An Open-label Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 25
- 主要终点
- Peak Concentration (Cmax) of Ocrelizumab After the First SC Injection
研究概览
简要总结
The main purpose of this study is to evaluate the pharmacokinetics (PK) of ocrelizumab administered subcutaneously (SC) in children and adolescents aged 10 to <18 years with RRMS. The study consists of a 48-week treatment period, an Optional Ocrelizumab Extension (OOE) period of at least 48 weeks, and Safety Follow-up (SFU) for 104 weeks.
详细描述
For participants who are under 18 years old at the end of the OOE period, it may be extended until the participant turns 18 years old (or as required per local regulation) or until commercial ocrelizumab intravenous (IV) is approved for children and adolescents and available in the country for these participants, whichever occurs first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents from 10 years to less than 18 years of age, at the time of baseline visit
- •Body weight ≥25 kg
- •Diagnosis of RRMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, or McDonald criteria 2017 or 2024
- •Neurologic stability for at least 30 days prior to screening, and between screening and baseline
- •Expanded Disability Status Scale (EDSS) score, 0-5.5, at screening
- •Must have received all childhood required vaccinations as per local/national recommendations for childhood vaccination against infectious diseases
排除标准
- •Participants who are positive for aquaporin 4 (AQP4) or myelin oligodendrocyte glycoprotein (MOG) antibody are not eligible to participate in the study
- •Any known presence or suspicion of other neurologic disorders that may mimic multiple sclerosis (MS)
- •History or known presence of recurrent or chronic infection (e.g., human immunodeficiency virus [HIV], syphilis, tuberculosis [TB])
- •Contraindications against SC injections or other conditions not suitable for SC injections, e.g., extremely thin SC fat layer
- •History of a severe allergic or anaphylactic reaction to humanized or murine monoclonal antibody or known hypersensitivity to any component of ocrelizumab solution
- •Contraindications to mandatory premedications (i.e., corticosteroids and histamines), including closed-angle glaucoma for antihistamines
- •Participants who have previously received treatment with B cell-targeted therapies, including ocrelizumab
- •Any previous treatment with alemtuzumab, anti-CD4, cladribine, mitoxantrone, daclizumab, laquinimod, total body irradiation, or bone marrow transplantation
- •Treatment with any investigational agent within 24 weeks of screening or 5 half-lives, whichever is longer (or longer if indicated by the PD action of the drug)
研究组 & 干预措施
Ocrelizumab
Participants will receive ocrelizumab co-formulated with recombinant human hyaluronidase (rHuPH20), 480 milligrams (mg) (body weight <35 kilograms [kg]) or 920 mg (body weight ≥35 kg), as a SC injection, every 6 months during the 48-week treatment and OOE periods.
干预措施: Ocrelizumab co-formulated with rHuPH20 (Drug)
结局指标
主要结局
Peak Concentration (Cmax) of Ocrelizumab After the First SC Injection
时间窗: Up to 24 weeks
Area Under the Concentration-time Curve Over a Dosing Interval (AUCtau) After the First SC Injection of Ocrelizumab
时间窗: Up to 24 weeks
次要结局
- Number of Participants With Anti-drug Antibodies (ADAs) to Ocrelizumab(Up to 260 weeks)
- Incidence and Nature of Adverse Events (AEs)(Up to 260 weeks)
- Percentage of Participants Who Discontinued Study Treatment due to AEs(Up to 96 weeks)
- Levels of Cluster of Differentiation 19+ (CD19+) B-cell Count in Blood(Up to 260 weeks)
- Number of Participants With ADAs to rHuPH20(Up to 260 weeks)