計劃書編號MOG001
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
2026/07/01
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
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
MOG-AD 是一種發生在血清MOG 抗體的發炎性脫髓鞘疾病。MOG-AD 最常以視神經炎(ON)呈現(發生在54%至61%的病患)，接
著為脊髓炎、急性瀰散性腦脊髓炎(ADEM)或出現類似ADEM 的情況(例如腦幹發作) (Wynford-Thomas 等人，2019)。已有44%至83%的
MOG-AD 病患通報出現復發病程(Cobo-Calvo 等人，2018)且越來越常影響視神經(Jurynczyk 等人，2017)。Rozanolixizumab 是一種人源
化抗FcRn 單株抗體，特別設計用於抑制IgG 與FcRn 結合，但不會抑制白蛋白與FcRn 的結合。MOG-AD 包含致病性IgG 抗體，而用阻斷FcRn 的方式移除IgG 抗體可能會帶來降低自體免疫攻擊與復發的臨床效益。當前試驗將評估rozanolixizumab 相對於安慰劑用於患有MOG-AD 的參與者之療效、安全性、藥物動力學(PK)以及藥效學(PD)。
雙盲試驗期(A 部分)
主要目標
評估rozanolixizumab 用於治療患有MOG-AD 的參與者之療效次要目標
在患有MOG-AD 的參與者中，評估rozanolixizumab 的安全性及耐受性
其他目標
評估rozanolixizumab 的PK 特性
評估rozanolixizumab 抗藥抗體(ADA)的發生率與出現情況
評估rozanolixizumab 的PD 作用
評估rozanolixizumab 對總蛋白質、白蛋白、α-和β-球蛋白、IgM、IgA、IgE、血清與血漿補體濃度的影響
評估rozanolixizumab 對探索性生物標記的作用
評估rozanolixizumab 治療對疫苗效價的影響
針對已接種COVID-19 疫苗的試驗參與者，評估rozanolixizumab對疫苗反應的影響
開放性延伸期(OLE)試驗期(B 部分)
主要目標
在患有MOG-AD 的參與者中，進一步評估rozanolixizumab 的安全性及耐受性
次要目標
提供ARR 在OLE 治療期期間的其他療效資訊
提供OLE 治療期期間的額外敘述性非比較療效資訊，以補充說明雙盲治療期
藥品名稱
注射劑
主成份
Rozanolixizumab
劑型
solution for injection
劑量
140mg/mL
評估指標
主要試驗目的
主要試驗指標(療效)：
• 隨機分配至首次經獨立中央判定復發(TTFR)的時間
主要試驗指標(療效)：
• 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
Participants are eligible to be included in the study only if all of the following criteria apply:
Age
1. Participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent. For Japan-specific requirements, see Appendix 9, Section 10.9.
Type of Participant and Disease Characteristics
2b. Confirmed diagnosis of MOG-AD consistent with published diagnostic criteria for MOG-AD (Banwell 2023).
3. Removed.
4a. 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.
5. Participant must be clinically stable at the time of the Screening Visit and during the Screening Period
Weight
6. Participant weighs at least 35kg (for males and females) at Screening.
Sex
7a. Male or female
− Removed.
− A female participant is eligible to participate if she is not pregnant (see Appendix 4 [(Section 10.4)]), not breastfeeding, and at least one of the following conditions applies:
◦ Not a woman of childbearing potential (WOCBP) as defined in Appendix 4 (Section 10.4)
OR
A WOCBP who agrees to follow the contraceptive guidance in Appendix 4 (Section 10.4) during the treatment period and for at least 90 days after the last dose of study treatment.
Informed Consent
8. Participant is capable of giving signed informed consent as described in Appendix 1 (Section 10.1.3) which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. For France-specific requirements, see Appendix 9 (Section 10.9).
Other
9. Participant is considered reliable and capable of adhering to the protocol visit schedule or medication intake according to the judgment of the investigator.
Age
1. Participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent. For Japan-specific requirements, see Appendix 9, Section 10.9.
Type of Participant and Disease Characteristics
2b. Confirmed diagnosis of MOG-AD consistent with published diagnostic criteria for MOG-AD (Banwell 2023).
3. Removed.
4a. 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.
5. Participant must be clinically stable at the time of the Screening Visit and during the Screening Period
Weight
6. Participant weighs at least 35kg (for males and females) at Screening.
Sex
7a. Male or female
− Removed.
− A female participant is eligible to participate if she is not pregnant (see Appendix 4 [(Section 10.4)]), not breastfeeding, and at least one of the following conditions applies:
◦ Not a woman of childbearing potential (WOCBP) as defined in Appendix 4 (Section 10.4)
OR
A WOCBP who agrees to follow the contraceptive guidance in Appendix 4 (Section 10.4) during the treatment period and for at least 90 days after the last dose of study treatment.
Informed Consent
8. Participant is capable of giving signed informed consent as described in Appendix 1 (Section 10.1.3) which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. For France-specific requirements, see Appendix 9 (Section 10.9).
Other
9. Participant is considered reliable and capable of adhering to the protocol visit schedule or medication intake according to the judgment of the investigator.
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
