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

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ClinicalTrials.gov Identifier: NCT03486899
Recruitment Status : Active, not recruiting
First Posted : April 3, 2018
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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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


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.




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 ]


Information from the National Library of Medicine

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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486899


  Show 91 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03486899     History of Changes
Other Study ID Numbers: MB130-068
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Liver Cirrhosis
Non-alcoholic Fatty Liver Disease
Fibrosis
Pathologic Processes
Digestive System Diseases