EUCTR2020-000894-26-BG进行中（未招募）1 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 PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 699
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •? Ages 18-55 years at time of screening
- •? Ability to comply with the study protocol
- •? Diagnosis of PPMS in accordance with the revised McDonald Criteria
- •? Expanded disability status scale (EDSS) score at screening and
- •baseline >=3- 6.5, inclusive
- •? Average T25FWT score over two trials at screening and over two trials
- •at baseline respectively, up to 150 (inclusive) seconds
- •? Average 9HPT score over four trials (two trials with each hand) at screening and over four trials at
- •baseline (two trials with each hand) respectively, up to 250 (inclusive) seconds
- •? Score of >=2.0 on the Functional Systems (FS) scale for the pyramidal
- •system that was due to lower extremity findings at screening and
- •? Documented MRI of brain with abnormalities consistent with MS
- •? Participants requiring symptomatic treatment for MS and/or
- •physiotherapy must be treated at a stable dose. No initiation of
- •symptomatic treatment for MS or physiotherapy within 4 weeks of
- •randomization
- •? Patients must be neurologically stable for at least 30 days prior to
- •randomization and baseline assessments
- •? Disease duration from the onset of MS symptoms: 1] If EDSS score at
- •screening is <=5.0, disease duration from the onset of MS symptoms
- •must be less than 10 years , 2] If EDSS score at screening is >5.0,
- •disease duration from the onset of MS symptoms must be less than 15
- •years Documented evidence of the presence at least one of cerebrospinal fluidspecific
- •oligoclonal bands
- •? For females of childbearing potential, agreement to remain abstinent
- •or use adequate contraceptive method
- •? For female patients without reproductive potential: Females may be
- •enrolled if post-menopausal unless the patient is receiving a hormonal
- •therapy for her menopause or if surgically sterile
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 699
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •? History of relapsing remitting or secondary 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
- •? Receipt of a live or live-attenuated vaccine within 6 weeks prior to
- •randomization
- •? Inability to complete an MRI or contraindication to gadolinium
- •administration
- •? Contraindications to mandatory pre medications for IRRs
- •? Known presence of other neurologic disorders that could interfere with
- •the diagnosis of MS or assessments of efficacy and/or safety during the
- •? Any concomitant disease that may require chronic treatment with
- •systemic corticosteroids or immunosuppressants during the course of
- •? Significant, uncontrolled disease, that may preclude patient from
- •participating in the study
- •? History of or currently active primary or secondary (non-drug related)
- •immunodeficiency
- •? Pregnant or breastfeeding or intending to become pregnant during the
- •? Lack of peripheral venous access
- •? History of alcohol or other drug abuse within 12 months prior to
- •?Treatment with any investigational agent within 24 weeks prior to
- •screening or five half-lives of the investigational drug (whichever is
- •longer) or treatment with any experimental procedure for MS Previous
- •use of anti-CD20s (including ocrelizumab), unless the last infusion was
- •more than 2 years before screening, or if B-cell count is normal, and if
- •the stop of the treatment was not motivated by safety reasons or lack of
- •? Any previous treatment with mitoxantrone, cladribine, atacicept,
- •alemtuzumab and daclizumab
- •? Previous treatment with fingolimod, siponimod, or ozanimod within 6
- •weeks of baseline
- •? Previous treatment with natalizumab within 4.5 months of baseline
- •? Previous treatment with interferons beta (1a or 1b), or glatiramer
- •acetate within 2 weeks of baseline
- •? Previous treatment with any other immunomodulatory or
- •immunosuppressive medication not already listed above without
- •appropriate washout as described in the applicable local label. If the
- •washout requirements are not described in the applicable local label,
- •then the wash out period must be five times the half-life of the
- •medication. The PD effects of the previous medication must also be
- •considered when determining the required time for washout.
- •? Any previous treatment with bone marrow transplantation and
- •hematopoietic stem cell transplantation
- •? Any previous history of transplantation or anti-rejection therapy
- •? Treatment with IV Ig or plasmapheresis within 12 weeks prior to
- •randomization
- •? Systemic corticosteroid therapy within 4 weeks prior to screening
- •? Positive screening tests for active, latent, or inadequately treated
- •hepatitis B
- 另有 4 项未显示
研究者
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