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Test positive, as determined by the central laboratory, for at least one of the following lupus related autoantibodies at the time of screening: antinuclear antibody>/= 1:80, anti-double-stranded deoxyribonucleic acid (dsDNA) antibody, or anti-Smith antibody.

Qualify as having Systemic Lupus Erythematosus (SLE), according to the SLE International Collaborating Clinics (SLICC) Classification Criteria в‰Ґ 12 weeks before the screening visit Evaluar la seguridad y tolerabilidad de BMS-986256 frente a placebo en pacientes con LES activo

Caracterizar el estado de salud comunicado por el paciente en pacientes con LES activo con BMS-986256 Evaluar el efecto ahorrador de esteroides de BMS-986256 frente a placebo en pacientes con LES activo Evaluar la eficacia de BMS-986256 frente a placebo en las medidas de la respuesta clГnica global y especГfica del Гіrgano en pacientes con LES activo Evaluar la eficacia de BMS-986256 frente a placebo usando una medida compuesta de mejora en la actividad del lupus que estГЎ principalmente determinada por el BILAG-2004, en pacientes con LES activo Evaluar la eficacia de BMS-986256 frente a placebo usando una medida compuesta de mejora en la actividad del lupus con reducciГіn de CS y mantenimiento a un nivel bajo en pacientes con LES activo

To assess the safety and tolerability of BMS-986256 versus placebo in participants with active SLE To characterize patient-reported health status in participants with active SLE on BMS-986256 To assess the steroid-sparing effect of BMS-986256 versus placebo in participants with active SLE To assess the efficacy of BMS-986256 versus placebo on measures of global and organ-specific clinical response in participants with active SLE To assess the efficacy of BMS-986256 versus placebo using an alternative composite measure of improvement in lupus activity that is primarily driven by the British Isles Lupus Assessment Group (BILAG), in participants in active SLE To assess the efficacy of BMS-986256 versus placebo using a composite measure of improvement in lupus activity with corticosteroids (CS) reduction and maintenance at a low level in participants with active SLE Evaluar la eficacia de BMS-986256 frente a placebo usando una medida compuesta de mejora en la actividad del lupus que estГЎ principalmente determinada por el SLEDAI, en pacientes con LES activo To assess the efficacy of BMS-986256 versus placebo using a composite measure of improvement in lupus activity that is primarily driven by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), in participants with active SLE LES:enfermedad crГіnica autoinmune en que el sistema inmune ataca sus propios tejidos,causando inflamaciГіn y daГ±o tisular en los Гіrganos afectados (piel,articulaciones,riГ±ones,corazГіn y otros Гіrganos).Дiseases - Immune System Diseases Д®.1.2 Medical condition or disease under investigationДЎ0028395 - Musculoskeletal and connective tissue disordersД¬ondition being studied is a rare disease SLE is a chronic autoimmune disease in which the immune system attacks its own tissues, causing inflammation and tissue damage in the affected organs (skin, joints, kidneys, heart and other organs). Medical condition in easily understood language Medicinal product containing genetically modified organismsД®.1 Medical condition or disease under investigation Immunological medicinal product (such as vaccine, allergen, immune serum) one involving a medical device)Д¬ommittee on Advanced therapies (CAT) has issued a classification for this productД¬ombination product that includes a device, but does not involve an Advanced Therapy The IMP has been designated in this indication as an orphan drug in the CommunityД.3.8 to D.3.10 IMP Identification Details (Active Substances)ДЄctive substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)Д¬ombination ATIMP (i.e.

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IMP to be used in the trial has a marketing authorisation Status of the IMP to be used in the clinical trial Trial is part of a Paediatric Investigation PlanД®MA Decision number of Paediatric Investigation Plan

WHO Universal Trial Reference Number (UTRN) non-technical, languageДЄ Study Evaluating the Efficacy and Safety of BMS-986256 Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)Д®ficacia y seguridad de BMS-986256 en comparaciГіn con placebo en pacientes con lupus eritematoso sistГ©mico activo Title of the trial for lay people, in easily understood, i.e. A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of BMS-986256 in Participants with Active Systemic Lupus Erythematosus.Д®studio fase 2, multicГ©ntrico, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de BMS-986256 en pacientes con lupus eritematoso sistГ©mico activo

Uninstall ctivo