NCT07321093招募中3 期
A Double-blind, Randomized Clinical Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Biocad
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- Total number of T1 gadolinium-enhancing (Gd+) lesions up to Week 24.
研究概览
简要总结
The aim of this study is to compare the efficacy, safety profile, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-281 and the reference drug in subjects with relapsing multiple sclerosis.
详细描述
The study includes the following periods:
- Screening (not more than 28 days from the date of signing the ICF).
- Double-blind period - Week 0-72.
- Open-label period - Weeks 72-96.
- Follow-up period - Weeks 96-100. The screening examination is aimed at confirming the eligibility of the subjects for the study. After confirming the eligibility, the subject will be randomized with equal probability into one of two groups (BCD-281 and the reference drug).
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
- Triple (Participant, Care Provider, Investigator)
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
- •Provided written ICF to participate in the study.
- •Male and female subjects aged 18 to 55 years inclusive at the time of signing the ICF.
- •Diagnosis of multiple sclerosis, established in accordance with the McDonald criteria for the diagnosis of multiple sclerosis (2017 revision).
- •Relapsing-remitting multiple sclerosis.
- •The total EDSS score 0-5.5 inclusive.
- •Documentary evidence of the following at the time of signing the ICF:
- •at least one relapse within the last12 months, and/or
- •2 relapses within the last 24 months, and/or
- •at least 1 T1 Gd+ lesion detected on brain MRI and 1 relapse within 24 months prior to signing the ICF.
- •Presence of IgG antibodies to the Varicella-Zoster virus.
- •Neurological stability for 30 days prior to signing the ICF.
- •Subject's willingness to discontinue previously prescribed DMTs from the day of the first administration of the IP and throughout the study.
- •The ability of the subject to follow the Protocol procedures, according to the Investigator.
- •Willingness of subjects of both sexes and their sexual partners of childbearing potential to use reliable methods of contraception from the time of signing ICF, throughout the study and for 5 months after the last dose of the drug in this study.
排除标准
- •Primary progressive or secondary progressive MS.
- •MS duration of more than 10 years with EDSS score of ≤2.0 at screening.
- •Malignant form of MS.
- •Other medical conditions that can affect the assessment of clinical picture of the MS.
- •Inability to obtain high-quality MRI images and/or the presence of contraindications to MRI and the administration of gadolinium-containing contrast agents.
- •Any comorbidities requiring treatment with systemic glucocorticoids and/or immunosuppressive drugs for the duration of the study, with the exception of MS.
- •History of progressive multifocal leukoencephalopathy.
- •Any acute or exacerbated chronic infections detected during screening that may have a negative impact on subject's safety during the study therapy.
- •Concomitant diseases and/or conditions that may affect the assessment of the clinical picture of the underlying disease and/or significantly increase the risk of AEs during the study.
- •Known alcohol or drug addiction, or current signs of alcohol/drug addiction.
- •History of severe depression and/or a Beck Depression Inventory score of ≥16 at screening examination.
- •History of a malignant disease within 5 years prior to screening.
- •A diagnosis of HIV infection, hepatitis B or C .
- •Inability to provide the subject with venous access.
- •Pregnancy or breastfeeding, pregnancy planning and oocyte donation throughout the study and for 5 months after the last dose of ocrelizumab.
- •A history of severe allergic or anaphylactic reactions to humanized and/or murine monoclonal antibodies.
- •A history of using any prohibited medications or treatments defined in the study protocol.
- •Abnormal laboratory blood values, as specified in the study protocol.
研究组 & 干预措施
BCD-281
Experimental
Subjects will receive 300 mg (for the first two infusions) and 600 mg via subsequent infusions.
干预措施: BCD-281 (Biological)
Ocrelizumab
Active Comparator
Subjects will receive 300 mg (for the first two infusions) and 600 mg via subsequent infusions.
干预措施: Ocrelizumab (Biological)
结局指标
主要结局
Total number of T1 gadolinium-enhancing (Gd+) lesions up to Week 24.
时间窗: up to Week 24
The total number of T1 Gd+ lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 12, 16, 20 and 24.
次要结局
- Time to first relapse.(up to Week 100)
- Annualized relapse rate (ARR).(up to Week 100)
- Total number of T1 Gd+ lesions at Weeks 48, 72, 100.(up to Week 100)
- Proportion of subjects without contrast-enhancing lesions.(up to Week 100)
- Proportion of subjects without confirmed relapses.(up to Week 100)
- Proportion of subjects without new or enlarged T2 lesions.(up to Week 100)
- Total number of new hypointense T1 lesions.(up to Week 100)
- Change in the volume of hypointense T1 lesions.(up to Week 100)
- Change in the volume of T2 lesions.(up to Week 100)
- Changes over time in Timed 25-Foot (7.62 meters) Walk Test performance.(up to Week 100)
- Total number of new or enlarged T2 lesions.(up to Week 100)
- Proportion of subjects with confirmed disability worsening (CDW).(up to Week 100)
- Combined unique active (CUA).(up to Week 100)
- Changes over time in the neurologic deficit according to the Expanded Disability Status Scale (EDSS).(up to Week 100)
- Changes over time in 9-Hole Peg Test (9HPT) performance.(up to Week 100)
- Changes over time in Symbol Digit Modalities Test (SDMT) performance.(up to Week 100)
- Change in quality of life using SF-36 questionnaire (36-Item Short Form Health Survey)(up to Week 100)
- Change in quality of life using EQ-5D questionnaire (EuroQol Five Dimensions)(up to Week 100)
- Proportion of subjects with confirmed disability progression (CDP).(up to Week 100)
- The proportion of subjects with confirmed overall disability worsening.(up to Week 100)
- Proportion of patients with adverse reactions(up to Week 100)
- Proportion of patients with serious adverse reactions(up to Week 100)
- AUC 168-336.(up to Week 100)
- Cmax.(up to Week 100)
- Tmax.(up to Week 100)
- T1/2.(up to Week 100)
- Kel.(up to Week 100)
- Ceoi.(up to Week 100)
- Ctrough.(up to Week 100)
- Pharmacodynamic endpoints.(up to Week 100)
- Proportion of subjects with binding antibodies (BAbs).(up to Week 100)
- Proportion of subjects with neutralizing antibodies (NAbs).(up to Week 100)
- Time to BAb/NAb positivity.(up to Week 100)
研究者
研究点 (1)
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