A Phase III, Multicenter, Open-Label, Uncontrolled Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)

ReclutandoFase 3ClinicalTrials.gov

ID: NCT05199688Tipo: INTERVENTIONALInicio: 31 de mar de 2026Fin estimado: 12 de sept de 2029

Traducción no disponible, mostrando original

Resumen

This study will primarily evaluate the pharmacokinetics of satralizumab in pediatric patients aged 2-11 years with anti-aquaporin-4 (AQP4) antibody seropositive neuromyelitis optica spectrum disorder (NMOSD). Efficacy, safety, tolerability, and pharmacodynamics will be evaluated in a descriptive manner, given the small number of patients who will be enrolled in this study.

Elegibilidad

Edad mínima: 2 YearsEdad máxima: 11 YearsSexo: ALL

Criterios de inclusión

Age at screening 2-11 years, inclusive
Body weight at screening \>=10 kg
For female patients of childbearing potential (postmenarchal): agreement to either remain completely abstinent (refrain from heterosexual intercourse) or to use a reliable means of contraception
Diagnosed as having NMOSD with AQP4 antibody seropositive status as defined by the Wingerchuk 2015 criteria Clinical evidence of at least one documented attack (including first attack) in the last year prior to screening
Neurological stability for \>=30 days prior to both screening and baseline
Expanded Disability Status Scale (EDSS) 0 to 6.5
For patients receiving a baseline immunosuppressant treatment and planning to continue on these therapies, treatment must be at stable dose for 4 weeks prior to baseline

Criterios de exclusión

Pregnancy or lactation
Evidence of other demyelinating disease mimicking NMOSD
Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline
Evidence of chronic active hepatitis B or C
Evidence of untreated latent or active tuberculosis (TB)
Receipt of a live or live-attenuated vaccine within 6 weeks prior to baseline
History of severe allergic reaction to a biologic agent

Intervenciones

drug

Satralizumab

Participants will receive satralizumab treatment for a minimum of 48 weeks and then will have the opportunity to enter an optional satralizumab extension (OSE) period.

Ubicaciones

Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan

Ciudad Autonoma Buenos Aires, Argentina

RECRUITING

Clinica Universitaria Reina Fabiola

Córdoba, Argentina

RECRUITING

Patrocinadores

PrincipalHoffmann-La Roche

Contactos

Reference Study ID Number: WN41733 https://forpatients.roche.com/

CONTACT

global-roche-genentech-trials@gene.com 888-662-6728 (U.S.)

Global Medical Information

CONTACT

global.medical_information@roche.com

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Phase III, Multicenter, Open-Label, Uncontrolled Study ... | EligiMed