FREXALT · EFC17919

This master protocol includes two phase 3 trials for adults with relapsing forms of multiple sclerosis. The efficacy and safety of frexalimab are evaluated in comparison to teriflunomide under a randomized, double-blind design.

Master protocol of two independent, randomized, double-blind, Phase 3 studies comparing efficacy and safety of frexalimab (SAR441344) to teriflunomide in adult participants with relapsing forms of multiple sclerosis EUDRACT 2023-504358-36

Sponsor: SANOFI

Phase: III

Status: Follow-up

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Public study eligibility criteria

Inclusion

  • * The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria.
  • * The participant has an EDSS score ≤5.5 at the first visit (Screening Visit)
  • * The participant must have at least 1 of the following prior to screening:
  • * ≥1 documented relapse within the previous year OR
  • * ≥2 documented relapses within the previous 2 years, OR
  • * ≥1 documented Gd enhancing lesion on an MRI scan within the previous year.
  • * Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion

  • * The participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria
  • * The participant has a history of infection or may be at risk for infection:
  • * The presence of psychiatric disturbance or substance abuse.
  • * History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment.
  • * Current hypogammaglobulinemia defined by Ig levels below the LLN at Screening or a history of primary hypogammaglobulinemia.
  • * A history or presence of disease that can mimic MS symptoms, such as, but not limited to neuromyelitis optica spectrum disorder, systemic lupus erythematosus, Sjogren's syndrome, acute disseminated encephalomyelitis, and myasthenia gravis.
  • * The participant has had a relapse in the 30 days prior to randomization.
  • * The participant has contraindication for MRI, ie, presence of pacemaker, metallic implants in high risk areas (ie, artificial heart valves, aneurysm/vessel clips), presence of metallic material (eg, shrapnel) in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI scans.
  • The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.