計劃書編號IGM-2323-101
試驗已結束
2024-03-01 - 2027-05-31
Phase I
召募中4
ICD-10M32.0
藥物導致之藥源性全身性紅斑性狼瘡
ICD-10M32.10
全身性紅斑性狼瘡侵及(侵犯、涉及)器官或系統
ICD-10M32.11
全身性紅斑性狼瘡心內膜炎
ICD-10M32.12
全身性紅斑性狼瘡心包膜炎
ICD-10M32.13
全身性紅斑性狼瘡侵及(侵犯、涉及)肺臟
ICD-10M32.14
全身性紅斑性狼瘡腎絲球疾病
ICD-10M32.15
全身性紅斑性狼瘡小管間質性腎病
ICD-10M32.19
全身性紅斑性狼瘡侵及(侵犯、涉及)其他器官或系統
ICD-10M32.8
其他型式的全身性紅斑性狼瘡
ICD-10M32.9
全身性紅斑性狼瘡
ICD-9710.0
全身性紅斑狼瘡
一項第 1b 期、開放性、多中心試驗，評估 Imvotamab 使用於標準療法失敗之重度全身性紅斑性狼瘡參與者的安全性、耐受性、藥物動力學和藥效學
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試驗申請者
保瑞爾生技股份有限公司
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試驗委託 / 贊助單位名稱
保瑞爾生技股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2026/06/01
試驗主持人及試驗醫院
適應症
全身性紅斑性狼瘡
紅斑性狼瘡
試驗目的
imvotamab 的安全性與耐受性
藥品名稱
靜脈輸注液
主成份
Imvotamab
劑型
246
劑量
52.5mg/10.5mL
評估指標
• imvotamab 的安全性和耐受性 【時間範圍：最長至第 52 週】：不良事件 (AE)、嚴重不良事件 (SAE)，包括嚴重感染事件和伺機性感染的發生率
主要納入條件
Key Inclusion Criteria:
‧ Age ? 18 years at the time of signing ICF
‧ Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (ACR) Classification Criteria at least 16 weeks or more prior to screening
‧ Highly active SLE disease, as demonstrated by a total systemic lupus erythematosus disease activity index (SLEDAI-2K) total score of ? 10 at screening
‧ Active SLE disease despite treatment with at least 1 immunosuppressive or biologic standard-of-care agent (e.g., methotrexate, azathioprine, mycophenolate mofetil, belimumab, anifrolumab) determined at the discretion of the investigator after at least 3 months of treatment.
‧ It must be planned that the background standard-of-care treatment remains at a stable dose throughout the Screening Period and up to Week 8.Key Exclusion Criteria:
‧ Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of imvotamab.
‧ Any lupus-associated neuropsychiatric disease.
‧ Active lupus nephritis with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2, calculated according to the Chronic Kidney Disease Epidemiology Collaboration equation, classified as World Health Organization (WHO) Class IV.
‧ Prednisone-equivalent > 30 mg/day, including immediate and extended-release oral formulations.
‧ Drug-induced lupus.
‧ Participants with a history of catastrophic or severe anti-phospholipid syndrome within 12 months prior to screening.
‧ Age ? 18 years at the time of signing ICF
‧ Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (ACR) Classification Criteria at least 16 weeks or more prior to screening
‧ Highly active SLE disease, as demonstrated by a total systemic lupus erythematosus disease activity index (SLEDAI-2K) total score of ? 10 at screening
‧ Active SLE disease despite treatment with at least 1 immunosuppressive or biologic standard-of-care agent (e.g., methotrexate, azathioprine, mycophenolate mofetil, belimumab, anifrolumab) determined at the discretion of the investigator after at least 3 months of treatment.
‧ It must be planned that the background standard-of-care treatment remains at a stable dose throughout the Screening Period and up to Week 8.Key Exclusion Criteria:
‧ Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of imvotamab.
‧ Any lupus-associated neuropsychiatric disease.
‧ Active lupus nephritis with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2, calculated according to the Chronic Kidney Disease Epidemiology Collaboration equation, classified as World Health Organization (WHO) Class IV.
‧ Prednisone-equivalent > 30 mg/day, including immediate and extended-release oral formulations.
‧ Drug-induced lupus.
‧ Participants with a history of catastrophic or severe anti-phospholipid syndrome within 12 months prior to screening.
試驗計畫預計收納受試者人數
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台灣人數
5 人
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全球人數
18 人
