Efficacy and Safety of Switching to Ivarmacitinib in Patients With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to IL-4Rα Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Eczema Area and Severity Index (EASI 75) at Week 16
研究概览
简要总结
Atopic dermatitis (AD) is a skin condition characterized by a rash and itching, resulting from skin inflammation. Ivarmacitinib is an approved medication for treating AD.
This study assessed the efficacy and safety of switching to the JAK1 inhibitor ivarmacitinib over 16 weeks in patients with moderate-to-severe atopic dermatitis and inadequate response to IL-4Rα inhibitors under real-world conditions.
It is expected that there will be no additional burden for participants in this trial.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 75 years.
- •Patients diagnosed with moderate-to-severe atopic dermatitis and treated with IL-4Rα inhibitors according to standard regimens for a minimum of 12 weeks.
- •Meeting any of the following disease activity criteria: EASI ≥16, WI-NRS ≥4.
排除标准
- •Treatment with other JAK inhibitors, including topical formulations, within one week before enrollment.
- •Subjects with clinically significant diseases of the heart, liver, kidney, or other major organ systems.
- •Subject has any of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat, if deemed necessary:
- •a. Absolute lymphocyte count of <0.50 x 10^9 /L (<500/mm3);b. Absolute Neutrophil Count (ANC) of <1 X 10^9/L (<1000/mm3);c. Hemoglobin level < 80 g/L.
- •Subject with a prior history of thromboembolic events, including deep vein thromboses (DVT), pulmonary embolism, cerebrovascular accidents and those with known inherited conditions that predispose to hypercoagulability.
- •Presence of an active severe acute or chronic bacterial, fungal, or viral infection requiring systemic therapy.
- •Subjects with active tuberculosis or known active hepatitis B and/or hepatitis C infection.
- •Subject has any malignancies or has a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
- •Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception.
研究组 & 干预措施
Ivarmacitinib for Moderate-to-Severe Atopic Dermatitis with Inadequate Response to IL-
干预措施: Ivarmacitinib Sulfate Tablets (Drug)
结局指标
主要结局
Eczema Area and Severity Index (EASI 75) at Week 16
时间窗: 16 Weeks
Proportion of subjects achieving at least a 75% improvement in Eczema Area and Severity Index (EASI 75) from baseline at Week 16
Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at Week 16
时间窗: 16 Weeks
Proportion of subjects achieving an improvement of Worst-Itch Numeric Rating Scale (WI-NRS) ≥4 from baseline at Week 16
次要结局
- Investigator's Global Assessment (IGA) score of 0/1 at Week 16(16 Weeks)
- EASI 75 at Week 2, 4, 8 and 12(Week 2, 4, 8 and 12)
- Worst-Itch Numeric Rating Scale (WI-NRS) at Week 2, 4, 8 and 12(Week 2, 4, 8 and 12)
- Change of Patient-Oriented Eczema Measure (POEM) from baseline at Week 2, 4, 8, 12 and 16(Day 1 to Week 16)
- Change of dermatology life quality index (DLQI) from baseline at Week 2, 4, 8, 12, and 16(Day 1 to Week 16)
研究者
Zhang jianzhong
PhD
Peking University People's Hospital