A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Abrocitinib in Subjects With Moderate to Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 14
- 主要终点
- Change from baseline in hand modified Total Lesion Symptom Score (mTLSS)
研究概览
简要总结
This study aims to evaluate the safety, efficacy and tolerability of abrocitinib in subjects with moderate to severe chronic hand eczema, and its effects on skin biomarkers using a noninvasive method of tape stripping.
详细描述
This randomized, double-blind, placebo-controlled, multicenter, phase 2 study aims to evaluate the efficacy of abrocitinib in 84 adult subjects with moderate to severe chronic hand eczema, and its effects on skin biomarkers using a noninvasive method of tape stripping.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subject, 18 years of age or older, at the time of consent.
- •Subject has a history of moderate to severe CHE for at least 6 months prior to Day
- •Subject has refractory hand eczema
- •Subject has moderate to severe CHE at screening and Day 1, as defined by a hand PGA of 3 or
- •Contraceptive use by women of childbearing potential or their male partners during the study and until ≥ 4 weeks after the last study product administration
- •Female subject of childbearing potential has had a negative serum pregnancy test at screening and negative urine pregnancy test on Day
- •Subject is willing to participate and is capable of giving informed consent.
- •Subjects must be willing to comply with all study procedures and must be available for the duration of the study.
排除标准
- •Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
- •Subject has known or suspected allergic contact dermatitis of the hands and is unable to avoid exposure to the causative allergen or subjects with suspected or expected changes in irritant or allergen exposures from screening through the end of the study.
- •Subject has active skin infections of the hands.
- •Subject has a history or has current active psoriasis.
- •Subject has a history of eczema herpeticum within 12 months prior to screening, and/or a history of 2 or more episodes of eczema herpeticum in the past.
- •Subject has a history of skin disease or presence of skin condition.
- •Subject has a history of cancer prior to Day
- •Subject has any clinically significant medical condition (including psychiatric condition) or physical/laboratory/vital signs abnormality.
- •Subject has a current or past medical history of conditions associated with thrombocytopenia, coagulopathy, or platelet dysfunction.
- •Subject has a current or recent clinically significant viral, bacterial, fungal, or parasitic infection.
- •Subject has a history of clinically significant heart disease.
- •Subject is ≥ 50 years old AND has a history of heart attack, other clinically significant heart problems, stroke, or blood clots (in the opinion of the investigator).
- •Presence of laboratory abnormalities at the screening visit.
- •Subject has received any marketed or investigational biological agent within 12 weeks or 5 half lives (whichever is longer) prior to Day
- •Subject has used any topical treatments that could have an impact on CHE within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, topical retinoids, crisaborole, calcineurin inhibitors, ruxolitinib, tars, bleach, bleach baths, antimicrobials, medical devices.
- •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.
研究组 & 干预措施
Abrocitinib 200 mg
Abrocitinib at dose 200 mg will be orally administered once daily for 32 weeks.
干预措施: Abrocitinib 200 mg (Drug)
Abrocitinib 100 mg
Abrocitinib at dose 100 mg will be orally administered once daily for 32 weeks.
干预措施: Abrocitinib 100 mg (Drug)
Placebo then abrocitinib
Placebo will be orally administered once daily for 16 weeks (Part A) then abrocitinib 200 mg will be orally administered once daily for 16 weeks (Part B).
干预措施: Abrocitinib 200 mg (Drug)
Placebo then abrocitinib
Placebo will be orally administered once daily for 16 weeks (Part A) then abrocitinib 200 mg will be orally administered once daily for 16 weeks (Part B).
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in hand modified Total Lesion Symptom Score (mTLSS)
时间窗: Week 16
The mTLSS is an assessment of the severity of each of the following: erythema, scaling, lichenification/hyperkeratosis, vesicles, oedema, fissures, and pruritus/pain. Each of these are rated using a 4-point severity scale.These ratings are then added to create a total mTLSS calculated as the sum of assigned individual scores with a maximum value of 21 (most severe disease) and a minimum of 0 (no disease).
次要结局
- Change from baseline in hand modified Total Lesion Symptom Score (mTLSS)(Weeks 2, 4 and 12)
- Reduction from baseline in hand Physician's Global Assessment (PGA)(Weeks 2, 4, 12 and 16)
- Change from baseline in Hand Eczema Severity Index (HECSI)(Weeks 2, 4, 12 and 16)
- Change from baseline in Extent of Disease affected with moderate to severe chronic hand eczema (CHE)(Weeks 2, 4, 12 and 16)
- Patient Global Assessment (PaGA) measurements(Weeks 2, 4, 12 and 16)
- Change from baseline in hand Dermatology Life Quality Index (DLQI)(Weeks 2, 4, 12 and 16)
- Change from baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)(Weeks 2, 4, 12 and 16)
- Change from baseline in pain Numerical Rating Scale (NRS)(Weeks 2, 4, 12 and 16)
- Change from baseline in itch Numerical Rating Scale (NRS)(Weeks 2, 4, 12 and 16)