Estudio Multicéntrico, de Grupos Paralelos, Doble Ciego, de 2 Brazos, de Fase III para Investigar la Eficacia y Seguridad de Anifrolumab Administrado por Inyección Subcutánea Añadido al Tratamiento Estándar en Comparación con Placebo Añadido al Tratamiento Estándar en Participantes Adultos con Miopatías Inflamatorias Idiopáticas (Polimiositis y Dermatomiositis)

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06455449Tipo: INTERVENTIONALInicio: 20 de jun de 2024Fin estimado: 4 de ago de 2028

Resumen

El propósito de este estudio multicéntrico, aleatorizado, controlado con placebo y doble ciego es evaluar la eficacia y seguridad de anifrolumab subcutáneo en comparación con placebo sobre la actividad global de la enfermedad en participantes con miopatías inflamatorias idiopáticas (MII) de moderadas a graves [polimiositis (PM) o dermatomiositis (DM)] que reciben tratamiento estándar (TE).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Capable of giving informed consent.
years old
Body weight ≥40 kg
Must have "probable" or "definite" diagnosis of PM or DM according to the 2017 ACR/EULAR classification criteria for adult myositis.
Moderate or severe disease activity per core set measurements.
Currently receiving oral prednisone or other polymyositis or dermatomyositis treatments at a stable dose.
No history of active tuberculosis or severe COVID-19.
Male and female participants must follow contraception guidelines.

Criterios de exclusión

Participants with documented inclusion body myositis (IBM), immune mediation necrotizing myositis (IMNM), juvenile myositis (if diagnosed within 10 years prior to signing the ICF), drug-induced myositis, cancer associated myositis, amyopathic DM, and non inflammatory myopathies (eg, muscular dystrophies).
PM and DM patients at a high risk of malignancy.
Participants with rapidly progressive interstitial lung disease.
Participants with severe muscle damage or permanent weakness due to non-PM or non-DM conditions (i.e. stroke) as per the investigator's opinion.
Any history of severe case of herpes zoster infection
History of cancer (except adequately treated basal cell carcinoma or cervical cancer in-situ), immunodeficiency, HIV, HBV, active HCV .
Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.
Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to randomization.
Recent non-opportunistic infection requiring hospitalization or anti-infective treatment.
Recent or concurrent enrollment in another clinical study with an investigational product.
Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding

Intervenciones

combination_product

Anifrolumab (blinded)

Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks

other

Placebo

Matched placebo delivered subcutaneously, once weekly for 52 weeks

combination_product

Anifrolumab (unblinded, open label)

At Week 52, all study participants on anifrolumab or placebo will receive open label anifrolumab once weekly for an additional 52 weeks

Ubicaciones

Research Site

Buenos Aires, Argentina

RECRUITING

Research Site

CABA, Argentina

RECRUITING

Research Site

Ciudad de Buenos Aires, Argentina

RECRUITING

Research Site

Quilmes, Argentina

RECRUITING

Research Site

San Miguel de Tucumán, Argentina

RECRUITING

Patrocinadores

PrincipalAstraZeneca

Contactos

AstraZeneca Clinical Study Information Center

CONTACT

information.center@astrazeneca.com 1-877-240-9479

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.

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