Back to resultsA Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis (BANFF)
Primary Purpose
Non-alcoholic Steatohepatitis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
BFKB8488A
Sponsored by
About this trial
This is an interventional treatment trial for Non-alcoholic Steatohepatitis
Eligibility Criteria
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
Sites / Locations
- Cullman Clinical Trials
- Arizona Liver Health - Chandler
- Arizona Liver Health - Tucson
- Orange Grove Family Practice
- Arkansas Gastroenterology
- Gregory Wiener, MD
- Community Cancer Institute (CCI)
- National Research Inst.
- Conquest Clinical Research
- UC San Diego Airway Research and Clinical Trials Center
- National Research Institute - Panorama City
- South Denver Gastroenterology
- Excel Medical Research
- Premier Research Associate, Inc
- Covenant Research
- Gastrointestinal Specialists of Georgia, PC
- Grand Teton Research Group, PLLC
- Gastroenterology Associates, LLC
- Avant Research Associates, LLC
- Walter Reed Army Medical Center
- Huron Gastroenterology Associates
- Kansas City Research Institute, LLC
- Amici Clinical Research
- Duke Medical Center; Gen Clinic Research Ctr
- Wexner Medical Center; Ohio State University; Investigational Drug Services; Pharmacy Department
- University of Pittsburgh Medical Center
- Pinnacle Clinical Research - Austin
- Texas Digetive Disease Consultants - Austin
- Liver Institute at Renaissance
- South Texas Research Institute
- Texas Digestive Disease Consultant - Ft Worth (TDDC - Ft Worth)
- Liver Associates of Texas - Houston
- Quality Research Inc
- American Research Corporation Inc.
- Clinical Trials of Texas, Inc
- Pinnacle Clinical Research - San Antonio
- Texas Digestive Disease Consultants - San Marcos
- Virginia Commonwealth University
- Hunter Holmes McGuire V.A. Medical Center
- Hospital Erasme
- Antwerp University Hospital
- Universitair Ziekenhuis Gent
- CHU Hopitaux de Bordeaux
- Hospices Civils de Lyon
- CHU de Nice
- Hopital Pitie-Salpetriere APHP
- Hôpital d'Enfants, Service d?onco-hématologie pédiatrique
- Fundacion de Investigacion de Diego
- Hospital Universitari Vall d'Hebron
- Hospital Universtiario Virgen del Rocio
- Hospital Clinico Universitario de Valencia; Servicio de Anatomia Patologica
- Consorci Hospital General Universitari de València
- Hospital Universitari i Politecnic La Fe; Servicio de Neurología
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Placebo Comparator
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Arm Label
Fixed Dose: Placebo
Individualized Dose: Placebo
Fixed Dose: BFKB8488A Dose A
Fixed Dose: BFKB8488A Dose B
Fixed Dose: BFKB8488A Dose C
Individualized Dose: BFKB8488A
Arm Description
Participants will receive a fixed dose of placebo matched to BFKB8488A.
Participants will received a dose of placebo matched to BFKB8488A.
Participants will receive BFKB8488A.
Participants will receive BFKB8488A.
Participants will receive BFKB8488A.
Participants will receive increasing doses of BFKB8488A up to the highest tolerated dose .
Outcomes
Primary Outcome Measures
Proportion of Participants with NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52
Secondary Outcome Measures
Change from Baseline in Hepatic Fat Fraction as Assessed by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at Week 52
Proportion of Participants with Improvement in Liver Histology
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
Percentage of Participants with Adverse Events
Serum Concentration of BFKB8488A
Percentage of Participants with Anti-Drug Antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04171765
Brief Title
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis
Acronym
BANFF
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
January 23, 2023 (Actual)
Study Completion Date
January 23, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with non-alcoholic steatohepatitis (NASH).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Steatohepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fixed Dose: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a fixed dose of placebo matched to BFKB8488A.
Arm Title
Individualized Dose: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will received a dose of placebo matched to BFKB8488A.
Arm Title
Fixed Dose: BFKB8488A Dose A
Arm Type
Experimental
Arm Description
Participants will receive BFKB8488A.
Arm Title
Fixed Dose: BFKB8488A Dose B
Arm Type
Experimental
Arm Description
Participants will receive BFKB8488A.
Arm Title
Fixed Dose: BFKB8488A Dose C
Arm Type
Experimental
Arm Description
Participants will receive BFKB8488A.
Arm Title
Individualized Dose: BFKB8488A
Arm Type
Experimental
Arm Description
Participants will receive increasing doses of BFKB8488A up to the highest tolerated dose .
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive subcutaneous (SC) placebo matched to BFKB8488A.
Intervention Type
Drug
Intervention Name(s)
BFKB8488A
Intervention Description
Participants will receive subcutaneous (SC) BFKB8488A.
Primary Outcome Measure Information:
Title
Proportion of Participants with NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
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
Week 52
Title
Proportion of Participants with Improvement in Liver Histology
Time Frame
Week 52
Title
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
Title
Percentage of Participants with Adverse Events
Time Frame
Week 58
Title
Serum Concentration of BFKB8488A
Time Frame
At pre-defined intervals from baseline to Week 58
Title
Percentage of Participants with Anti-Drug Antibodies
Time Frame
Week 58
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Cullman Clinical Trials
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35055
Country
United States
Facility Name
Arizona Liver Health - Chandler
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Arizona Liver Health - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Orange Grove Family Practice
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Arkansas Gastroenterology
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Gregory Wiener, MD
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Community Cancer Institute (CCI)
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
National Research Inst.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Conquest Clinical Research
City
Orange
State/Province
California
ZIP/Postal Code
92886
Country
United States
Facility Name
UC San Diego Airway Research and Clinical Trials Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
National Research Institute - Panorama City
City
Santa Monica
State/Province
California
ZIP/Postal Code
90402
Country
United States
Facility Name
South Denver Gastroenterology
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Excel Medical Research
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Facility Name
Premier Research Associate, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Covenant Research
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34240
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Grand Teton Research Group, PLLC
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Gastroenterology Associates, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Avant Research Associates, LLC
City
Crowley
State/Province
Louisiana
ZIP/Postal Code
70526
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889-0001
Country
United States
Facility Name
Huron Gastroenterology Associates
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Kansas City Research Institute, LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Amici Clinical Research
City
Raritan
State/Province
New Jersey
ZIP/Postal Code
08869
Country
United States
Facility Name
Duke Medical Center; Gen Clinic Research Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wexner Medical Center; Ohio State University; Investigational Drug Services; Pharmacy Department
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1228
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Pinnacle Clinical Research - Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
Texas Digetive Disease Consultants - Austin
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Liver Institute at Renaissance
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
South Texas Research Institute
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
Texas Digestive Disease Consultant - Ft Worth (TDDC - Ft Worth)
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Liver Associates of Texas - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Quality Research Inc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
American Research Corporation Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Clinical Trials of Texas, Inc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Pinnacle Clinical Research - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Texas Digestive Disease Consultants - San Marcos
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219-1901
Country
United States
Facility Name
Hunter Holmes McGuire V.A. Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Hospital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Antwerp University Hospital
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
CHU Hopitaux de Bordeaux
City
CHU Hopitaux De Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06602
Country
France
Facility Name
Hopital Pitie-Salpetriere APHP
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital d'Enfants, Service d?onco-hématologie pédiatrique
City
Vandoeuvre
ZIP/Postal Code
54500
Country
France
Facility Name
Fundacion de Investigacion de Diego
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universtiario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia; Servicio de Anatomia Patologica
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Consorci Hospital General Universitari de València
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe; Servicio de Neurología
City
Valencia
ZIP/Postal Code
46026
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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).
Learn more about this trial
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis
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