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A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Participants With Primary Progressive Multiple Sclerosis (FENtrepid)

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ClinicalTrials.gov Identifier: NCT04544449
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : July 9, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE September 4, 2020
First Posted Date  ICMJE September 10, 2020
Last Update Posted Date July 9, 2021
Actual Study Start Date  ICMJE October 26, 2020
Estimated Primary Completion Date May 30, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2020)
Time to onset of composite 12-week confirmed disability progression (cCDP12) [ Time Frame: Minimum of 120 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2020)
  • Time to onset of composite 24-week CDP (cCDP24) [ Time Frame: Minimum of 120 weeks ]
  • Time to onset of 12-week CDP (CDP12) [ Time Frame: Minimum of 120 weeks ]
  • Time to onset of 24-week CDP (CDP24) [ Time Frame: Minimum of 120 weeks ]
  • Percentage Change in Total Brain Volume assessed by MRI [ Time Frame: From Week 24 to Week 120 ]
  • Change from Baseline in Participant-Reported Physical Impacts of Multiple Sclerosis (MS) [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 ]
    Measured by the Multiple Sclerosis Impact Scale, 29-Item [MSIS-29] physical scale.
  • Time to onset of 12-week confirmed 4-point worsening in Symbol Digit Modality Test (SDMT) score [ Time Frame: Minimum of 120 weeks ]
  • Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to 4.5 years ]
  • Plasma Concentrations of fenebrutinib at specified timepoints [ Time Frame: Up to 4.5 years ]
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 And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Participants With Primary Progressive Multiple Sclerosis
Official Title  ICMJE A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Patients With Primary Progressive Multiple Sclerosis.
Brief Summary A study to evaluate the efficacy and safety of fenebrutinib on disability progression in adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible participants will be randomized 1:1 to either daily oral fenebrutinib (or placebo) or intravenous (IV) ocrelizumab (or placebo) in a blinded fashion through an interactive voice or web-based response system (IxRS). Approximately 946 participants will be enrolled and will be recruited globally. Participants who discontinue study medication early or discontinue from the study will not be replaced. The Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Sponsor will also be blinded.
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis, Primary Progressive
Intervention  ICMJE
  • Drug: fenebrutinib
    Participants will receive fenebrutinib.
  • Drug: ocrelizumab
    Participants will receive ocrelizumab.
  • Drug: placebo
    Participants will receive fenebrutinib-matching placebo and ocrelizumab-matching placebo.
Study Arms  ICMJE
  • Experimental: fenebrutinib
    Participants will receive oral fenebrutinib and intravenous (IV) ocrelizumab-matching placebo.
    Interventions:
    • Drug: fenebrutinib
    • Drug: placebo
  • Active Comparator: ocrelizumab
    Participants will receive intravenous (IV) ocrelizumab and oral fenebrutinib-matching placebo.
    Interventions:
    • Drug: ocrelizumab
    • Drug: placebo
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: September 4, 2020)
946
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 17, 2028
Estimated Primary Completion Date May 30, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • A diagnosis of PPMS in accordance to the revised 2017 McDonald Criteria (Thompson et al. 2018).
  • Expanded Disability Status Scale (EDSS) score from 3.0 to 6.5 inclusive at screening.
  • For participants currently receiving proton pump inhibitors (PPIs), H2-receptor antagonists (H2RAs), symptomatic treatment for Multiple Sclerosis (MS) (e.g. fampridine, cannabis) and/or physiotherapy: treatment at a stable dose during the screening period prior to the initiation of study treatment and plans to remain at a stable dose for the duration of study treatment.
  • Ability to complete the 9-Hole Peg Test (9-HPT) for each hand in < 240 seconds.
  • Ability to perform Timed 25-Foot Walk Test (T25FWT).
  • For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs.
  • For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm.

Exclusion Criteria:

  • Any known or suspected active infection at screening, including but not limited to a positive screening tests for Hepatitis B and C, an active or latent or inadequately treated infection with tuberculosis (TB), a confirmed or suspected progressive multifocal leukoencephalopathy (PML).
  • Participants with a previous history of a serious Infusion-Related Reaction (IRR) (Common Terminology Criteria for Adverse Events [CTCAE] Grade >= 4) and/or any hypersensitivity reaction to ocrelizumab.
  • History of cancer including hematologic malignancy and solid tumors within 10 years of screening.
  • Known presence of other neurological disorders, clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease.
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids, immunosuppressants or specific medication that could impact the primary evaluation of the study.
  • History of alcohol or other drug abuse within 12 months prior to screening.
  • Female participants who are pregnant or breastfeeding or intending to become pregnant during the study or 6 or 12 months (as applicable from the local label for ocrelizumab) after final dose of study drug.
  • Male participants intending to father a child during the study or 6 or 12 months (as applicable from the local label for ocrelizumab) after final dose of study drug.
  • Lack of peripheral venous access.
  • Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period.
  • Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization.

OLE Inclusion Criteria:

  • Completed the Double-Blind Treatment (DBT) phase of the study (remaining on study treatment; no other Disease-Modifying Therapy (DMT) administered) and who, in the opinion of the investigator, may benefit from treatment with fenebrutinib.
  • For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs.
  • For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: GN41791 http://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 Argentina,   Australia,   Brazil,   Canada,   France,   Israel,   Peru,   Poland,   Portugal,   Puerto Rico,   Russian Federation,   Spain,   Turkey,   Ukraine,   United States
Removed Location Countries Austria,   Belgium,   Czechia,   Denmark,   Germany,   Greece,   Hungary,   Italy,   Mexico,   New Zealand,   Switzerland,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT04544449
Other Study ID Numbers  ICMJE GN41791
2019-003919-53 ( EudraCT Number )
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 Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date July 2021

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