2024-517980-22-00招募中2 期
A Phase II, Randomized, Open-Label, Parallel Group, Multicenter Study to Assess Bioequivalence of Two Subcutaneous Formulations of Ocrelizumab in Patients with Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 31
- 主要终点
- The primary PK parameters of ocrelizumab: area under the serum concentration−time curve (AUC) and maximum serum concentration observed (Cmax)
研究概览
简要总结
To assess bioequivalence of the ocrelizumab subcutaneous (SC) test formulation to the ocrelizumab SC reference formulation
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age 18−65 years, inclusive, at the time of signing Informed Consent Form
- •Diagnosis of relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) according to the revised McDonald 2017 criteria (Thompson et al. 2018) or the most current McDonald criteria at the time of study start
- •Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening
- •For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 6 months after the final dose of ocrelizumab.
- •For female participants without childbearing potential: – Female participants may be enrolled if postmenopausal
排除标准
- •Participants who have previously received anti-CD20s (including ocrelizumab) less than 2 years before screening
- •Participants who have previously received anti-CD20s (including ocrelizumab) more than 2 years before screening if one of the following conditions is met: – B-cell count is below lower limit of normal (LLN), or – The discontinuation of the treatment was due to safety reasons
- •Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with 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 or currently active primary or secondary (non−drug-related) immunodeficiency
- •History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
- •Previous treatment with cladribine, atacicept, and alemtuzumab
结局指标
主要结局
The primary PK parameters of ocrelizumab: area under the serum concentration−time curve (AUC) and maximum serum concentration observed (Cmax)
The primary PK parameters of ocrelizumab: area under the serum concentration−time curve (AUC) and maximum serum concentration observed (Cmax)
次要结局
- Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5 grading scale
- Change from baseline in selected vital signs
- Change from baseline in selected clinical laboratory test results
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (31)
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