NCT05602207已完成4 期
Clinical and Molecular Effects of Abrocitinib in Subjects With Atopic Dermatitis With an Unsatisfactory Response or Facial Erythema After Treatment With Dupilumab
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 12
- 主要终点
- Change from baseline of Eczema Area and Severity Index (EASI)
研究概览
简要总结
This is a single-arm, open-label study that will examine the effect of abrocitinib in subjects with atopic dermatitis.
详细描述
This study is being conducted to evaluate the efficacy, safety, and molecular effects of abrocitinib in subjects with an unsatisfactory response or facial erythema after at least 12 weeks of treatment with dupilumab. Approximately 60 subjects with atopic dermatitis will receive abrocitinib once daily for 12 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject 18 years of age or older, at the time of consent.
- •Subject has clinically confirmed diagnosis of active atopic dermatitis (AD), according to Hanifin and Rajka criteria.
- •Subject has at least a 1-year history of AD and had no significant flares in AD for at least 4 weeks before screening.
- •Subjects who had moderate to severe AD before initiating dupilumab treatment.
- •Subject currently has an unsatisfactory response or facial erythema after at least 12 weeks of treatment with dupilumab, defined as follows:
- •A global vIGA-AD ≥ 2, at least 1% BSA with facial erythema, and a modified vIGA-AD for the face ≥2 at screening and Day 1 OR
- •A global vIGA-AD ≥ 2, at least 3% BSA affected by AD on the trunk and/or limbs, and a modified vIGA-AD for the trunk/limbs ≥ 2 at screening and Day 1.
排除标准
- •Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
- •Subject has clinically infected AD.
- •Subject has a history of skin disease or presence of skin condition that would interfere with the study assessments.
- •Subject has a history of cancer within 5 years prior to Day
- •Subject has a history of lymphoproliferative disorder, lymphoma, or leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
- •Subject has any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
- •Subject is known to have immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency.
- •Subject has a current or recent clinically serious infection.
- •Subject has used abrocitinib prior to Day
- •Subject has a known hypersensitivity to abrocitinib or its excipients.
- •Subject has a known history of clinically significant drug or alcohol abuse within 6 months prior to Day 1 that in the opinion of the investigator will preclude participation in the study.
研究组 & 干预措施
Abrocitinib 100 mg tablet (marketed drug)
Experimental
干预措施: Abrocitinib (Drug)
结局指标
主要结局
Change from baseline of Eczema Area and Severity Index (EASI)
时间窗: at Week 12
The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, induration/infiltration (papules), excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percentage of body surface area (BSA) involved for each body region and for the proportion of the body region to the whole body. The primary endpoint is the change from baseline in EASI at Week 12.
次要结局
- Change from baseline of the MMP12 Skin Biomarker Level(at Week 12)
- Change from baseline of Validated Investigator Global Assessment for atopic dermatitis (vIGA-AD)(at Week 12)
- Change from baseline of Peak pruritus Numerical Rating Scale (NRS)(over 12 weeks)
- Change from baseline of Body Surface Area (BSA)(at Week 12)
- Change from baseline of Facial Eczema Area and Severity Index (EASI)(at Week 12)
- Change from baseline of Modified validated Investigator Global Assessment for atopic dermatitis (vIGA-AD)(at Week 12)
- Change from baseline of the CCL18 Skin Biomarker Level(at Week 12)
- Change from baseline of the Keratin 16 Skin Biomarker Level(at Week 12)
- Change from baseline of the S100A7 Skin Biomarker Level(at Week 12)
- Change from baseline of the S100A8 Skin Biomarker Level(at Week 12)
- Change from baseline of the S100A9 Skin Biomarker Level(at Week 12)
研究者
研究点 (12)
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