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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

  • Clinical Trial Information

    Trial Contact: Carlo, Charlene S; Monserrate, Francheska; Melendez, Thomas L; Mondragon, Diana; Flores-Vega, Mariangelis

  • 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

  • Objective

    To demonstrate if remibrutinib is superior to teriflunomide in reducing the frequency of confirmed relapses

  • 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