A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis (FALCON 1)

• ClinicalTrials.gov Identifier: NCT03486899
• Recruitment Status: Active, not recruiting
• First Posted: April 3, 2018
• Last Update Posted: September 18, 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 stage 3 liver fibrosis (severe fibrosis).

Condition or disease	Intervention/treatment	Phase
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: 160 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 Stage 3 Liver Fibrosis
• Actual Study Start Date: May 4, 2018
• Estimated Primary Completion Date: January 16, 2020
• Estimated Study Completion Date: September 27, 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 or NASH improvement with no worsening of fibrosis as determined by liver biopsy [ Time Frame: 24 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: 24 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: 24 weeks ]

Secondary Outcome Measures :

1. Proportion of participants with NASH CRN Fibrosis Score improvement as determined by liver biopsy [ Time Frame: 24 weeks ]
2. Proportion of participants with Ishak Score improvement as determined by liver biopsy [ Time Frame: 24 weeks ]
3. Proportion of participants with a decrease in collagen proportionate area (CPA) as determined by liver biopsy [ Time Frame: 24 weeks ]
4. Proportion of participants with NASH resolution without worsening of fibrosis as determined by liver biopsy [ Time Frame: 24 weeks ]
5. Proportion of participants with NASH resolution as determined by liver biopsy [ Time Frame: 24 weeks ]
6. Proportion of participants with NASH improvement without worsening of fibrosis as determined by liver biopsy [ Time Frame: 24 weeks ]
7. Proportion of participants with NASH improvement as determined by liver biopsy [ Time Frame: 24 weeks ]
8. Proportion of participants with progression to cirrhosis, as determined by liver biopsy [ Time Frame: 24 weeks ]
9. Incidence 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, 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

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: NCT03486899 History of Changes
• Other Study ID Numbers: MB130-068
• First Posted: April 3, 2018
• Last Update Posted: September 18, 2019
• Last Verified: September 2019

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

Additional relevant MeSH terms:

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