NCT06945458已完成1 期
A Phase 1b Open-label, Multicenter, Single-arm Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered KT-621 in Adult Participants With Moderate to Severe Atopic Dermatitis
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 12
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
This is a study to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of orally administered KT-621 in adult male and female patients with moderate to severe atopic dermatitis (AD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 18 to 55 years (inclusive) at the time of screening
- •Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures
- •Participants must have had chronic atopic dermatitis (AD) for at least 1 year before Screening.
- •Moderate to very severe eczema as determined by Eczema Area and Severity Index (EASI) score of at least 16 at the baseline visit.
- •A validated Investigator Global Assessment (vIGA) score of at least 3 at the baseline visit, indicating moderate to severe AD.
- •At least 10% body surface area (BSA) of AD involvement at the baseline visit.
- •Weekly average Peak Pruritus Numeric Rating Scale (NRS) of at least 4 at the baseline visit.
- •Documented history within 6 months prior to baseline visit of either inadequate response or contraindication to topical medications for AD.
- •Application of stable dose of moisturizer at least twice daily for at least 7 consecutive days immediately prior to the baseline visit.
排除标准
- •Participants who have a clinically relevant history of respiratory, gastrointestinal (GI), renal, hepatic, hematological, lymphatic, endocrinological, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, ophthalmological, or connective tissue diseases or disorders.
- •Participants who have any surgical or medical procedure planned during participation in the study.
- •Participants with a history of alcohol or substance abuse within the previous 2 years.
- •Participants who have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results.
- •Participants whose results from clinical laboratory safety tests are outside the local reference range at Screening.
- •Participants who have been dosed with any investigational drug or device in a clinical study within 8 weeks or 5 half-lives (whichever is longer) of KT-621 administration.
- •Participants with a history of lack of response to any medication targeting interleukin (IL)-4, IL-13, and/or janus kinase (JAK)- signal transducer and activator of transcription (STAT) pathways (e.g. dupilumab, tralokinumab, upadacitinib, abrocitinib) at approved doses after at least 16 weeks of therapy.
- •Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
- •Female participants of childbearing potential with a positive or undetermined pregnancy result at the Screening and baseline visits.
- •Participants with a known sensitivity to any of the components of KT-
- •Participants who are a member of the investigational team or his/her immediate family.
研究组 & 干预措施
KT-621
Experimental
Each participant receives daily oral doses of KT-621 throughout the 28-day treatment period.
干预措施: KT-621 (Drug)
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: From enrollment through the safety follow-up visit on Day 43
Incidence of treatment-emergent potentially clinically-significant abnormalities in electrocardiogram (ECG) results, vital signs, or laboratory test results from the serum chemistry, hematology (with differential), chemistry, or coagulation panels.
时间窗: From enrollment through the safety follow-up visit on Day 43
次要结局
- Plasma PK parameter estimates of KT-621 derived from plasma concentration-time data(From baseline visit through the safety follow-up visit on Day 43)
研究者
研究点 (12)
Loading locations...
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