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

Conditions

Secondary progressive multiple sclerosis

Brief summary

Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS)

Detailed description

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)

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGPlacebo to Remibrutinib (LOU064) film-coated tablets

DRUGLOU064

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS)	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Outcome results

None listed