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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genentech, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings