2023-506467-34-00招募中3 期
A Phase IIIb Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 357
- 试验地点
- 49
- 主要终点
- 1. Time to onset of cCDP sustained for at least 12 weeks. Time to onset of cCDP is defined as the first occurrence of a predefined confirmed progression event measured by EDSS, T25FWT or 9-HPT
研究概览
简要总结
To demonstrate the superiority of a higher dose of ocrelizumab over the approved dose of ocrelizumab as assessed by risk reduction in composite confirmed disability progression (cCDP) sustained for at least 12 weeks
研究设计
- 分配方式
- Randomized
- 主要目的
- Optional CSF Biomarker Substudy
- 盲法
- Double (Investigator, Subject)
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
- •Ages 18−55 years at time of screening
- •Diagnosis of RMS (i.e., RRMS or aSPMS where patients still experience relapses) in accordance with the revised McDonald Criteria 2017
- •At least two documented clinical relapses within the last 2 years prior to screening, or one clinical relapse in the year prior to screening (with no relapse 30 days prior to screening and at baseline)
- •Patients must be neurologically stable for at least 30 days prior to randomization and baseline assessments
- •Expanded disability status scale (EDSS) score, at screening and baseline, from 0 to 5.5 inclusive
- •Documented MRI of brain with abnormalities consistent with MS
排除标准
- •History of primary progressive MS at screening
- •Any known or suspected active infection at screening or baseline, or any major episode of infection requiring hospitalization or treatment with IV anti microbials within 8 weeks prior to and during screening or treatment with oral anti microbials within 2 weeks prior to and during screening
- •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
- •Known presence of other neurologic disorders that could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study
结局指标
主要结局
1. Time to onset of cCDP sustained for at least 12 weeks. Time to onset of cCDP is defined as the first occurrence of a predefined confirmed progression event measured by EDSS, T25FWT or 9-HPT
1. Time to onset of cCDP sustained for at least 12 weeks. Time to onset of cCDP is defined as the first occurrence of a predefined confirmed progression event measured by EDSS, T25FWT or 9-HPT
次要结局
- 1. Time to onset of 24 week cCDP (cCDP24)
- 2. Time to onset of 48-week cCDP (cCDP48)
- 3. Time to onset of cCDP12 independent of protocol-defined relapses (PDR), also termed progression independent of relapse activity (PIRA) as per Kappos et al 2020
- 4. Time to ≥ 20% increase in 12 week confirmed T25FWT
- 5. Time to ≥ 20% increase in 24 week confirmed T25FWT
- 6. Annual rate of percent change from baseline in total brain volume
- 7. Time to 12-week confirmed 4-point worsening in Symbol Digit Modalities test (SDMT)
- 8. Time to 12-week confirmed 8-point increase in 12-Item Multiple Sclerosis Walking Scale (MSWS-12)
- 9. Change in NfL (i.e. ratio to baseline) at Week 48 for patients assigned to the higher dose ocrelizumab group
- 10. Change in NfL (i.e ratio to baseline) at Week 48 for patients assigned to the approved dose ocrelizumab group
- 11. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
- 12. Change from baseline in clinical laboratory test results (including hematology, chemistry, and Ig levels)
- 13. Change from baseline in vital signs (including systolic and diastolic blood pressure, and pulse rate) following study treatment administration
- 14. Serum concentration of ocrelizumab at specified timepoints
- 15. B-cell levels in blood (including comparing the degree of B-cell depletion between the doses)
- 16. Proportion of participant achieving 5 or less B-cells per microliter of blood
- 17. Proportion of participants achieving 5 or less B-cells per microliter of blood in participants with the high versus low affinity Fcgamma Receptor 3A (FcγR3A) genotype per arm
- 18. Change from Baseline in the anti-drug antibodies (ADAs) levels
- 19. Levels of Neurofilament Light Chain (NfL) in blood
- 20. Levels of interleukin-6 (IL-6) in blood
- 21. Levels of blood B cells
- 22. Levels of Lymphocytes in blood
- 23. Proportion of participants with different DNA genotypes
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (49)
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