Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis: a Non-inferiority Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 256
- 试验地点
- 32
- 主要终点
- Area under the curve of Atopic Dermatitis Control Tool (ADCT)
研究概览
简要总结
The goal of this clinical trial is to compare a step-down strategy of spacing dupilumab injections with a standard maintenance treatment in adolescents and adults with controlled Atopic dermatitis (AD) for at least six months. The impact of dosage reduction strategies will be assessed with an innovative primary endpoint: the area under the curve of the weekly ADCT assessment.
详细描述
For both groups:
At inclusion visit :
- Patient information and signature of consent form
- Randomisation
- Previous medical history
- Clinical exam
- Recording ADCT, EASI, IGA, NRS pruritus, DLQI or CDLQI, EQ-5D-5L
Weekly during 12 months (by patients on https://hestia.chu-nantes.fr) :
- Self-assessment of ADCT
- Date of dupilumab injections
- Batch number of dupilumab
- Amount of topical corticosteroids
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
- •Age ≥ 12 years
- •Moderate to severe AD treated with dupilumab every 2 weeks
- •Written informed consent (patient and/or person who has parental authority)
- •Dupilumab treatment for at least one year
- •Controlled AD (ADCT<7 and IGA ≤ 2) and assessed as controlled by the investigator since at least 6 months without tapering dosage of dupilumab
- •Amount of topical treatment (TCS or calcineurin inhibitor) stable for 6 months and less than 60 g/month
排除标准
- •Patients with Side effects of dupilumab
- •Non controlled AD: ADCT ≥ 7 or IGA ≥ 3
- •Female patient must not be pregnant*, breastfeeding or considering becoming pregnant
- •Patient under judicial protection
- •Adults under guardianship or trusteeship
研究组 & 干预措施
Experimental Group
Injections will be spaced as :
- Every 3 weeks between M0 and M4,
- Every 4 weeks between M4 and M8 (if ADCT<7 and IGA ≤ 2, AD assessed as controlled by the investigator and stable amount of local treatment used),
- Then every 5 weeks until the end of the clinical trial (M12) (if ADCT<7 and IGA ≤ 2, AD assessed as controlled by the investigator and stable amount of local treatment used).
In case of ADCT≥7 or IGA > 2 or disease assessed as uncontrolled by the investigator, the injection interval treatment will be step up to the previous interval.
The treatment is administered subcutaneously and can be delivered in pen or syringe for subcutaneous injection.
The dosage is usually :
- 300 mg per injection for adults and adolescents (12-17 years) weighing more than 60 kg
- 200 mg per injection for adolescents (12-17 years) weighing less than 60 kg.
干预措施: Dupilumab step-down (Drug)
结局指标
主要结局
Area under the curve of Atopic Dermatitis Control Tool (ADCT)
时间窗: over 12 months
to demonstrate the non-inferiority of a step down dosage strategy of dupilumab as compared with maintenance of initial treatment, on long-term control of the disease severity at one year in adolescents and adults patients with controlled AD.The primary endpoint is the Area under the curve of Atopic Dermatitis Control Tool (ADCT) score achieved by the patient every week during one year. As the ADCT score refers to the last 7 days, a weekly assessment is the most accurate to detect all variations in disease severity intensity.
次要结局
- Mean difference in EASI score(every 4 months over 12 months)
- Mean difference in Investigator global assessment(every 4 months over 12 months)
- Mean difference in Itch numerical rating scale(every 4 months over 12 months)
- The patient quality of life will be assessed with the DLQI (Dermatology Life Quality Index) measured at M4, M8, M12 or with the CDLQI (Children Dermatology Life Quality Index) for children under 16. Mean difference in DLQI (CDLQI for children <16)(every 4 months over 12 months)
- cost-utility analysis performed from a health care system perspective(over 12 months)
- Incremental cost-utility ratio (cost per Quality-Adjusted Life-Years, QALYs) from a health care system perspective(over 12 months)