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

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ClinicalTrials.gov Identifier: NCT04171765
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE November 19, 2019
First Posted Date  ICMJE November 21, 2019
Last Update Posted Date April 8, 2021
Actual Study Start Date  ICMJE September 30, 2020
Estimated Primary Completion Date March 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2019)
Proportion of Participants with NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52 [ Time Frame: Week 52 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2019)
  • 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 ]
  • Proportion of Participants with Improvement in Liver Histology [ Time Frame: 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 [ Time Frame: Week 52 ]
  • Percentage of Participants with Adverse Events [ Time Frame: Week 58 ]
  • Serum Concentration of BFKB8488A [ Time Frame: At pre-defined intervals from baseline to Week 58 ]
  • Percentage of Participants with Anti-Drug Antibodies [ Time Frame: Week 58 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis
Official Title  ICMJE 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
Brief Summary This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with non-alcoholic steatohepatitis (NASH).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Non-alcoholic Steatohepatitis
Intervention  ICMJE
  • Drug: Placebo
    Participants will receive subcutaneous (SC) placebo matched to BFKB8488A.
  • Drug: BFKB8488A
    Participants will receive subcutaneous (SC) BFKB8488A.
Study Arms  ICMJE
  • Placebo Comparator: Fixed Dose: Placebo
    Participants will receive a fixed dose of placebo matched to BFKB8488A.
    Intervention: Drug: Placebo
  • Placebo Comparator: Individualized Dose: Placebo
    Participants will received a dose of placebo matched to BFKB8488A.
    Intervention: Drug: Placebo
  • Experimental: Fixed Dose: BFKB8488A Dose A
    Participants will receive BFKB8488A.
    Intervention: Drug: BFKB8488A
  • Experimental: Fixed Dose: BFKB8488A Dose B
    Participants will receive BFKB8488A.
    Intervention: Drug: BFKB8488A
  • Experimental: Fixed Dose: BFKB8488A Dose C
    Participants will receive BFKB8488A.
    Intervention: Drug: BFKB8488A
  • Experimental: Individualized Dose: BFKB8488A
    Participants will receive increasing doses of BFKB8488A up to the highest tolerated dose .
    Intervention: Drug: BFKB8488A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 19, 2019)
260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2022
Estimated Primary Completion Date March 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Belgium,   France,   Puerto Rico,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04171765
Other Study ID Numbers  ICMJE GC41033
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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).
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP