A Study on the Efficacy and Safety of Ivarmacitinib in the Treatment of Moderate to Severe Atopic Dermatitis in Adolescents and Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 主要终点
- Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline 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 aims to evaluate the effectiveness and safety of Ivarmacitinib in the treatment of moderate-to-severe atopic dermatitis under real-world conditions. It will assess the time to pruritus improvement and skin lesion clearance, collect large-sample safety data, analyze disease improvement across patient subgroups with different baseline characteristics, and explore the impact of various maintenance treatment regimens on disease recurrence.
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
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 12 and 75 years;
- •Diagnosed with moderate-to-severe atopic dermatitis (AD) ;
- •Participants (and legal representatives for adolescents) able to understand and communicate with the investigator.
排除标准
- •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:
- •Absolute lymphocyte count of <0.50 x 10^9 /L (<500/mm3);
- •Absolute Neutrophil Count (ANC) of <1 X 10^9/L (<1000/mm3);
- •Hemoglobin level < 80 g/L.
- •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.
- •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.
- •Subjects with clinically significant diseases of the heart, liver, kidney, or other major organ systems.
- •Female subject who is pregnant, breastfeeding, or considering pregnancy during the study.
研究组 & 干预措施
Treatment of Moderate-to-Severe Atopic Dermatitis with Ivarmacitinib in Adolescents and Adults
干预措施: Ivarmacitinib Sulfate Tablets (Drug)
结局指标
主要结局
Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16
时间窗: Baseline and Week 16
EASI is a tool used to measure the extent (area) and severity of atopic dermatitis based on assessments of the head/ neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness , thickness, scratching, and lichenification. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
次要结局
- Time to achieve a ≥4-point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS).(Baseline and Day 7)
- The proportion of patients achieving an Investigator's Global Assessment (IGA) response at each scheduled visit, defined as an IGA score of 0 or 1 with at least a 2-point reduction from baseline.(Baseline and Week 1、2、4、8、12、16、24、32、40、52)
- The proportion of subjects achieving EASI 75 at each scheduled visit.(Baseline and Week 1、2、4、8、12、24、32、40、52)
- Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Patient Oriented Eczema Measure (POEM) Total Score(Baseline and Week 1、2、4、8、12、16、24、32、40、52)
- Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Dermatology Life Quality Index (DLQI)(Baseline and Week 1、2、4、8、12、16、24、32、40、52)
- The recurrence of atopic dermatitis.(Week 16、52)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(From Baseline to 30 days following last dose of study drug (Week 52))