A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis

NCT04171765 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: GC41033
• Study Type: interventional
• Target: 46
• Locations: 5 countries
• Sites: 53

Brief Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with non-alcoholic steatohepatitis (NASH).

Conditions

Non-alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52

  Resolution of non-alcoholic steatohepatitis (NASH) is defined as a non-alcoholic fatty liver disease activity score (NAS) of 0-1 for inflammation, 0 for ballooning, and any value for steatosis as determined by a central reader. Worsening of fibrosis is defined as any increase in NASH Clinical Research Network (CRN) fibrosis stage as determined by a central reader.

  Week 52

Secondary Outcomes (3)

• Change From Baseline in Hepatic Fat Fraction as Assessed by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at Week 52

  Baseline, Week 16, Week 52

• Proportion of Participants With Improvement in Liver Histology From Baseline and no Worsening of Fibrosis at Week 52

  Week 52

• Proportion of Participants With Improvement in Liver Fibrosis of at Least One Stage, as Defined by NASH Clinical Research Network (CRN), and no Worsening of NASH at Week 52

  Week 52

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Participants will receive a fixed dose of placebo matched to BFKB8488A.

Drug: Placebo

Fixed Dose: BFKB8488A Dose A

EXPERIMENTAL

Participants will receive BFKB8488A.

Drug: BFKB8488A

Fixed Dose: BFKB8488A Dose B

EXPERIMENTAL

Participants will receive BFKB8488A.

Drug: BFKB8488A

Fixed Dose: BFKB8488A Dose C

EXPERIMENTAL

Participants will receive BFKB8488A.

Drug: BFKB8488A

Interventions

Placebo DRUG

Participants will receive subcutaneous (SC) placebo matched to BFKB8488A.

Placebo

BFKB8488A DRUG

Participants will receive subcutaneous (SC) BFKB8488A.

Fixed Dose: BFKB8488A Dose A; Fixed Dose: BFKB8488A Dose B; Fixed Dose: BFKB8488A Dose C

Eligibility Criteria

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

You may qualify if:

• Confirmed diagnosis of NASH as documented through liver biopsy performed no more than 6 months before randomization, defined according to NASH CRN criteria along with a NASH CRN fibrosis score between F2 and F3
• Hepatic steatosis on MRI (\>= 8% average PDFF) prior to randomization

You may not qualify if:

• History of any liver disease other than NASH, except for resolved, self-limited illnesses such as Hepatitis A or E, and previous Hepatitis C
• Weight gain \> 10% or loss \> 5% within 3 months prior to randomization
• History of liver transplantation
• Current or history of significant alcohol consumption

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (53)

Cullman Clinical Trials

Cullman, Alabama, 35055, United States

Location

Arizona Liver Health - Chandler

Chandler, Arizona, 85224, United States

Location

Arizona Liver Health - Tucson

Tucson, Arizona, 85711, United States

Location

Orange Grove Family Practice

Tucson, Arizona, 85741, United States

Location

Arkansas Gastroenterology

North Little Rock, Arkansas, 72117, United States

Location

Gregory Wiener, MD

Chula Vista, California, 91910, United States

Location

Community Cancer Institute (CCI)

Fresno, California, 93720, United States

Location

National Research Inst.

Los Angeles, California, 90057, United States

Location

Conquest Clinical Research

Orange, California, 92886, United States

Location

UC San Diego Airway Research and Clinical Trials Center

San Diego, California, 92103, United States

Location

National Research Institute - Panorama City

Santa Monica, California, 90402, United States

Location

South Denver Gastroenterology

Englewood, Colorado, 80113, United States

Location

Excel Medical Research

Boca Raton, Florida, 33434, United States

Location

Premier Research Associate, Inc

Miami, Florida, 33165, United States

Location

Covenant Research

Sarasota, Florida, 34240, United States

Location

Gastrointestinal Specialists of Georgia, PC

Marietta, Georgia, 30060, United States

Location

Grand Teton Research Group, PLLC

Idaho Falls, Idaho, 83404, United States

Location

Gastroenterology Associates, LLC

Baton Rouge, Louisiana, 70809, United States

Location

Avant Research Associates, LLC

Crowley, Louisiana, 70526, United States

Location

Walter Reed Army Medical Center

Bethesda, Maryland, 20889-0001, United States

Location

Huron Gastroenterology Associates

Ypsilanti, Michigan, 48197, United States

Location

Kansas City Research Institute, LLC

Kansas City, Missouri, 64131, United States

Location

Amici Clinical Research

Raritan, New Jersey, 08869, United States

Location

Duke Medical Center; Gen Clinic Research Ctr

Durham, North Carolina, 27710, United States

Location

Wexner Medical Center; Ohio State University; Investigational Drug Services; Pharmacy Department

Columbus, Ohio, 43210-1228, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Pinnacle Clinical Research - Austin

Austin, Texas, 78746, United States

Location

Texas Digetive Disease Consultants - Austin

Cedar Park, Texas, 78613, United States

Location

Liver Institute at Renaissance

Edinburg, Texas, 78539, United States

Location

South Texas Research Institute

Edinburg, Texas, 78539, United States

Location

Texas Digestive Disease Consultant - Ft Worth (TDDC - Ft Worth)

Fort Worth, Texas, 76104, United States

Location

Liver Associates of Texas - Houston

Houston, Texas, 77030, United States

Location

Quality Research Inc

San Antonio, Texas, 78209, United States

Location

American Research Corporation Inc.

San Antonio, Texas, 78215, United States

Location

Clinical Trials of Texas, Inc

San Antonio, Texas, 78229, United States

Location

Pinnacle Clinical Research - San Antonio

San Antonio, Texas, 78229, United States

Location

Texas Digestive Disease Consultants - San Marcos

San Marcos, Texas, 78666, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219-1901, United States

Location

Hunter Holmes McGuire V.A. Medical Center

Richmond, Virginia, 23249, United States

Location

Hospital Erasme

Brussels, 1070, Belgium

Location

Antwerp University Hospital

Edegem, 2650, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

CHU Hopitaux de Bordeaux

CHU Hopitaux de Bordeaux, 33000, France

Location

Hospices Civils de Lyon

Lyon, 69004, France

Location

CHU de Nice

Nice, 06602, France

Location

Hopital Pitie-Salpetriere APHP

Paris, 75013, France

Location

Hôpital d'Enfants, Service d?onco-hématologie pédiatrique

Vandœuvre-lès-Nancy, 54500, France

Location

Fundacion de Investigacion de Diego

San Juan, 00927, Puerto Rico

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universtiario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Clinico Universitario de Valencia; Servicio de Anatomia Patologica

Valencia, 46010, Spain

Location

Consorcio Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Hospital Universitari i Politecnic La Fe; Servicio de Neurología

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Limitations and Caveats

Because the study was terminated early, the interpretation of its data is limited, and early dropout may confound the results.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

1-800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  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: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 21, 2019
• Study Start: September 30, 2020
• Primary Completion: January 23, 2023
• Study Completion: January 23, 2023
• Last Updated: April 16, 2024
• Results First Posted: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

US (39); PR (1); ES (5); BE (3); FR (5)