A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Systemic Lupus Erythematosus

CompletadoFase 2ClinicalTrials.gov

ID: NCT03920267Tipo: INTERVENTIONALInicio: 26 de mar de 2019Fin estimado: 21 de mar de 2025

Traducción no disponible, mostrando original

Resumen

The main objective of the trial is to characterize the long-term safety and tolerability of BMS-986165 in subjects with Systemic Lupus Erythematosus (SLE).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Completion of SLE Study (NCT03252587) through the protocol-required treatment period, and currently receiving blinded study drug. Note: If a subject is not receiving blinded study drug due to exceptional circumstances (eg, missed investigational product \[IP\] due to COVID-19 pandemic, delays in study approval, etc), the subject may be allowed to enroll with approval from the BMS Clinical Trial Physician or designee.

Criterios de exclusión

Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or considered unsuitable by the investigator for any other reason
Evidence of active tuberculosis (TB)

Intervenciones

drug

BMS-986165

Specified dose on specified days

Ubicaciones

Clinica Adventista Belgrano

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0125

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0098

Rosario, Santa Fe Province, Argentina

Local Institution - 0091

San Miguel de Tucum, Tucumán Province, Argentina

Local Institution - 0100

CABA, Argentina

Local Institution - 0122

Córdoba, Argentina

Local Institution - 0095

Mendoza, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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