Resumen

El propósito de este estudio es evaluar la eficacia clínica, seguridad, FC y FD de múltiples niveles de dosis de ESK-001 en comparación con placebo en pacientes adultos con LES.

Descripción detallada

Este estudio constará de un período de selección de 5 semanas, un período de tratamiento de 48 semanas y un período de seguimiento de 4 semanas, para un total de 57 semanas. Cada participante será aleatorizado para recibir ESK-001 o placebo durante 48 semanas. Se dispondrá de un estudio de extensión abierta para los pacientes que completen el estudio.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

Patients with 6 or more months of SLE according to the 2019 EULAR/ACR criteria, have positive autoantibodies or low complement at screening, and have active SLE as measured by SLEDAI-2K of 6 or more, or 4 or more if joint involvement is present.
Patients need to be on treatment which can be:
A stable dose of oral corticosteroid (≤40 mg/day prednisone or equivalent) for a minimum of 2 weeks prior to signing of the informed consent form (ICF) at the Screening Visit. The dose of oral corticosteroid the patient is taking should not increase between screening and Week 0 (Day 1).
And/or antimalarial treatment (e.g., hydroxychloroquine, chloroquine, quinacrine),
And/or no more than 1 of the following conventional DMARDS:
Azathioprine ≤200 mg/day
Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 g/day
Oral, subcutaneous, or intramuscular (IM) methotrexate ≤20 mg/week.

Criterios de exclusión

Drug-induced SLE or other autoimmune diseases that, in the opinion of the Investigator, are likely to confound efficacy assessments
Active, proliferative lupus nephritis that in the Investigator's opinion may require treatment not allowed by the protocol
Current disease other than SLE that, in the opinion of the Investigator, is likely to interfere with SLE disease activity assessments. Examples include severe fibromyalgia, severe osteoarthritis and severe cardiorespiratory diseases.
Active severe or unstable neuropsychiatric SLE including, but not limited to the following: aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending or transverse myelitis, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; new seizures; cerebellar ataxia; and mononeuritis multiplex.
That would make the patient unable to fully understand the ICF, or
Where, in the opinion of the Principal Investigator, protocol-specified SOC is insufficient and utilization of a more aggressive therapeutic approach not permitted in the protocol, is indicated
Known history of a primary immunodeficiency or an underlying condition such as HIV infection or splenectomy that predisposes the patient to infection
Currently active, clinically significant infection of any kind
Clinically significant chronic infection (eg, osteomyelitis, bronchiectasis) within 8 weeks prior to signing the ICF (chronic fungal nail infections are allowed)
Any infection requiring hospitalization or treatment with IV anti-infectives not completed at least 4 weeks prior to signing the ICF
Any infection requiring oral anti-infectives (including antivirals) within 2 weeks prior to Day 1
Any severe herpes infection at any time prior to Week 0 (Day 1), including, but not limited to, disseminated herpes (ever), herpes encephalitis (ever), recurrent herpes zoster (defined as 2 episodes within 2 years), or ophthalmic herpes (ever)
Active herpes zoster infection within 12 weeks of prior to signing the ICF
Active herpes simplex virus within 4 weeks of Day 1

Ubicaciones

Investigator Site #3012

CABA, Buenos Aires, Argentina

Investigator Site #3001

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Investigator Site #3016

La Plata, Buenos Aires, Argentina

Investigator Site #3009

San Miguel de Tucumán, Tucman, Argentina

Investigator Site #3010

San Miguel de Tucumán, Tucman, Argentina

Investigator Site #3015

San Miguel de Tucumán, Tucumán Province, Argentina

Investigator Site #3023

Buenos Aires, Argentina

Investigator Site #3008

Mendoza, Argentina

Estudio de fase 2, multicéntrico, multinacional, aleatorizado, doble ciego, controlado con placebo para evaluar la seguridad, eficacia y farmacocinética de múltiples niveles de dosis de ESK-001 en pacientes adultos con lupus eritematoso sistémico