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

NCT02135536 — Phase 2, Completed, 36 participants, NGM Biopharmaceuticals, Inc
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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

RegistryNCT02135536
StatusCompleted
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment36 (Actual)
SponsorNGM Biopharmaceuticals, Inc (Industry); collaborators: NGM Biopharmaceuticals Australia Pty Ltd
ConditionsPrimary Biliary Cirrhosis
InterventionsNGM282 (Biological)
Datesstart 2014-05-01, primary completion 2016-02-01, completion 2016-02-01, first posted 2014-05-12, last updated 2017-03-28
Locations17 sites in United States, Australia, New Zealand

Related Papers Related Patents Related Grants Related Experts
All trials for Primary Biliary Cirrhosis All trials of NGM282

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
NGM282 Dose 1ExperimentalBiological: NGM282NGM282 Dose 1
NGM282 Dose 2ExperimentalBiological: NGM282NGM282 Dose 2
NGM282 Dose 3ExperimentalBiological: NGM282NGM282 Dose 3
  • NGM282 (Biological): NGM282

+Outcome measures

Primary outcomes

  • Absolute change in plasma ALP from Baseline to Week 12 [12 weeks]

Secondary outcomes

  • Percentage change in bilirubin, ALT, AST, and GGT from Baseline to Week 12 and Week 24 [12 weeks and 24 weeks]

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Locations (17)

FacilityCityCountryStatus
NGM Clinical Study Site 103Phoenix, ArizonaUnited States
NGM Clinical Study Site 108Coronado, CaliforniaUnited States
NGM Clinical Study Site 101Detroit, MichiganUnited States
NGM Clinical Study Site 105Durham, North CarolinaUnited States
NGM Clinical Study Site 102Dallas, TexasUnited States
NGM Clinical Study Site 113San Antonio, TexasUnited States
NGM Clinical Study Site 602Sydney, New South WalesAustralia
NGM Clinical Study Site 606Sydney, New South WalesAustralia
NGM Clinical Study Site 609Sydney, New South WalesAustralia
NGM Clinical Study Site 611Sydney, New South WalesAustralia
NGM Clinical Study Site 614Brisbane, QueenslandAustralia
NGM Clinical Study Site 607Adelaide, South AustraliaAustralia
NGM Clinical Study Site 608Adelaide, South AustraliaAustralia
NGM Clinical Study Site 601Melbourne, VictoriaAustralia
NGM Clinical Study Site 613Melbourne, VictoriaAustralia
NGM Clinical Study Site 401AucklandNew Zealand
NGM Clinical Study Site 402ChristchurchNew Zealand

+Investigators