Non-inferiority study of frexalimab subcutaneous administration compared to intravenous administration in adult participants with multiple sclerosis.
Key facts
- Where
- Cagliari, Foggia, Milan, Montichiari, Rome és Rozzano, OlaszországSee the 7 sites
- Phase
- 3. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Olaszország
- Azienda Socio Sanitaria Locale N. 8 Di CagliariCagliari, OlaszországNo longer taking part
- Azienda Ospedaliero Universitaria Ospedali RiunitiFoggia, OlaszországNo longer taking part
- IRCCS Foundation Istituto Neurologico Carlo BestaMilan, OlaszországNo longer taking part
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di BresciaMontichiari, OlaszországNo longer taking part
- Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata FonRome, OlaszországNo longer taking part
- San Camillo Forlanini HospitalRome, OlaszországNo longer taking part
- Humanitas Mirasole S.p.A.Rozzano, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sanofi-Aventis Recherche & Developpement
- Trial code
- EU 2024-519304-28-00
- Record updated
- 2026. október 23.
- Original description
To determine the non-inferiority of frexalimab SC administration compared to frexalimab IV administration as measured by pharmacokinetic parameters (part A)Read full original descriptionShow less
A randomized, Phase 3, open-label study to investigate pharmacokinetics, safety, and efficacy of subcutaneous compared to intravenous frexalimab in adult participants with multiple sclerosis.
To determine the non-inferiority of frexalimab SC administration compared to frexalimab IV administration as measured by pharmacokinetic parameters (part A)
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 a history of infection or may be at risk for infection; 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 been diagnosed with primary progressive MS according to the 2017 revision of the McDonald diagnostic criteria; Fever within 28 days of the Screening Visit; The participant has a contraindication for MRI.