A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C

NCT03420768 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IM025-006
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study of experimental medication BMS-986263 in adult patients with advanced hepatic fibrosis (scar tissue in the liver caused by inflammation that is far on in progress) after the patient is cured of hepatitis C (an infection caused by a virus that attacks the liver and leads to inflammation).

Conditions

Hepatic Cirrhosis; Liver Fibrosis

Outcome Measures

Primary Outcomes (1)

• The Number of Participants Who Achieve ≥ 1 Stage Improvement in Liver Fibrosis (METAVIR Score) as Determined by Liver Biopsy After 12 Weeks of Treatment

  The number of participants who achieve ≥ 1 stage improvement in liver fibrosis is used to asses the effects of treatment compared to placebo. The METAVIR system is used to assess the extent of inflammation and fibrosis by histopathological evaluation in a liver biopsy of patients with hepatitis C virus (HCV). It assesses liver biopsies for activity grade (A0-A3) and fibrosis stage (Stage 1 - 4). Participants without a measurement at Week 12 are considered non-responders. Activity Grade: A0 = no activity; A1 = mild activity; A2 = moderate activity; A3 = severe activity Fibrosis stage: 1 = portal fibrosis without septa ; 2 = portal fibrosis with few septa; 3 = numerous septa without cirrhosis; 4 = cirrhosis

  Week 12

Secondary Outcomes (6)

• Change From Baseline in Collagen Proportionate Area (CPA) After 12 Weeks of Treatment

  Baseline and Week 12

• The Number of Participants With ≥ 1 Stage Improvement in Liver Fibrosis (Ishak Score) After 12 Weeks of Treatment

  Week 12

• The Number of Participants With ≥ 2 Stage Improvement in Liver Fibrosis (METAVIR Score) After 12 Weeks of Treatment

  Week 12

• The Number of Participants With ≥ 2 Stage Improvement in Liver Fibrosis (Ishak Score) After 12 Weeks of Treatment

  Week 12

• The Number of Participants With ≥ 15% Decrease From Baseline in Liver Stiffness as Measured by Magnetic Resonance Elastography (MRE) at Day 85

  Baseline and day 85

Study Arms (7)

Part 1 BMS-986263 45mg weekly

EXPERIMENTAL

Drug: BMS-986263

Part 1 BMS-986263 90mg weekly

EXPERIMENTAL

Drug: BMS-986263

Part 1 Placebo weekly

PLACEBO COMPARATOR

Other: Placebo

Part 2 BMS-986263 45mg every 2 weeks

EXPERIMENTAL

Drug: BMS-986263

Part 2 BMS-986263 90mg every 2 weeks

EXPERIMENTAL

Drug: BMS-986263

Part 2 BMS-986263 90mg every 4 weeks

EXPERIMENTAL

Drug: BMS-986263

Part 2 Placebo every 2 weeks

PLACEBO COMPARATOR

Other: Placebo

Interventions

BMS-986263 DRUG

Administered by intravenous (IV) infusion

Part 1 BMS-986263 45mg weekly; Part 1 BMS-986263 90mg weekly; Part 2 BMS-986263 45mg every 2 weeks; Part 2 BMS-986263 90mg every 2 weeks; Part 2 BMS-986263 90mg every 4 weeks

Placebo OTHER

Administered by intravenous (IV) infusion

Part 1 Placebo weekly; Part 2 Placebo every 2 weeks

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must provide documentation showing a sustained virologic response (SVR) for at least 1 year (52 weeks) prior to the date of screening (SVR is defined as a negative hepatitis C RNA greater than or equal to 12 weeks from the end of therapy)
• Participants must have METAVIR Stage 3 or 4 (or equivalent if using other classification; eg, Ishak)

You may not qualify if:

• Other causes of liver disease (eg, alcoholic liver disease, HBV \[serologically positive as determined using United States Centers for Disease Control and Prevention guidance for interpretation of hepatitis B serologic test results\], autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, NASH, hemochromatosis)
• Participants having liver diseases associated with infection with any other hepatitis virus
• Detectable HCV RNA at screening
• Child-Pugh score \> 6
• Model for End-Stage Liver Disease score \>12
• Evidence of HCC at screening based on alpha-fetoprotein (AFP) levels: AFP \> 100 ng/mL (\> 82.6 IU/mL) OR AFP ≥ 50 and ≤ 100 ng/mL (≥ 41.3 IU/mL and ≤ 82.6 IU/ mL) with liver ultrasound showing findings suspicious for HCC, or any imaging technique (eg, magnetic resonance imaging \[MRI\] or computed tomography; based on local assessment), or ultrasound
• Blood transfusion in the last 6 months prior to screening due to the risk of re-infection with HCV, HBV, HIV, etc
• Participant has any disease or condition which, in the opinion of the investigator, might compromise patient safety (eg, hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, central nervous system, or compliment-mediated disease); or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of BMS 986263, or would place the participant at increased risk

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

The Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Related Publications (1)

• Lawitz EJ, Shevell DE, Tirucherai GS, Du S, Chen W, Kavita U, Coste A, Poordad F, Karsdal M, Nielsen M, Goodman Z, Charles ED. BMS-986263 in patients with advanced hepatic fibrosis: 36-week results from a randomized, placebo-controlled phase 2 trial. Hepatology. 2022 Apr;75(4):912-923. doi: 10.1002/hep.32181. Epub 2021 Dec 13.

  PMID: 34605045 DERIVED

Related Links

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

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 5, 2018
• Study Start: February 14, 2018
• Primary Completion: December 10, 2018
• Study Completion: May 28, 2019
• Last Updated: February 4, 2022
• Results First Posted: February 4, 2022

Record last verified: 2022-02

Locations

US (1)