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
- 进行中（未招募）
- 入组人数
- 193
- 试验地点
- 61
- 主要终点
- Maximum Serum Concentration (Cmax) of Ocrelizumab
研究概览
简要总结
The main purpose of this study is to assess the bioequivalence of ocrelizumab SC test formulation to the marketed ocrelizumab SC reference formulation in participants with either relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). The study consists of 2 phases: a controlled phase, where participants in each group will receive one dose of test or reference formulation and a continuation phase, where all participants in both groups will receive ocrelizumab SC test formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 RMS or 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
排除标准
- •Participants who have previously received anti-cluster of differentiation (CD) 20s (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
- •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
- •Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- •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, pulmonary, 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
- •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 virus (HBV)
研究组 & 干预措施
Ocrelizumab Test Formulation
Participants will receive ocrelizumab test formulation, as SC injection, as per a pre-defined dosing regimen during the controlled phase and continuation phase.
干预措施: Ocrelizumab Test Formulation (Drug)
Ocrelizumab Reference Formulation
Participants will receive ocrelizumab reference formulation, 920 mg, as SC injection, on Day 1 during the controlled phase. Thereafter, participants will receive ocrelizumab test formulation, as SC injection, as per a pre-defined dosing regimen during the continuation phase.
干预措施: Ocrelizumab Reference Formulation (Drug)
Ocrelizumab Reference Formulation
Participants will receive ocrelizumab reference formulation, 920 mg, as SC injection, on Day 1 during the controlled phase. Thereafter, participants will receive ocrelizumab test formulation, as SC injection, as per a pre-defined dosing regimen during the continuation phase.
干预措施: Ocrelizumab Test Formulation (Drug)
结局指标
主要结局
Maximum Serum Concentration (Cmax) of Ocrelizumab
时间窗: Up to 12 weeks
Maximum Serum Concentration (Cmax) of Ocrelizumab
时间窗: Up to 12 weeks
Area Under the Serum Concentration-time Curve Over the First 12 Weeks Post-dose (AUC0-12W) of Ocrelizumab
时间窗: Up to 12 weeks
次要结局
- Number of Participants With Adverse Events (AEs)(Up to 168 weeks)