Resumen

Estudio para evaluar la farmacocinética (PK), farmacodinámica (PD), eficacia y seguridad de anifrolumab en niños con lupus eritematoso sistémico (LES) activo moderado a grave.

Descripción detallada

Este estudio tiene como objetivo caracterizar la farmacocinética, farmacodinámica, eficacia y seguridad de la solución de anifrolumab para infusión comparada con la solución de placebo para infusión en participantes pediátricos con lupus eritematoso sistémico activo grave que se encuentran bajo terapia de fondo estándar de atención. La duración del estudio para un participante será de aproximadamente 116 semanas, lo que incluye: * Período de selección de hasta 30 días. * La Parte A consiste en un período farmacocinético de cuatro semanas, doble ciego, controlado con placebo y aleatorizado. * La Parte B es un período de seguridad/eficacia doble ciego, controlado con placebo y aleatorizado de 48 semanas (para participantes que pasan de la Parte A) o 52 semanas (para participantes de novo). * La Parte C es un período de extensión abierto de 52 semanas. * La Parte D es un período de seguimiento de seguridad. Una visita de seguridad a las 12 semanas tras la última dosis.

Elegibilidad

Edad mínima: 5 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

Participant's parent/caregiver/legally authorized representative and participant (if required per local country regulation) capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Informed assent is to be provided by the participant per local country regulation.
Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) criteria for at least 3 months prior to signing the ICF.
Participant should meet all of following tuberculosis (TB) criteria:
A. No signs or symptoms of active TB B. No medical history or past physical examinations suggestive of active TB C. No recent contact with a person with active TB or if there has been such contact, referral to a TB specialist for evaluation and initiation of treatment for latent TB, if warranted, prior to the first administration of study intervention in accordance with local SoC D. No history of latent TB without documented completion of treatment prior to initial screening visit
Female participants of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at randomization.
Female participants of childbearing and male participants must adhere to the contraception methods.

Criterios de exclusión

Known diagnosis of an IFN-mediated autoinflammatory interferonopathy.
History of, or current diagnosis of, clinically significant non-SLE-related vasculitides.
In participants aged 11 years and above: history or evidence of suicidal ideation.
History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF.
Any positive result on screening for human immunodeficiency virus.
Active hepatitis B surface antigen OR hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody and detectable HCV ribonucleic acid (RNA) or any active or recent case of Herpes Zoster infection.
Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.
History of severe COVID-19 infection requiring hospitalization, intensive care unit care, or assisted ventilation or any prior COVID-19 infection with unresolved sequelae. Any mild/asymptomatic COVID-19 infection (laboratory confirmed or suspected based on clinical symptoms).
Prior use of anifrolumab.
Prior treatment with directly acting cytotoxic B-cell depleting therapeutics (eg, rituximab) \< 26 weeks prior to ICF signature.
Blood transfusion or receipt of blood products except albumin within 4 weeks prior to signing the ICF.

Intervenciones

biological

Anifrolumab

Participants will receive anifrolumab via IV infusion.

drug

Placebo

Participants will receive matching placebo via IV infusion

Ubicaciones

Research Site

Buenos Aires, Argentina

WITHDRAWN

Research Site

Córdoba, Argentina

RECRUITING

Research Site

Rosario, Argentina

RECRUITING

Research Site

San Miguel de Tucumán, Argentina

NOT_YET_RECRUITING

Patrocinadores

PrincipalAstraZeneca

Contactos

AstraZeneca Clinical Study Information Center

CONTACT

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