The Impact of Dupilumab on Quality of Life in Moderate to Severe Atopic Dermatitis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Psychological General Well-Being Scale (PGWB)
研究概览
简要总结
This is a single-arm, open-label study, which will examine the effect of dupilumab on quality of life in atopic dermatitis patients.
详细描述
This is a single center, open-label study, which will examine the effect of dupilumab on quality of life in atopic dermatitis (AD). Thirty patients with moderate to severe AD will receive dupilumab for a treatment period of 52 weeks (i.e. last injection on week 48). Improvement in patient quality of life after 52 weeks of treatment with dupilumab will be evaluated using validated dermatologic and non-dermatologic psychometric instruments. The primary endpoint is the improvement in quality of life measured by change in Psychological General Well-Being scale (PGWB) at Week 16 from baseline. Additionally, patients will be given a video recording device to document their experience with the study drug at home. Video footage of patient experiences will be compiled at the end of the study. The compiled video footage will subsequently be watched and analyzed to further understand the experiences of atopic dermatitis patients, and how undergoing dupilumab treatment alters these patients' experiences and attitudes with their skin disease.
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
- •Ability to provide written informed consent and comply with the protocol
- •At least 18 years of age
- •Diagnosis of atopic dermatitis at least 6 months prior to enrollment, having stable (unchanged) disease for at least 2 months
- •Non-immune-compromised status
- •Subjects have moderate-to-severe atopic dermatitis, classified as Eczema Area and Severity Index (EASI) score greater than or equal to 6
- •Subject is considered a candidate for phototherapy or systemic therapy
- •Subjects of child-bearing potential must have a negative urine pregnancy test within 7 days prior to first dose of dupilumab
- •Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study
- •Subject meets concomitant medication requirements (see below)
排除标准
- •Younger than 18 years of age
- •Has mild atopic dermatitis, classified as EASI score less than 6
- •History of known or suspected intolerance to any of the ingredients of the investigational study product
- •Evidence of skin conditions other than atopic dermatitis that would interfere with study-related evaluations of atopic dermatitis.
- •History of immune-compromised status [e.g. human immunodeficiency virus (HIV) positive status or other immune suppressing drug] or a congenital or acquired immunodeficiency or subject testing positive for HIV during screening procedures
- •Has a poorly controlled medical condition including, but not limited to, unstable cardiovascular disease, poorly controlled diabetes, recent stroke, history of recurrent infections, or any other condition for which, in the opinion of the investigator, participation in the study would place the subject at risk
- •Has a history of or ongoing drug or alcohol abuse
- •Is not willing to comply with concomitant medication requirements
- •Is known, or suspected of being unable to comply with the study protocol
- •Subjects who are well controlled on current treatment for atopic dermatitis and participation in the study may worsen disease control significantly
研究组 & 干预措施
Dupilumab treatment
30 subjects will receive dupilumab for a treatment period of 52 weeks. All patients quality of life measures will be assessed with Psychological General Well-Being scale (PGWB), Work Productivity and Activity Impairment scale (WPAI), and Dermatology Life Quality Index (DLQI). Symptom and satisfaction will be assessed with Treatment Satisfaction Questionnaire for Medication (TSQM), Itch Numerical Rating Scale, Pain Numerical Rating Scale, and Pittsburgh Sleep Quality Assessment (PSQI).
干预措施: Dupilumab (Drug)
结局指标
主要结局
Psychological General Well-Being Scale (PGWB)
时间窗: 16 weeks
The primary endpoint is the improvement in quality of life measured by change in Psychological General Well-Being scale (PGWB) at Week 16 from baseline. It is a self-reported, 22 item questionnaire, scored 0-5 and summed. PGWB will be administered at every study visit.
次要结局
- PSQI(16 weeks)
- Work Productivity and Activity Impairment Scale (WPAI:SHP)(16 weeks)
- Dermatology Life Quality Index (DLQI)(16 weeks)
- Itch Numerical Rating Scale(16 weeks)
- Pain Numerical Rating Scale(16 weeks)