Resumen

El propósito de este estudio aleatorizado, doble ciego, controlado con placebo y de grupos paralelos es determinar la eficacia de frexalimab para retrasar la progresión de la discapacidad y la seguridad de hasta 36 meses de administración doble ciego de la intervención del estudio en comparación con placebo en participantes masculinos y femeninos con EMSP-NR (con edades de 18 a 60 años en el momento de la incorporación). Las personas con diagnóstico de EMSP-NR son elegibles para incorporarse siempre que cumplan todos los criterios de inclusión y ninguno de los criterios de exclusión. Los detalles del estudio incluyen: * Este estudio orientado por eventos finalizará cuando se alcance el número objetivo de eventos cCDP a 6 meses, y se espera que el estudio dure 43 meses desde la aleatorización del primer participante hasta el cierre común del estudio. * El número de visitas programadas será de hasta 25 (incluidas 3 visitas de seguimiento), con una frecuencia de visitas mensual durante los primeros 6 meses y luego cada 3 meses. * Si no se alcanza el número preespecificado de eventos para el cCDP a 6 meses en la V21/S180, las visitas programadas continuarán cada 3 meses.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 60 YearsSexo: ALL

Criterios de inclusión

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.
For patients eligible to be treated with siponimod: 1) does not tolerate it due to side effects or safety reasons, or 2) has failed siponimod treatment due to perceived lack of efficacy, or 3) has declined siponimod treatment.

Criterios de exclusión

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 immunoglobulin levels (IgG and/or IgM) below the lower limits of normal (LLN) at Screening or a history of primary hypogammaglobulinemia. Patients with a history of secondary hypogammaglobulinemia induced by anti-C20 monoclonal antibodies (eg, ocrelizumab, ofatumumab, ublituximab, rituximab) may be considered for study inclusion provided their immunoglobulin levels are within the normal limits (WNL) at time of Screening.
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.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ubicaciones

Investigational Site Number : 0320002

CABA, Buenos Aires, Argentina

ACTIVE_NOT_RECRUITING

Investigational Site Number : 0321010

CABA, Buenos Aires F.D., Argentina

ACTIVE_NOT_RECRUITING

Investigational Site Number : 0320007

CABA, Buenos Aires F.D., Argentina

ACTIVE_NOT_RECRUITING

Investigational Site Number : 0320001

CABA, Buenos Aires F.D., Argentina

ACTIVE_NOT_RECRUITING

Investigational Site Number : 0320003

Rosario, Santa Fe Province, Argentina

ACTIVE_NOT_RECRUITING

Estudio de fase 3, aleatorizado, doble ciego, que compara la eficacia y seguridad de frexalimab (SAR441344) frente a placebo en participantes adultos con esclerosis múltiple secundaria progresiva no recidivante

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Frexalimab

Placebo

MRI contrast-enhancing agents

Ubicaciones

Investigational Site Number : 0320002

Investigational Site Number : 0321010

Investigational Site Number : 0320007

Investigational Site Number : 0320001

Investigational Site Number : 0320003

Patrocinadores

Contactos

Trial Transparency email recommended (Toll free number for US & Canada)