NCT07533019招募中2 期
A Phase 2, Randomized, 24-Week, Multicenter, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Investigate Efficacy and Safety of LY4005130 in Adult Participants With Non-Segmental Vitiligo
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
- 66
- 试验地点
- 45
- 主要终点
- Percentage of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI) 75
研究概览
简要总结
The purpose of this study is to evaluate how well LY4005130 is tolerated and what side effects may occur in participants with non-segmental vitiligo (NSV) when compared with placebo. The study drug will be administered intravenously (IV) (into a vein in the arm).
Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible participants must have the following at both screening and baseline:
- •A clinical diagnosis of non-segmented vitiligo (NSV) for at least 3 months
- •Body surface area (BSA) involvement of 4% to 60%, inclusive, excluding involvement at palms of the hands, soles of the feet, or dorsal aspect of the feet
- •BSA involvement of ≥0.5% on the face
- •F-VASI ≥0.5 and T-VASI ≥3, and
- •Either active or stable disease at both screening and baseline
排除标准
- •Participants who have other types of vitiligo that are not considered active or stable vitiligo
- •Currently have active forms of other disorders of pigmentation
- •Currently have active forms of inflammatory skin disease(s) or evidence of skin conditions that would interfere with evaluation of vitiligo or response to treatment
- •Have a superficial skin infection within 2 weeks before baseline. Participants may be rescreened after the infection is resolved
- •Have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse within 1 year prior to screening
- •Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking the study intervention or interfere with the interpretation of data
- •Any previous JAK inhibitor therapy, systemic or topical (for example, ruxolitinib, tofacitinib, baricitinib, upadacitinib, filgotinib, lestaurtinib, pacritinib) will NOT be allowed. Participant MUST be JAK inhibitor therapy-naïve
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 Facial Vitiligo Area Scoring Index (F-VASI) 75
时间窗: Week 24
次要结局
- Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 75(Week 24)
- Pharmacodynamics (PD): Change from Baseline in Gene Expression of Select Genes from Skin Biopsy(Baseline, Week 24)
- Pharmacokinetics (PK): Observed Trough of LY4005130 Serum Concentration(Week 24)
研究者
研究点 (45)
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