2025-524164-37-00招募中2 期
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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 9
- 试验地点
- 7
研究概览
简要总结
To evaluate the pharmacokinetic (PK) of ocrelizumab subcutaneous (SC) in children and adolescents with RRMS
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •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
- •The 2024 McDonald criteria will also be accepted (Montalban et al 2025).
- •Must have received all childhood required vaccinations as per local/national recommendations for childhood vaccination against infectious diseases
- •Expanded Disability Status Scale (EDSS) score, 0-5.5, at screening
- •Agreement to adhere to the contraception requirements
- •Neurologic stability for at least 30 days prior to screening, and between screening and baseline
排除标准
- •Any known presence or suspicion of other neurologic disorders that may mimic MS, including, but not limited to, acute disseminated encephalomyelitis (ADEM), neuromyelitis-optica or neuromyelitis-optica spectrum disorders and any neurologic, somatic, or metabolic condition that could interfere with brain function or normal cognitive or neurological development
- •Participants who are positive for aquaporin 4 (AQP4) or myelin oligodendrocyte glycoprotein (MOG) antibody are not eligible to participate in the study
- •Infection requiring hospitalization or treatment with IV anti-infective agents
- •History or known presence of recurrent or chronic infection (e.g., human immunodeficiency virus, syphilis, tuberculosis)
- •Receipt of a live or live-attenuated vaccine within 6 weeks prior to treatment allocation
- •⦁ Previous treatment with B-cell-targeted therapies ⦁ Percentage of CD4 < 30% ⦁ Absolute Neutrophil Count < 1.5x1000/microliter ⦁ Lymphocyte count below the lower limit of normal (LLN) for age- and sex-specific reference range
研究组 & 干预措施
Ocrevus, Ocrevus 920 mg solution for injection
Test
干预措施: Ocrevus 920 mg solution for injection (Drug)
Ocrevus, Ocrevus 920 mg solution for injection
Test
干预措施: Ocrevus (Drug)
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (7)
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