A randomized, treatment open-label, dose-blinded parallelgroup, three arm, proof-of-concept clinical trial toinvestigate the efficacy and safety of LNP023 comparedwith rituximab in the treatment of subjects with idiopathic membranous nephropathy

ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 2 期
状态: 招募中
发起方

研究概览入排标准研究者记录与标识符相似试验

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

•1. Written informed consent must be obtained before any study assessment is performed.
•2. Able to communicate well with the investigator, to understand and comply with the
•requirements of the study.
•3. Female or male adult (more than or equal to 18 years) subjects at screening visit with a diagnosis of idiopathic (primary) MN confirmed by renal biopsy within 24 months prior to screening. A renal biopsy may be taken at any time during the run-in period to confirm the diagnosis of MN
•and facilitate subject eligibility, if the most recent biopsy was performed greater than 24 months prior to the screening visit.
•4. Anti-PLA2R antibody titer of more than or equal to 100 RU/mL at screening visit (based on the EuroImmun ELISA test).
•5. Less than or equal to 50% reduction in both anti-PLA2R level and 24h urine protein between first measurement at screening or run-in visit and baseline.
•6. Urine protein more than or equal to 3.5 g per 24h at run-in and baseline visits.
•7. Estimated GFR (using the CKD-EPI formula)more than or equal to 45 mL per min per 1.73 m2 at screening visit.
•8. Weight of at least 35 kg and body mass index (BMI) of at least 15 kg per m2.
•9. Receiving stable dose at the maximum recommended dose according to local guidelines or
•maximum tolerated dose of ACEi and/or ARB and/or statins and/or diuretics. The dose of ACEi or ARB must be stable for at least 8 weeks prior to Day 1, defined as <25% dose change over this 8 week period.
•10. Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus
•influenzae (in accordance with local guidelines) at least 28 days prior to Day 1 and no
•longer than 5 years prior to Day 1.
•11. Subject agrees to collect 24h urine sample at home and to bring it to the investigational
•site at specific visits.

排除标准

•1. Secondary causes of MN, e.g. systemic autoimmune diseases, solid or haematological
•malignancies, infections or chronic intake of drugs (e.g. gold salts, NSAIDs, penicillamines)
•2. Diagnostic renal biopsy showing evidence of crescent formation in glomeruli, suggestive
•of an alternative or additional diagnosis to primary idiopathic MN.
•3. Previous treatment with B-cell depleting or B-cell modifying agents such as, but not
•limited to rituximab, belimumab, daratumomab or bortezomib.
•4. Previous treatment with immunosuppressive agents such as cyclophosphamide, chlorambucil, mycophenolate mofetil (or equivalent), cyclosporine, tacrolimus or azathioprine within 90 days prior to Day 1. Low dose systemic corticosteroid therapy is permitted, though the subject should have been on stable dose equivalent to less than or equal to 10 mg prednisolone for at least 90 days prior to Day 1
•5. Administration of any live vaccination within 4 weeks prior to Day 1
•6. Previous treatment with gemfibrozil or strong CYP2C8 inhibitors such as clopidogrel within 7 days prior to Day 1
•7. Use of other investigational drugs within 30 days (e.g. small molecules) or 5 half-lives of
•screening or until the expected pharmacodynamic effect has returned to baseline (e.g. biologics), whichever is longer; or longer if required by local regulations
•8. History of malignancy of any organ system (other than localised basal cell carcinoma of
•the skin or in-situ cervical cancer), treated or untreated, within the past 5 years prior to
•screening start, regardless of whether there is evidence of local recurrence or metastases
•9. History of clinically significant ECG abnormalities, or any of the following ECG
•abnormalities at screening or baseline visit:
•a. QTcF more than 450 msec (males)
•b. QTcF more than 460 msec (females)
•History of familial long QT syndrome or known family history of Torsades de Pointes
•Use of agents known to prolong the QT interval unless they can be permanently
•discontinued for the duration of the study
•10. Presence or suspicion (based on judgment of the investigator) of active infection within
•30 days prior to Day 1, or history of severe recurrent bacterial infections
•11. Pregnancy or nursing (lactation), where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human
•Chrorionic Gonadotropin (hCG) laboratory test
•12. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic contraception during dosing and for 1 week after stopping of LNP023 or for 12 months after stopping rituximab. Basic
•contraception methods include:
•a. Barrier methods of contraception: Condom or Occlusive cap.

研究者

发起方

ovartis Healthcare Pvt Ltd

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