A Study of NGM282 in Patients With Primary Sclerosing Cholangitis

NCT ID: NCT02704364

Last Updated: 2025-06-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-06-30

Brief Summary

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

Detailed Description

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Conditions

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Primary Sclerosing Cholangitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NGM282 Dose 1

NGM282 Dose 1

Group Type EXPERIMENTAL

NGM282

Intervention Type BIOLOGICAL

NGM282 Dose 2

NGM282 Dose 2

Group Type EXPERIMENTAL

NGM282

Intervention Type BIOLOGICAL

Placebo

Placebo

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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NGM282

Intervention Type BIOLOGICAL

Placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NGM Biopharmaceuticals, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen J Rossi, PharmD

Role: STUDY_DIRECTOR

NGM Biopharmaceuticals, Inc

Locations

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NGM Clinical Study Site 118

Sacramento, California, United States

Site Status

NGM Clinical Study Site 112

San Clemente, California, United States

Site Status

NGM Clinical Study Site 127

San Francisco, California, United States

Site Status

NGM Clinical Study Site 106

Aurora, Colorado, United States

Site Status

NGM Clinical Study Site 115

Washington D.C., District of Columbia, United States

Site Status

NGM Clinical Study Site 110

Gainesville, Florida, United States

Site Status

NGM Clinical Study Site 124

Lakewood Rch, Florida, United States

Site Status

NGM Clinical Study Site 105

Miami, Florida, United States

Site Status

NGM Clinical Study Site 109

Indianapolis, Indiana, United States

Site Status

NGM Clinical Study Site 104

Detroit, Michigan, United States

Site Status

NGM Clinical Study Site 102

Kansas City, Missouri, United States

Site Status

NGM Clinical Study Site 107

St Louis, Missouri, United States

Site Status

NGM Clinical Study Site 103

New York, New York, United States

Site Status

NGM Clinical Study Site 116

Durham, North Carolina, United States

Site Status

NGM Clinical Study Site 120

Cincinnati, Ohio, United States

Site Status

NGM Clinical Study Site 114

Nashville, Tennessee, United States

Site Status

NGM Clinical Study Site 113

Dallas, Texas, United States

Site Status

NGM Clinical Study Site 117

Dallas, Texas, United States

Site Status

NGM Clinical Study Site 119

Houston, Texas, United States

Site Status

NGM Clinical Study Site 125

Southlake, Texas, United States

Site Status

NGM Clinical Study Site 111

Charlottesville, Virginia, United States

Site Status

NGM Clinical Study Site 122

Newport News, Virginia, United States

Site Status

NGM Clinical Study Site 101

Norfolk, Virginia, United States

Site Status

NGM Clinical Study Site 121

Richmond, Virginia, United States

Site Status

NGM Clinical Study Site 108

Seattle, Washington, United States

Site Status

NGM Clinical Study Site 126

Seattle, Washington, United States

Site Status

NGM Clinical Study Site 301

Paris, , France

Site Status

NGM Clinical Study Site 402

Amsterdam, , Netherlands

Site Status

NGM Clinical Study Site 407

Amsterdam, , Netherlands

Site Status

NGM Clinical Study Site 406

Leiden, , Netherlands

Site Status

NGM Clinical Study Site 401

Nijmegen, , Netherlands

Site Status

NGM Clinical Study Site 404

Rotterdam, , Netherlands

Site Status

NGM Clinical Study Site 405

Utrecht, , Netherlands

Site Status

NGM Clinical Study Site 505

Birmingham, , United Kingdom

Site Status

NGM Clinical Study Site 504

Liverpool, , United Kingdom

Site Status

NGM Clinical Study Site 502

London, , United Kingdom

Site Status

NGM Clinical Study Site 501

Newcastle, , United Kingdom

Site Status

NGM Clinical Study Site 503

Norwich, , United Kingdom

Site Status

Countries

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United States France Netherlands United Kingdom

References

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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.

Reference Type DERIVED
PMID: 33898959 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2015-003392-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15-0106

Identifier Type: -

Identifier Source: org_study_id

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