ChiCTR2600122783 版本V1.0 版本创建时间2026/04/17 15:28:29 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2600122783 

最近更新日期：

Date of Last Refreshed on：

2026-04-17 15:28:20 

注册时间：

Date of Registration：

2026-04-17 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项在多发性硬化成人参与者中比较 frexalimab 皮下给药与静脉给药的药代动力学、安全性和疗效的随机、Ⅲ 期、开放标签研究

Public title：

A randomized, Phase 3, open-label study to investigate pharmacokinetics, safety, and efficacy of subcutaneous compared to intravenous frexalimab in adult participants with multiple sclerosis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项在多发性硬化成人参与者中比较 frexalimab 皮下给药与静脉给药的药代动力学、安全性和疗效的随机、Ⅲ 期、开放标签研究

Scientific title：

A randomized, Phase 3, open-label study to investigate pharmacokinetics, safety, and efficacy of subcutaneous compared to intravenous frexalimab in adult participants with multiple sclerosis

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

周红雨 

研究负责人：

周红雨 

Applicant：

Hongyu Zhou 

Study leader：

Hongyu Zhou 

申请注册联系人电话：

Applicant telephone：

+86 18980601675

研究负责人电话：

Study leader's telephone：

+86 189 8060 1675

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

924339836@qq.com

研究负责人电子邮件：

Study leader's E-mail：

zhouhy@scu.edu.cn

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

四川省成都市武侯区国学巷37号

研究负责人通讯地址：

四川省成都市武侯区国学巷37号

Applicant address：

No. 37, Guoxue Lane, Wuhou District, Chengdu City, Sichuan Province

Study leader's address：

No. 37, Guoxue Lane, Wuhou District, Chengdu City, Sichuan Province

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

四川大学华西医院

Applicant's institution：

West China Hospital of Sichuan University

研究负责人所在单位：

四川大学华西医院

Affiliation of the Leader：

West China Hospital of Sichuan University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2025年临床试验(西药)审(478)号

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

四川大学华西医院临床试验伦理审查委员会

Name of the ethic committee：

Ethics Committee on Clinical Trial,West China Hospital of Sichuan University

伦理委员会批准日期：

Date of approved by ethic committee：

2026-01-20 00:00:00

伦理委员会联系人：

左泽锦

Contact Name of the ethic committee：

Zuo Zejing

伦理委员会联系地址：

四川省成都市武侯区国学巷37号

Contact Address of the ethic committee：

No. 37, Guoxue Lane, Wuhou District, Chengdu City, Sichuan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 28 85422654

伦理委员会联系人邮箱：

Contact email of the ethic committee：

326579980@qq.com

研究实施负责（组长）单位：

四川大学华西医院

Primary sponsor：

West China Hospital of Sichuan University

研究实施负责（组长）单位地址：

四川省成都市武侯区国学巷37号

Primary sponsor's address：

No. 37, Guoxue Lane, Wuhou District, Chengdu City, Sichuan Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

四川省

市(区县)：

Country：

China

Province：

Sichuan

City：

单位(医院)：

四川大学华西医院

具体地址：

四川省成都市武侯区国学巷37号

Institution
hospital：

West China Hospital of Sichuan University

Address：

No. 37, Guoxue Lane, Wuhou District, Chengdu City, Sichuan Province

经费或物资来源：

赛诺菲（中国）投资有限公司

Source(s) of funding：

Sanofi-Aventis Recherche & Développement

Target disease：

multiple sclerosis

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 III期临床试验 

Study phase：

3

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

确定 frexalimab SC 给药与 frexalimab IV 给药相比的药代动力学非劣效性。  

Objectives of Study：

To determine the non-inferiority of frexalimab SCadministration compared to frexalimab IV administration as measured by pharmacokinetic parameters.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

A 组（RMS） 1.参与者在签署知情同意书时，年龄必须在 18 至 55 岁（含）之间。 2.参与者必须根据 2017 年修订版 McDonald 诊断标准诊断为 RMS（24）。 3.在首次访视（筛选访视）时，参与者的扩展残疾状态量表（EDSS）评分必须≤5.5。 4.在筛选前参与者必须满足至少一种以下情况： - 在过去一年内有≥1 次复发的记录，或 - 在过去两年内有≥2 次复发的记录，或 - 在过去一年内的 MRI 扫描中有≥1 个 GdE 病灶的记录。 注：对于前 2 个标准，MS 的初次临床脱髓鞘发作应计为一次复发。 B 组（nrSPMS） 1.参与者必须既往根据 2017 年修订版 McDonald 诊断标准被诊断为 RRMS（24）。 2.参与者在签署知情同意书时，年龄必须在 18 至 60 岁（含）之间。 3.参与者必须根据 2013 年修订的临床病程标准（25）当前诊断为 SPMS（26）。 4.参与者必须具有在筛选前 12 个月内观察到残疾进展的记录。 5.参与者必须至少 24 个月未出现临床复发。 6.参与者在首次访视（筛选访视）时的 EDSS 评分必须在 3.0 至 6.5 分（含）之间。仅当符合 A 组和 B 组特定标准的参与者同时符合以下所有标准时才有资格入组研究。 全部 1.参加临床研究的参与者采用的避孕措施应符合当地有关避孕方法的法规要求。 (1)男性参与者:男性参与者如果同意在研究干预期间和研究干预末次给药后至少 24 周遵守以下要求，则有资格参加研究：避免捐赠精子。 外加以下任意一项： 1)能够以禁欲（不进行异性间性交）作为其日常和首选的生活方式（长期和持续禁欲），并同意坚持禁欲。 2)必须同意使用下文详细说明的避孕/屏障方法。 3)同意使用男用避孕套，并应告知参与者女性伴侣使用高效避孕方法的益处（描述见第 10.4 节附录 4 避孕和屏障要求），因为在与目前未怀孕的有生育能力的女性（WOCBP）性交时，避孕套可能会破裂或渗漏。 (2）女性参与者 :女性参与者如果未处于妊娠期或哺乳期且符合以下至少一个条件，则有资格参加研究： 1)不是 WOCBP，定义见附录 4 避孕和屏障指南（第 10.4 节）。 2)是 WOCBP，同意在研究干预给药期间（开始干预给药前生效）和研究干预末次给药后至少 24 周内使用附录 4 避孕和屏障指南（第 10.4 节）中所述的高效避孕方法（年失败率＜1%），并且同意在此期间不捐献或冻存卵子（卵细胞、卵母细胞）用于生殖目的。 3)WOCBP 在研究干预首次给药前 24 小时内进行的高灵敏度妊娠试验（尿或血清，根据当地法规要求）的结果必须为阴性，参见第 8.3.5 节妊娠试验。如果尿妊娠试验的结果无法确认为阴性（如，不明确的结果），则需进行血清妊娠试验。在这种情况下，如果血清妊娠试验的结果呈阳性，则必须排除该参与者。 ? 研究期间和研究干预给药之后的其他妊娠试验要求请参见研究活动流程表（第 1.3 节） 。 4)如果当地法规允许，研究者将负责审查病史、月经史和近期性生活，以降低纳入妊娠早期未发现怀孕的女性的风险。 5)国家特定避孕要求参见附录 8（第 10.8 节）。 2.能够按照附录 1（第 10.1.3 节）所述提供已签署的知情同意书，其中包括遵循知情同意书（ICF）和本方案中列出的要求和限制。在法定成年年龄大于 18 岁的国家，参与者的法定授权代表还必须签署一份特定的 ICF。

Inclusion criteria

Group A (RMS) 1. Participants must be between 18 and 55 years of age (inclusive) at the time of signing the informed consent form. 2. Participants must have a diagnosis of RMS according to the 2017 Revised McDonald Diagnostic Criteria(24). 3. Participant must have an Expanded Disability Status Scale (EDSS) score of ≤ 5.5 at the first visit (screening visit). 4. Participants must meet at least one of the following conditions prior to screening: - Documented ≥1 relapse within the past year, or - Documented ≥2 relapses within the past two years, or - Documented ≥1 GdE lesion on MRI scan within the past year. Note: For the first 2 criteria, an initial episode of clinical demyelinating in MS should be counted as one relapse. Group B (nrSPMS) 1. Participants must have a previous diagnosis of RRMS according to the 2017 Revised McDonald Diagnostic Criteria(24). 2. Participants must be between 18 and 60 years of age (inclusive) at the time of signing the informed consent form. 3. Participants must have a current diagnosis of SPMS according to the 2013 Revised Criteria for the Clinical Course (25) (26). 4. Participants must have a record of observed disability progression within 12 months prior to screening. 5. Participants must be clinically relapse-free for at least 24 months. 6. Participants must have an EDSS score between 3.0 and 6.5 points (inclusive) at the first visit (screening visit). Participants who meet the specific criteria for Cohorts A and B will only be eligible for enrollment in the study if they meet all of the following criteria at the same time. All 1. Participants participating in clinical studies should use contraceptive measures that comply with local regulations regarding contraceptive methods. (1) Male participants: Male participants are eligible to participate in the study if they agree to comply with the following requirements during study intervention and for at least 24 weeks after the last dose of study intervention: Refrain from donating sperm. Plus any of the following: 1) Able to practice abstinence (abstinence from heterosexual intercourse) as their daily and preferred lifestyle (long-term and continuous abstinence) and agree to adhere to abstinence. 2) Must agree to use a contraceptive/barrier method as detailed below. 3) agree to use a male condom and should inform the participant of the benefits of using a highly effective method of contraception (see Section 10.4 Appendix 4 Contraception and Barrier Requirements for a description) as the condom may rupture or leak during sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. (2) Female participants: Female participants are eligible for the study if they are not pregnant or lactating and meet at least one of the following criteria: 1) Not a WOCBP, as defined in Appendix 4 Contraceptive and Barrier Guidelines (Section 10.4). 2) Is a WOCBP who agrees to use a highly effective method of contraception (annual failure rate <1%) as described in the Appendix 4 Contraceptive and Barrier Guidelines (Section 10.4) for the duration of study intervention administration (effective prior to initiation of intervention administration) and for at least 24 weeks after the last dose of study intervention (Section 10.4) and agrees not to donate or cryopreserve eggs (oocytes, oocytes) for reproductive purposes during this period. 3) WOCBP must have a negative result of a highly sensitive pregnancy test (urine or serum, as required by local regulations) performed within 24 hours prior to the first dose of study intervention, see Section 8.3.5 Pregnancy Test. If the urine pregnancy test result cannot be confirmed as negative (eg, ambiguous result), a serum pregnancy test is performed. In this case, if the result of the serum pregnancy test is positive, the participant must be excluded. ? See the Study Activity Flow Table (Section 1.3) for additional pregnancy test requirements during the study and after study intervention administration. 4) If local regulations permit, the investigator will be responsible for reviewing medical history, menstrual history, and recent sexual activity to reduce the risk of inclusion of women who are not detected to be pregnant in the first trimester. 5) See Appendix 8 (Section 10.8) for country-specific contraceptive requirements. 2. Able to provide signed informed consent as described in Appendix 1 (Section 10.1.3), which includes compliance with the Informed Consent Form (ICF) and the requirements and restrictions listed in this protocol. In countries where the legal age of majority is greater than 18 years, the participant's legally authorized representative must also sign a specific ICF.

排除标准：

1.参与者必须根据2017年修订版McDonald诊断标准诊断为原发进展型MS(24)。 2.参与者有感染史或可能存在感染风险: (1)T淋巴细胞或T淋巴细胞受体疫苗接种、移植(包括实体器官、干细胞和骨髓移植)和/或抗排斥治疗史。 (2)参与者在首次研究干预给药前3个月内接种了任何活(减毒)疫苗(包括但不限于水痘带状疱疹疫苗、口服脊髓灰质炎疫苗和鼻用流感疫苗)。 (3)有进行性多灶性脑白质病(PML)诊断史或筛选MRI有提示PML的发现。有活动性或潜伏性结核(TB)病史;应在筛选时进行TB检查，如研究期间有临床指征，应再次进行检查，可根据临床判断、临界结果或临床上疑似TB感染时重复进行检查。TB筛选检查可参见附录2(第10.2节)。 (4)注:研究者可视需要安排传染病专家会诊，例如，检查结果不明确或怀疑检查结果为假阳性的情况。如果传染病专家认为检查结果为假阳性且无临床意义，并确认参与者可入组试验，研究者必须在源数据中对此予以记录，然后可对参与者进行随机化。 (5)人类免疫缺陷病毒(HIV)感染史(例如，任何己知的HIV检测阳性或参与者访谈信息)。 (6)严重的全身性病毒、细菌或真菌感染(例如，感染性肺炎、肾盂肾炎)、筛选前30天和筛选期间需要住院治疗或IV注射抗生素的感染或重大慢性病毒、细菌或真菌感染(例如，骨髓炎)。 (7)参与者有侵袭性机会性感染史，包括但不限于组织胞浆菌病、李斯特菌病、球孢子菌病、念珠菌病、耶氏肺孢子虫和曲霉病。 (8)在筛选访视前28天内发热(≥38°C;但是，如果由一过性和轻度耳、鼻、喉病毒感染导致，可根据研究者的判断允许参与者入组)。 (9)经研究者判断，可能对参与本研究或本研究中的IMP给药产生不利影响的任何其他活动性感染。 3.存在精神紊乱或物质滥用，证据为: (1)筛选访视前2年内任何需要住院的精神疾病、行为症状或抑郁病史。筛选访视前6个月内有自杀未遂的记录，或基线/筛选时根据哥伦比亚自杀严重程度评定量表(C-SSRS)自杀想法为第4或第5类，或者如果根据研究者判断，参与者有实施自杀行为的风险。 (2)在筛选访视前一年内有活动性酒精使用相关疾病、滥用酒精或药物史。 4.在筛选访视期间获得的以下发现，经研究者判断为具有临床意义:筛选时任何实验室检查值超出正常范围(除非没有临床意义)。异常ECG。注:如果某个异常实验室检查值被认为是暂时性的，则可以在筛选时重新进行一次检测。 5.可能对参加研究造成不利影响或使共同主要终点无法评价的情况: (1)经神经内科主治医生确定，由于已存在的健康状况而预期寿命较短。 (2)根据研究者的判断，曾有或现存显著的其他伴随疾病，包括但不限于可能对参加研究造成不利影响的心血管疾病(包括II期或IV期心力衰竭，根据纽约心脏病协会心功能分级)，或肾脏(例如，正在接受透析)、神经系统、内分泌、胃肠道、代谢、肺部或淋巴系统疾病。 (3)急性肝病、肝硬化、慢性肝病(除非确认病情稳定>6个月)。 (4)确认筛选时的ALT>2XULN或中性粒细胞<1500/mm2(非裔参与者除外，其为中性粒细胞≤1000/mm3)或淋巴细胞<1000/mm3。 (5)筛选访视前有恶性肿瘤史(已经有效治疗的宫颈原位癌或进行了适当治疗的非转移性皮肤鳞状细胞癌或基底细胞癌除外)的参与者也应被排除。 (6)有需要经常使用全身性类固醇的疾病史，包括但不限于类风湿关节炎、克罗恩病和系统性红斑狼疮。 (7)参与者的任何其他医学状况或并发症使其无法进行共同主要终点评价或会对参加本研究造成不利影响，具体由研究者判定。 6.有血栓栓塞事件的病史、临床证据、怀疑血栓栓塞事件或有重大风险，以及心肌梗死、中风和/或抗磷脂综合征和需要抗血栓治疗的任何参与者。 7.当前存在低丙球蛋白血症，定义为筛选时Ig水平(IgG和/或IgM)低于LLN，或有原发性低丙球蛋白血症病史。对于有抗CD20mAb(例如，奥瑞利珠单抗、奥法妥木单抗、ublituximab、利妥昔单抗)诱导的继发性低丙球蛋白血症病史的患者，如果其筛选时Ig水平在正常范围内，则可考虑入选研究。 8.既往或当前存在可模拟MS症状的疾病，包括但不限于视神经脊髓炎谱系疾病、系统性红斑狼疮、干燥综合征、急性播散性脑脊髓炎和重症肌无力。 9.参与者在进行任何基线评估前的规定时间范围内接受过以下任何药物/治疗(干扰素β或醋酸格拉替雷治疗无需洗脱，但第1天当天和之后不允许使用): 10.参与者对任何研究干预或其成分过敏，或有药物过敏或其他过敏，研究者认为禁忌参与本研究。 11.参与者之前曾暴露于frexalimab。 12.参与者曾在以下时间使用其他研究药物:筛选访视前84天内或其他研究药物的5个半衰期内，以时间较长者为准。 13.在开始研究干预给药之前，筛选时丙型肝炎抗体检测结果呈阳性。只有确证丙型肝炎RNA检测结果为阴性后，才能入组因既往已消退的疾病而丙型肝炎抗体检测结果呈阳性的参与者。乙型肝炎表面抗原(HBsAg)和抗乙型肝炎核心抗体(抗HBc Ab)。如果抗HBs阴性且抗HBc阳性:进行乙型肝炎病毒DNA检测以确认。 14.参与者存在MRI禁忌症，即装有起搏器、高风险部位有金属植入物(即人造心脏瓣E14.膜、动脉瘤/血管夹)、高风险部位有金属物质(例如，弹片)，或有将妨碍完成研究方案规定的所有MRI扫描的幽闭恐怖症史。注:存在禁忌症的患者可入组研究，但其进行MRI扫描时不得使用造影剂。 15.因违反法律法规而被羁押的个人;囚犯或被合法拘留者。 16.研究者认为参与者不适合参加研究(无论原因为何;包括医学或临床状况)或参与者可能存在不依从研究程序的风险。 17.参与者为临床研究中心的雇员或直接参与研究实施的其他个人，或此类个人的直系亲属(结合ICH-GCP条例E6第1.61节)。 18.任何限制参与者入组研究的国家相关的特定法规，参见附录8(第10.8节)(国家特定要求)。

Exclusion criteria：

1. Participants must have a diagnosis of primary progressive MS according to the 2017 revised McDonald diagnostic criteria (24). 2. Participant has a history of infection or may be at risk for infection: (1) History of T lymphocyte or T lymphocyte receptor vaccination, transplantation (including solid organ, stem cell, and bone marrow transplantation), and/or anti-rejection therapy. (2) Participants have received any live (attenuated) vaccine (including but not limited to varicella-zoster vaccine, oral polio vaccine, and nasal influenza vaccine) within 3 months prior to the first dose of study intervention. (3) History of diagnosis of progressive multifocal leukoencephalopathy (PML) or screening MRI with findings suggestive of PML. History of active or latent tuberculosis (TB); TB examination should be performed at screening, and if there is a clinical indication during the study, the examination should be performed again, and the examination can be repeated based on clinical judgment, borderline results, or when TB infection is clinically suspected. TB screening tests can be found in Appendix 2 (Section 10.2). (4) Note: The investigator may arrange an infectious disease specialist consultation as needed, for example, if the test result is unclear or suspected to be a false positive. If the infectious disease specialist determines that the test result is false positive and not clinically significant, and confirms that the participant is eligible for enrollment in the trial, the investigator must document this in the source data and then the participant can be randomized. (5) History of human immunodeficiency virus (HIV) infection (e.g., any known positive HIV test or participant interview information). (6) Serious systemic viral, bacterial, or fungal infection (e.g., infectious pneumonia, pyelonephritis), infection requiring hospitalization or IV injection of antibiotics in the 30 days prior to screening and during screening, or significant chronic viral, bacterial, or fungal infection (e.g., osteomyelitis). (7) Participant has a history of invasive opportunistic infections, including but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, Pneumocystis jirovecii, and aspergillosis. (8) Fever (≥38°C; However, if caused by transient and mild ear, nose, and throat viral infections, the participant may be allowed to enroll at the discretion of the investigator). (9) Any other active infection that, in the judgment of the investigator, may adversely affect participation in this study or IMP administration in this study. 3. Presence of mental disorders or substance abuse, as evidenced by: (1) Any history of mental illness, behavioral symptoms, or depression requiring hospitalization within 2 years prior to the screening visit. Documented suicide attempt within 6 months prior to the screening visit, or category 4 or 5 suicidal ideation according to the Columbia Suicide Severity Rating Scale (C-SSRS) at baseline/screening, or if the participant is at risk of committing suicidal behavior according to the investigator's judgment. (2) Active alcohol use-related illness, history of alcohol abuse, or drug abuse within one year prior to the screening visit. 4. The following findings obtained during the screening visit, judged by the investigator to be clinically significant: Any laboratory test values outside the normal range at screening (unless not clinically significant). Abnormal ECG. Note: If an abnormal lab check value is considered temporary, the test can be redone at screening. 5. Conditions that may adversely affect participation in the study or make the common primary endpoint unevaluable: (1) The attending neurology physician determined that the life expectancy is short due to pre-existing health conditions. (2) Have or are significant other concomitant diseases, including, but not limited to, cardiovascular disease (including stage II or IV heart failure, according to the New York Heart Association cardiac function classification), or renal (e.g., on dialysis), neurological, endocrine, gastrointestinal, metabolic, pulmonary, or lymphatic system disease that may adversely affect study participation. (3) Acute liver disease, cirrhosis, chronic liver disease (unless confirmed to be stable for 6 months> (4) Confirm ALT>2XULN or neutrophil <1500/mm2 (except for participants of African descent, who are neutrophils ≤1000/mm3) or lymphocytes at screening <1000/mm3. (5) Participants with a history of malignancy (except for carcinoma in situ of the cervix that has been effectively treated or non-metastatic squamous cell carcinoma or basal cell carcinoma of the skin that has undergone appropriate treatment) before the screening visit should also be excluded. (6) History of diseases requiring regular use of systemic steroids, including but not limited to rheumatoid arthritis, Crohn's disease, and systemic lupus erythematosus. (7) Any other medical condition or complication of the participant that precludes the evaluation of the common primary endpoint or will adversely affect participation in this study, as judged by the investigator. 6. History of thromboembolic events, clinical evidence, suspected thromboembolic events, or at significant risk, as well as myocardial infarction, stroke, and/or antiphospholipid syndrome and any participant requiring antithrombotic therapy. 7. Current presence of hypoproglobulinemia, defined as Ig levels (IgG and/or IgM) lower than LLN at screening, or a history of primary hypoproglobulinemia. Patients with a history of secondary hypoproglobulinemia induced by anti-CD20mAbs (e.g., aurelizumab, ofatumumab, ublituximab, rituximab) may be considered for inclusion in the study if their Ig levels are within the normal range at screening. 8. Presence of previous or current disease that mimics MS symptoms, including but not limited to neuromyelitis optica spectrum disease, systemic lupus erythematosus, Sj?gren's syndrome, acute disseminated encephalomyelitis, and myasthenia gravis. 9. Participant has received any of the following medications/treatments (interferon β or glatiramer acetate treatment without elution but not allowed on and after Day 1) within the specified time frame prior to any baseline assessments: 10. Participants are allergic to any study intervention or its components, or have drug allergies or other allergies that the investigator considers contraindicated to participate in this study. 11. Participant has had prior exposure to frexalimab. 12. Participant has used other investigational drugs at the following times: within 84 days prior to the screening visit or within 5 half-lives of other investigational drugs, whichever is longer. 13. Positive hepatitis C antibody test result at screening before starting study intervention administration. Participants with a positive hepatitis C antibody test result due to a previous resolved disease will be enrolled only after confirming a negative hepatitis C RNA test result. Hepatitis B surface antigen (HBsAg) and anti-hepatitis B core antibody (anti-HBc Ab). If anti-HBs negative and anti-HBc positive: Hepatitis B virus DNA test is performed to confirm. 14. Participant has contraindications to MRI, i.e., has a pacemaker, metal implants (i.e., artificial heart valve E14. membranes, aneurysms/clamps) at high-risk sites, metallic substances (e.g., shrapnel) at high-risk sites, or has a history of claustrophobia that would preclude completion of all MRI scans specified in the study protocol. Note: Patients with contraindications can be enrolled in the study, but they must not use contrast agents when undergoing MRI scanning. 15. Individuals detained for violating laws and regulations; Prisoners or legally detained. 16. The investigator considers the participant to be unsuitable for the study (regardless of the reason; including medical or clinical conditions) or the participant may be at risk for non-compliance with study procedures. 17. Participant is an employee of the clinical research center or other individual directly involved in the conduct of the study, or an immediate family member of such individual (combined with ICH-GCP Regulation E6 Section 1.61). 18. For country-specific regulations that restrict participant enrollment in the study, see Appendix 8 (Section 10.8) (country-specific requirements).

研究实施时间：

Study execute time：

从 From 2026-03-01 00:00:00至 To 2028-11-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-04-17 00:00:00 至 To 2027-01-28 00:00:00  

干预措施：

Interventions：

组别：

frexalimab SC

样本量：

80

Group：

frexalimab SC

Sample size：

干预措施：

frexalimab 皮下给予

干预措施代码：

Intervention：

frexalimab administered subcutaneously

Intervention code：

组别：

frexalimab IV

样本量：

80

Group：

frexalimab IV

Sample size：

干预措施：

frexalimab 静脉给药

干预措施代码：

Intervention：

Frexalimab intravenous administration

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川省 

市(区县)：

  

Country：

China 

Province：

Sichuan 

City：

 

单位(医院)：

四川大学华西医院 

单位级别：

三级甲等 

Institution
hospital：

West China Hospital of Sichuan University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

  

Country：

China 

Province：

Guangdong 

City：

 

单位(医院)：

东莞市人民医院 

单位级别：

三级甲等 

Institution
hospital：

Dongguan People's Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 四川省 

市(区县)：

  

Country：

China 

Province：

Sichuan 

City：

 

单位(医院)：

四川省人民医院 

单位级别：

三级甲等 

Institution
hospital：

Sichuan Provincial People's Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 辽宁省 

市(区县)：

  

Country：

China 

Province：

Liaoning 

City：

 

单位(医院)：

中国医科大学附属盛京医院 

单位级别：

三级甲等 

Institution
hospital：

Shengjing Hospital, Affiliated to China Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 北京市 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

北京大学第一医院 

单位级别：

三级甲等 

Institution
hospital：

Peking University First Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 北京市 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

首都医科大学附属北京天坛医院 

单位级别：

三级甲等 

Institution
hospital：

Beijing Tiantan Hospital, Capital Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

  

Country：

China 

Province：

Guangdong 

City：

 

单位(医院)：

中山大学附属第三医院（中山大学肝脏病医院） 

单位级别：

三级甲等 

Institution
hospital：

The Third Affiliated Hospital of Sun Yat-sen University (Sun Yat-sen University Liver Hospital)

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 河北省 

市(区县)：

  

Country：

China 

Province：

Hebei 

City：

 

单位(医院)：

河北医科大学第二医院 

单位级别：

三级甲等 

Institution
hospital：

The Second Hospital of Hebei Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

第 20 周至第 24 周的曲线下面积（AUCW20-W24）,

指标类型：

主要指标

Outcome：

Area under the curve over the interval W20 to W24 (AUCW20-W24).

Type：

Primary indicator

测量时间点：

测量方法：

采血检测

Measure time point of outcome：

Measure method：

Blood testing

指标中文名：

第 24 周时的 GdE T1 病灶总数

指标类型：

次要指标

Outcome：

Total number of GdE T1 lesions at W24

Type：

Secondary indicator

测量时间点：

第 24 周

测量方法：

MRI检测

Measure time point of outcome：

W24

Measure method：

MRI testing

指标中文名：

稳态时的谷浓度（Ctrough, SS）

指标类型：

主要指标

Outcome：

Trough concentration at steady state (Ctrough,SS)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

凝血（血浆）

组织：

Sample Name：

Coagulation (plasma)

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

血液

组织：

Sample Name：

blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 55 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

使用交互式应答技术（IRT）集中将所有参与者随机分配至研究干预组。IRT 生成参与者随机化列表，并根据该表为参与者分配干预编号和相应的干预药盒。将按 MS 类型（RMS 与 nrSPMS）、体重（＜70 kg、≥70 kg）和地区（美国或非美国）进行随机化分层。

Randomization Procedure (please state who generates the random number sequence and by what method)：

All participants will be centrally assigned to randomized study intervention using an interactive response technology (IRT). The IRT generates the participant randomization list and allocates the intervention number and the corresponding intervention kits to the participants according to it.Randomization will be stratified by type of MS (RMS versus nrSPMS), weight (<70 kg, 70 kg) and region (US or non-US).

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

开放标签

Blinding：

Open-label study

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

使用电子病例报告表和EDC数据采集和管理由两个部分组成，一为病历记录表（CRF），二为电子采集和管理系统（EDC）

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Use eCRF and EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-04-17 15:28:20