計劃書編號MOG001
NCT Number(ClinicalTrials.gov Identfier)NCT05063162
試驗執行中
2023-03-01 - 2025-09-09
Phase III
尚未開始6
ICD-10G36.0
視神經脊髓炎 [Devic氏病]
ICD-9341.0
視神經髓質炎
一項隨機分配、雙盲、安慰劑對照、多中心、有開放性延伸期之第三期樞紐性試驗，評估rozanolixizumab 用於患有髓鞘少突膠質細胞糖蛋白(MOG)抗體相關疾病(MOG-AD) 之成年參與者的療效和安全性
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試驗申請者
百瑞精鼎國際股份有限公司
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試驗委託 / 贊助單位名稱
百瑞精鼎國際股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
實際收案人數
0 尚未開始
實際收案人數
0 尚未開始
實際收案人數
0 尚未開始
實際收案人數
0 尚未開始
實際收案人數
0 尚未開始
適應症
髓鞘少突膠質細胞糖蛋白(MOG)抗體相關疾病
試驗目的
主要: 評估rozanolixizumab 用於治療患有MOG-AD 的參與者之療效
藥品名稱
注射劑
主成份
Rozanolixizumab
劑型
solution for injection
劑量
140mg/mL
評估指標
隨機分配至首次經獨立中央判定復發(TTFR)的時間
主要納入條件
Participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent
Confirmed diagnosis of MOG-AD consistent with published diagnostic criteria for MOG-AD
Participant has history of relapsing MOG-AD with at least 1 documented relapse over the last 12 months and a documented positive serum MOG Ab test using a cell-based assay (CBA) within 6 months prior to randomization
Participant must be clinically stable at the time of the Screening Visit and during the Screening Period
Confirmed diagnosis of MOG-AD consistent with published diagnostic criteria for MOG-AD
Participant has history of relapsing MOG-AD with at least 1 documented relapse over the last 12 months and a documented positive serum MOG Ab test using a cell-based assay (CBA) within 6 months prior to randomization
Participant must be clinically stable at the time of the Screening Visit and during the Screening Period
主要排除條件
Exclusion Criteria:
Participant has been diagnosed with a neurological autoimmune disease (including multiple sclerosis (MS) and aquaporin-4 positive neuromyelitis optica spectrum disorder (NMOSD)), or a systemic autoimmune disease that in the opinion of the investigator can interfere with the safety of the participant
Participant has a clinically important active infection (including unresolved or not adequately treated infection) as assessed by the investigator, including participants with a serious infection within 6 weeks prior to the first dose of the investigational medicinal product (IMP)
Participant has a current or medical history of primary immunodeficiency
Participant tests positive for aquaporin-4 antibodies at Screening
Participant has a serum total IgG level ≤ 5.5g/L
Participant has been diagnosed with a neurological autoimmune disease (including multiple sclerosis (MS) and aquaporin-4 positive neuromyelitis optica spectrum disorder (NMOSD)), or a systemic autoimmune disease that in the opinion of the investigator can interfere with the safety of the participant
Participant has a clinically important active infection (including unresolved or not adequately treated infection) as assessed by the investigator, including participants with a serious infection within 6 weeks prior to the first dose of the investigational medicinal product (IMP)
Participant has a current or medical history of primary immunodeficiency
Participant tests positive for aquaporin-4 antibodies at Screening
Participant has a serum total IgG level ≤ 5.5g/L
試驗計畫預計收納受試者人數
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台灣人數
10 人
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全球人數
104 人
