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

F. Hoffmann-La Roche Ltd0 个研究点目标入组 125 人开始时间: 2015年10月30日最近更新: 2024年1月8日

试验速览

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•Age 18-75 years
•Diagnosis of SLE, according to current American College of Rheumatology criteria
•Diagnosis of ISN/RPS 2003 Class III or IV LN as evidenced by renal biopsy performed within 6 months prior to screening. Patients may co-exhibit Class V disease in addition to either Class III or Class IV disease.
•Patients must demonstrate active urinary sediment as evidenced by >=10 red blood cells/high power field or the presence of red cell casts.
•Proteinuria (urine protein to creatinine ratio) >1.0
•For women who are not postmenopausal (>=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 <1% 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 108
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 12

•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 GFR <30 milliliter per minute 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 patient 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
•History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ (except basal cell carcinomas of the skin that have been treated or excised and have resolved)

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