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 |
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Recruitment Status :
Active, not recruiting
First Posted : April 3, 2018
Last Update Posted : August 11, 2020
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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 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 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 7, 2018 |
| Actual Primary Completion Date : | May 29, 2020 |
| Estimated Study Completion Date : | December 20, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Non-alcoholic fatty liver disease
| Arm | Intervention/treatment |
|---|---|
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Experimental: BMS-986036 Dose Level 1
Administered by subcutaneous injection.
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Drug: BMS-986036
Specified dose on specified days.
Other Name: Pegbelfermin |
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Experimental: BMS-986036 Dose Level 2
Administered by subcutaneous injection.
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Drug: BMS-986036
Specified dose on specified days.
Other Name: Pegbelfermin |
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Experimental: BMS-986036 Dose Level 3
Administered by subcutaneous injection.
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Drug: BMS-986036
Specified dose on specified days.
Other Name: Pegbelfermin |
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Placebo Comparator: Placebo
Administered by subcutaneous injection.
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Other: Placebo
Specified dose on specified days. |
Primary Outcome Measures :
- 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 ]
- 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 ]
- 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 :
- Proportion of participants with NASH CRN Fibrosis Score improvement as determined by liver biopsy [ Time Frame: 24 weeks ]
- Proportion of participants with Ishak Score improvement as determined by liver biopsy [ Time Frame: 24 weeks ]
- Proportion of participants with a decrease in collagen proportionate area (CPA) as determined by liver biopsy [ Time Frame: 24 weeks ]
- Proportion of participants with NASH resolution without worsening of fibrosis as determined by liver biopsy [ Time Frame: 24 weeks ]
- Proportion of participants with NASH resolution as determined by liver biopsy [ Time Frame: 24 weeks ]
- Proportion of participants with NASH improvement without worsening of fibrosis as determined by liver biopsy [ Time Frame: 24 weeks ]
- Proportion of participants with NASH improvement as determined by liver biopsy [ Time Frame: 24 weeks ]
- Proportion of participants with progression to cirrhosis, as determined by liver biopsy [ Time Frame: 24 weeks ]
- Incidence of adverse events (AE) [ Time Frame: Up to 52 weeks ]
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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
Locations
Show 89 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT03486899 |
| Other Study ID Numbers: |
MB130-068 |
| First Posted: | April 3, 2018 Key Record Dates |
| Last Update Posted: | August 11, 2020 |
| Last Verified: | August 2020 |
| 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 Non-alcoholic Fatty Liver Disease Liver Cirrhosis |
Fibrosis Pathologic Processes Digestive System Diseases |