Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 3 for:    BFKB8488A

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04171765
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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

Condition or disease Intervention/treatment Phase
Non-alcoholic Steatohepatitis Drug: Placebo Drug: BFKB8488A Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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
Actual Study Start Date : September 30, 2020
Estimated Primary Completion Date : March 15, 2022
Estimated Study Completion Date : May 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Fixed Dose: Placebo
Participants will receive a fixed dose of placebo matched to BFKB8488A.
Drug: Placebo
Participants will receive subcutaneous (SC) placebo matched to BFKB8488A.

Placebo Comparator: Individualized Dose: Placebo
Participants will received a dose of placebo matched to BFKB8488A.
Drug: Placebo
Participants will receive subcutaneous (SC) placebo matched to BFKB8488A.

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.

Experimental: Individualized Dose: BFKB8488A
Participants will receive increasing doses of BFKB8488A up to the highest tolerated dose .
Drug: BFKB8488A
Participants will receive subcutaneous (SC) BFKB8488A.




Primary Outcome Measures :
  1. Proportion of Participants with NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52 [ Time Frame: Week 52 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Proportion of Participants with Improvement in Liver Histology [ Time Frame: Week 52 ]
  3. 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 ]
  4. Percentage of Participants with Adverse Events [ Time Frame: Week 58 ]
  5. Serum Concentration of BFKB8488A [ Time Frame: At pre-defined intervals from baseline to Week 58 ]
  6. Percentage of Participants with Anti-Drug Antibodies [ Time Frame: Week 58 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 or loss > 5% within 3 months prior to randomization
  • History of liver transplantation
  • Current or history of significant alcohol consumption

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04171765


Contacts
Layout table for location contacts
Contact: Reference Study ID Number: GC41033 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
Show Show 51 study locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT04171765    
Other Study ID Numbers: GC41033
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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).

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases