| Participants are eligible to be included in the study only if all of the following criteria apply:
Participants who are capable of giving signed informed consent and able tocomplete the study protocol
Participants who are aged 18 to 55 years inclusive at the time of signing Informed
Consent Form
A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria (Thompson et al. 2018) and one of the following:
– At least two documented clinical relapses within the last 2 years or one documented clinical relapse within 12 months of screening (but not within the 30 days prior to screening)
– Documented evidence of the presence of at least one T1 Gd+ lesion on MRI in the 6 months prior to randomization (may include the screening MRI)
Note: RMS may include active secondary progressive MS as defined by Lublin 2014.
Expanded Disability Status Scale (EDSS) at screening from 0 to 5.5 points
For women of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs.
For men: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm
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Participants are excluded from the study if any of the following criteria apply:
Disease duration of >10 years from the onset of symptoms and an EDSS score at screening < 2.0
Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 28 days after the final dose of fenebrutinib. Women of childbearing potential must have a negative serum pregnancy test result at screening and negative urine pregnancy tests at all subsequent visits. If a urine pregnancy test is positive, it must be confirmed by a serum pregnancy test, ideally from the central laboratory.
Men intending to father a child during the study or within 28 days after final dose of study drug
A diagnosis of primary progressive MS or non-active secondary progressive MS
Any known or suspected active infection at screening or baseline (excluding onychomycosis), or any major episode of infection requiring hospitalization or treatment with IV anti-microbials within 8 weeks prior to or during screening or treatment with oral anti-microbials within 2 weeks prior to or during screening
History of progressive multifocal leukoencephalopathy (PML)
History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening
Presence of other neurological disorders, including, but not limited to, the following:
– History of ischemic cerebrovascular disorders (e.g., stroke, transient ischemic attack, spontaneous intracranial hemorrhage, or traumatic intracranial hemorrhage) or ischemia of the spinal cord
– History or known presence of CNS or spinal cord tumor (e.g., meningioma,glioma)
– History or known presence of potential metabolic causes of myelopathy (e.g., untreated vitamin B12 deficiency)
– History or known presence of sarcoidosis. |
Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) |
18 Year(s) |
55 Year(s) |
Both |