FREXA SC · EFC18098

Phase 3 study in adults with multiple sclerosis investigating the pharmacokinetics, safety, and clinical and radiological effects of frexalimab. It compares subcutaneous administration versus intravenous administration.

A randomized, phase III, open label study to investigate pharmacokinetics, safety, radiological and clinical effects of subcutaneous frexalimab (SAR441344) compared to intravenous frexalimab in adult participants with multiple sclerosis.

Sponsor: SANOFI

Phase: III

Status: Follow-up

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Public study eligibility criteria

Inclusion

  • Group A (RMS) - The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.
  • Group B (nrSPMS) - The participant must have an EDSS score between 3.0 and 6.5 points, inclusive, at the first visit (Screening Visit).
  • Participants from Group A and Group B are eligible to be included in the study only if all of the following criteria also apply: - Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Group A (RMS) - The participant must have been diagnosed with RMS in accordance with the 2017 revised McDonald criteria.
  • Group A (RMS) - The participant must have an Expanded Disability Status Scale (EDSS) score of ≤5.5 at the first visit (Screening Visit).
  • Group A (RMS) - 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.
  • Group B (nrSPMS) - Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria.
  • Group B (nrSPMS) - The participant must be 18 to 60 years of age, inclusive, at the time of signing the informed consent.
  • Group B (nrSPMS) - The participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013.
  • Group B (nrSPMS) - The participant must have documented evidence of disability progression observed during the 12 months before screening.
  • Group B (nrSPMS) - The participant must have an absence of clinical relapses for at least 24 months.

Exclusion

  • The participant has been diagnosed with primary progressive MS according to the 2017 revision of the McDonald diagnostic criteria.
  • The participant has a history of infection or may be at risk for infection.
  • Fever within 28 days of the Screening Visit
  • 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 antiphospholipid syndrome and any participants requiring antithrombotic treatment.
  • Current hypogammaglobulinemia defined by Ig levels (IgG and/or IgM) below the LLN at screening or a history of primary hypogammaglobulinemia
  • A history or presence of disease that can mimic MS symptoms.
  • The participant has a contraindication for MRI.