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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03486912
Recruitment Status : Active, not recruiting
First Posted : April 3, 2018
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 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 : September 17, 2020
Estimated Study Completion Date : October 27, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: BMS-986036 Dose Level 1 Drug: BMS-986036
Specified dose on specified days.
Other Name: Pegbelfermin
Experimental: BMS-986036 Dose Level 2 Drug: BMS-986036
Specified dose on specified days.
Other Name: Pegbelfermin
Experimental: BMS-986036 Dose Level 3 Drug: BMS-986036
Specified dose on specified days.
Other Name: Pegbelfermin
Placebo Comparator: Placebo Other: Placebo
Specified dose on specified days.


Outcome Measures
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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 ]

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 as determined by liver biopsy [ Time Frame: 48 weeks ]
  3. Proportion of participants with a ≥ 1 stage improvement in fibrosis without improvment of NASH as determined by liver biopsy [ Time Frame: 48 weeks ]
  4. Proportion of participants with a decrease in collagen propionate area (CPA) as determined by liver biopsy [ Time Frame: 48 weeks ]
  5. Proportion of participants with NASH resolution as determined by liver biopsy [ Time Frame: 48 weeks ]
  6. Proportion of participants with NASH improvement as determined by liver biopsy [ Time Frame: 48 weeks ]
  7. Number of adverse events (AE) [ Time Frame: Up to 52 weeks ]
  8. Incidence of treatment emergent Adverse Events (AEs) [ Time Frame: Up To 52 Weeks ]
  9. Incidence of treatment emergent Serious Adverse Events (SAEs) [ Time Frame: Up To 52 Weeks ]
  10. Frequency of treatment emergent Adverse Events (AEs) [ Time Frame: Up To 52 Weeks ]
  11. Change from Baseline in Electrocardiogram (ECG) parameter: QT interval corrected using Fridericia's formula (QTcF) [ Time Frame: At week 24 and Week 48 ]
  12. Change from Baseline in Heart Rate [ Time Frame: Up to 52 weeks ]
  13. Change from Baseline in Respiration Rate [ Time Frame: Up to 52 weeks ]
  14. Change from Baseline in Body temperature [ Time Frame: Up to 52 weeks ]
  15. Number of participants with a change from baseline in physical examination [ Time Frame: Up to Week 52 ]
  16. Number of clinically significant changes in lab assessment of blood serum [ Time Frame: Up to 52 weeks ]
  17. Number of clinically significant changes in lab assessment of blood [ Time Frame: Up to 52 weeks ]
  18. Number of clinically significant changes in lab assessment of urine [ Time Frame: Up to 52 weeks ]
  19. Change from baseline in Bone Mineral Density [ Time Frame: at week 48 and week 76 ]
  20. Change of baseline in Anti-BMS-986036 antibodies [ Time Frame: up to 108 weeks ]
  21. Change of baseline in Anti-FGF21 antibodies [ Time Frame: up to 108 weeks ]
  22. Pre-dose concentration of BMS-986036 [ Time Frame: Up to Week 52 ]
  23. Post Dose concentration of BMS-986-036 [ Time Frame: at first dose and week 24 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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
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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): NCT03486912


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03486912    
Other Study ID Numbers: MB130-069
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020

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