Clinical Trial Details

Trial ID: L0203
Source ID: NCT04171765
Associated Drug: BFKB8488A
Title: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis
Acronym: BANFF
Status: Active, not recruiting
Study Results: No Results Available
Results: --
Conditions: Non-alcoholic Steatohepatitis
Interventions: Drug: Placebo|Drug: BFKB8488A
Outcome Measures: Proportion of Participants with NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52|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
Sponsor/Collaborators: Genentech, Inc.
Gender: All
Age: 18 Years to 75 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 260
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Care Provider)|Primary Purpose: Treatment
Start Date: September 30, 2020
Completion Date: May 30, 2022
Results First Posted: --
Last Update Posted: February 4, 2022
Locations: Cullman Clinical Trials, Cullman, Alabama, United States|Arizona Liver Health - Chandler, Chandler, Arizona, United States|Arizona Liver Health - Tucson, Tucson, Arizona, United States|Arkansas Gastroenterology, North Little Rock, Arkansas, United States|Gregory Wiener, MD, Chula Vista, California, United States|Community Cancer Institute (CCI), Fresno, California, United States|National Research Inst., Los Angeles, California, United States|Conquest Clinical Research, Orange, California, United States|UC San Diego Airway Research and Clinical Trials Center, San Diego, California, United States|National Research Institute - Panorama City, Santa Monica, California, United States|South Denver Gastroenterology, Englewood, Colorado, United States|Excel Medical Research, Boca Raton, Florida, United States|Premier Research Associate, Inc, Miami, Florida, United States|Covenant Research, Sarasota, Florida, United States|Gastrointestinal Specialists of Georgia, PC, Marietta, Georgia, United States|Grand Teton Research Group, PLLC, Idaho Falls, Idaho, United States|Gastroenterology Associates, LLC, Baton Rouge, Louisiana, United States|Avant Research Associates, LLC, Crowley, Louisiana, United States|Walter Reed Army Medical Center, Bethesda, Maryland, United States|Huron Gastroenterology Associates, Ypsilanti, Michigan, United States|Kansas City Research Institute, LLC, Kansas City, Missouri, United States|Amici Clinical Research, Raritan, New Jersey, United States|Duke Medical Center; Gen Clinic Research Ctr, Durham, North Carolina, United States|Wexner Medical Center; Ohio State University; Investigational Drug Services; Pharmacy Department, Columbus, Ohio, United States|University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States|Pinnacle Clinical Research - Austin, Austin, Texas, United States|Texas Digetive Disease Consultants - Austin, Cedar Park, Texas, United States|Liver Institute at Renaissance, Edinburg, Texas, United States|South Texas Research Institute, Edinburg, Texas, United States|Texas Digestive Disease Consultant - Ft Worth (TDDC - Ft Worth), Fort Worth, Texas, United States|Liver Associates of Texas - Houston, Houston, Texas, United States|Quality Research Inc, San Antonio, Texas, 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|Texas Digestive Disease Consultants - San Marcos, San Marcos, Texas, United States|Virginia Commonwealth University, Richmond, Virginia, United States|Hunter Holmes McGuire V.A. Medical Center, Richmond, Virginia, United States|Hospital Erasme, Bruxelles, Belgium|Antwerp University Hospital, Edegem, Belgium|Universitair Ziekenhuis Gent, Gent, Belgium|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|H??pital d'Enfants, Service d'onco-h??matologie p??diatrique, Vandoeuvre, France|Fundacion de Investigacion de Diego, San Juan, Puerto Rico|Hospital Universitari Vall d'Hebron, Barcelona, Spain|Hospital Universtiario Virgen del Rocio, Sevilla, Spain|Hospital Clinico Universitario de Valencia; Servicio de Anatomia Patologica, Valencia, Spain|Consorci Hospital General Universitari de Val??ncia, Valencia, Spain|Hospital Universitari i Politecnic La Fe; Servicio de Neurolog??a, Valencia, Spain
URL: https://ClinicalTrials.gov/show/NCT04171765

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D034 BFKB8488A Biological drug -- KLB inhibitor; Type 1 FGFR antagonist -- Under clinical trials Details
D328 Serine Chemical drug DB00133 SRR Improve insulin resistance Under clinical trials Details