A Study of NGM282 in Patients With Primary Sclerosing Cholangitis

NGM Biopharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Primary Sclerosing Cholangitis

Treatments: Biological: NGM282; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02704364

15-0106

2015-003392-30 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 62 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 3 patient groups

NGM282 Dose 1

Experimental group

Description:

NGM282 Dose 1

Treatment:

Biological: NGM282

NGM282 Dose 2

Experimental group

Description:

NGM282 Dose 2

Treatment:

Biological: NGM282

Placebo

Active Comparator group

Description:

Placebo

Treatment:

Other: Placebo