Resumen

El propósito de este estudio es evaluar la eficacia de ustekinumab medida por la reducción de la actividad de la enfermedad en sujetos con lupus eritematoso sistémico (LES) activo, un trastorno crónico del tejido conectivo que puede manifestarse con erupción cutánea, artritis, problemas renales y anemia, entre otras complicaciones.

Descripción detallada

Estudio multicéntrico (con más de un centro de investigación médica), aleatorizado (el fármaco del estudio se asigna al azar), doble ciego (ni el investigador ni el participante conocen el fármaco del estudio), controlado con placebo, de prueba de concepto sobre ustekinumab en participantes con lupus eritematoso sistémico activo. Los participantes serán seleccionados para cumplir todos los criterios de inclusión y ninguno de los criterios de exclusión, y recibirán ustekinumab o placebo junto con medicación de base concomitante. La respuesta de los participantes se evaluará principalmente mediante el Índice de Respuesta al Lupus Eritematoso Sistémico 2000 (SRI-4). La seguridad de los participantes se evaluará a lo largo de todo el estudio.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Subjects must have documented medical history to meet SLICC classification criteria for SLE for a minimum of 3 months prior to first dose
At least 1 well-documented (subject file, referring physician letter, or laboratory result), unequivocally positive, documented test for autoantibodies in medical history including either of the following: ANA, and/or anti-dsDNA antibodies, and/or anti-Smith antibodies
At least 1 unequivocally positive autoantibody test including ANA and/or anti-dsDNA antibodies and/or anti-Smith antibodies detected during screening
At least 1 BILAG A and/or 2 BILAG B domain scores observed during screening prior to first administration of study agent
Demonstrate active disease based on SLEDAI-2K score greater than or equal to (\>=) 6 observed during screening and assessed approximately 2 to 6 weeks prior to randomization. Must also have SLEDAI-2K score \>= 4 for clinical features (ie, SLEDAI excluding laboratory results) at Week 0 prior to the first administration of study agent
Have received a single B cell targeting agent within 3 months prior to first study agent administration; or received more than 1 previous B cell targeting therapy including belimumab or epratuzamab within 6 months prior to first administration of the study agent; or received B cell depleting therapy (eg, rituximab) within 12 months prior to first administration of the study agent or have evidence of continued B-cell depletion following such therapy
Have ever received ustekinumab
Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin that has been treated with no evidence of recurrence for at least 3 months before the first study agent administration and carcinoma in situ of the cervix that has been surgically cured)

Criterios de exclusión

Have other inflammatory diseases that might confound the evaluations of efficacy, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), RA/lupus overlap, psoriasis or active Lyme disease
Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 4 months after receiving the last administration of study agent

Intervenciones

drug

Ustekinumab IV

Weight-range based dosing of approximately 6 mg/kg of ustekinumab intravenously at Week 0.

drug

Placebo Infusion

Placebo intravenously at Week 0.

drug

Placebo SC

Placebo subcutaneously at Weeks 8 and 16.

drug

Ustekinumab SC

Ustekinumab 90 mg subcutaneously every 8 weeks up to Week 40 and up to Week 104 in study extension (for eligible participants)

other

Concomitant Medication

Concomitant treatment (mycophenolate, azathioprine/6-mercaptopurine, methotrexate, hydroxychloroquine and/or chloroquine, oral corticosteroids, NSAIDs, antihypertensive medications, and topical medications) through Week 48, as well as through the study extension although tapering of corticosteroids is encouraged beyond Week 48.

Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, de prueba de concepto, sobre ustekinumab en sujetos con lupus eritematoso sistémico activo

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Ustekinumab IV

Placebo Infusion

Placebo SC

Ustekinumab SC

Concomitant Medication

Ubicaciones

Patrocinadores