2024-519985-35-00招募中2 期
Obinutuzumab for systemic lupus erythematosus pure membranous nephropathy: a phase II trial (OBLUMEN)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 34
- 主要终点
- At W52 after the first obinutuzumab infusion : Complete Renal Response (CRR) AND No intercurrent event
研究概览
简要总结
To assess, in patients with pure class V lupus nephritis, the efficacy of obinutuzumab to reach complete renal response as defined by 2024 international KDIGO guidelines, 52 weeks after the first obinutuzumab infusion
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 75 years old included
- •Diagnosis of SLE fulfilling the 2019 EULAR/ACR classification criteria (score ≥ 10)
- •Pure class V lupus nephritis, defined on a renal biopsy sample following the ISN/RPS 2003 criteria AND - Nephrotic range proteinuria (UPCr or UACr > 3 g/g) at screening visit OR - Uncontrolled proteinuria after at least 3 months of well-conducted anti-proteinuric therapy [UPCR> 1 g/g despite maximal or maximally tolerated dose of ACEi or ARB + SGLT2i therapy +/- diuretic therapy] and up to 12 months after pure class V lupus nephritis diagnosis.
- •For women of childbearing age, agreement to remain abstinent (refrain from heterosexual intercourse) or willingness to use appropriate and effective contraception, as recommended when using obinutuzumab (18 months after last infusion)
- •Signature of informed consent
- •French social security affiliation (beneficiary or legal)
- •Time interval between kidney biopsy showing pure class V LN and baseline visit of no more than 12 months
排除标准
- •Ongoing treatment (induction or maintenance) for proliferative LN (class III-A or IV-A)
- •Receipt of any of the following excluded therapies: - Any anti-CD20 therapy such as rituximab, ocrelizumab, or ofatumumab less than 6 months prior to screening or during screening. If an anti-CD20 therapy has been received between 6 and 12 months prior to screening, the peripheral CD19+ B-cell count by flow cytometry must be > 25 cells/µL - Cyclophosphamide, tacrolimus, ciclosporin, mycophenolate mofetil, pulse methylprednisolone or voclosporin during the 2 months prior to screening or during screening. Patients maintained on low-dose corticosteroids (<10 mg/day prednisone equivalent) for a prolonged period as part of the management of a previous and resolved flare are eligible for trial participation. - Any biologic therapy (other than anti-CD20) such as, but not limited to, belimumab, ustekinumab, anifrolumab, secukinumab, or atacicept during the 2 months prior to screening or during screening - Oral inhibitors of Janus-associated kinase (JAK), Bruton’s tyrosine kinase (BTK), or tyrosine kinase 2 (TYK2), including baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or fenebrutinib or any investigational agent during the 2 months prior to screening or during screening - Any live vaccine during the 28 days prior to screening or during screening
- •Contraindication to the use of obinutuzumab, its premedication drugs or hypersensitivity to its excipients
- •Fewer than 10 non-sclerosed glomeruli analyzable on renal biopsy establishing the diagnosis of pure class V lupus nephritis
- •Ongoing pregnancy or breastfeeding women
- •Active bacterial, viral or fungal infection requiring treatment, including active hepatitis B infection (HBsAg-positive with detectable HBV DNA)
- •Unexplained fever
- •Pre-existing neutropenia (absolute neutrophil count <1.5 × 10⁹/L) or other clinically significant haematological abnormality (e.g., platelet count <100 × 109/L), given the increased risk of severe or febrile neutropenia with obinutuzumab.
- •History of progressive multifocal leukoencephalopathy (PML), or current unexplained neurological signs or symptoms suggestive of PML.
- •Need for a live attenuated vaccine that cannot be deferred until after B-cell reconstitution
- •CKD stage 4 or 5, defined as eGFR <30 ml/min/1.73m2 according to CKD-EPI creatinine equation measured two times in an interval of 3 months (to be dissociated from acute kidney injury).
- •Obsolescence of more than 60% of glomeruli or tubulo-interstitial scarring of more than 60% on kidney biopsy
- •Patients with a previously documented kidney disease causing proteinuria (> 0.3 g/g or > 0.3 g/day) more than 1 year prior to the diagnosis of pure class V LN.
- •Exclusion of primary membranous nephropathy, defined by positive anti-PLA2R antibodies on serum and/or glomerular PLA2R staining on kidney biopsy
- •Patients already included in an interventional study (RIPH1, clinical investigation or clinical trial)
- •Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
- •Negativity for anti-nuclear antibodies (< 1/80) on immunofluorescence assay
- •Severe extra-renal (i.e but not limited to : cardiac, central nervous system, pulmonary, enteric) lupus flare requiring high dose (> 1 mg/kg/day) corticosteroids.
结局指标
主要结局
At W52 after the first obinutuzumab infusion : Complete Renal Response (CRR) AND No intercurrent event
At W52 after the first obinutuzumab infusion : Complete Renal Response (CRR) AND No intercurrent event
次要结局
- To assess the proportion of patients that are free from corticosteroids at W52
- To assess the quality of life of patients at W52
- To quantify adverse events, serious adverse events, and adverse events of special interest (neutropenia, new cancer, infusion related events, infections) between the first obinutuzumab infusion and W52.
- To quantify the proportion of patient with no-kidney response (NKR), partial renal response (PRR), complete renal response (CRR) and renal relapses without any intercurrent event during follow-up at W52.
- To quantify the proportion of patients reaching immunologic remission (normalization C3 and C4 levels and negativation of anti-dsDNA) and the number of renal and extrarenal flares during follow-up at W52.
研究者
Dr BROUSSE Romain
Scientific
Assistance Publique Hopitaux De Paris
研究点 (34)
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