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Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis

858 patients around the world

Available in Puerto Rico, Brazil, Argentina, Chile

Sanofi

5Research sites

858Patients around the world

This study is for people with

Multiple sclerosis

Secondary progressive multiple sclerosis

To 60 Years

All Gender

: Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria.
Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013 endorsed by an Adjudication Committee.
Participant must have documented evidence of disability progression observed during the 12 months before screening. Eligibility will be analyzed by an Adjudication Committee.
Absence of clinical relapses for at least 24 months.
The participant must have an EDSS score at screening from 3.0 to 6.5 points, inclusive.
Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

: 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.
History or current 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 sensitivity to any of the study interventions, or components thereof, or has a drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
The participant was previously exposed to frexalimab.

Instituto de Neurología Cognitiva (INECO)

Recruiting

Marcelo Torcuato de Alvear 1632, C1021 Cdad. Autónoma de Buenos Aires, Argentina

L2IP Instituto de Pesquisas Clínicas

Recruiting

SGAS 613, Conj. E Bloco A , Sala 06 - Subsolo , Asa Sul - Brasília/DF, CEP: 70.200-730

Clínica Neurologica e Neurocirurgica de Joinville Ltda

Recruiting

Rua Miguel Couto, 133 – Anita Gabribaldi – Joinville/SC – CEP 89202-190

CPQuali Pesquisa Clínica

Recruiting

Avenida Angélica, 916 Conjunto 506 - São Paulo 01228-000

Jordy Sinapse Medicina LTDA ME

Recruiting

Avenida Sabiá, 418 - Moema/São Paulo, SP - CEP:04515-000

StudyFREVIVA

SponsorSanofi

Conditions

Secondary progressive multiple sclerosis

Requirements

To 60 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06141486