A Phase II, Open-Label Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus

TerminadoFase 2ClinicalTrials.gov

ID: NCT03407482Tipo: INTERVENTIONALInicio: 9 de ene de 2018Fin estimado: 20 de nov de 2019

Traducción no disponible, mostrando original

Resumen

This Phase II, multicenter, open-label extension (OLE) study will evaluate the long-term safety and efficacy of GDC-0853 in participants with systemic lupus erythematosus (SLE) who have completed Study GA30044 (NCT02908100) up to 48 weeks.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 76 YearsSexo: ALL

Criterios de inclusión

Able to comply with the study protocol, in the investigator's judgment
Completion of Study GA30044 up to 48 weeks
Acceptable safety and tolerability during Study GA30044 as determined by the investigator

Criterios de exclusión

Met protocol-defined treatment-stopping criteria during Study GA30044
An adverse event in Study GA30044 that required permanent discontinuation of study drug
In the opinion of the investigator, any new, significant, uncontrolled comorbidity or new clinical manifestation (related to SLE or not) that requires medications not allowed in this protocol; or could put the participant at undue risk from a safety perspective
Any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the participant's participation in the study in the opinion of the investigator in consultation with the Medical Monitor

Intervenciones

drug

GDC-0853

Participants received GDC-0853 at a dose of 200mg, as per the dosing schedule described above.

Ubicaciones

APRILLUS

Buenos Aires, Argentina

Hospital Italiano de La Plata

La Plata, Argentina

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

San Juan, Argentina

Centro Médico Privado de Reumatología

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalGenentech, Inc.

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