Clinical trial NCT02704364: A 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Sclerosing Cholangitis
Lead sponsor: NGM Biopharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2016-03-10
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Mean Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Mean Percent Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis
timeFrame: Baseline to Week 12
measure: Mean Rate of Change in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis
timeFrame: Baseline to Week 12
measure: Mean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis
timeFrame: Baseline to Week 12
measure: Mean Percent Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis
timeFrame: Baseline to Week 12
measure: Mean Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis
timeFrame: Baseline to Week 12
measure: Mean Percent Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis
timeFrame: Baseline to Week 12
measure: Mean Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis
timeFrame: Baseline to Week 12
measure: Mean Percent Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis
timeFrame: Baseline to Week 12
measure: Mean Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis
timeFrame: Baseline to Week 12
measure: Mean Percent Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis
timeFrame: Baseline to Week 12
measure: Mean Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis
timeFrame: Baseline to Week 12
measure: Mean Percent Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis
timeFrame: Baseline to Week 12
measure: Mean Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis
timeFrame: Baseline to Week 12
measure: Mean Percent Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis
timeFrame: Baseline to Week 12
measure: Mean Change From Baseline in Calprotectin in Patients With Primary Sclerosing Cholangitis
timeFrame: Baseline to Week 12
measure: Mean Change From Baseline in Enhanced Liver Fibrosis Score in Patients With Primary Sclerosing Cholangitis
timeFrame: Baseline to Week 12
measure: Severity of Inflammatory Bowel Disease-Associated Intestinal Symptoms in Patients With Primary Sclerosing Cholangitis
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: NGM Clinical Study Site 118
state: California
city: San Clemente
country: United States
facility: NGM Clinical Study Site 112
state: California
city: San Francisco
country: United States
facility: NGM Clinical Study Site 127
state: California
city: Aurora
country: United States
facility: NGM Clinical Study Site 106
state: Colorado
city: Washington
country: United States
facility: NGM Clinical Study Site 115
state: District of Columbia
city: Gainesville
country: United States
facility: NGM Clinical Study Site 110
state: Florida
city: Lakewood Ranch
country: United States
facility: NGM Clinical Study Site 124
state: Florida
city: Miami
country: United States
facility: NGM Clinical Study Site 105
state: Florida
city: Indianapolis
country: United States
facility: NGM Clinical Study Site 109
state: Indiana
city: Detroit
country: United States
facility: NGM Clinical Study Site 104
state: Michigan
city: Kansas City
country: United States
facility: NGM Clinical Study Site 102
state: Missouri
city: Saint Louis
country: United States
facility: NGM Clinical Study Site 107
state: Missouri
city: New York
country: United States
facility: NGM Clinical Study Site 103
state: New York
city: Durham
country: United States
facility: NGM Clinical Study Site 116
state: North Carolina
city: Cincinnati
country: United States
facility: NGM Clinical Study Site 120
state: Ohio
city: Nashville
country: United States
facility: NGM Clinical Study Site 114
state: Tennessee
city: Dallas
country: United States
facility: NGM Clinical Study Site 113
state: Texas
city: Dallas
country: United States
facility: NGM Clinical Study Site 117
state: Texas
city: Houston
country: United States
facility: NGM Clinical Study Site 119
state: Texas
city: Southlake
country: United States
facility: NGM Clinical Study Site 125
state: Texas
city: Charlottesville
country: United States
facility: NGM Clinical Study Site 111
state: Virginia
city: Newport News
country: United States
facility: NGM Clinical Study Site 122
state: Virginia
city: Norfolk
country: United States
facility: NGM Clinical Study Site 101
state: Virginia
city: Richmond
country: United States
facility: NGM Clinical Study Site 121
state: Virginia
city: Seattle
country: United States
facility: NGM Clinical Study Site 108
state: Washington
city: Seattle
country: United States
facility: NGM Clinical Study Site 126
state: Washington
city: Paris
country: France
facility: NGM Clinical Study Site 301
city: Amsterdam
country: Netherlands
facility: NGM Clinical Study Site 402
city: Amsterdam
country: Netherlands
facility: NGM Clinical Study Site 407
city: Leiden
country: Netherlands
facility: NGM Clinical Study Site 406
city: Nijmegen
country: Netherlands
facility: NGM Clinical Study Site 401
city: Rotterdam
country: Netherlands
facility: NGM Clinical Study Site 404
city: Utrecht
country: Netherlands
facility: NGM Clinical Study Site 405
city: Birmingham
country: United Kingdom
facility: NGM Clinical Study Site 505
city: Liverpool
country: United Kingdom
facility: NGM Clinical Study Site 504
city: London
country: United Kingdom
facility: NGM Clinical Study Site 502
city: Newcastle
country: United Kingdom
facility: NGM Clinical Study Site 501
city: Norwich
country: United Kingdom
facility: NGM Clinical Study Site 503
Study officials:
affiliation: NGM Biopharmaceuticals, Inc
name: Stephen J Rossi, PharmD
role: STUDY_DIRECTOR
References:
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.