NCT07217015进行中（未招募）2 期
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
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 68
- 主要终点
- Change from baseline in Eczema Area and Severity Index (EASI) score
研究概览
简要总结
This phase 2b study is designed to evaluate the safety and efficacy of KT-621 in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD), a common form of eczema. The main goals of this study are to learn how effective KT-621 is at reducing the severity and extent of AD, the safety and tolerability of KT-621, how KT-621 behaves in the body, and how the body responds to KT-621. This is a 16-week double-blind, placebo-controlled study with a 52-week open-label period.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be 12 to 75 years of age, inclusive, at the time of signing the IAF (informed assent form) and/or ICF (informed consent form).
- •Must have 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.
- •Must have an EASI score ≥ 16 at the Screening and Baseline visits.
- •Must have a vIGA-AD score ≥ 3 (scale of 0 to 4) at the Screening and Baseline visits.
- •Must have at least 10% BSA of AD involvement at the Screening and Baseline visits.
- •Must have a weekly average Peak Pruritus NRS value ≥ 4 at the Baseline visit.
- •Must have a history within the 6 months prior to the Baseline visit of either an inadequate response to, or inability to take, topical medications for the treatment of AD.
- •Must apply a stable dose of moisturizer at least twice daily for at least 7 consecutive days immediately prior to the Baseline visit. Participants should be willing to continue using moisturizer twice daily during the study.
- •Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, other study-related procedures, and questionnaires, including completing the electronic diary (e-diary), for the duration of the study as required by the study protocol.
- •Must agree to contraceptive requirements in compliance with the clinical study and local requirements.
排除标准
- •Must not have an unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the Investigator in the 4 weeks before the baseline visit.
- •Must not have other skin conditions, such as contact dermatitis, psoriasis, tinea corporis, or lupus erythematosus, that may interfere with study assessments.
- •Must not 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.
- •Must not have any surgical or medical procedure planned during participation in the study.
- •Must not have a history of alcohol or substance abuse within the previous 2 years.
- •Must not be pregnant or breastfeeding; must not be a woman planning to become pregnant or breastfeed during the study.
- •Must not have 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.
- •Must not have results from clinical laboratory safety tests that are outside the local reference range at Screening.
- •Must not 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.
- •Female participants of childbearing potential must not have a positive or undetermined pregnancy result at the Screening and baseline visits.
- •Must not have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results.
- •Must not be taking or have taken any prespecified prohibited therapies within a specific timeframe as evaluated by the Investigator.
- •Must not have a known sensitivity to any of the components of KT-
- •Must not be a member of the investigational team or his/her immediate family.
研究组 & 干预措施
Group 3: KT-621 Dose 3
Experimental
干预措施: KT-621 (Drug)
Group 1: KT-621 Dose 1
Experimental
干预措施: KT-621 (Drug)
Group 4: Placebo
Placebo Comparator
干预措施: Placebo (Other)
Group 2: KT-621 Dose 2
Experimental
干预措施: KT-621 (Drug)
结局指标
主要结局
Change from baseline in Eczema Area and Severity Index (EASI) score
时间窗: From baseline through Week 16
次要结局
- Change from baseline in the Dermatology Life Quality Index (DLQI)(From baseline to Week 16, and to Week 68)
- Incidence of treatment-emergent adverse events (TEAEs)(From baseline through Week 16, and from Week 16 through Week 68)
- Incidence of treatment-emergent serious adverse events (SAEs)(From baseline through Week 16, and from Week 16 through Week 68)
- Percentage change from baseline in body surface area (BSA) affected by AD(From baseline to Week 16 and to Week 68)
- Percentage change from baseline in the Peak Pruritus NRS score(From baseline to Week 16, and to Week 68)
- Proportion of participants with at least a 4-point improvement from baseline in the Peak Pruritus Numerical Rating Scale (NRS)(At Week 16 and at Week 68)
- Proportion of participants who achieve a validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score of 0 to 1 (on a 5-point scale) and a reduction from the baseline value of at least 2 points(At Week 16 and at Week 68)
- Proportion of participants with EASI-50, EASI-75, and EASI-90(At Week 16 and at Week 68)
- Percentage change from baseline in the EASI score(From baseline to Week 68)
- Percentage change from baseline in the SCORing Atopic Dermatitis (SCORAD) score(From baseline to Week 16, and to Week 68)
- Change from baseline in the Patient-Oriented Eczema Measure (POEM)(From baseline to Week 16, and to Week 68)
- Plasma concentration of KT-621 derived from plasma concentration time data(From baseline to Week 16, and to Week 68)
- Change from baseline in the Dermatology Life Quality Index (DLQI) or the Children's Dermatology Life Quality Index (c-DLQI)(From baseline to Week 16, and to Week 68)
研究者
研究点 (68)
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