This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate mofetil (MMF)/mycophenolic acid (MPA) with placebo plus MMF/MPA in participants with proliferative LN.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Diagnosis of Systemic Lupus Erythematosus (SLE), according to current American College of Rheumatology (ACR) criteria
Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV LN as evidenced by renal biopsy performed within 6 months prior to or during screening. Participants may co-exhibit Class V disease in addition to either Class III or Class IV disease
Proteinuria (urine protein to creatinine ratio) greater than (\>) 1.0
For women who are not postmenopausal (greater than or equal to \[\>/=\] 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of less than (\<) 1 percent (%) per year, during the treatment period and for at least 18 months after the last dose of study drug
For men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \<1% per year during the treatment period and for at least 12 months after the last dose of study drug and agreement to refrain from donating sperm during this same period

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
Presence of rapidly progressive glomerulonephritis
Severe renal impairment as defined by estimated Glomerular Filtration Rate (GFR) \<30 milliliters per minute (mL/min) or the need for dialysis or renal transplant
Greater than 50% of glomeruli with sclerosis on renal biopsy
Treatment with cyclophosphamide or calcineurin inhibitors within the 3 months prior to randomization
Unstable disease with thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions
History of severe allergic or anaphylactic reactions to monoclonal antibodies or known hypersensitivity to any component of the obinutuzumab infusion
Significant or uncontrolled medical disease in any organ system not related to SLE or LN, which, in the investigator's opinion, would preclude participant participation
Concomitant chronic conditions, excluding SLE, (e.g., asthma, Crohn's disease) that required oral or systemic steroid use in the 52 weeks prior to screening
Previous treatment with an anti-cluster of differentiation (CD20)-targeted therapy within 12 months
Previous treatment with a biologic B-cell-targeted therapy (other than anti-CD20) within 6 months of randomization
Known intolerance to MMF or MPA

Intervenciones

drug

Mycophenolate Mofetil/Mycophenolic Acid

MMF/MPA will be administered as per schedule specified in the respective arm.

drug

Obinutuzumab

Obinutuzumab will be administered as per schedule specified in the respective arm.

other

Placebo

Placebo matching to obinutuzumab will be administered as per schedule specified in the respective arm.

drug

Methylprednisolone

Methylprednisolone IV will be administered as per schedule specified in the respective arm.

drug

Prednisone

Prednisone will be administered as per schedule specified in the respective arm.

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Mycophenolate Mofetil/Mycophenolic Acid

Obinutuzumab

Placebo

Methylprednisolone

Prednisone

Ubicaciones

Cemic; Haematology

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

Organizacion Medica de Investigacion

Patrocinadores