A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Participants With Primary Progressive Multiple Sclerosis
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.
- Multiple Sclerosis, Primary Progressive
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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.
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Double (Participant, Investigator)
- Masking Description
- Sponsor will also be blinded.
|Participants will receive oral fenebrutinib and intravenous (IV) ocrelizumab-matching placebo.||
|Participants will receive intravenous (IV) ocrelizumab and oral fenebrutinib-matching placebo.||
- Hoffmann-La Roche
Study ContactReference Study ID Number: GN41791 http://www.roche.com/about_roche/roche_worldwide.htm
888-662-6728 (U.S. and Canada)