LOU064: Remibrutinib vs. Teriflunomide
A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib
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Clinical Trial Information
Trial Contact: Carlo, Charlene S; Monserrate, Francheska; Melendez, Thomas L; Mondragon, Diana; Flores-Vega, Mariangelis
Trial Phone: 321.841.1324 ; 321-841-4717 ; 321.841.6813 ; 3218419454 ; 321-841-717
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IRB No: 22.171.08
Protocol Abbrev: LOU064
Principal Investigator: Amy (Amparo) Gutierrez, MD, FAAN
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: CLOU064C12301
Treatment: Teriflunomide (Aubagio) or Remibrutinib
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT05147220
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Objective
To demonstrate if remibrutinib is superior to teriflunomide in reducing the frequency of confirmed relapses
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Key Eligibility
Age 18-55, RMS diagnosis, history of relapse within past two years or 1 active Gd-enhancing lesion within the past year, EDSS 0-5.5, and neurologically staple 1 month prior to screening and randomization
