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

April 8, 2024 updated by: Genentech, Inc.

A Phase II, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Patients With Non-Alcoholic Steatohepatitis

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1070
        • Hospital Erasme
      • Edegem, Belgium, 2650
        • Antwerp University Hospital
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
  • France
      • CHU Hopitaux De Bordeaux, France, 33000
        • CHU Hopitaux de Bordeaux
      • Lyon, France, 69004
        • Hospices Civils de Lyon
      • Nice, France, 06602
        • CHU de Nice
      • Paris, France, 75013
        • Hopital Pitie-Salpetriere APHP
      • Vandoeuvre, France, 54500
        • Hôpital d'Enfants, Service d?onco-hématologie pédiatrique
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Fundacion de Investigacion de Diego
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Sevilla, Spain, 41013
        • Hospital Universtiario Virgen del Rocio
      • Valencia, Spain, 46014
        • Consorcio Hospital General Universitario de Valencia
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe; Servicio de Neurología
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia; Servicio de Anatomia Patologica
  • United States
    • Alabama
      • Cullman, Alabama, United States, 35055
        • Cullman Clinical Trials
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Arizona Liver Health - Chandler
      • Tucson, Arizona, United States, 85741
        • Orange Grove Family Practice
      • Tucson, Arizona, United States, 85711
        • Arizona Liver Health - Tucson
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Arkansas Gastroenterology
    • California
      • Chula Vista, California, United States, 91910
        • Gregory Wiener, MD
      • Fresno, California, United States, 93720
        • Community Cancer Institute (CCI)
      • Los Angeles, California, United States, 90057
        • National Research Inst.
      • Orange, California, United States, 92886
        • Conquest Clinical Research
      • San Diego, California, United States, 92103
        • UC San Diego Airway Research and Clinical Trials Center
      • Santa Monica, California, United States, 90402
        • National Research Institute - Panorama City
    • Colorado
      • Englewood, Colorado, United States, 80113
        • South Denver Gastroenterology
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Excel Medical Research
      • Miami, Florida, United States, 33165
        • Premier Research Associate, Inc
      • Sarasota, Florida, United States, 34240
        • Covenant Research
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia, PC
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Grand Teton Research Group, PLLC
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Gastroenterology Associates, LLC
      • Crowley, Louisiana, United States, 70526
        • Avant Research Associates, LLC
    • Maryland
      • Bethesda, Maryland, United States, 20889-0001
        • Walter Reed Army Medical Center
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Huron Gastroenterology Associates
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Kansas City Research Institute, LLC
    • New Jersey
      • Raritan, New Jersey, United States, 08869
        • Amici Clinical Research
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Medical Center; Gen Clinic Research Ctr
    • Ohio
      • Columbus, Ohio, United States, 43210-1228
        • Wexner Medical Center; Ohio State University; Investigational Drug Services; Pharmacy Department
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Texas
      • Austin, Texas, United States, 78746
        • Pinnacle Clinical Research - Austin
      • Cedar Park, Texas, United States, 78613
        • Texas Digetive Disease Consultants - Austin
      • Edinburg, Texas, United States, 78539
        • South Texas Research Institute
      • Edinburg, Texas, United States, 78539
        • Liver Institute at Renaissance
      • Fort Worth, Texas, United States, 76104
        • Texas Digestive Disease Consultant - Ft Worth (TDDC - Ft Worth)
      • Houston, Texas, United States, 77030
        • Liver Associates of Texas - Houston
      • San Antonio, Texas, United States, 78229
        • Pinnacle Clinical Research - San Antonio
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc
      • San Antonio, Texas, United States, 78209
        • Quality Research Inc
      • San Antonio, Texas, United States, 78215
        • American Research Corporation Inc.
      • San Marcos, Texas, United States, 78666
        • Texas Digestive Disease Consultants - San Marcos
    • Virginia
      • Richmond, Virginia, United States, 23219-1901
        • Virginia Commonwealth University
      • Richmond, Virginia, United States, 23249
        • Hunter Holmes McGuire V.A. Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fixed Dose: BFKB8488A Dose A
Participants will receive BFKB8488A.
Drug: BFKB8488A
Participants will receive subcutaneous (SC) BFKB8488A.
Experimental: Fixed Dose: BFKB8488A Dose B
Participants will receive BFKB8488A.
Drug: BFKB8488A
Participants will receive subcutaneous (SC) BFKB8488A.
Experimental: Fixed Dose: BFKB8488A Dose C
Participants will receive BFKB8488A.
Drug: BFKB8488A
Participants will receive subcutaneous (SC) BFKB8488A.
Placebo Comparator: Placebo
Participants will receive a fixed dose of placebo matched to BFKB8488A.
Drug: Placebo
Participants will receive subcutaneous (SC) placebo matched to BFKB8488A.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52
Time Frame: 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 Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Hepatic Fat Fraction as Assessed by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at Week 52
Time Frame: Baseline, Week 16, 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
Time Frame: 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
Time Frame: Week 52
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2020

Primary Completion (Actual)

January 23, 2023

Study Completion (Actual)

January 23, 2023

Study Registration Dates

First Submitted

November 19, 2019

First Submitted That Met QC Criteria

November 19, 2019

First Posted (Actual)

November 21, 2019

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC41033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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