An Open-label, Randomized, Actual Use Study of Dupilumab Auto-injector Device in Patients With Atopic Dermatitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Type of validated AI device-associated PTFs during the treatment period divided by total number of actual injections.
研究概览
简要总结
To collect data on actual-use to assess technical performance and user injections of dupilumab auto-injection device by patients with atopic dermatitis (AD).
详细描述
Study is conducted in 2 parts: part A and part B.
Part A - Patients with moderate-to-severe AD will be randomized to receive dupilumab (dose 1) by auto-injector (AI) device or prefilled syringe.
Once part A is completely enrolled, part B will randomize patients with moderate-to-severe AD to receive dupilumab (dose 2) by auto-injector (AI) device or prefilled syringe.
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
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic atopic dermatitis for at least 3 years with inadequate response to topical medications within 6 months before screening
- •Willing and able to comply with all clinic visits and study-related procedures
- •Provide signed informed consent
排除标准
- •Patient < 30.0 kilograms (Kg) in weight
- •Patient who has previously participated in a dupilumab clinical study
- •Patient who has been treated with the following:
- •An investigational drug within 8 weeks or within 5 half-lives (if known),whichever is longer, before the baseline visit
- •Immunosuppressive/ immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mufti, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.) or Phototherapy for AD within 4 weeks before the baseline visit
- •An experimental monoclonal antibody within 5 half-lives or within 6◦months prior to visit 1 if the half-life is unknown
- •Biologic agents within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever is longer
- •Anti-immunoglobulin E therapy (omalizumab) within 130 days prior to visit 1
- •A live (attenuated) vaccine within 4 weeks before the baseline visit
- •Patient who has initiated treatment with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (patients may continue using stable doses of such moisturizers if initiated before the screening visit)
- •Patient who has skin comorbidities that may interfere with study assessments
- •Patient with a planned or anticipated major surgical procedure during the patient's participation in this study
- •Women of childbearing potential unwilling to use adequate birth control measures during the study
- •Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
1 - Dupilumab (Part A)
Dose (dose 1) as per protocol delivered by auto-injector device
干预措施: Dupilumab (Drug)
1 - Dupilumab (Part A)
Dose (dose 1) as per protocol delivered by auto-injector device
干预措施: Auto-injector Device (Device)
2 - Dupilumab (Part A)
Dose (dose 1) as per protocol delivered by prefilled syringe
干预措施: Dupilumab (Drug)
2 - Dupilumab (Part A)
Dose (dose 1) as per protocol delivered by prefilled syringe
干预措施: Prefilled syringe (Device)
3 - Dupilumab (Part B)
Dose (dose 2) as per protocol delivered by auto-injector device
干预措施: Dupilumab (Drug)
3 - Dupilumab (Part B)
Dose (dose 2) as per protocol delivered by auto-injector device
干预措施: Auto-injector Device (Device)
4 - Dupilumab (Part B)
Dose (dose 2) as per protocol delivered by prefilled syringe
干预措施: Dupilumab (Drug)
4 - Dupilumab (Part B)
Dose (dose 2) as per protocol delivered by prefilled syringe
干预措施: Prefilled syringe (Device)
结局指标
主要结局
Type of validated AI device-associated PTFs during the treatment period divided by total number of actual injections.
时间窗: To week 12
Number of validated AI device-associated product technical failures (PTFs) during the treatment period divided by total number of actual injections
时间窗: To week 12
次要结局
- Number of patients with an AI device-associated PTF(To week 12)
- Percentage of patients with an AI device-associated PTF(To week 12)
- Number of patients with response to patient satisfaction questions with the AI device(To week 12)
- Number of patients with an AI device-associated PTC(To week 12)
- Number of AI device-associated product technical complaints (PTCs) divided by total number of actual injections(To week 12)
- Type of AI device-associated PTCs divided by total number of actual injections(To week 12)
- Percentage of patients with an AI device-associated PTC(To week 12)
- Number of AI device-associated failed drug deliveries (defined as patient failure to administer the full dose at a given attempt, excluding PTF) divided by total number of actual injections(To week 12)
- Type of AI device-associated failed drug deliveries (defined as patient failure to administer the full dose at a given attempt, excluding PTF) divided by total number of actual injections(To week 12)
- Percentage of patients with response to patient satisfaction questions with the AI device(To week 12)
- Number of patients with an AI device-associated failure to deliver dose(To week 12)
- Percentage of patients with an AI device-associated failure to deliver dose(To week 12)