A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis

NCT ID: NCT03486899

Last Updated: 2022-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-19
• Study Completion Date: 2021-08-17

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 stage 3 liver fibrosis (severe fibrosis).

Conditions

Liver Fibrosis; Nonalcoholic Fatty Liver Disease (NAFLD); Nonalcoholic Steatohepatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BMS-986036 Dose Level 1

Administered by subcutaneous injection.

Group Type: EXPERIMENTAL

BMS-986036

Intervention Type: DRUG

Specified dose on specified days.

BMS-986036 Dose Level 2

Administered by subcutaneous injection.

Group Type: EXPERIMENTAL

BMS-986036

Intervention Type: DRUG

Specified dose on specified days.

BMS-986036 Dose Level 3

Administered by subcutaneous injection.

Group Type: EXPERIMENTAL

BMS-986036

Intervention Type: DRUG

Specified dose on specified days.

Placebo

Administered by subcutaneous injection.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Specified dose on specified days.

Interventions

BMS-986036

Specified dose on specified days.

Intervention Type: DRUG

Placebo

Specified dose on specified days.

Intervention Type: OTHER

Other Intervention Names

Pegbelfermin

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, with: a) a score of at least 1 for each NAS component (steatosis, lobular inflammation, and ballooning), as assessed by the central reader, and b) stage 3 liver fibrosis according to the NASH CRN classification, as assessed by the central reader
• Participants 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 [HCV] infection, 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution - 0087

Madison, Alabama, United States

Local Institution - 0005

Chandler, Arizona, United States

Local Institution - 0088

Phoenix, Arizona, United States

Local Institution - 0001

Phoenix, Arizona, United States

The Institute for Liver Health - Tucson

Tucson, Arizona, United States

Kindred Medical Institute for Clinical Trials

Corona, California, United States

Local Institution - 0092

Coronado, California, United States

University of California San Diego

La Jolla, California, United States

Local Institution - 0017

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

GastroIntestinal Biosciences

Los Angeles, California, United States

Catalina Research Institute

Montclair, California, United States

Local Institution - 0008

Oakland, California, United States

Local Institution - 0044

Oxnard, California, United States

Huntington Medical Research Institutes - HMRI Liver Center

Pasadena, California, United States

Local Institution - 0019

Pasadena, California, United States

Local Institution - 0074

Redwood City, California, United States

Local Institution - 0013

Rialto, California, United States

Local Institution - 0089

San Clemente, California, United States

Medical Associates Research Group

San Diego, California, United States

Local Institution - 0068

San Francisco, California, United States

Bridgeport Hospital

Bridgeport, Connecticut, United States

MedStar Georgetown University Hospital

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

Local Institution - 0079

Coral Gables, Florida, United States

Top Medical Research

Cutler Bay, Florida, United States

Local Institution - 0100

Gainesville, Florida, United States

Clinical Research of Homestead

Homestead, Florida, United States

Local Institution - 0082

Jacksonville, Florida, United States

Local Institution - 0003

Lakewood Rch, Florida, United States

Local Institution - 0002

Miami, Florida, United States

A+ Research

Miami, Florida, United States

IMIC Research

Miami, Florida, United States

Sensible Healthcare

Ocoee, Florida, United States

Local Institution - 0081

Orlando, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Local Institution - 0105

Marietta, Georgia, United States

Tandem Clinical Research

Marrero, Louisiana, United States

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

Local Institution - 0027

New Orleans, Louisiana, United States

Local Institution - 0007

Baltimore, Maryland, United States

Local Institution - 0057

Catonsville, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

NECCR PrimaCare Research

Fall River, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Local Institution - 0063

Chesterfield, Missouri, United States

Saint Lukes Hospital of Kansas City

Kansas City, Missouri, United States

Saint Louis University

St Louis, Missouri, United States

University at Buffalo

Buffalo, New York, United States

Local Institution - 0078

Manhasset, New York, United States

Local Institution - 0083

New York, New York, United States

Local Institution - 0038

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Local Institution - 0067

Butner, North Carolina, United States

Local Institution - 0064

Charlotte, North Carolina, United States

Local Institution - 0096

Concord, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Local Institution - 0009

Philadelphia, Pennsylvania, United States

Local Institution - 0006

Pittsburgh, Pennsylvania, United States

Local Institution - 0047

Germantown, Tennessee, United States

Local Institution - 0041

Hermitage, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Texas Clinical Research Institute

Arlington, Texas, United States

Local Institution - 0066

Austin, Texas, United States

Local Institution - 0053

Dallas, Texas, United States

Local Institution - 0052

Dallas, Texas, United States

Texas Digestive Disease Consultants - Dallas

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Texas Digestive Disease Consultants - Southlake

Fort Worth, Texas, United States

Local Institution - 0004

Houston, Texas, United States

Local Institution - 0059

Houston, Texas, United States

Local Institution - 0062

Houston, Texas, United States

Local Institution - 0029

San Antonio, Texas, United States

Local Institution - 0012

San Antonio, Texas, United States

Local Institution - 0101

San Antonio, Texas, United States

University of Vermont Medical Center

Burlington, Vermont, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Gastroenterology Associates, PC

Manassas, Virginia, United States

Local Institution - 0069

Norfolk, Virginia, United States

The Gastroenterology Group

Reston, Virginia, United States

Bon Secours Liver Institute of Richmond

Richmond, Virginia, United States

Local Institution - 0077

Richmond, Virginia, United States

Local Institution - 0049

Richmond, Virginia, United States

Kurume University Hospital

Kurume, Fukuoka, Japan

Local Institution - 0056

Yokohama, Kanagawa, Japan

Local Institution - 0072

Kashihara, Nara, Japan

Toranomon Hospital

Minato, Tokyo, Japan

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Fukushima Medical University Hospital

Fukushima, , Japan

Countries

United States; Japan

References

Loomba R, Sanyal AJ, Nakajima A, Neuschwander-Tetri BA, Goodman ZD, Harrison SA, Lawitz EJ, Gunn N, Imajo K, Ravendhran N, Akahane T, Boone B, Yamaguchi M, Chatterjee A, Tirucherai GS, Shevell DE, Du S, Charles ED, Abdelmalek MF. Pegbelfermin in Patients With Nonalcoholic Steatohepatitis and Stage 3 Fibrosis (FALCON 1): A Randomized Phase 2b Study. Clin Gastroenterol Hepatol. 2024 Jan;22(1):102-112.e9. doi: 10.1016/j.cgh.2023.04.011. Epub 2023 Apr 23.

Reference Type: DERIVED

PMID: 37088457 (View on PubMed)

Brown EA, Minnich A, Sanyal AJ, Loomba R, Du S, Schwarz J, Ehman RL, Karsdal M, Leeming DJ, Cizza G, Charles ED. Effect of pegbelfermin on NASH and fibrosis-related biomarkers and correlation with histological response in the FALCON 1 trial. JHEP Rep. 2023 Jan 7;5(4):100661. doi: 10.1016/j.jhepr.2022.100661. eCollection 2023 Apr.

Reference Type: DERIVED

PMID: 36866389 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33657443 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Investigator Inquiry Form

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

MB130-068

Identifier Type: -

Identifier Source: org_study_id