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Trial record 1 of 1 for:    GN41791
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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 : April 29, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Primary Progressive Drug: fenebrutinib Drug: ocrelizumab Drug: placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 946 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Sponsor will also be blinded.
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : October 26, 2020
Estimated Primary Completion Date : October 30, 2025
Estimated Study Completion Date : May 17, 2028

Resource links provided by the National Library of Medicine

Drug Information available for: Ocrelizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: fenebrutinib
Participants will receive oral fenebrutinib and intravenous (IV) ocrelizumab-matching placebo.
 Drug: fenebrutinib
Participants will receive fenebrutinib.

Drug: placebo
Participants will receive fenebrutinib-matching placebo and ocrelizumab-matching placebo.
Active Comparator: ocrelizumab
Participants will receive intravenous (IV) ocrelizumab and oral fenebrutinib-matching placebo.
 Drug: ocrelizumab
Participants will receive ocrelizumab.

Drug: placebo
Participants will receive fenebrutinib-matching placebo and ocrelizumab-matching placebo.


Outcome Measures
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Primary Outcome Measures :
  1. Time to onset of composite 12-week confirmed disability progression (cCDP12) [ Time Frame: Minimum of 120 weeks ]

Secondary Outcome Measures :
  1. Time to onset of composite 24-week CDP (cCDP24) [ Time Frame: Minimum of 120 weeks ]
  2. Time to onset of 12-week CDP (CDP12) [ Time Frame: Minimum of 120 weeks ]
  3. Time to onset of 24-week CDP (CDP24) [ Time Frame: Minimum of 120 weeks ]
  4. Percentage Change in Total Brain Volume assessed by MRI [ Time Frame: From Week 24 to Week 120 ]
  5. 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.

  6. Time to onset of 12-week confirmed 4-point worsening in Symbol Digit Modality Test (SDMT) score [ Time Frame: Minimum of 120 weeks ]
  7. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to 4.5 years ]
  8. Plasma Concentrations of fenebrutinib at specified timepoints [ Time Frame: Up to 4.5 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of PPMS in accordance to the revised 2017 McDonald Criteria (Thompson et al. 2018).
  • Disability progression in the 12 months prior to screening.
  • Expanded Disability Status Scale (EDSS) score from 3.0 to 6.5 inclusive at screening.
  • Pyramidal functional subscore >=2 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) in <150 seconds.
  • 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 for 28 days 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.
Contacts and Locations
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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): NCT04544449


Contacts
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Contact: Reference Study ID Number: GN41791 https://forpatients.roche.com/ 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04544449    
Other Study ID Numbers: GN41791
2019-003919-53 ( EudraCT Number )
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: April 29, 2022
Last Verified: April 2022
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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Ocrelizumab
Immunologic Factors
Physiological Effects of Drugs