A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus

CompletadoFase 2ClinicalTrials.gov

ID: NCT03252587Tipo: INTERVENTIONALInicio: 21 de sept de 2017Fin estimado: 28 de oct de 2021

Reumatología

Traducción no disponible, mostrando original

Resumen

This study will investigate BMS-986165 to assess its effects in participants with systemic lupus erythematosus (SLE).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Systemic lupus erythematosus (SLE) disease diagnosed ≥ 24 weeks before the screening visit
Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE
One of the following: elevated antinuclear antibodies (ANA) ≥ 1:80 or positive anti- double-stranded deoxyribonucleic acid (dsDNA) (positive includes indeterminate results) or positive anti-Smith (anti-Sm) as determined by the central laboratory
Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI-2K score ≥ 4 points with joint involvement and/or rash \[score must be confirmed by Central Review Services (CRS)\]
Men and women must agree to follow specific methods of contraception, if applicable

Criterios de exclusión

Drug-induced SLE, certain other autoimmune diseases, and active, severe lupus nephritis
SLE overlap syndromes such as scleroderma and mixed connective tissue disease
Clinically significant abnormalities on chest x-ray or electrocardiogram (ECG)
History of any significant drug allergy

Intervenciones

drug

BMS-986165

Specified dose on specified days

other

Placebo

Specified dose on specified days

Ubicaciones

Local Institution - 0166

Caba, Buenos Aires, Argentina

Local Institution - 0139

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0185

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0136

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0138

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0152

Rosario, Santa Fe Province, Argentina

Local Institution - 0097

San Miguel de Tucum, Tucumán Province, Argentina

Local Institution - 0096

Córdoba, Argentina

Hospital Privado Centro Medico de Cordoba

Córdoba, Argentina

Local Institution - 0137

Mendoza, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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