Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Expanded Disability Status Scale (EDSS) score of 0 - 5.5 at screening
A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria
Ability to complete the 9-hole Peg Test (9-HPT) for each hand in \< 240 seconds
Ability to perform the 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
Completed the 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
Participants randomized to the teriflunomide treatment arm during the DBT phase must undergo the accelerated teriflunomide elimination procedure (ATEP) prior to the first administration of open-label 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
You may not be if
Disease duration of \> 10 years from the onset of symptoms and an EDSS score at screening \< 2.0
Female participants who are pregnant or breastfeeding, or intending to become pregnant
Male participants who intend to father a child during the study
A diagnosis of primary progressive multiple sclerosis (PPMS) or non-active secondary progressive multiple sclerosis (SPMS)
Any known or suspected active infection at screening, including but not limited to a positive screening tests for hepatitis B (HBV) and hepatitis C (HCV), an active or latent or inadequately treated infection with tuberculosis (TB), a confirmed or suspected progressive multifocal leukoencephalopathy (PML)
History of cancer including hematologic malignancy and solid tumors within 10 years of screening
Known presence of other neurological disorders, that could interfere with the diagnosis of MS or assessments of efficacy or safety during the study and clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal (GI) disease
Rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption
Hypoproteinemia
Acute liver disease
Chronic liver disease unless considered stable for \> 6 months
Presence of cirrhosis (Child-Pugh Class A, B, or C) or Gilbert's syndrome
Participants with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia or thrombocytopenia
Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
History of alcohol or other drug abuse within 12 months prior to screening
History of or currently active primary or secondary (non-drug-related) immunodeficiency, including known history of human immunodeficiency virus (HIV) infection
Inability to complete an MRI scan
Adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to screening (inhaled and topical corticosteroids are allowed)
Receipt of a live-attenuated vaccine within 6 weeks prior to randomization
Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period
Chronic liver disease unless considered stable for \> 6 months
