NCT07533006招募中2 期
A Phase 2, Randomized, Multicenter, Double-Blind, Placebo-Controlled Proof of Concept Study to Investigate Efficacy and Safety of LY4005130 in Adult Participants With Severe Alopecia Areata
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 30
- 主要终点
- Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Less than or Equal to (≤) 20
研究概览
简要总结
The purpose of this study is to evaluate how well LY4005130 works in participants with severe alopecia areata (hair loss) when compared with placebo, and how well it's tolerated and what side effects may occur. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
The study drug will be administered intravenously (IV) (into a vein in the arm).
The study will last approximately 48 weeks, including screening.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have severe Alopecia Areata (AA) that meets all of the following criteria:
- •Hair loss encompassing ≥50% and ≤90% of the scalp, as measured by Severity of Alopecia Tool (SALT) score
- •The duration of the current episode of severe AA is at least 6 months and does not exceed 4 years
- •No significant spontaneous hair regrowth in the investigator's opinion for at least 6 months
- •Agree not to use any AA treatments during the study
排除标准
- •Primarily "diffuse" type of AA (characterized by diffuse hair shedding)
- •Are currently experiencing other forms of alopecia
- •Participants who, in the opinion of the investigator, are currently experiencing or have a history of unstable concomitant disease that requires frequent hospitalizations, and/or frequent use of systemic immunosuppressants that may interfere with participation in the study
- •Have received oral JAK Inhibitors in the past
- •Have had any major surgery within 8 weeks prior to screening or will require major surgery during the study
- •Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo administered IV
干预措施: Placebo (Drug)
LY4005130
Experimental
LY4005130 administered intravenously (IV)
干预措施: LY4005130 (Drug)
结局指标
主要结局
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Less than or Equal to (≤) 20
时间窗: Week 24
次要结局
- Percentage of Participants Achieving At Least 50 Percent (%) Improvement from Baseline (SALT50)(Week 24)
- Pharmacokinetics (PK): Trough Concentrations of LY4005130(Baseline Through Week 20)
- Pharmacodynamics (PD): Change from Baseline in Gene Expression of Select Genes from Scalp Biopsy(Baseline, Week 24)
研究者
研究点 (30)
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