A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

CompletadoFase 2ClinicalTrials.gov

ID: NCT03845517RENIS: IS003824Tipo: INTERVENTIONALInicio: 18 de abr de 2019Fin estimado: 5 de oct de 2023

Traducción no disponible, mostrando original

Resumen

Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Male and/or female subjects between ≥18 and ≤75 years of age inclusive.
Diagnosis of moderate to severe active Lupus.
Receiving a stable dose of methotrexate, azathioprine, leflunomide, mizoribine, mycophenolate/mycophenolic acid, anti-malarials or corticosteroids.

Criterios de exclusión

Active renal lupus
Severe active central nervous system (CNS) lupus
Have cancer or a history of cancer within 5 years of screening.
Have a history of thrombosis (venous or arterial) or other vascular complications within the last 6 months, or any history of either recurrent thrombosis or a pulmonary embolus.
Active bacterial, viral, fungal, mycobacterial or other infections
Psychiatric condition including recent or active suicidal ideation or behavior
Have active fibromyalgia/myofascial/chronic pain.
Pregnant female subjects; breastfeeding female subjects; females subjects planning to become pregnant during the study; fertile male subjects and WOCBP who are unwilling or unable to use a highly effective method of contraception.

Intervenciones

drug

Placebo

drug

PF-06700841 15 mg

drug

PF-06700841 30 mg

drug

PF-06700841 45 mg

Ubicaciones

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, Tucumán Province, Argentina

Patrocinadores

PrincipalPfizer

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