A Multicenter, Open-Label, Long-Term Treatment Study of Intravenously Administered BIIB092 in Patients With Progressive Supranuclear Palsy Who Participated in Study CN002003
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 47
- 试验地点
- 13
- 主要终点
- Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Deaths
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and tolerability of multiple intravenous (IV) infusions of BIIB092 in participants with Progressive Supranuclear Palsy (PSP). The study will also assess the pharmacodynamic (PD) effects of BIIB092 on cerebrospinal fluid (CSF) N-terminal tau, pharmacokinetics (PK), and immunogenicity of BIIB092 in participants with PSP.
详细描述
This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a licensing agreement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 41 Years 至 86 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed treatment in Study CN
- •A diagnosis of probable or possible PSP consistent with Study CN002003 criteria with no new medical information or diagnoses since enrollment into Study CN002003 that might confer doubt on the PSP diagnosis.
- •Able to tolerate Magnetic Resonance Imaging (MRI).
- •Able to perform all protocol-specified assessments and comply with the study visit schedule.
- •Have reliable caregiver to accompany patient to all study visits. Caregiver must be able to read, understand, and speak local language fluently to ensure comprehension of informed consent and informant-based assessments of patient. Caregiver must also have frequent contact with patient (at least 3 hours per week at one time or at different times) and be willing to monitor the patient's health and concomitant medications throughout the study.
- •Patient must reside outside a skilled nursing facility or dementia care facility at the time of enrollment
- •Women of childbearing potential (WOCBP) and sexually active fertile men with partners who are WOCBP must use highly effective birth control.
排除标准
- •Presence of an unstable, clinically significant medical condition other than PSP including, but not limited to: hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal, immunological, psychological or neurological disease or malignancy.
- •Contraindication to undergoing a lumbar puncture (LP).
- •Recent drug or alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (4th Edition).
- •Treatment with any investigational drugs (including placebo) other than BIIB092 or placebo given in Study CN002003 or devices within 90 days prior to enrollment
- •Any vaccination within 30 days prior to study drug administration.
- •Contraindication to the MRI examination for any reason
- •Any other sound medical, psychiatric, and/or social reason as determined by the investigator
- •Known history of human immunodeficiency virus.
- •Evidence of organ dysfunction or significant deterioration from prior values in CN002003 beyond what is consistent with the target population or that would place the patient at increased risk or risk of early study discontinuation.
- •Inability to be venipunctured and/or tolerate venous access.
- •History of allergy, hypersensitivity, or serious adverse reaction to monoclonal antibodies or related compounds or allergy to any of the components of the study drug
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Panel 1: BIIB092
BIIB092 administered by intravenous (IV) infusion, once every four weeks.
干预措施: BIIB092 (Drug)
Panel 2: BIIB092
BIIB092 administered by intravenous (IV) infusion, once every four weeks.
干预措施: BIIB092 (Drug)
Panel 3: BIIB092
BIIB092 administered by intravenous (IV) infusion, once every four weeks.
干预措施: BIIB092 (Drug)
Panel 4: BIIB092 (Expansion Panel)
BIIB092 administered by intravenous (IV) infusion, once every four weeks.
干预措施: BIIB092 (Drug)
结局指标
主要结局
Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Deaths
时间窗: Day 1 through study completion (approximately 1.5 years or later)
Percentage of Participants with Marked Abnormalities in Clinical Laboratory Tests, Vital sign Measurements, ECGs, and Physical and Neurological Examinations
时间窗: Day 1 through study completion (approximately 1.5 years or later)
次要结局
- Percent Change from Baseline in Cerebrospinal Fluid (CSF) Concentrations of unbound N-terminal Tau at Week 48(Baseline, Week 48)
- End-of-Infusion Serum Concentration of BIIB092(Day 1 through study completion (approximately 1.5 years or later))
- Number of Participants with drug antibodies (anti-BIIB092) in Serum(Up to study completion (approximately 1.5 years or later))
- Serum Trough Concentration (C-trough) of BIIB092(Up to study completion (approximately 1.5 years or later))