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

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

Patrocinadores

Patrocinador principal: Genentech, Inc.

Fuente Genentech, Inc.
Resumen breve

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

Estado general Recruiting
Fecha de inicio September 30, 2020
Fecha de Terminación May 30, 2022
Fecha de finalización primaria March 15, 2022
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Proportion of Participants with NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52 Week 52
Resultado secundario
Medida Periodo de tiempo
Change from Baseline in Hepatic Fat Fraction as Assessed by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at Week 52 Week 52
Proportion of Participants with Improvement in Liver Histology 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 Week 52
Percentage of Participants with Adverse Events Week 58
Serum Concentration of BFKB8488A At pre-defined intervals from baseline to Week 58
Percentage of Participants with Anti-Drug Antibodies Week 58
Inscripción 260
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Placebo

Descripción: Participants will receive subcutaneous (SC) placebo matched to BFKB8488A.

Tipo de intervención: Drug

Nombre de intervención: BFKB8488A

Descripción: Participants will receive subcutaneous (SC) BFKB8488A.

Elegibilidad

Criterios:

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 or loss > 5% within 3 months prior to randomization

- History of liver transplantation

- Current or history of significant alcohol consumption

Género: All

Edad mínima: 18 Years

Edad máxima: 75 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Clinical Trials Study Director Hoffmann-La Roche
Contacto general

Apellido: Reference Study ID Number: GC41033 www.roche.com/about_roche/roche_worldwide.htm

Teléfono: 888-662-6728 (U.S. and Canada)

Email: [email protected]

Ubicación
Instalaciones: Estado:
Central Research Associates Inc | Birmingham, Alabama, 35205, United States Withdrawn
Cullman Clinical Trials | Cullman, Alabama, 35055, United States Recruiting
Arizona Liver Health - Chandler | Chandler, Arizona, 85224, United States Recruiting
Arizona Liver Health - Tucson | Tucson, Arizona, 85711, United States Recruiting
Arkansas Gastroenterology | North Little Rock, Arkansas, 72117, United States Recruiting
Gregory Wiener, MD | Chula Vista, California, 91910, United States Recruiting
Community Cancer Institute (CCI) | Fresno, California, 93720, United States Recruiting
National Research Inst. | Los Angeles, California, 90057, United States Recruiting
National Research Inst. | Los Angeles, California, 90057, United States Not yet recruiting
UC San Diego Airway Research and Clinical Trials Center | San Diego, California, 92103, United States Not yet recruiting
National Research Institute - Panorama City | Santa Monica, California, 90402, United States Recruiting
South Denver Gastroenterology | Englewood, Colorado, 80113, United States Recruiting
Excel Medical Research | Boca Raton, Florida, 33434, United States Recruiting
Bioclinica Research | Orlando, Florida, 32806, United States Withdrawn
Covenant Research | Sarasota, Florida, 34240, United States Recruiting
Gastrointestinal Specialists of Georgia, PC | Marietta, Georgia, 30060, United States Recruiting
Gastroenterology Associates, LLC | Baton Rouge, Louisiana, 70809, United States Recruiting
Walter Reed Army Medical Center | Bethesda, Maryland, 20889-0001, United States Not yet recruiting
Huron Gastroenterology Associates | Ypsilanti, Michigan, 48197, United States Recruiting
HealthPartners | Saint Paul, Minnesota, 55130, United States Not yet recruiting
Kansas City Research Institute, LLC | Kansas City, Missouri, 64131, United States Recruiting
Duke Medical Center; Gen Clinic Research Ctr | Durham, North Carolina, 27710, United States Not yet recruiting
Wexner Medical Center; Ohio State University; Investigational Drug Services; Pharmacy Department | Columbus, Ohio, 43210-1228, United States Not yet recruiting
University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania, 15213, United States Recruiting
Pinnacle Clinical Research - Austin | Austin, Texas, 78746, United States Recruiting
Texas Digetive Disease Consultants - Austin | Cedar Park, Texas, 78613, United States Recruiting
Liver Institute at Renaissance | Edinburg, Texas, 78539, United States Recruiting
South Texas Research Institute | Edinburg, Texas, 78539, United States Recruiting
Texas Digestive Disease Consultant - Ft Worth (TDDC - Ft Worth) | Fort Worth, Texas, 76104, United States Recruiting
Liver Associates of Texas - Houston | Houston, Texas, 77030, United States Recruiting
Quality Research Inc | San Antonio, Texas, 78209, United States Recruiting
American Research Corporation Inc. | San Antonio, Texas, 78215, United States Recruiting
Clinical Trials of Texas, Inc | San Antonio, Texas, 78229, United States Not yet recruiting
Pinnacle Clinical Research - San Antonio | San Antonio, Texas, 78229, United States Recruiting
Texas Digestive Disease Consultants - San Marcos | San Marcos, Texas, 78666, United States Recruiting
Hunter Holmes McGuire V.A. Medical Center | Richmond, Virginia, 23249, United States Recruiting
Virginia Commonwealth University | Richmond, Virginia, 23298, United States Not yet recruiting
Hospital Erasme | Bruxelles, 1070, Belgium Not yet recruiting
Antwerp University Hospital | Edegem, 2650, Belgium Not yet recruiting
Universitair Ziekenhuis Gent | Gent, 9000, Belgium Not yet recruiting
CHU Hopitaux de Bordeaux | CHU Hopitaux De Bordeaux, 33000, France Not yet recruiting
Hospices Civils de Lyon | Lyon, 69004, France Not yet recruiting
CHU de Nice | Nice, 06602, France Not yet recruiting
Hopital Pitie-Salpetriere APHP | Paris, 75013, France Not yet recruiting
Hôpital d'Enfants, Service d'onco-hématologie pédiatrique | Vandoeuvre, 54500, France Not yet recruiting
Fundacion de Investigacion de Diego | San Juan, 00927, Puerto Rico Not yet recruiting
Ubicacion Paises

Belgium

France

Puerto Rico

United States

Fecha de verificación

July 2020

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Condición Examinar
Número de brazos 6
Grupo de brazo

Etiqueta: Fixed Dose: Placebo

Tipo: Placebo Comparator

Descripción: Participants will receive a fixed dose of placebo matched to BFKB8488A.

Etiqueta: Individualized Dose: Placebo

Tipo: Placebo Comparator

Descripción: Participants will received a dose of placebo matched to BFKB8488A.

Etiqueta: Fixed Dose: BFKB8488A Dose A

Tipo: Experimental

Descripción: Participants will receive BFKB8488A.

Etiqueta: Fixed Dose: BFKB8488A Dose B

Tipo: Experimental

Descripción: Participants will receive BFKB8488A.

Etiqueta: Fixed Dose: BFKB8488A Dose C

Tipo: Experimental

Descripción: Participants will receive BFKB8488A.

Etiqueta: Individualized Dose: BFKB8488A

Tipo: Experimental

Descripción: Participants will receive increasing doses of BFKB8488A up to the highest tolerated dose .

Acrónimo BANFF
Datos del paciente Yes
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Double (Participant, Care Provider)

Fuente: ClinicalTrials.gov