A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis

TerminadoFase 3ClinicalTrials.gov

ID: NCT04963270Tipo: INTERVENTIONALInicio: 19 de oct de 2021Fin estimado: 2 de sept de 2024

Traducción no disponible, mostrando original

Resumen

This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in participants with generalized myasthenia gravis (gMG).

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

Signed Informed Consent Form
For adolescent patients: Informed Consent Form for study participation signed by the parents or a legal guardian, and patient assent obtained, as per local requirements
Ability to comply with the study protocol procedures
Confirmed diagnosis of gMG (anti-AChR, anti-MuSK or anti-LRP4 present at screening)
A total MG-ADL score of ≥ 5 points at screening with more than 50% of this score attributed to non-ocular items
MGFA severity Class II-IV
Ongoing gMG treatment at a stable dose
For female patients of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab.

Criterios de exclusión

History of thymectomy within 12 months prior to screening
Ocular MG (MGFA Class I) and myasthenic crisis (MGFA Class V) within the last 3 months prior to screening
Known disease other than gMG that would interfere with the course and conduct of the study
Positive screening tests for hepatitis B virus (HBV) and hepatitis C virus (HCV)
Evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection)
Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the last dose

Intervenciones

drug

Satralizumab

Satralizumab will be administered as a subcutaneous injection

other

Placebo

Satralizumab placebo will be administered as a subcutaneous injection

Ubicaciones

Hospital Italiano

CABA, Argentina

Hospital Ramos Mejía

CABA, Argentina

Hospital Britanico

Ciudad Autonoma Bs As, Argentina

Fundación Scherbovsky

Mendoza, Argentina

INECO Neurociencias Orono

Rosario, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

ColaboradorChugai Pharmaceutical

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