Clinical trial NCT03486912: A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis
Official title: A Phase 2B Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of BMS-986036 (PEG-FGF21) in Adults With Nonalcoholic Steatohepatitis (NASH) and Compensated Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatic Cirrhosis
Liver Fibrosis
Nonalcoholic Fatty Liver Disease (NAFLD)
Nonalcoholic Steatohepatitis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-04-03
Enrollment: 155
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: This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by alcohol) and liver cirrhosis (liver damage characterized by normal liver tissue being replaced by scar tissue).


Eligibility criteria: Inclusion Criteria:

* Liver biopsy performed within 6 months (26 weeks) prior to the screening period. If historical biopsy is not available, a liver biopsy will be performed during the screening period. Biopsy must be consistent with NASH and cirrhosis according to the NASH CRN classification, as assessed by the central reader
* Must be taking anti-diabetic, anti-obesity, or anti-dyslipidemic medications must have been on stable regimens for at least 3 months (12 weeks) (6 weeks for statins) prior to and during the screening period
* Participants taking vitamin E at doses greater than or equal to (\>=) 800 IU/day must have been on stable doses for at least 6 months (26 weeks) prior to and during the screening period. Vitamin E treatment (\>=800 IU/day) must not have been initiated after the qualifying liver biopsy was performed

Exclusion Criteria:

* Other causes of liver disease (e.g., alcoholic liver disease, hepatitis B virus infection, chronic hepatitis C virus infection \[HCV\], autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, α-1-antitrypsin deficiency, iron overload, and hemochromatosis); participants with HCV sustained viral response (undetectable HCV RNA) for at least 2 years prior to biopsy confirming study eligibility may be eligible
* Current or past history of hepatocellular carcinoma (HCC)
* Past or current evidence of hepatic decompensation (e.g., ascites, variceal bleeding, hepatic encephalopathy and/or spontaneous bacterial peritonitis) or liver transplantation
* Medical history of gastroesophageal varices, except if esophagogastroduodenoscopy \[EGD\] performed within 12 months prior to the Screening Period has shown \<= Grade 1 varices

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 48
timeFrame: From first dose to 48 weeks after first dose
Secondary outcomes:
measure: The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Ishak Fibrosis Score at Week 48
timeFrame: From first dose to 48 weeks after first dose
measure: The Percentage of Participants With Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) or NASH Improvement at Week 48
timeFrame: From first dose to 48 weeks after first dose
measure: The Percentage of Participants Who Achieved >=1 Point Improvement in Fibrosis at Week 48
timeFrame: From first dose to 48 weeks after first dose
measure: The Percentage of Participants With Any Improvement in Collagen Proportionate Area (CPA) at Week 48
timeFrame: From first dose to 48 weeks after first dose
measure: The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution at Week 48
timeFrame: From first dose to 48 weeks after first dose
measure: The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Improvement at Week 48
timeFrame: From first dose to 48 weeks after first dose
Other outcomes:
Locations:
city: Madison
country: United States
facility: North Alabama Health Research, LLC
state: Alabama
city: Chandler
country: United States
facility: Local Institution - 0005
state: Arizona
city: Phoenix
country: United States
facility: Local Institution - 0088
state: Arizona
city: Phoenix
country: United States
facility: Local Institution - 0006
state: Arizona
city: Tucson
country: United States
facility: Local Institution - 0090
state: Arizona
city: Coronado
country: United States
facility: Local Institution - 0092
state: California
city: Corona
country: United States
facility: Kindred Medical Institute for Clinical Trials
state: California
city: La Jolla
country: United States
facility: Local Institution - 0038
state: California
city: Los Angeles
country: United States
facility: Local Institution - 0017
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: GastroIntestinal Biosciences
state: California
city: Montclair
country: United States
facility: Catalina Research Institute
state: California
city: Oakland
country: United States
facility: Kaiser Permanente
state: California
city: Oxnard
country: United States
facility: Diverse Research Solutions
state: California
city: Pasadena
country: United States
facility: Huntington Medical Research Institutes - HMRI Liver Center
state: California
city: Pasadena
country: United States
facility: Local Institution - 0020
state: California
city: Redwood City
country: United States
facility: Local Institution - 0073
state: California
city: Rialto
country: United States
facility: Local Institution - 0012
state: California
city: San Clemente
country: United States
facility: Local Institution - 0089
state: California
city: San Diego
country: United States
facility: Local Institution
state: California
city: San Diego
country: United States
facility: Local Institution - 0014
state: California
city: San Francisco
country: United States
facility: Local Institution - 0068
state: California
city: Bridgeport
country: United States
facility: Local Institution - 0042
state: Connecticut
city: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Coral Gables
country: United States
facility: Local Institution - 0079
state: Florida
city: Cutler Bay
country: United States
facility: Top Medical Research
state: Florida
city: Homestead
country: United States
facility: Clinical Research of Homestead
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Lakewood Ranch
country: United States
facility: Local Institution - 0001
state: Florida
city: Miami
country: United States
facility: Local Institution - 0003
state: Florida
city: Miami
country: United States
facility: A+ Research
state: Florida
city: Miami
country: United States
facility: IMIC Research
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare
state: Florida
city: Orlando
country: United States
facility: Local Institution - 0081
state: Florida
city: Tampa
country: United States
facility: Local Institution
state: Florida
city: Atlanta
country: United States
facility: Local Institution
state: Georgia
city: Marietta
country: United States
facility: Local Institution - 0108
state: Georgia
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: New Orleans
country: United States
facility: Local Institution - 0026
state: Louisiana
city: Baltimore
country: United States
facility: Local Institution - 0010
state: Maryland
city: Catonsville
country: United States
facility: Local Institution - 0058
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Fall River
country: United States
facility: NECCR PrimaCare Research
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Kansas City
country: United States
facility: Local Institution - 0031
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Local Institution - 0036
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Butner
country: United States
facility: Local Institution - 0067
state: North Carolina
city: Charlotte
country: United States
facility: Local Institution - 0064
state: North Carolina
city: Concord
country: United States
facility: Northeast GI Research Division
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution - 0009
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0004
state: Pennsylvania
city: Chattanooga
country: United States
facility: Local Institution
state: Tennessee
city: Germantown
country: United States
facility: Local Institution - 0046
state: Tennessee
city: Hermitage
country: United States
facility: Local Institution - 0041
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute
state: Texas
city: Austin
country: United States
facility: Local Institution - 0066
state: Texas
city: Dallas
country: United States
facility: Local Institution - 0051
state: Texas
city: Dallas
country: United States
facility: Local Institution - 0053
state: Texas
city: Dallas
country: United States
facility: Texas Digestive Disease Consultants - Dallas
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Local Institution - 0084
state: Texas
city: Houston
country: United States
facility: Local Institution - 0002
state: Texas
city: Houston
country: United States
facility: Local Institution - 0057
state: Texas
city: Houston
country: United States
facility: Local Institution - 0063
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 0028
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 0011
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 0102
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Manassas
country: United States
facility: Gastroenterology Associates, PC
state: Virginia
city: Norfolk
country: United States
facility: Local Institution - 0069
state: Virginia
city: Reston
country: United States
facility: The Gastroenterology Group
state: Virginia
city: Richmond
country: United States
facility: Bon Secours Liver Institute of Richmond
state: Virginia
city: Richmond
country: United States
facility: Local Institution - 0077
state: Virginia
city: Richmond
country: United States
facility: Local Institution - 0050
state: Virginia
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Yokohama
country: Japan
facility: Local Institution - 0055
state: Kanagawa
city: Kashihara
country: Japan
facility: Local Institution - 0072
state: Nara
city: Minato
country: Japan
facility: Toranomon Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Abdelmalek MF, Charles ED, Sanyal AJ, Harrison SA, Neuschwander-Tetri BA, Goodman Z, Ehman RA, Karsdal M, Nakajima A, Du S, Tirucherai GS, Klinger GH, Mora J, Yamaguchi M, Shevell DE, Loomba R. The FALCON program: Two phase 2b randomized, double-blind, placebo-controlled studies to assess the efficacy and safety of pegbelfermin in the treatment of patients with nonalcoholic steatohepatitis and bridging fibrosis or compensated cirrhosis. Contemp Clin Trials. 2021 May;104:106335. doi: 10.1016/j.cct.2021.106335. Epub 2021 Feb 28.