A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BIIB023 in Subjects With Lupus Nephritis

TerminadoFase 2ClinicalTrials.gov

ID: NCT01499355Tipo: INTERVENTIONALInicio: 1 de jul de 2012Fin estimado: 1 de dic de 2015

Traducción no disponible, mostrando original

Resumen

The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of participants with active, biopsy-proven lupus nephritis. The secondary objectives of this study are to assess the safety and tolerability of BIIB023 compared with placebo in this study population.

Descripción detallada

Participants who complete this study through Week 52 will be offered the option to enter an Extension study under a separate protocol 211LE202 (NCT0193089).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Documented diagnosis of systemic lupus erythematosus (SLE) according to current American College of Rheumatology (ACR) criteria. At least 4 ACR criteria must be documented, 1 of which must be a positive antinuclear antibody (ANA), anti Sm, or anti dsDNA antibody.
Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV lupus nephritis with either active or active/chronic disease, confirmed by biopsy within 3 months prior to Screening. Participants are permitted to have co existing Class V lupus nephritis. If a renal biopsy has not been performed within 3 months of the Screening Visit, one can be performed during the Screening Period after all other eligibility criteria have been confirmed. The local histological diagnosis must be confirmed by the central study pathologist.
Must have proteinuria at Screening (from a 24 hour urine sample collection) defined as urinary protein:creatinine ratio (uPCR) \>1.0 mg/mg.

Criterios de exclusión

Retinitis, poorly-controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE at Screening
Estimated glomerular filtration rate (eGFR) \<30 mL/min per 1.73 m\^2 (calculated using the abbreviated Modification of Diet in Renal Disease equation) or the presence of oliguria or end-stage renal disease requiring dialysis or transplantation
Subjects requiring dialysis within 12 months prior to Screening
History of renal transplant
Treatment with any biologic B-cell-depleting therapy (e.g., anti-CD20 \[rituximab\], anti-CD22 \[epratuzumab\], anti-BLyS/B-cell activating factor \[e.g., briobacept, belimumab\] therapy), or TACI-Ig within 12 months prior to Run-in Day 1.

Intervenciones

biological

BIIB023

biological

Placebo

drug

mycophenolate mofetil

titrated to a target daily dose of 2 g (1 g twice daily)

drug

oral corticosteroids

oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day

Ubicaciones

Research Site

Capital Federal, Ciudad Autonoma Buenos Aires, Argentina

Research Site

Córdoba, Córdoba Province, Argentina

Research Site

San Miguel de Tucumán, Tucumán Province, Argentina

Research Site

Ciudad Autonoma Buenos Aires, Argentina

Research Site

La Plata, Argentina

Research Site

San Juan, Argentina

Research Site

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalBiogen

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