A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Participants With Primary Progressive Multiple Sclerosis (FENtrepid)
Type of Study/Intervention
Form of MS
Primary Progressive MS
A study to evaluate the efficacy and safety of fenebrutinib on disability progression in adult participants with Primary Progressive Multiple Sclerosis (PPMS).
– 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.
– 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 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.
Anticipated start date
Royal Melbourne Hospital, Parkville, VIC
STUDY COORDINATOR: Katherine.Fazzolari@mh.org.au
Box Hill Hospital , Box Hill , VIC
STUDY COORDINATOR: firstname.lastname@example.org
Liverpool Hospital, Liverpool, NSW
STUDY COORDINATOR: Patience.Murambiwa@health.nsw.gov.au
John Hunter Hospital, New Lambton Heights, NSW
STUDY COORDINATOR: Nicole.Lingard@health.nsw.gov.au
St Vincents Hospital Melbourne, Fitzroy VIC
STUDY COORDINATOR: JUDY.CHIN@svha.org.au
Brain and Mind Centre, Camperdown, NSW
STUDY COORDINATOR: email@example.com
Austin Hospital, Heidelberg, VIC
STUDY COORDINATOR: NCRESS@austin.org.au
Princess Alexandra Hospital, Woolloongabba, QLD
STUDY COORDINATOR firstname.lastname@example.org
You can find further information here.
NSW, QLD, VIC