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

Non-alcoholic Steatohepatitis Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04171765
• Other study ID #: GC41033
• Status: Terminated
• Phase: Phase 2
• Start date: September 30, 2020
• Est. completion date: January 23, 2023

Study information

• Verified date: April 2024
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: January 23, 2023
• Est. primary completion date: January 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Steatohepatitis

Intervention

Drug:
• Placebo
Participants will receive subcutaneous (SC) placebo matched to BFKB8488A.
• BFKB8488A
Participants will receive subcutaneous (SC) BFKB8488A.

Locations

Country	Name	City	State
Belgium	Hospital Erasme	Bruxelles
Belgium	Antwerp University Hospital	Edegem
Belgium	Universitair Ziekenhuis Gent	Gent
France	CHU Hopitaux de Bordeaux	CHU Hopitaux De Bordeaux
France	Hospices Civils de Lyon	Lyon
France	CHU de Nice	Nice
France	Hopital Pitie-Salpetriere APHP	Paris
France	Hôpital d'Enfants, Service d?onco-hématologie pédiatrique	Vandoeuvre
Puerto Rico	Fundacion de Investigacion de Diego	San Juan
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universtiario Virgen del Rocio	Sevilla
Spain	Consorcio Hospital General Universitario de Valencia	Valencia
Spain	Hospital Clinico Universitario de Valencia; Servicio de Anatomia Patologica	Valencia
Spain	Hospital Universitari i Politecnic La Fe; Servicio de Neurología	Valencia
United States	Pinnacle Clinical Research - Austin	Austin	Texas
United States	Gastroenterology Associates, LLC	Baton Rouge	Louisiana
United States	Walter Reed Army Medical Center	Bethesda	Maryland
United States	Excel Medical Research	Boca Raton	Florida
United States	Texas Digetive Disease Consultants - Austin	Cedar Park	Texas
United States	Arizona Liver Health - Chandler	Chandler	Arizona
United States	Gregory Wiener, MD	Chula Vista	California
United States	Wexner Medical Center; Ohio State University; Investigational Drug Services; Pharmacy Department	Columbus	Ohio
United States	Avant Research Associates, LLC	Crowley	Louisiana
United States	Cullman Clinical Trials	Cullman	Alabama
United States	Duke Medical Center; Gen Clinic Research Ctr	Durham	North Carolina
United States	Liver Institute at Renaissance	Edinburg	Texas
United States	South Texas Research Institute	Edinburg	Texas
United States	South Denver Gastroenterology	Englewood	Colorado
United States	Texas Digestive Disease Consultant - Ft Worth (TDDC - Ft Worth)	Fort Worth	Texas
United States	Community Cancer Institute (CCI)	Fresno	California
United States	Liver Associates of Texas - Houston	Houston	Texas
United States	Grand Teton Research Group, PLLC	Idaho Falls	Idaho
United States	Kansas City Research Institute, LLC	Kansas City	Missouri
United States	National Research Inst.	Los Angeles	California
United States	Gastrointestinal Specialists of Georgia, PC	Marietta	Georgia
United States	Premier Research Associate, Inc	Miami	Florida
United States	Arkansas Gastroenterology	North Little Rock	Arkansas
United States	Conquest Clinical Research	Orange	California
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Amici Clinical Research	Raritan	New Jersey
United States	Hunter Holmes McGuire V.A. Medical Center	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	American Research Corporation Inc.	San Antonio	Texas
United States	Clinical Trials of Texas, Inc	San Antonio	Texas
United States	Pinnacle Clinical Research - San Antonio	San Antonio	Texas
United States	Quality Research Inc	San Antonio	Texas
United States	UC San Diego Airway Research and Clinical Trials Center	San Diego	California
United States	Texas Digestive Disease Consultants - San Marcos	San Marcos	Texas
United States	National Research Institute - Panorama City	Santa Monica	California
United States	Covenant Research	Sarasota	Florida
United States	Arizona Liver Health - Tucson	Tucson	Arizona
United States	Orange Grove Family Practice	Tucson	Arizona
United States	Huron Gastroenterology Associates	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  France,  Puerto Rico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Proportion of Participants With Improvement in Liver Histology From Baseline and no Worsening of Fibrosis at Week 52		Week 52
Secondary	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