Nervous System Diseases
Conditions
Interventions
Oral Placebo
Sponsors
F. Hoffmann La Roche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ? To evaluate the efficacy of fenebrutinib compared with placebo on the total number of new gadolinium-enhancing T1 MRI lesions | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of fenebrutinib on MRI lesions | — |
Countries
Kenya
Contacts
Public ContactDilraj Sohki
Principal investigator
Outcome results
None listed