Nervous System Diseases
Conditions
Interventions
Active Comparator teriflunomide
Sponsors
Hoffmann La Roche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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.
Exclusion criteria
Exclusion criteria: -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 PPMS or non-active SPMS. -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). -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. -Rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. -Hypoproteinemia. -Participants with several renal or hepatic disease impairment 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized Relapse Rate (ARR) [ Time Frame: Minimum of 96 weeks ] | — |
Secondary
| Measure | Time frame |
|---|---|
| -Time to onset of composite 12-week confirmed disability progression (cCDP12) [ Time Frame: Minimum of 96 weeks ] -Time to onset of composite 24-week confirmed disability progression (cCDP24) [ Time Frame: Minimum of 96 weeks ] -Time to onset of 12-week confirmed disability progression (CDP12) [ Time Frame: Minimum of 96 weeks ] -Time to onset of 24-week confirmed disability progression (CDP24) [ Time Frame: Minimum of 96 weeks ] -Total Number of T1Gd+ lesions, new and/or enlarging T2-weighted lesions as detected by MRI [ Time Frame: Baseline, Weeks 12, 24, 48 and 96 ] -Percentage Change in Total Brain Volume from Week 24 as assessed by MRI [ Time Frame: From Week 24 to Week 96 ] -Change in Participant-Reported Physical Impacts of Multiple Sclerosis (MS) [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and 96 ] -Measured by the Multiple Sclerosis, 29-Item [MSIS-29] physical scale. -Time to onset of 12-week confirmed 4-point worsening in Symbol Digit Modality Test (SDMT) score [ Time Frame: Minimum of 96 weeks ] -Change from Baseline to Week 48 in the Concentration of Serum Neurofilament Light chain (NfL) [ Time Frame: Up to 48 weeks ] -Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to 3.5 years ] -Plasma Concentrations of fenebrutinib at specified timepoints [ Time Frame: Up to 3.5 years ] | — |
Countries
Kenya
Contacts
Public ContactSaffra Knox
Senior Clinical Operations Lead
Outcome results
None listed