NCT07667322进行中（未招募）1 期
A Phase 1b Multicenter, Non-randomized, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Single Ascending Doses of a New Subcutaneous Formulation of Ocrelizumab in Patients With Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 12
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
The main purpose of this study is to evaluate the safety and tolerability of the ocrelizumab subcutaneous (SC) test formulation in participants with multiple sclerosis (MS). The study consists of two treatment phases: a dose-escalation and dose-continuation phase. Participants will receive single ascending doses of ocrelizumab SC during an initial dose-escalation phase, with the option to continue treatment with the selected dose of ocrelizumab SC in the dose-continuation phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Relapsing Multiple Sclerosis (RMS) according to the revised McDonald 2017 criteria (Thompson et al. 2018)
- •Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening
排除标准
- •Participants who have previously received anti-cluster of differentiation 20 (CD20s) (including ocrelizumab) less than 2 years before screening
- •Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antimicrobials within 8 weeks prior to and during screening or treatment with oral antimicrobials within 2 weeks prior to and during screening
- •History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
- •History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening
- •Immunocompromised state
- •Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
- •Significant, uncontrolled disease, such as cardiovascular (including cardiac arrhythmia), pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude participation in the study
- •Lack of peripheral venous access
- •Previous treatment with cladribine, atacicept, and alemtuzumab
- •Previous treatment with fingolimod, siponimod, ponesimod, or ozanimod within 6 weeks of baseline
- •Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
- •Any previous history of transplantation or anti-rejection therapy
- •Positive screening tests for active, latent, or inadequately treated hepatitis B
- •Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab
研究组 & 干预措施
Ocrelizumab SC
Experimental
Participants will receive single ascending doses of ocrelizumab SC, co-formulated with recombinant human hyaluronidase (rHuPH20) on Day 1 of the 24 week dose-escalation phase. Participants who opt to continue treatment in the dose continuation phase will receive ocrelizumab SC at a dose determined in the dose escalation phase, every 24 weeks (Q24W) for 144 weeks.
干预措施: Ocrelizumab Co-formulated With rHuPH20 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Up to 168 weeks
次要结局
- Number of Participants With Treatment-emergent ADAs to rHuPH20(Up to 168 weeks)
- Ocrelizumab Serum Concentration at Specified Timepoints Following Single SC Administration(Up to 168 weeks)
- Number of Participants With Treatment-emergent Anti-drug Antibodies (ADAs) to Ocrelizumab(Up to 168 weeks)
研究者
研究点 (12)
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