A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis
FALCON 2
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
1 other identifier
interventional
155
2 countries
91
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2018
Typical duration for phase_2
91 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2018
CompletedFirst Posted
Study publicly available on registry
April 3, 2018
CompletedStudy Start
First participant enrolled
June 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 14, 2021
CompletedResults Posted
Study results publicly available
October 13, 2022
CompletedOctober 13, 2022
October 1, 2022
2.3 years
March 30, 2018
August 22, 2022
October 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 48
An improvement in fibrosis is defined as a decrease of fibrosis by ≥1-stage in the NASH Clinical Research Network (CRN) Fibrosis Score at week 48 in liver biopsy. Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease activity score (NAS) by ≥ 1-stage. Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) by ≥1 point. Worsening of fibrosis is defined as an increase of fibrosis by ≥1 point as determined by the NASH CRN Fibrosis Score.
From first dose to 48 weeks after first dose
Secondary Outcomes (6)
The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Ishak Fibrosis Score at Week 48
From first dose to 48 weeks after first dose
The Percentage of Participants With Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) or NASH Improvement at Week 48
From first dose to 48 weeks after first dose
The Percentage of Participants Who Achieved >=1 Point Improvement in Fibrosis at Week 48
From first dose to 48 weeks after first dose
The Percentage of Participants With Any Improvement in Collagen Proportionate Area (CPA) at Week 48
From first dose to 48 weeks after first dose
The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution at Week 48
From first dose to 48 weeks after first dose
- +1 more secondary outcomes
Study Arms (4)
BMS-986036 Dose Level 1
EXPERIMENTALBMS-986036 Dose Level 2
EXPERIMENTALBMS-986036 Dose Level 3
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Specified dose on specified days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (91)
North Alabama Health Research, LLC
Madison, Alabama, 35758, United States
Local Institution - 0005
Chandler, Arizona, 85224, United States
Local Institution - 0088
Phoenix, Arizona, 85013, United States
Local Institution - 0006
Phoenix, Arizona, 85054, United States
Local Institution - 0090
Tucson, Arizona, 85712, United States
Kindred Medical Institute for Clinical Trials
Corona, California, 92879, United States
Local Institution - 0092
Coronado, California, 92118, United States
Local Institution - 0038
La Jolla, California, 92037, United States
Local Institution - 0017
Los Angeles, California, 90036, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
GastroIntestinal Biosciences
Los Angeles, California, 90067-2015, United States
Catalina Research Institute
Montclair, California, 91763, United States
Kaiser Permanente
Oakland, California, 94611, United States
Diverse Research Solutions
Oxnard, California, 93030, United States
Huntington Medical Research Institutes - HMRI Liver Center
Pasadena, California, 91105, United States
Local Institution - 0020
Pasadena, California, 91105, United States
Local Institution - 0073
Redwood City, California, 94063, United States
Local Institution - 0012
Rialto, California, 92377, United States
Local Institution - 0089
San Clemente, California, 92673, United States
Local Institution
San Diego, California, 92105, United States
Local Institution - 0014
San Diego, California, 92123, United States
Local Institution - 0068
San Francisco, California, 94115, United States
Local Institution - 0042
Bridgeport, Connecticut, 06610, United States
Local Institution
Washington D.C., District of Columbia, 20007, United States
Local Institution - 0079
Coral Gables, Florida, 33134, United States
Top Medical Research
Cutler Bay, Florida, 33189, United States
Clinical Research of Homestead
Homestead, Florida, 33030, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224, United States
Local Institution - 0001
Lakewood Rch, Florida, 34211, United States
Local Institution - 0003
Miami, Florida, 33136, United States
A+ Research
Miami, Florida, 33144, United States
IMIC Research
Miami, Florida, 33157, United States
Sensible Healthcare
Ocoee, Florida, 34761, United States
Local Institution - 0081
Orlando, Florida, 32806, United States
Local Institution
Tampa, Florida, 33606, United States
Local Institution
Atlanta, Georgia, 30309, United States
Local Institution - 0108
Marietta, Georgia, 30060, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Local Institution - 0026
New Orleans, Louisiana, 70121, United States
Local Institution - 0010
Baltimore, Maryland, 21202, United States
Local Institution - 0058
Catonsville, Maryland, 21228, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
NECCR PrimaCare Research
Fall River, Massachusetts, 02721, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
Local Institution - 0031
Kansas City, Missouri, 64111, United States
Saint Louis University
St Louis, Missouri, 63110, United States
University at Buffalo
Buffalo, New York, 14203, United States
Northwell Health
Manhasset, New York, 11030, United States
Mount Sinai Hospital
New York, New York, 10003, United States
Local Institution - 0036
New York, New York, 10016, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Local Institution - 0067
Butner, North Carolina, 27509-1626, United States
Local Institution - 0064
Charlotte, North Carolina, 28204, United States
Northeast GI Research Division
Concord, North Carolina, 28027, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Local Institution - 0009
Philadelphia, Pennsylvania, 19107, United States
Local Institution - 0004
Pittsburgh, Pennsylvania, 15213, United States
Local Institution
Chattanooga, Tennessee, 37421, United States
Local Institution - 0046
Germantown, Tennessee, 38138, United States
Local Institution - 0041
Hermitage, Tennessee, 37076, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-5280, United States
Texas Clinical Research Institute
Arlington, Texas, 76012, United States
Local Institution - 0066
Austin, Texas, 78757, United States
Local Institution - 0051
Dallas, Texas, 75203, United States
Local Institution - 0053
Dallas, Texas, 75234, United States
Texas Digestive Disease Consultants - Dallas
Dallas, Texas, 75246, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Local Institution - 0084
Fort Worth, Texas, 76104, United States
Local Institution - 0002
Houston, Texas, 77002, United States
Local Institution - 0057
Houston, Texas, 77030, United States
Local Institution - 0063
Houston, Texas, 77030, United States
Local Institution - 0028
San Antonio, Texas, 78215, United States
Local Institution - 0011
San Antonio, Texas, 78229, United States
Local Institution - 0102
San Antonio, Texas, 78229, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Gastroenterology Associates, PC
Manassas, Virginia, 20110, United States
Local Institution - 0069
Norfolk, Virginia, 23502, United States
The Gastroenterology Group
Reston, Virginia, 20191, United States
Bon Secours Liver Institute of Richmond
Richmond, Virginia, 23226, United States
Local Institution - 0077
Richmond, Virginia, 23249, United States
Local Institution - 0050
Richmond, Virginia, 23298, United States
Kurume University Hospital
Kurume, Fukuoka, 8300011, Japan
Local Institution - 0055
Yokohama, Kanagawa, 236-0004, Japan
Local Institution - 0072
Kashihara, Nara, 6348522, Japan
Toranomon Hospital
Minato, Tokyo, 105-8470, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 1600016, Japan
Fukushima Medical University Hospital
Fukushima, 960-1295, Japan
Related Publications (2)
Abdelmalek MF, Sanyal AJ, Nakajima A, Neuschwander-Tetri BA, Goodman ZD, Lawitz EJ, Harrison SA, Jacobson IM, Imajo K, Gunn N, Halegoua-DeMarzio D, Akahane T, Boone B, Yamaguchi M, Chatterjee A, Tirucherai GS, Shevell DE, Du S, Charles ED, Loomba R. Pegbelfermin in Patients With Nonalcoholic Steatohepatitis and Compensated Cirrhosis (FALCON 2): A Randomized Phase 2b Study. Clin Gastroenterol Hepatol. 2024 Jan;22(1):113-123.e9. doi: 10.1016/j.cgh.2023.04.012. Epub 2023 Apr 23.
PMID: 37088458DERIVEDAbdelmalek 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.
PMID: 33657443DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2018
First Posted
April 3, 2018
Study Start
June 12, 2018
Primary Completion
October 8, 2020
Study Completion
September 14, 2021
Last Updated
October 13, 2022
Results First Posted
October 13, 2022
Record last verified: 2022-10