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

Phase 2

Completed

• Conditions: Primary Biliary Cirrhosis
• Interventions: Biological: NGM282

• Registration Number: NCT02135536
• Lead Sponsor: NGM Biopharmaceuticals, Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-08
• Study First Submitted QC: 2014-05-08
• Study First Posted: 2014-05-12
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2017-03
• Disposition First Submitted: 2017-03-27
• Disposition First Submitted QC: 2017-03-27
• Last Update Submitted: 2017-03-27
• Disposition First Posted: 2017-03-28
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NGM282 Dose 1	NGM282	NGM282 Dose 1
NGM282 Dose 3	NGM282	NGM282 Dose 3
NGM282 Dose 2	NGM282	NGM282 Dose 2

Primary Outcome Measures

Name	Time	Method
Absolute change in plasma ALP from Baseline to Week 12	12 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage change in bilirubin, ALT, AST, and GGT from Baseline to Week 12 and Week 24	12 weeks and 24 weeks

Trial Locations

Locations (17)

NGM Clinical Study Site 609; 🇦🇺 Sydney, New South Wales, Australia

NGM Clinical Study Site 602; 🇦🇺 Sydney, New South Wales, Australia

NGM Clinical Study Site 608; 🇦🇺 Adelaide, South Australia, Australia

NGM Clinical Study Site 101; 🇺🇸 Detroit, Michigan, United States

NGM Clinical Study Site 105; 🇺🇸 Durham, North Carolina, United States

NGM Clinical Study Site 103; 🇺🇸 Phoenix, Arizona, United States

NGM Clinical Study Site 614; 🇦🇺 Brisbane, Queensland, Australia

NGM Clinical Study Site 611; 🇦🇺 Sydney, New South Wales, Australia

NGM Clinical Study Site 113; 🇺🇸 San Antonia, Texas, United States

NGM Clinical Study Site 102; 🇺🇸 Dallas, Texas, United States

NGM Clinical Study Site 402; 🇳🇿 Christchurch, New Zealand

NGM Clinical Study Site 401; 🇳🇿 Auckland, New Zealand

NGM Clinical Study Site 607; 🇦🇺 Adelaide, South Australia, Australia

NGM Clinical Study Site 108; 🇺🇸 Coronado, California, United States

NGM Clinical Study Site 601; 🇦🇺 Melbourne, Victoria, Australia

NGM Clinical Study Site 606; 🇦🇺 Sydney, New South Wales, Australia

NGM Clinical Study Site 613; 🇦🇺 Melbourne, Victoria, Australia