NCT04948645终止1 期
A Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of ABBV-CLS-7262 in Subjects With Amyotrophic Lateral Sclerosis Followed by an Active Treatment Extension
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 13
- 主要终点
- Safety and Tolerability
研究概览
简要总结
ABBV-CLS-7262 is an investigational drug being researched for the treatment of Amyotrophic Lateral Sclerosis. This is an up to 156-week, 2-part study. Part 1 will be a 4-week, randomized, double-blind, placebo-controlled study; Part 2 will be up to a 152-week active treatment extension (ATE) during which all subjects will receive ABBV-CLS-7262.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have an identified, reliable caregiver
- •Confirmed diagnosis of Familial ALS or Sporadic ALS
- •First ALS symptoms occurred ≤36 months before screening
- •Able to swallow solids
- •No known active COVID-19 infection at screening
- •Vital capacity ≥50% predicted value (for sex, age, ethnic origin, and height) at screening
- •If taking concomitant standard-of-care medications approved for the treatment of ALS (or their components), subjects must be on a stable dose of the medication(s) for >30 days prior to Baseline in order to enter the study. For edaravone, a stable dose is defined by having completed 2 treatment cycles prior to Baseline.
排除标准
- •History of dementia/severe cognitive problems at screening
- •History of clinically significant medical conditions (other than ALS) or any other reason, including any physical, psychological, or psychiatric condition that, in the opinion of the Investigator, would compromise the safety or interfere with the subject's participation in the study, or would make the subject an unsuitable candidate to receive study drug, or would put the subject at risk by participating in the study.
- •History of abnormal screening laboratory or imaging results that, in the opinion of the Investigator, are indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurologic, and/or other major disease that would preclude administration of ABBV-CLS-
- •Documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix
- •If female, is known to be pregnant, breastfeeding, considering becoming pregnant, or donating/banking eggs during the study or within 30 days or >5 half-lives (whichever is longer) after the last dose of study drug
- •If male, plans to donate sperm or father a child during the study or within 30 days after the last dose of study drug
- •Known to have received any investigational product within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study
- •History of ABBV-CLS-7262 use prior to participation in this study
- •Recent (within 6 months prior to Screening) history of drug or alcohol abuse
- •Previous participation in a stem cell clinical study for treatment of ALS
- •Current or anticipated use of diaphragmatic pacing during the study period
- •Tracheostomy or use of non-invasive ventilatory support ≥22 hours a day
研究组 & 干预措施
Fosigotifator Low Dose
Active Comparator
干预措施: Fosigotifator (Drug)
Fosigotifator Medium Dose
Active Comparator
干预措施: Fosigotifator (Drug)
Fosigotifator High Dose
Active Comparator
干预措施: Fosigotifator (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: Baseline Up to Approximately Day 28
Number of patients with treatment-related adverse events as assessed by CTCAE v4.03
Pharmacokinetics
时间窗: Baseline Up to Approximately Day 28
Area Under the Curve \[AUC\]
次要结局
- CSF Pharmacokinetics(Baseline Up to Approximately Day 28)
- Safety and Tolerability(Baseline Up to Approximately Week 156)
研究者
研究点 (13)
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