NGM Clinical Study Site 102
Dallas, Texas, United States
NGM Clinical Study Site 113
San Antonio, Texas, United States
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
Sydney, New South Wales, Australia
NGM Clinical Study Site 614
Brisbane, Queensland, Australia
NGM Clinical Study Site 607
Adelaide, South Australia, Australia
NGM Clinical Study Site 608
Adelaide, South Australia, Australia
NGM Clinical Study Site 601
Melbourne, Victoria, Australia
NGM Clinical Study Site 613
Melbourne, Victoria, Australia
NGM Clinical Study Site 401
Auckland, New Zealand
NGM Clinical Study Site 402
Christchurch, New Zealand
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Stephen J Rossi, PharmD
NGM Biopharmaceuticals, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2014
First Posted
May 12, 2014
Study Start
May 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
March 28, 2017
Record last verified: 2017-03