A Randomized, Double-blind, Parallel-group Study to Compare the Pharmacokinetics, Efficacy, Pharmacodynamics, Safety, and Immunogenicity of CYB704 (Proposed Ocrelizumab Biosimilar) and Ocrevus® in Participants With Relapsing Multiple Sclerosis (RMS) [STRIVE-MS].
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Sandoz
- 入组人数
- 183
- 试验地点
- 45
- 主要终点
- Area under the concentration time curve
研究概览
简要总结
The goal of this clinical trial is to learn if drug CYB704, a proposed biosimilar to Ocrevus, works to treat multiple sclerosis in the same way as the reference product Ocrevus(R).
The main questions it aims to answer are:
- Is CYB704 distributed in the body in the same way as the reference product (demonstration of pharmacokinetic (PK) similarity)?
- Does have CYB704 the same treatment effect and side effects as the reference product?
Researchers will compare CYB704 to a Ocrevus (Ocrevus-US and Ocrevus-EU). Participants will:
- Take drug CYB704 or Ocrevus (Ocrevus-US and Ocrevus-EU)
- Visit the clinic for at least 15 treatment visits, checkups and tests
- Will undergo regular magnetic resonance imaging (MRI) examinations
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
- •Diagnosis of RMS (relapsing remitting multiple sclerosis (MS) or active secondary progressive MS)
- •Evidence of recent disease activity as defined in study protocol
- •Expanded Disability Status scale score of 0 to 5.5 (inclusive) at screening
- •Neurological stability (no new signs or symptoms referable to Central Nervous System (CNS) within 30 days before both screening and first study treatment
排除标准
- •Diagnosis of primary progressive MS
- •Disease duration of more than 10 years in participants with an Expanded Disability Status Scale (EDSS) ≤2.0 at screening
- •Inability to complete an MRI or contraindication to gadolinium administration
- •History of allergic or anaphylactic reactions to ocrelizumab or one of the premedications (methylprednisolone or equivalent corticosteroid, antihistamine, antipyretic)
- •Pregnant participants
- •Current or history of medical conditions as outlined in the study protocol
- •Prohibited medications (current and history) as outlined in the study protocol
- •Abnormal laboratory blood values as outlined in the study protocol
研究组 & 干预措施
Ocrevus-US/Ocrevus-EU
Drug: Ocrevus-US/Ocrevus-EU Patients will be dosed 300 mg on day 1 and day 15 with Ocrevus-US. Subsequent dose of 600 mg Ocrevus-EU will be administered 24 weeks after the initial dose.
干预措施: Ocrevus-EU (Biological)
CYB704
Drug: CYB704 (Ocrelizumab) Patients will be dosed 300 mg on day 1 and day 15. Subsequent dose of 600 mg will be administered 24 weeks after the initial dose.
干预措施: CYB704 (Biological)
Ocrevus-US/Ocrevus-EU
Drug: Ocrevus-US/Ocrevus-EU Patients will be dosed 300 mg on day 1 and day 15 with Ocrevus-US. Subsequent dose of 600 mg Ocrevus-EU will be administered 24 weeks after the initial dose.
干预措施: Ocrevus-US (Biological)
结局指标
主要结局
Area under the concentration time curve
时间窗: Week 1 - 3, week 3 - 25
Demonstrate similar PK between Ocrevus and CYB704
次要结局
- Area under the plasma concentration versus time curve (AUC)(Week 1 - 25)
- Peak Plasma Concentration (Cmax)(Day 1 and Day 15)
- CD19+ B-cell count(Up to 48 weeks)
- Number of new T1 GdE lesions on brain MRI scans(Up to 48 weeks)
- Number of T1 GdE lesions(Up to 48 weeks)
- Number of new/enlarging T2 lesions(Up to 48 weeks)
- Number of combined unique active lesions(Up to 48 weeks)
- Annualized Relapse Rate(Up to 48 weeks)
- Treatment emergent Adverse Events and Serious Adverse Events(Up to 48 weeks)
- Rate of patients with anti-drug antibodies(Up to 48 weeks)