NCT07483450进行中（未招募）4 期
A Multicenter, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Chinese Patients With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 17
- 主要终点
- RMS Cohort: Annualized Protocol-defined Relapse Rate
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy of ocrelizumab in participants with relapsing multiple sclerosis (RMS) and to characterize the ocrelizumab pharmacodynamic (PD) profile in Chinese participants with primary progressive multiple sclerosis (PPMS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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/PPMS in accordance with the revised 2017 McDonald Criteria
- •EDSS score from 0-5.5 (RMS) or 3.0-6.5 (PPMS), inclusive, at screening and baseline
- •Documented MRI of brain with abnormalities consistent with MS before screening
排除标准
- •Diagnosis of PPMS or non-active secondary progressive multiple sclerosis (SPMS) (only for RMS cohort)
- •History of relapsing remitting multiple sclerosis (RRMS) or SPMS at screening (only for PPMS cohort)
- •Disease duration of more than 10 years in participants with an EDSS ≤ 2.0 at screening (only for RMS cohort)
- •History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
- •Inability to complete an MRI scan or contraindication to Gd administration
- •Contraindications to mandatory pre-medications (i.e., corticosteroids and antihistamines)
- •Known presence of other neurologic disorders if they could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study
- •Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
- •Known history of human immunodeficiency virus (HIV) infection
- •Lack of peripheral venous access
- •Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab), unless the last infusion was at least 6 months prior to screening
- •Positive screening tests for hepatitis B virus (HBV) and/or hepatitis C virus (HCV)
研究组 & 干预措施
RMS Cohort
Experimental
Participants with RMS will receive ocrelizumab, 300 milligrams (mg), intravenous (IV) infusions on Days 1 and 15 of Cycle 1 and thereafter as a single infusion of 600 mg, IV, for all subsequent cycles every 24 weeks (Q24W) (1 Cycle=24 weeks).
干预措施: Ocrelizumab (Drug)
PPMS Cohort
Experimental
Participants with PPMS will receive ocrelizumab, 300 mg, IV infusions on Days 1 and 15 of Cycle 1 and thereafter as a single infusion of 600 mg, IV, at Week 24 (1 Cycle=24 weeks).
干预措施: Ocrelizumab (Drug)
结局指标
主要结局
RMS Cohort: Annualized Protocol-defined Relapse Rate
时间窗: Up to approximately 1.6 years
PPMS Cohort: B-cell Levels in Blood
时间窗: Up to Week 48
PPMS Cohort: Percentage of Participants Achieving Cluster of Differentiation 19 (CD19+) B-cell Levels of <10 Cells/Microliter (μL) at Week 48
时间窗: At Week 48
次要结局
- RMS Cohort: Percentage of Participants Who Have No Evidence of Disease Activity (NEDA3) During a 48-week Period(Up to Week 48)
- RMS Cohort: Percentage of Relapse-free Participants by Week 48(Up to Week 48)
- RMS Cohort: Percentage of Participants Who Have NEDA3 During a 24-week Period(Up to Week 24)
- RMS Cohort: Total Number of T1 Gadolinium (Gd)-enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI)(Up to Week 48)
- RMS Cohort: Total Number of New or Enlarging T2 Hyperintense Lesions as Detected by Brain MRI(Up to Week 48)
- RMS and PPMS Cohorts: Change From Baseline to Week 48 in the Concentration of Serum Neurofilament Light Chain (Nfl)(Baseline up to Week 48)
- RMS and PPMS Cohorts: Change From Baseline to Week 48 in Expanded Disability Status Scale (EDSS)(Baseline up to Week 48)
- RMS and PPMS Cohorts: Change From Baseline to Week 48 in Timed 25-Foot Walk Test (T25FWT)(Baseline up to Week 48)
- RMS and PPMS Cohorts: Change From Baseline to Week 48 in 9-Hole Peg Test (9-HPT)(Baseline up to Week 48)
- RMS and PPMS Cohorts: Change From Baseline in EuroQoL 5-Dimension Questionnaire (5-Level Version; EQ-5D-5L) Index Score at Week 48(Baseline, Week 48)
- RMS and PPMS Cohorts: Serum Concentration of Ocrelizumab(Up to Week 48)
- RMS Cohort: B-cell Levels in Blood(Up to Week 48)
- RMS Cohort: Percentage of Participants Achieving CD19+ B-cell Levels of <10 cells/μL at Week 48(At Week 48)
- PPMS Cohort: Total Number of T1 Gd-enhancing Lesions as Detected by Brain MRI at Week 24 and Week 48(Week 24 and Week 48)
- PPMS Cohort: Total Number of New or Enlarging T2 Hyperintense Lesions as Detected by Brain MRI at Week 24 and Week 48(Week 24 and Week 48)
- RMS and PPMS Cohorts: Number of Participants With Adverse Events (AEs)(Up to approximately 1.8 years)
- RMS and PPMS Cohorts: Change from Baseline in T-cell Level(Up to approximately 1.8 years)
- RMS and PPMS Cohorts: Percentage of Participants With Suicidal Ideation or Behaviour, as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)(Up to approximately 1.8 years)
研究者
研究点 (17)
Loading locations...
相似试验
招募中
3 期
A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis2023-505980-36-00F. Hoffmann-La Roche AG363
招募中
3 期
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis2023-506467-34-00F. Hoffmann-La Roche AG357
招募中
3 期
Ocrelizumab VErsus Rituximab off-Label at the Onset of Relapsing MS Disease (OVERLORD-MS)Multiple Sclerosis2024-510716-71-00Helse Bergen HF214
尚未招募
3 期
A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)Relapsing-remitting Multiple SclerosisNCT07503340Hoffmann-La Roche25
招募中
4 期
A Study to Evaluate B Cell Levels in Infants Potentially Exposed to Ocrelizumab During Pregnancy - The MINORE Study2024-510974-25-00F. Hoffmann-La Roche AG10