A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis (FALCON 2)

• ClinicalTrials.gov Identifier: NCT03486912
• Recruitment Status: Active, not recruiting
• First Posted: April 3, 2018
• Last Update Posted: July 15, 2019
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Hepatic Cirrhosis; Liver Fibrosis; Nonalcoholic Fatty Liver Disease (NAFLD); Nonalcoholic Steatohepatitis	Drug: BMS-986036; Other: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 4, 2018
• Estimated Primary Completion Date: January 9, 2020
• Estimated Study Completion Date: April 5, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: BMS-986036 Dose Level 1; Administered by subcutaneous injection.	Drug: BMS-986036; Specified dose on specified days.; Other Name: Pegbelfermin
Experimental: BMS-986036 Dose Level 2; Administered by subcutaneous injection.	Drug: BMS-986036; Specified dose on specified days.; Other Name: Pegbelfermin
Experimental: BMS-986036 Dose Level 3; Administered by subcutaneous injection.	Drug: BMS-986036; Specified dose on specified days.; Other Name: Pegbelfermin
Placebo Comparator: Placebo; Administered by subcutaneous injection.	Other: Placebo; Specified dose on specified days.

Outcome Measures

Primary Outcome Measures :

1. Proportion of participants who achieve ≥1 stage improvement in fibrosis without worsening of NASH as determined by liver biopsy [ Time Frame: 48 weeks ]
2. NASH Clinical Research Network (CRN) Fibrosis Score [Fibrosis measured on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal); 2 (perisinusoidal and portal/periportal); 3 (bridging fibrosis); 4 (cirrhosis)] [ Time Frame: 48 weeks ]
3. NAFLD Activity Score (NAS) [NASH disease activity in the liver measured on a 0-8 scale: unweighted sum of steatosis, or fat (scale: 0-3), lobular inflammation (scale: 0-3), and hepatocellular ballooning (scale: 0-2)] [ Time Frame: 48 weeks ]

Secondary Outcome Measures :

1. Proportion of participants with Ishak Score improvement as determined by liver biopsy [ Time Frame: 48 weeks ]
2. Proportion of participants with a ≥ 1 stage improvement in fibrosis without worsening of NASH or NASH improvement as determined by liver biopsy [ Time Frame: 48 weeks ]
3. Proportion of participants with a decrease in collagen propionate area (CPA) as determined by liver biopsy [ Time Frame: 48 weeks ]
4. Proportion of participants with NASH resolution as determined by liver biopsy [ Time Frame: 48 weeks ]
5. Proportion of participants with NASH improvement as determined by liver biopsy [ Time Frame: 48 weeks ]
6. Number of adverse events (AE) [ Time Frame: Up to 52 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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
• 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 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 could apply

Contacts and Locations

  Show 91 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trial Information  BMS Clinical Trial Patient Recruiting  Investigator Inquiry Form  FDA Safety Alerts and Recalls 

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03486912 History of Changes
• Other Study ID Numbers: MB130-069
• First Posted: April 3, 2018
• Last Update Posted: July 15, 2019
• Last Verified: July 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Liver Cirrhosis; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Fibrosis; Pathologic Processes; Digestive System Diseases