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Phase 2 Study of NGM282 in Patients With Primary Sclerosing Cholangitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02704364
Recruitment Status : Completed
First Posted : March 10, 2016
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
NGM Biopharmaceuticals, Inc

Tracking Information
First Submitted Date  ICMJE February 29, 2016
First Posted Date  ICMJE March 10, 2016
Last Update Posted Date July 18, 2018
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2016)
The mean and percent change in ALP from Baseline to Week 12 [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02704364 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2016)
The mean and percent change in ALT from Baseline to Week 12 [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2 Study of NGM282 in Patients With Primary Sclerosing Cholangitis
Official Title  ICMJE 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
Brief Summary The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Sclerosing Cholangitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Primary Sclerosing Cholangitis
Intervention  ICMJE
  • Biological: NGM282
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: NGM282 Dose 1
    NGM282 Dose 1
    Intervention: Biological: NGM282
  • Experimental: NGM282 Dose 2
    NGM282 Dose 2
    Intervention: Biological: NGM282
  • Active Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2017)
62
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2016)
60
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Netherlands,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02704364
Other Study ID Numbers  ICMJE 15-0106
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NGM Biopharmaceuticals, Inc
Study Sponsor  ICMJE NGM Biopharmaceuticals, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Stephen J Rossi, PharmD NGM Biopharmaceuticals, Inc
PRS Account NGM Biopharmaceuticals, Inc
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP