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Phase 2 Study of NGM282 in Patients With Primary Sclerosing Cholangitis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NGM Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT02704364
First received: February 29, 2016
Last updated: March 7, 2017
Last verified: March 2017
  Purpose
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Sclerosing Cholangitis.

Condition Intervention Phase
Primary Sclerosing Cholangitis Biological: NGM282 Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of NGM282 Administered for 12 Weeks in Patients With Primary Sclerosing Cholangitis

Resource links provided by NLM:


Further study details as provided by NGM Biopharmaceuticals, Inc:

Primary Outcome Measures:
  • The mean and percent change in ALP from Baseline to Week 12 [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • The mean and percent change in ALT from Baseline to Week 12 [ Time Frame: 12 weeks ]

Estimated Enrollment: 60
Study Start Date: February 2016
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NGM282 Dose 1
NGM282 Dose 1
Biological: NGM282
Experimental: NGM282 Dose 2
NGM282 Dose 2
Biological: NGM282
Active Comparator: Placebo
Placebo
Other: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of PSC

Exclusion Criteria:

  • Clinically significant acute or chronic liver disease of an etiology other than PSC
  • Secondary or IgG4 related sclerosing cholangitis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02704364

  Show 38 Study Locations
Sponsors and Collaborators
NGM Biopharmaceuticals, Inc
Investigators
Study Director: Stephen J Rossi, PharmD NGM Biopharmaceuticals, Inc
  More Information

Responsible Party: NGM Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02704364     History of Changes
Other Study ID Numbers: 15-0106
Study First Received: February 29, 2016
Last Updated: March 7, 2017

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 18, 2017