CTIS2022-502184-38-00招募中1 期
A Randomized, Double-Blind, Placebo-Controlled Study of Intravenously Administered ALE.F02 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Renal Sparing in Antineutrophil Cytoplasmic Antibody Associated Vasculitis With Rapidly Progressive Glomerulonephritis - ALE.F02.03
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 75
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Are male or female patients =18 years of age of any race or ethnicity with a score of <7 on the Clinical Frailty Scale in the 3 months preceding the onset of RPGN attributed to AAV; Note: The PI should assess the Clinical Frailty Scale based on medical history and interview with the patient., 6. Have a weight of =130 kg;, 2. Must be willing and able to comply with the study requirements and give informed consent for participation in the study;, 3. Must be willing to have a renal biopsy procedure performed no later than prior to study drug administration at the Week 6 Visit; alternatively, a historical biopsy performed up to 45 days prior to the initiation of study drug administration is considered acceptable;, 4. Have been newly diagnosed with RPGN within 45 days prior to the initiation of study drug treatment, as demonstrated by the following: - Evidence of loss of renal function with an eGFR of =50 mL/min/1.73 m2 and =10 mL/min/1.73 m2; and - History of proteinuria of any degree AND/OR hematuria that is temporally associated with the presenting episode of illness and supports the diagnosis of RPGN., 5. Are suspected of having RPGN attributed to AAV at Screening based on clinical laboratory diagnostic criteria, including a positive test for an ANCA, ie, anti MPO or anti-PR3;, 7. Female patients must not be pregnant or lactating at Screening and 1 of the following conditions must apply: - Is a female of childbearing potential and agrees to use a highly effective method of birth control during their participation in the study and for at least 5 half-lives or a minimum of 30 days after the last dose of study drug, or as recommended in the Summary of Product Characteristics (SmPC) of any authorized AxMP given as part of background SOC therapy, whichever is longer; or - Is a female of nonchildbearing potential., 8. Female patients must agree not to donate ova for 6 months after the last dose of study drug or as recommended in the SmPC of any authorized AxMP given as part of background SOC therapy, whichever is longer;, 9. Male patients must agree to use contraception, in the form of either sexual abstinence or a condom, during their participation in the study and for 90 days after the last dose of study drug or as recommended in the SmPC of any authorized AxMP given as part of background SOC therapy, whichever is longer; and, 10. Male patients must agree to abstain from sperm donation during their participation in the study and for 90 days after the last dose of study drug or as recommended in the SmPC of any authorized AxMP given as part of background SOC therapy, whichever is longer.
排除标准
- •1. Have a history of previous RPGN that resolved or ameliorated (ie, the patient had a documented case of RPGN and has suffered a relapse);, 7. Have received a course of SOC therapy which exceeds a high-dose prolonged regimen of treatment of ANCA RPGN, such as >3000 mg of IV methylprednisoloneequipotent glucocorticoids, or >1 mg/kg/day of oral glucocorticoids (prednisone equivalent) for >14 days (doses are provided as a guidance for assessment of intensity; patients who received highdose glucocorticoids should be discussed with and approved by the Medical Monitor and the Sponsor);, 8. Have been treated or planned to be treated with protocol prohibited medications., 10. Have participated in an investigational drug or device study and received investigational therapy <30 days or 5 half lives, whichever is the greater, prior to the first dose of study drug. For biological investigational drugs, the exclusionary period may not be <90 days prior to the first dose of study drug;, 9. Have poor venous access;, 21. Have alveolar haemorrhage with hypoxia defined by an oxygen saturation <85% or that requires the use of invasive or noninvasive ventilatory support;, 22. Have undergone dialysis within 7 days prior to Screening;, 23. Have undergone therapeutic plasma exchange within 7 days prior to Screening; or, 11. Have a contraindicated skin condition with the exception of dermatological disorders or skin rashes that are attributable to, or known to be associated with, the underlying diagnosis of AAV, which shall not be exclusionary., 12. Have a diagnosis of systemic lupus erythematosus-AAV overlap syndrome;, 13. Have a diagnosis of eosinophilic granulomatosis with polyangiitis;, 18. Have not recovered from AEs and/or complications from major surgery prior to the first dose of study drug; Note: The PI should consult with the Medical Monitor and Sponsor to determine if ongoing, significant complications from major surgery are exclusionary., 14. Have evidence of uncontrolled respiratory, cardiac, hepatic, endocrine, central nervous system, or renal disease, unrelated to RPGN or AAV, that the PI believes cannot be readily brought under control, or any other medical condition that in the opinion of the PI renders the patient unsuitable for enrollment and could prevent the successful completion of the study;, 15. Have received a live vaccine within 30 days prior to Screening;, 16. Have received any vaccine within 7 days of the first dose of study drug other than against influenza or pneumococcal infection;, 17. Are employed by the PI or the study site, have direct involvement in the proposed study or other studies under the direction of that PI, or are a family member of the PI or study site personnel;, 24. Have known hypersensitivity to the study drug or any of the excipients used in the formulation of the study drug., 19. Have active or known history of alcohol or substance abuse within 1 year prior to Day 1/Randomization or have a positive urine drug screen for drugs of abuse at Screening;, 2. Have a positive serology test for anti-glomerular basement membrane antibodies;, 20. Have been diagnosed within the preceding 5 years with a malignant neoplastic disease, other than locally invasive cutaneous squamous or basal cell carcinoma;, 3. Have evidence of active or latent TB determined by a positive (not indeterminate) QuantiFERON®-TB Gold test (or equivalent). In countries where QuantiFERON®-TB Gold test (or equivalent) is not available, radiological
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