Efficacy and safety study of frexalimab (SAR441344) in adults with relapsing forms of multiple sclerosis
Key facts
- Where
- Győr és Kaposvár, MagyarországSee the 2 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?
- Do you take blood thinners, or have you had a blood clotting problem?
Where in Magyarország
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato KorhazGyőr, MagyarországNo longer taking part
- Somogy Vármegyei Kaposi Mór Oktató KórházKaposvár, MagyarországNo 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 2023-504358-36-00
- Record updated
- 2026. október 28.
- Original description
To assess the efficacy of frexalimab compared to a daily dose of 14 mg teriflunomide measured by ARR in participants with relapsing forms of MSRead full original descriptionShow less
Randomized, double-blind, Phase 3 study comparing efficacy and safety of frexalimab (SAR441344) to teriflunomide in adult participants with relapsing forms of multiple sclerosis
To assess the efficacy of frexalimab compared to a daily dose of 14 mg teriflunomide measured by ARR in participants with relapsing forms of MS
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 had a relapse in the 30 days prior to randomization; 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 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 participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria.