Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis

NCT02026401 — Phase 2, Completed, 45 participants, NGM Biopharmaceuticals, Inc
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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

RegistryNCT02026401
StatusCompleted
PhasePhase 2
Study typeInterventional; randomized, factorial, masking: double, treatment
Enrollment45 (Actual)
SponsorNGM Biopharmaceuticals, Inc (Industry); collaborators: NGM Biopharmaceuticals Australia Pty Ltd
ConditionsPrimary Biliary Cirrhosis
InterventionsNGM282, Placebo (Biological)
Datesstart 2014-02-01, primary completion 2014-12-01, completion 2014-12-01, first posted 2014-01-03, last updated 2017-03-28
Locations17 sites in United States, Australia

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

-Summary

The purpose of this study is to determine the safety, tolerability, and activity of 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
PlaceboPlacebo comparatorBiological: PlaceboPlacebo
  • NGM282 (Biological)
  • Placebo (Biological)

+Outcome measures

Primary outcomes

  • Absolute change in plasma ALP from Baseline to Day 28 [28 days]

Secondary outcomes

  • Absolute change in bilirubin from Baseline to Day 28 [28 days]

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+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 104Richmond, VirginiaUnited 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 604Melbourne, VictoriaAustralia
NGM Clinical Study Site 613Melbourne, VictoriaAustralia

+Investigators