NCT07453602招募中1 期
A Phase 1a/1b, Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234 in Healthy Volunteers and Subjects With Moderate to Severe Atopic Dermatitis.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 5
- 主要终点
- Number and percentage of participants who experience an adverse event (AE) or serious adverse event (SAE)
研究概览
简要总结
This is a first-in-human, Phase 1, double-blind, randomized, placebo-controlled, dose-escalation study evaluating ARQ-234. The study is designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ARQ-234 in two populations: healthy volunteers and participants with moderate to severe atopic dermatitis (AD). Healthy volunteers will participate in Single Ascending Dose (SAD) Cohorts 1-5. Participants with moderate to severe AD will be enrolled in SAD Cohorts 6-7, Multiple Ascending Dose (MAD) Cohorts, and a Proof-of-Concept (POC) expansion cohort.
详细描述
The study consists of 3 parts with staggered initiation:
- Part A - Phase 1a SAD: ARQ-234 will be assessed in single ascending dose cohorts in healthy volunteer participants and participants with atopic dermatitis.
- Part B - Phase 1b MAD: ARQ-234 will be assessed in multiple ascending cohorts in participants with atopic dermatitis.
- Part C - Phase 1b POC Expansion: ARQ-234 will be assessed in participants with atopic dermatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(All Participants):
- •Able and willing to provide written informed consent.
- •Adults 18-65 years (inclusive) at consent.
- •Generally healthy at screening/baseline (no clinically significant findings on medical history, exam, vitals, ECG, or safety labs, per investigator).
- •Contraception requirements: Females of childbearing potential: negative pregnancy tests at screening and baseline and agree to use highly effective contraception (plus barrier method) during the study and for 4 months after last dose. Males if sexually active with a pregnant partner or a female of childbearing potential, agree to condom use during the study and for 4 months after last dose.
- •Body weight by study part: Part A (SAD) & Part B (MAD): 50-100 kg (inclusive), Part C (POC): 50-125 kg (inclusive)
- •Inclusion Criteria for atopic dermatitis (AD) Participants (Parts A Cohorts 6-7, Part B, Part C):
- •Diagnosis of moderate-to-severe atopic dermatitis for ≥ 6 months prior to screening.
- •Meets minimum disease severity at baseline: Part A Cohorts 6-7: BSA ≥7%, vIGA-AD 3-4, EASI ≥10 at Baseline, Parts B and C: BSA ≥10%, vIGA-AD 3-4, EASI ≥16 at Baseline.
- •Inadequate response, intolerance, or medical inappropriateness of topical AD therapies (and/or prior systemic AD therapy failure within the last year may qualify as inadequate response).
排除标准
- •(All Participants):
- •Any clinically significant medical or psychiatric condition that could increase risk, interfere with participation, or confound results (per investigator).
- •Significant renal impairment or clinically significant hepatic impairment (per protocol/part-specific definitions).
- •Clinically significant cytopenias or clinically significant abnormal liver tests at screening (per protocol).
- •History of anaphylaxis/serious hypersensitivity (including significant hypersensitivity to local anesthetics).
- •History of attempted suicide or significant current risk, per investigator).
- •Chronic or significant infection history or positive screening tests for hepatitis B, hepatitis C, HIV, or tuberculosis (including positive QuantiFERON or history of active/latent TB).
- •Known/suspected immunosuppression or history of invasive opportunistic infections or unusually frequent/recurrent/prolonged infections (per investigator).
- •Recent herpes zoster that poses risk or may affect interpretation (per investigator).
- •Malignancy within 5 years prior to screening
- •Positive urine drug screen at screening (Part A/Part B only) or drug/alcohol abuse within 12 months, or other condition likely to impair compliance (per investigator).
- •Unable to discontinue prohibited medications/treatments per protocol.
- •Major surgery within 4 weeks prior to baseline or planned during participation.
- •Participation in another trial or receipt of investigational product within 12 weeks (or 5 half-lives, whichever longer) before baseline.
- •Prior cell-depleting therapy (e.g., rituximab) within 6 months prior to baseline (or until lymphocytes normalize, whichever longer).
- •Blood products within 4 weeks prior to baseline or planned during participation.
- •Live (attenuated) vaccines within 28 days prior to baseline or planned during the study.
- •Pregnant or breastfeeding, or planning pregnancy during the study or within 4 months after last dose.
- •Known/suspected allergy to ARQ-234 or its excipients.
- •Unable to communicate/understand the local language or otherwise unsuitable per investigator.
- •Family member of study staff or sponsor.
- •Exclusion Criteria for atopic dermatitis (AD) Participants (Parts A Cohorts 6-7, Part B, Part C):
- •Skin disease(s) other than AD that would interfere with assessments.
- •Active systemic/local infection, including actively infected AD, or infection requiring oral/IV antimicrobials within 14 days before baseline.
- •Phototherapy/tanning bed use within 4 weeks prior to baseline.
- •Biologic therapy for AD within 3 months or 5 half-lives (whichever longer) prior to baseline.
- •Expected need for rescue therapy for AD within the first 2 weeks after baseline.
- •History of eczema herpeticum within 12 months or ≥2 prior episodes.
研究组 & 干预措施
ARQ-234
Experimental
干预措施: ARQ-234 (Biological)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number and percentage of participants who experience an adverse event (AE) or serious adverse event (SAE)
时间窗: From screening to the last follow up visit for each study part (Part A: 16 weeks, Part B: 30 weeks, Part C: 30 weeks)
Percent change from Baseline in the Eczema Area and Severity Index (EASI) score, a validated measure of disease severity in atopic dermatitis.
时间窗: From Baseline to Week 16
次要结局
- Absolute change and percent change from baseline in the percentage of body surface area affected by atopic dermatitis(From Baseline to Week 16)
- Absolute change and percent change from baseline in itch severity as measured by the Itch Numeric Rating Scale(From Baseline to Week 16)
- Serum concentrations of study drug to characterize the pharmacokinetic (PK) profile(From Baseline to Week 16)
- Percentage of participants achieving at least a 50% improvement from baseline in EASI total score (EASI-50)(From Baseline to Week 16)
- Percentage of participants achieving at least a 75% improvement from baseline in EASI total score (EASI-75)(From Baseline to Week 16)
- Absolute change and percent change from baseline in SCORing Atopic Dermatitis (SCORAD) score(From Baseline to Week 16)
- Percentage of participants achieving at least a 50% improvement from baseline in SCORAD total score(From Baseline to Week 16)
- Percentage of participants achieving at least a 75% improvement from baseline in SCORAD score(From Baseline to Week 16)
- Absolute change and percent change from baseline in Patient-Oriented Eczema Measure (POEM) score(From Baseline to Week 16)
- Percentage of participants achieving an Investigator's Global Assessment (IGA) score of 0 (Clear) or 1 (Almost Clear) with at least a 2-grade improvement from baseline(From Baseline to Week 16)
- Percentage of participants with an IGA score of 0 (Clear) or 1 (Almost Clear)(From Baseline to Week 16)
- Percentage of participants with an IGA score of 0 (Clear)(From Baseline to Week 16)
研究者
研究点 (5)
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