NCT07011706招募中2 期
A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ATI-045 in Patients With Moderate-to-Severe Atopic Dermatitis
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
- 96
- 试验地点
- 61
- 主要终点
- Percent Change in Eczema Area and Severity Index (EASI)
研究概览
简要总结
This study evaluates ATI-045 versus placebo in patients with Moderate-to-Severe Atopic Dermatitis.
详细描述
A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ATI-045 in Patients with Moderate-to-Severe Atopic Dermatitis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic atopic dermatitis that has been present for ≥ 6 months before the screening visit and with no significant AD flares during the past 4 weeks before screening
- •Have active moderate to severe AD at screening and baseline visits
- •EASI score ≥ 16 and ≥10% BSA at the screening and baseline visits
- •History of inadequate response to treatment for AD with topical medications; or determination that topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks)
- •Patient applied a stable dose of non-medicated topical moisturizer (ideally once or twice daily) for ≥ 7 days prior to the baseline visit and agrees to continue use during study
排除标准
- •Treatment with any of the following:
- •Intravenous immunoglobulin within 12 weeks prior to the baseline visit (W0D1)
- •Systemic antibiotics within 2 weeks prior to the baseline visit (W0D1)
- •Topical antibiotics within 1 week prior the baseline visit (W0D1)
- •Topical medicated treatment that could affect atopic dermatitis should be prohibited for at least 2 weeks prior to baseline visit. Example: topical corticosteroids, crisaborole, calcineurin inhibitors, ruxolitinib, roflumilast, tars, antimicrobials, medical devices, and bleach baths.
- •Topical products containing urea within 1 week prior to baseline visit (W0D1)
- •Doxepin, hydroxyzine, or diphenhydramine within 1 week prior to the baseline visit (W0D1)
- •Patient has used systemic treatments (other than biologics) that could affect AD less than 4 weeks or 5 half-lives (whichever is longer) prior to the baseline visit (W0D1), including, but not limited to, retinoids, calcineurin inhibitors, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine, oral/injectable corticosteroids, baricitinib, upadacitinib, and abrocitinib.
- •Biologics for AD treatments (such as dupilumab, tralokinumab, lebrikizumab, investigational biologics) within 5 half- lives or 12 weeks, whichever is longer prior to the baseline visit (W0D1)
- •An investigational drug (non-biologic) within 4 weeks or within 5 half-lives (if known), whichever is longer prior to the baseline visit (W0D1)
- •Phototherapy and photochemotherapy for AD within 4 weeks prior to the baseline visit (W0D1)
- •A live (attenuated) vaccine within 12 weeks prior to the baseline visit (W0D1)
- •History of anaphylaxis following biologic therapy.
- •History of allergy to corticosteroids, diphenhydramine, hydroxyzine, cetirizine, or fexofenadine.
研究组 & 干预措施
ATI-045 group
Experimental
ATI-045 group
干预措施: ATI-045 (Drug)
Placebo group
Placebo Comparator
Placebo group
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change in Eczema Area and Severity Index (EASI)
时间窗: Baseline to Week 24
Percent change from baseline in EASI score at Week 24
次要结局
- Investigator Global Assessment (vIGA) treatment success (IGA-TS)(Baseline to Week 24)
- EASI reduction(Baseline to Week 24)
- Peak Pruritus Numerical Rating Scale (PP-NRS) score(Baseline to Week 24)
- PP-NRS improvement(Baseline to Week 24)
- Body Surface Area (BSA)(Baseline to Week 24)
- Incidence and severity of safety measurements(From Baseline to Week 34)
- Anti-ATI-045 antidrug antibody (ADA)(From Baseline to Week 34)
研究者
研究点 (61)
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