CTRI/2023/06/053819招募中3 期
A randomized, double-blind, parallel group, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy, safety and tolerability of ianalumab on top of standard-of-care therapy in participants with active lupus nephritis (SIRIUS-LN)
ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Adult male and female participants aged 18 years or older at the time of baseline
- •--Weigh at least 35 kg at screening
- •--Have a confirmed clinical diagnosis of SLE according to EULAR/ACR SLE classification criteria
- •--Have a positive anti-nuclear antibody (ANA) test result
- •--Active LN at screening, as defined by meeting the 3 following criteria:
- •---Biopsy within 6 months prior to screening period indicating ISN/RPS class III or IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous LN. If no biopsy was performed within 6 months prior to screening period, a biopsy will need to be performed during the screening period after having met all other inclusion/exclusion criteria.
- •---UPCR =1.0 at Screening
- •---eGFR =25mL/min/1.73
- •--Participants must be currently on, or willing to initiate SoC induction therapy for LN according to the institutional practices using MPA (MMF or enteric-coated MPA sodium
- •--Receipt of at least one dose of pulse methylprednisolone i.v. (500-1000 mg) or equivalent for treatment of current episode of active LN
- •--ANA titer should be =1:80 at screening visit based on central laboratory result
- •--Able to provide signed informed consent
排除标准
- •--Severe renal impairment as defined by i.) Stage 4 Chronic Kidney Disease (CKD), or ii.) presence of oliguria (defined as a documented urine volume <400 mL/24 hrs), or iii.) End-Stage Renal Disease (ESRD) requiring dialysis or transplantation
- •--Sclerosis in >50% of glomeruli on renal biopsy
- •--Use of other investigational drugs within 5 half-lives of enrollment, or within
- •30 days or until the expected pharmacodynamic effect has returned to baseline
- •--Prior use of any B cell depleting therapy within 36 weeks prior to randomization or as long as B cell count <50 cells/µL
- •--Treatment with any of the following within 12 weeks prior to randomization
- •---belimumab, abatacept, TNF-a mAb, immunoglobulins (i.v./s.c.) plasmapheresis
- •---any other immuno-suppressants (i.v. or oral cyclophosphamide, calcineurin inhibitors, JAK inhibitors or other kinase inhibitors)
- •---thalidomide treatment and/or one of the following DMARDs: methotrexate or an imidazole derivative (e.g., azathioprine, mizoribine)
- •--Receipt of more than 3000 mg i.v. pulse methylprednisolone (cumulative dose) within 12 weeks prior to Baseline
- •--History of major organ transplant or hematopoietic stem cell/bone marrow transplant or are due to receive transplantation
- •--Any one of the following laboratory values at screening:
- •---Hemoglobin levels <8.0 g/dL
- •---Platelet count <75 x 103/µL
- •---Absolute neutrophil count (ANC) <1.0 x 103/µL
- •--Active viral, bacterial or other infections requiring systemic treatment at the time of screening, or history of recurrent clinically significant infection or of bacterial infections with encapsulated organisms
- •--History of known intolerance/hypersensitivity to MPA, oral corticosteroids, or any component of the study drug(s) or its excipients
- •--Receipt of live/attenuated vaccine within a 4-week period prior to randomization
- •--History of primary or secondary immunodeficiency, including a positive HIV test result
- •--History of malignancy of any organ system (other than localized basal cell carcinoma or squamous cell carcinoma of the skin or
- •--Any surgical, medical, psychiatric or additional physical condition that may jeopardize participation in this study
- •--Chronic infection with hepatitis B (HBV) or hepatitis C (HCV). Positive serology for hepatitis B surface antigen (HBsAg) excludes the participant.
- •--Evidence of active tuberculosis (TB) infection (after anti-TB treatment, participants with history of TB may become eligible according to national guidelines).
- •--Pregnant or nursing (lactating) women
- •--Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 6 months after stopping of investigational medication
研究者
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