A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 1/3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Celltrion
- 入组人数
- 512
- 试验地点
- 2
- 主要终点
- Area under the concentration-time curve in PK group
研究概览
简要总结
This is a double-blind, randomized, active-controlled, parallel group, Phase 1/3 study to compare efficacy, PK, PD and overall safety of CT-P53 with Ocrevus in patients with Relapsing-remitting Multiple Sclerosis.
详细描述
CT-P53, containing the active ingredient ocrelizumab, is a humanized monoclonal antibody that is being developed as a proposed biosimilar medicinal product to Ocrevus. The purpose of this study is to demonstrate similar efficacy, PK, PD and safety of CT-P53 and Ocrevus in patients with Relpasing-remitting Multiple Screlosis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed as multiple sclerosis (MS) in accordance with the revised McDonald criteria.
- •Patient has evidence of recent MS activity as defined in the study protocol
- •Patient has neurological stability for ≥30 days.
- •Patient with 0 to 6.0 (both inclusive) on the EDSS score.
排除标准
- •Patient diagnosed with primary or secondary progressive MS.
- •Patient diagnosed with MS for more than 15 years duration with an EDSS score ≤2.0 at Screening.
- •Patient unable to complete or has a contraindication to an MRI
- •Patient with contraindications and/or severe hypersensitivity to corticosteroids including methylprednisolone or any of the excipients of study drug or etcs defined in the study protocol.
- •Patient who has currently or history of any of medical conditions described in the study protocol.
- •Patients who have received or going to receive any of prohibited medications or treatments defined in the study protocol.
结局指标
主要结局
Area under the concentration-time curve in PK group
时间窗: Up to Week 24
To demonstrate PK comparability in terms of the area under the concentration time curve in patients with RRMS as follows: * Area under the concentration-time curve from time zero to Week 2 (AUC0-wk2) * Area under the concentration-time curve from Week 2 to Week 24 (AUCwk2-wk24)
Total number of new GdE lesions on T1-weighted brain MRI in Main study group
时间窗: Up to Week 24
To demonstrate the equivalence of CT-P53 to reference drug (EU-Ocrevus and US-Ocrevus) in terms of efficacy in patients with RRMS as determined by the total number of new gadolinium-enhancing (GdE) lesions on T1-weighted brain magnetic resonance imaging (MRI)
次要结局
- Absoulte CD19+ B-cell counts for PD assessments(Up to Week 96)
- Total body clearance in PK group(Up to Week 2)
- Annualized Relapse Rate (ARR)(Up to Week 96)
- Total Number of Lesions on Brain Magnetic Resonance Imaging(Up to Week 96)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Up to Week 96)
- Area under the concentration-time curve in PK group(Up to Week 16)
- Volume of distribution at steady state in PK group(Up to Week 2)
- Change in Expanded Disability Status Score (EDSS)(Up to Week 96)
- Change in Multiple Sclerosis Functional Composite Score (MSFCS)(Up to Week 96)
- Safety: Immunogenecity(Up to Week 96)
- Volume of Hypointense Lesions on T1-weighted Brain Magnetic Resonance Imaging(Up to Week 96)
- Brain Volume on Brain Magnetic Resonance Imaging(Up to Week 96)