jRCT2031250674进行中（未招募）不适用
A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging Study With an Open-label Period Investigating the Efficacy and Safety Profile of KT-621 Administered Orally to Participants with Moderate to Severe Atopic Dermatitis
未提供0 个研究点目标入组 15 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 12age 0month 0week old over 至 75age 0month 0week old under（—）
- 性别
- All
入选标准
- •12 to 75 years of age, inclusive, at the time of signing the informed consent form (ICF) or informed assent form (IAF)
- •Chronic AD that has been present for at least 3 years (for participants >= 18 years of age) or 1 year (for participants < 18 years of age) before the Screening visit, with the diagnosis of AD confirmed by photographs at Screening
- •EASI score >= 16 at the Screening and Baseline visit
- •vIGA-AD score >= 3 (scale of 0 to 4) at the Screening and Baseline visits
- •At least 10% BSA of AD involvement at the Screening and Baseline visits
- •Weekly average Peak Pruritus NRS >= 4 at the Baseline visit
- •History within the 6 months prior to the Baseline visit of either an inadequate response to, or contraindication to topical medications for the treatment of AD
- •Application of a stable dose of moisturizer at least twice daily for at least 7 consecutive days immediately prior to the Baseline visit
排除标准
- •An unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the Investigator in the 4 weeks prior to Baseline.
- •Known history of, or suspected, significant current immunosuppression, including a history of invasive opportunistic or helminth infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration
- •Clinically significant history or evidence of any active or suspected parasitic infection within 4 weeks of the Baseline visit, or travel within the 3 months before baseline to areas of high parasitic exposure, as determined by local or international health guidelines or epidemiological data
- •Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks of the Baseline visit, or superficial skin infections within 1 week of the Baseline visit
- •Presence of other skin conditions, such as contact dermatitis, psoriasis, tinea corporis, or lupus erythematosus, that may interfere with study assessments
- •Any other clinically significant disease, condition, or medical history that, in the opinion of the Investigator, would interfere with participant safety, study evaluations, and/or study procedures
- •Prohibited therapy received within a specified time frame prior to the Baseline visit
- •History of inadequate response to any therapeutic agent targeting IL-4, IL-13, and/or the JAK-STAT pathway (eg, dupilumab, lebrikizumab, upadacitinib, abrocitinib) at approved doses.
研究者
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