ISRCTN12809537进行中（未招募）1 期
A phase I, multicenter, single-arm study to evaluate the pharmacokinetics, pharmacodynamics, and safety of crovalimab in patients with lupus nephritis
F. Hoffmann-La Roche0 个研究点目标入组 15 人开始时间: 2022年3月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
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
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 27/04/2023:
- •1. Age 18 - 65 years at the time of signing the Informed Consent Form
- •2. Body weight =40 kg at screening
- •3. Active LN, as evidenced by either: 1) A kidney biopsy demonstrating active proliferative (Class III or IV) and/or membranous (Class V) LN, performed within 12 months of screening or during screening; or 2) biopsy-proven Class III, IV, and/or V LN at anytime before screening and an active LN flare, as determined by the investigator, requiring the equivalent of at least 0.5 mg/kg/day of prednisone during screening.
- •4. UPCR =1.5 g/g on a 24-hour urine collection at screening
- •5. Vaccination against Neisseria meningitidis (N. meningitidis) serotypes A, C, W, and Y <3 years prior to initiation of study treatment
- •6. Vaccination against Haemophilus influenzae type B and Streptococcus pneumoniae according to national vaccination recommendations
- •Previous participant inclusion criteria as of 06/12/2022:
- •1. Age 18 - 65 years at the time of signing the Informed Consent Form
- •2. Body weight =40 kg at screening
- •3. Active LN, as evidenced by a kidney biopsy demonstrating active proliferative (Class III or IV) and/or membranous (Class V) LN, performed within 12 months of screening or during screening
- •4. UPCR =1.5 g/g on a 24-hour urine collection at screening
- •5. Vaccination against Neisseria meningitidis (N. meningitidis) serotypes A, C, W, and Y <3 years prior to initiation of study treatment
- •6. Vaccination against Haemophilus influenzae type B and Streptococcus pneumoniae according to national vaccination recommendations
- •Previous participant inclusion criteria:
- •1. Age 18 - 65 years at the time of signing the Informed Consent Form
- •2. Body weight =40 kg at screening
- •3. Active LN, as evidenced by a kidney biopsy demonstrating active proliferative (Class III or IV) and/or membranous (Class V) LN, performed within 12 months of screening or during screening
- •4. UPCR = 1.5 g/g on a 24-hour urine collection at screening
- •5. Vaccination against Neisseria meningitidis (N. meningitidis) <3 years prior to initiation of study treatment
- •6. Vaccination against Haemophilus influenzae type B and Streptococcus pneumoniae according to national vaccination recommendations
排除标准
- •Current participant exclusion criteria as of 06/12/2022:
- •1. Pregnant or breastfeeding or intending to become pregnant during the study or within 46 weeks after the final dose of crovalimab or within 6 weeks after the final dose of mycopenolate mofetil (MMF), whichever is longer
- •2. Severe renal impairment, as defined by estimated glomerular filtration rate < 15 millimetres per minute per 1.73 metres square (mL/min/1.73 m²), need for dialysis or renal transplantation
- •3. Presence of rapidly-progressive glomerulonephritis
- •4. Active or evolving multisystem organ dysfunction or failure
- •5. Known or suspected hereditary complement deficiency
- •6. History of N. meningitidis infection within 6 months prior to screening and up to the first drug administration
- •7. History of serious recurrent or chronic infection
- •8. Known or suspected immune deficiency
- •9. Positive Human immunodeficiency virus (HIV) test or known HIV infection
- •10. Splenectomy < 6 months prior to screening
- •11. Participants who have a history of malignancy within 5 years prior to screening and up to the first dose of study treatment
- •12. History of hypersensitivity, allergic, or anaphylactic reactions to any ingredient contained in crovalimab, including hypersensitivity to human, humanized, or murine monoclonal antibodies or known hypersensitivity to any constituent of the product, or to corticosteroids or MMF
- •13. Current, previous or expected future treatment with a complement inhibitor within 46 weeks after the final crovalimab administration
- •14. Lack of peripheral venous access
- •15. Any condition requiring plasmapheresis
- •Previous participant exclusion criteria:
- •1. Pregnant or breastfeeding, or intending to become pregnant during the study or within 6 months after the final dose of crovalimab or within 6 weeks after the final dose of mycopenolate mofetil (MMF), whichever is longer
- •2. Severe renal impairment, as defined by estimated glomerular filtration rate < 15 millimetres per minute per 1.73 metres square (mL/min/1.73 m²), need for dialysis or renal transplantation
- •3. Presence of rapidly-progressive glomerulonephritis
- •4. Active or evolving multisystem organ dysfunction or failure
- •5. Known or suspected hereditary complement deficiency
- •6. History of N. meningitidis infection within 6 months prior to screening and up to the first drug administration
- •7. History of serious recurrent or chronic infection
- •8. Known or suspected immune deficiency
- •9. Positive Human immunodeficiency virus (HIV) test or known HIV infection
- •10. Splenectomy < 6 months prior to screening
- •11. Participants who have a history of malignancy within 5 years prior to screening and up to the first dose of study treatment
- •12. History of hypersensitivity, allergic, or anaphylactic reactions to any ingredient contained in crovalimab, including hypersensitivity to human, humanized, or murine monoclonal antibodies or known hypersensitivity to any constituent of the product, or to corticosteroids or MMF
- •13. Current, previous or expected future treatment with a complement inhibitor within 6 months after the final crovalimab administration
- •14. Lack of peripheral venous access
- •15. Any condition requiring plasmapheresis
研究者
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