A randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis

Trial status: Authorised Time to 3-month confirmed disability progression (3mCDP) on EDSS (key secondary), Time to 6-month confirmed disability improvement (6mCDI) on EDSS (key secondary), Time to 3-month worsening by at least 20% in Timed 25-Foot Walk (T25FW) (key secondary), Time to 3-month worsening by at least 20% in 9-Hole Peg Test (9-HPT) (key secondary), Annualized rate of new or enlarging T2 lesions (key secondary), Percentage of participants with annualized rate of brain atrophy > XX (key secondary), Time to 6-month worsening by at least 4 points in Symbol Digit Modalities Test (SDMT), Adverse events, laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating Scale (C-SSRS) Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS)

Time to 3-month confirmed disability progression (3mCDP) on EDSS (key secondary), Time to 6-month confirmed disability improvement (6mCDI) on EDSS (key secondary), Time to 3-month worsening by at least 20% in Timed 25-Foot Walk (T25FW) (key secondary), Time to 3-month worsening by at least 20% in 9-Hole Peg Test (9-HPT) (key secondary), Annualized rate of new or enlarging T2 lesions (key secondary), Percentage of participants with annualized rate of brain atrophy > XX (key secondary), Time to 6-month worsening by at least 4 points in Symbol Digit Modalities Test (SDMT), Adverse events, laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating Scale (C-SSRS)

Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 635 participants