2025-524727-41-00招募中2 期
J5D-MC-FPAC: A Phase 2a, 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
- 14
- 试验地点
- 5
- 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
To compare the efficacy of LY4005130 versus placebo in the treatment of participants with severe AA
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 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
SUB12581MIG
Placebo
干预措施: SUB12581MIG (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
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Less than or Equal to (≤) 20
次要结局
未报告次要终点
研究者
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.
研究点 (5)
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