Resumen del Estudio
El Lupus Eritematoso Sistémico (LES) es una enfermedad autoinmune compleja en la que el sistema inmunológico ataca por error a los propios tejidos del cuerpo, causando inflamación y daño en múltiples órganos. Este estudio clínico global de Fase 3 tiene como objetivo evaluar la seguridad y eficacia del medicamento Upadacitinib (actualmente aprobado para otras condiciones reumáticas como la artritis reumatoide) en pacientes adultos que presentan un LES con actividad de moderada a severa. Durante el estudio, que consta de varias etapas y una duración inicial de 52 semanas, se comparará el efecto del medicamento oral frente a un placebo. Los investigadores medirán si el tratamiento logra reducir significativamente la actividad de la enfermedad y mejorar la calidad de vida de los pacientes, monitoreando rigurosamente cualquier efecto adverso. Es una oportunidad para acceder a una terapia avanzada bajo estricta vigilancia médica en un entorno controlado.
Criterios de Elegibilidad
Resumen de Elegibilidad:Pueden participar adultos con diagnóstico clínico confirmado de Lupus (LES) y presencia de autoanticuerpos, que tengan actividad de la enfermedad de moderada a alta a pesar de estar recibiendo tratamiento estable. No pueden participar pacientes con nefritis lúpica severa reciente, lupus neuropsiquiátrico activo, otras enfermedades del tejido conectivo superpuestas (excepto Síndrome de Sjögren), o infecciones virales graves recientes.
- Clinical diagnosis of systemic lupus erythematosus (SLE) at least 24 weeks prior to screening as defined by the 2019 European Alliance of Associations for Rheumatology (EULAR)/ American College of Rheumatology (ACR) classification criteria for SLE.
- At Screening, must have at least one of the following:
- antinuclear antibody (ANA) positive (titer \>= 1:80)
- anti-double stranded deoxyribonucleic acid (dsDNA) positive
- anti-Smith positive
- Hybrid systemic lupus erythematosus disease activity index (hSLEDAI) \>= 6, of which \>= 4 points are clinical (not based on laboratory criteria), independently reviewed by the MCDR at Screening. Clinical hSLEDAI score (not based on laboratory criteria) must be re-confirmed as \>= 4 at the Baseline visit. Lupus headache or organic brain syndrome do not count towards the hSLEDAI points required for eligibility but should be documented on the hSLEDAI if present.
- Physician's Global Assessment (PhGA) \>= 1 during screening period.
- On stable background treatment for \>= 60 days prior to Baseline (with the exception of oral corticosteroid \[OCS\], which must be at a stable dose for \>=14 days prior to Baseline) with
- antimalarial(s) \[hydroxychloroquine \<= 400 mg daily, chloroquine \<= 500 mg daily, quinacrine \<= 100 mg daily\];
- and/or prednisone (or prednisone-equivalent) (\<= 20 mg daily);
- and/or no more than 1 of the following: azathioprine (\<= 150 mg daily), 6-mercaptopurine (\<= 150 mg daily), mycophenolate mofetil (\<= 2 g daily), mycophenolate sodium \<= 1,440 mg/day, leflunomide (\<= 20 mg daily), cyclosporine, tacrolimus, voclosporin (\<= 23.7 mg twice daily), methotrexate (\<= 25 mg weekly), or mizoribine (\<= 150 mg daily).
- Class III/IV lupus nephritis that was treated with induction therapy within the 6 months prior to Screening.
- Active neuropsychiatric SLE (excluding lupus headache) within the 6 months prior to Screening.
- SLE overlap syndromes including, but not limited to, rheumatoid arthritis, systemic sclerosis, polymyositis, dermatomyositis, or mixed connective tissue disease (Sjögren's syndrome is permitted).
- Antiphospholipid syndrome and prior unprovoked venous or arterial thrombosis who are not on stable and adequate anticoagulation.
- Two or more episodes of herpes zoster, or one or more episodes of disseminated herpes zoster or herpes zoster ophthalmicus.
- History of malignancy, except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix.
- Pregnancy, breastfeeding, or considering becoming pregnant during the study.
- Clinically relevant or significant ECG abnormalities at Screening.
- Planned elective surgery that would impact study procedures or assessments through the completion of the Week 52 assessments.