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Phase 2 Study of NGM282 in Patients With Primary Sclerosing Cholangitis

Primary Purpose

Primary Sclerosing Cholangitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NGM282
Placebo
Sponsored by
NGM Biopharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Sclerosing Cholangitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NGM Clinical Study Site 118
  • NGM Clinical Study Site 112
  • NGM Clinical Study Site 127
  • NGM Clinical Study Site 106
  • NGM Clinical Study Site 115
  • NGM Clinical Study Site 110
  • NGM Clinical Study Site 124
  • NGM Clinical Study Site 105
  • NGM Clinical Study Site 109
  • NGM Clinical Study Site 104
  • NGM Clinical Study Site 102
  • NGM Clinical Study Site 107
  • NGM Clinical Study Site 103
  • NGM Clinical Study Site 116
  • NGM Clinical Study Site 120
  • NGM Clinical Study Site 114
  • NGM Clinical Study Site 113
  • NGM Clinical Study Site 117
  • NGM Clinical Study Site 119
  • NGM Clinical Study Site 125
  • NGM Clinical Study Site 111
  • NGM Clinical Study Site 122
  • NGM Clinical Study Site 101
  • NGM Clinical Study Site 121
  • NGM Clinical Study Site 108
  • NGM Clinical Study Site 126
  • NGM Clinical Study Site 301
  • NGM Clinical Study Site 402
  • NGM Clinical Study Site 407
  • NGM Clinical Study Site 406
  • NGM Clinical Study Site 401
  • NGM Clinical Study Site 404
  • NGM Clinical Study Site 405
  • NGM Clinical Study Site 505
  • NGM Clinical Study Site 504
  • NGM Clinical Study Site 502
  • NGM Clinical Study Site 501
  • NGM Clinical Study Site 503

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

NGM282 Dose 1

NGM282 Dose 2

Placebo

Arm Description

NGM282 Dose 1

NGM282 Dose 2

Placebo

Outcomes

Primary Outcome Measures

The mean and percent change in ALP from Baseline to Week 12

Secondary Outcome Measures

The mean and percent change in ALT from Baseline to Week 12

Full Information

First Posted
February 29, 2016
Last Updated
July 16, 2018
Sponsor
NGM Biopharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02704364
Brief Title
Phase 2 Study of NGM282 in Patients With Primary Sclerosing Cholangitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NGM Biopharmaceuticals, Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Sclerosing Cholangitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sclerosing Cholangitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NGM282 Dose 1
Arm Type
Experimental
Arm Description
NGM282 Dose 1
Arm Title
NGM282 Dose 2
Arm Type
Experimental
Arm Description
NGM282 Dose 2
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Placebo
Intervention Type
Biological
Intervention Name(s)
NGM282
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The mean and percent change in ALP from Baseline to Week 12
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The mean and percent change in ALT from Baseline to Week 12
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen J Rossi, PharmD
Organizational Affiliation
NGM Biopharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
NGM Clinical Study Site 118
City
Sacramento
State/Province
California
Country
United States
Facility Name
NGM Clinical Study Site 112
City
San Clemente
State/Province
California
Country
United States
Facility Name
NGM Clinical Study Site 127
City
San Francisco
State/Province
California
Country
United States
Facility Name
NGM Clinical Study Site 106
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
NGM Clinical Study Site 115
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
NGM Clinical Study Site 110
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
NGM Clinical Study Site 124
City
Lakewood Ranch
State/Province
Florida
Country
United States
Facility Name
NGM Clinical Study Site 105
City
Miami
State/Province
Florida
Country
United States
Facility Name
NGM Clinical Study Site 109
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
NGM Clinical Study Site 104
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
NGM Clinical Study Site 102
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
NGM Clinical Study Site 107
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
NGM Clinical Study Site 103
City
New York
State/Province
New York
Country
United States
Facility Name
NGM Clinical Study Site 116
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
NGM Clinical Study Site 120
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
NGM Clinical Study Site 114
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
NGM Clinical Study Site 113
City
Dallas
State/Province
Texas
Country
United States
Facility Name
NGM Clinical Study Site 117
City
Dallas
State/Province
Texas
Country
United States
Facility Name
NGM Clinical Study Site 119
City
Houston
State/Province
Texas
Country
United States
Facility Name
NGM Clinical Study Site 125
City
Southlake
State/Province
Texas
Country
United States
Facility Name
NGM Clinical Study Site 111
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
NGM Clinical Study Site 122
City
Newport News
State/Province
Virginia
Country
United States
Facility Name
NGM Clinical Study Site 101
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
NGM Clinical Study Site 121
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
NGM Clinical Study Site 108
City
Seattle
State/Province
Washington
Country
United States
Facility Name
NGM Clinical Study Site 126
City
Seattle
State/Province
Washington
Country
United States
Facility Name
NGM Clinical Study Site 301
City
Paris
Country
France
Facility Name
NGM Clinical Study Site 402
City
Amsterdam
Country
Netherlands
Facility Name
NGM Clinical Study Site 407
City
Amsterdam
Country
Netherlands
Facility Name
NGM Clinical Study Site 406
City
Leiden
Country
Netherlands
Facility Name
NGM Clinical Study Site 401
City
Nijmegen
Country
Netherlands
Facility Name
NGM Clinical Study Site 404
City
Rotterdam
Country
Netherlands
Facility Name
NGM Clinical Study Site 405
City
Utrecht
Country
Netherlands
Facility Name
NGM Clinical Study Site 505
City
Birmingham
Country
United Kingdom
Facility Name
NGM Clinical Study Site 504
City
Liverpool
Country
United Kingdom
Facility Name
NGM Clinical Study Site 502
City
London
Country
United Kingdom
Facility Name
NGM Clinical Study Site 501
City
Newcastle
Country
United Kingdom
Facility Name
NGM Clinical Study Site 503
City
Norwich
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33898959
Citation
Sanyal AJ, Ling L, Beuers U, DePaoli AM, Lieu HD, Harrison SA, Hirschfield GM. Potent suppression of hydrophobic bile acids by aldafermin, an FGF19 analogue, across metabolic and cholestatic liver diseases. JHEP Rep. 2021 Feb 19;3(3):100255. doi: 10.1016/j.jhepr.2021.100255. eCollection 2021 Jun.
Results Reference
derived

Learn more about this trial

Phase 2 Study of NGM282 in Patients With Primary Sclerosing Cholangitis

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