Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients with Secondary Progressive Multiple Sclerosis
A Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients with Secondary Progressive Multiple Sclerosis
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Clinical Trial Information
Trial Contact: Monserrate, Francheska; Mondragon, Diana; Melendez, Thomas L; Carlo, Charlene S; Colon Morales, Veronica J
Trial Phone: 321-830-7617 ; 3218414717 ; 321.841.6813 ; 321.841.1324 ; 407-687-3769
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IRB No: S25.198.08
Protocol Abbrev: REMASTER
Principal Investigator: Amy (Amparo) Gutierrez, MD, FAAN
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: CLOU064P12301
Treatment: Remibrutinib 100 mg BID v Placebo
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT07225504
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Objective
To demonstrate efficacy of remibrutinib compared to placebo in delaying disability progression based on EDSS.
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Key Eligibility
Age 18-65, diagnosis of SPMS according to the 2017 revised McDonald criteria at Screening, Absence of clinical relapses in 24 months before screening/randomization, EDSS score of 3.0-6.0, evidence of disability progression in the 12 months before screening.
