NCT05265728终止3 期
A Single-Arm, Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered to Japanese Participants With Relapsing-Remitting Multiple Sclerosis Via a Subcutaneous Route of Administration
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 21
- 试验地点
- 12
- 主要终点
- Part 1: Cumulative Number of New Active Lesions up to Week 24 Identified Using Brain Magnetic Resonance Imaging (MRI) Scans
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of natalizumab 300 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) administrations up to 24 weeks in Japanese participants with relapsing-remitting multiple sclerosis (RRMS).
The secondary objectives of the study are to evaluate other clinical and magnetic resonance imaging (MRI) measures of efficacy of natalizumab 300 mg SC Q4W administrations in Japanese participants with RRMS, to evaluate the safety, tolerability, and immunogenicity of natalizumab 300 mg SC Q4W administrations up to 48 weeks in Japanese participants with RRMS, to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of natalizumab 300 mg SC Q4W administrations up to 24 weeks and for an additional 24 weeks in Japanese participants with RRMS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have had a diagnosis of RRMS, as defined by the revised 2017 McDonald's criteria. All other possible neurologic diagnoses must have been reasonably excluded by means of laboratory and/or imaging studies, in the opinion of the investigator.
- •Must have had an EDSS score between 0.0 and 5.5, inclusive.
- •Must have had screening MRI or documentation of an MRI within the participant's medical record within 12 months of the screening visit that revealed 3 or more T2 hyperintense lesions consistent with MS.
- •Was born in Japan, and biological parents and grandparents were of Japanese origin.
排除标准
- •Evidence of current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 14 days prior to Screening, between screening and baseline visit, or at baseline visit, including but not limited to a fever (temperature > 37.5 degrees Celsius [°C]), new and persistent cough, breathlessness, or loss of taste and/or smell.
- •Have close contact within 14 days prior to Day 1 with a SARS-CoV-2 positive individual.
- •Diagnosis of primary progressive MS or secondary progressive MS.
- •An MS exacerbation (relapse) within 30 days prior to enrolment or, in the opinion of the investigator, the participant not having stabilized from a previous relapse prior to enrolment (Day 1).
- •The participant is unable to have a brain MRI scan (e.g., a participant with a metal clip to repair a cerebral aneurysm).
- •Previous exposure to natalizumab.
- •Note: Other protocol specified Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Natalizumab
Experimental
Participants will receive natalizumab 300 mg SC Q4W for 48 weeks.
干预措施: Natalizumab (Drug)
结局指标
主要结局
Part 1: Cumulative Number of New Active Lesions up to Week 24 Identified Using Brain Magnetic Resonance Imaging (MRI) Scans
时间窗: Up to Week 24
New active lesions were defined as the sum of gadolinium (Gd)-enhancing lesions and non-enhancing new or newly enlarging T2 hyperintense lesions over a period of 24 weeks.
次要结局
- Part 2: Cumulative Number of New Active Lesions up to Week 48 Identified Using Brain MRI Scans(Up to Week 48)
- Part 1: Proportion of Participants With Any New Active Lesions at Week 24 Identified Using Brain MRI Scans(At Week 24)
- Part 2: Proportion of Participants With Any New Active Lesions at Week 48 Identified Using Brain MRI Scans(At Week 48)
- Change From Baseline in Number of Gd-Enhancing Lesions at Week 24 and Week 48(Baseline, Weeks 24 and 48)
- Number of Non-enhancing New or Newly Enlarging T2 Hyperintense Lesions at Week 24(At Week 24)
- Number of Non-enhancing New or Newly Enlarging T2 Hyperintense Lesions at Week 48(At Week 48)
- Number of New T1 Hypointense Lesions at Week 48(At Week 48)
- Visual Analog Scale (VAS) Score at Week 24 and Week 48(At Week 24 and Week 48)
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs(From first dose of study drug through 84 days after the last dose of study drug (up to Week 60))
- Percentage of Participants With Positive Anti-Natalizumab Antibodies(Baseline up to Week 48)
- Serum Trough Concentration (Ctrough) of Natalizumab(Pre-dose at Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48)
- Serum Concentration of Natalizumab Between Day 6 and Day 8(Between Day 6 and Day 8)
- Serum Soluble VCAM-1 Concentrations(Pre-dose at Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48)
- Number of New T1 Hypointense Lesions at Week 24(At Week 24)
- Annualized Relapse Rate (ARR) at Week 24, Week 48 and Week 52(At Week 24, Week 48 and Week 52)
- Proportion of Relapse-Free Participants at Week 24 and Week 52(At Week 24 and Week 52)
- Percentage of Participants With Positive Anti-John Cunningham Virus (Anti-JCV) Antibodies(Baseline up to Week 48)
- Number of Participants With Injection Site Reactions and Injection Reactions(From first dose of study drug through 84 days after the last dose of study drug (up to Week 60))
- Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Week 24 and Week 48(Baseline, Week 24 and Week 48)
- Trough Alpha-4 (α4) Integrin Saturation(Pre-dose at Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48)
研究者
研究点 (12)
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