DUPECZEMAIN : Double Blind Placebo-controlled Randomized Multicenter Study Assessing the Efficacy and Safety of Dupilumab in Moderate to Severe Chronic Hands Eczema Refractory to Highly Potent Topical Corticosteroids
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 4
- 主要终点
- severity score mTLSS (modified Total Lesion Symptom Score)
研究概览
简要总结
Dupilumab has recently demonstrated high efficacy and good safety profile in the treatment of moderate-to-severe atopic dermatitis. There is a crucial need of developing new treatment options in Chronic hand eczema refractory to topical therapy. Investigators hypothesise that Dupilumab will also have high efficacy and good safety profile in the treatment of moderate to severe Chronic hand eczema refractory to highly potent topical corticosteroids.
详细描述
Chronic hand eczema is a frequent chronic inflammatory skin disease which may have significant physical, psychological and social impact on daily activities, emotional and social life as well as work. In Chronic hand eczema, there is a close relationship between atopic dermatitis (that involves 70% of patients), sensitization to environmental antigens and irritant triggering factors. There are limited treatment options for Chronic hand eczema refractory to highly potent topical steroids. The only systemic treatment labelled in Chronic hand eczema, alitretinoin, is associated with moderate efficacy, high drop-out due to adverse events and it requires strict contraception measures in women of child bearing potential. Dupilumab has recently demonstrated high efficacy and good safety profile in the treatment of moderate-to-severe atopic dermatitis. There is a crucial need of developing new treatment options in Chronic hand eczema refractory to topical therapy. the investigators hypothesise that Dupilumab will also have high efficacy and good safety profile in the treatment of moderate to severe Chronic hand eczema refractory to highly potent 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
- Double (Participant, Investigator)
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
- •Patients affiliated to a social insurance protection regimen.
- •Patients with moderate to severe chronic (>6 months) hand eczema with an Investigator global assessment (IGA) of 3 or 4 (out of a scale of 0 to 4).
- •Patients intolerant (according to the physician) or resistant to highly potent topical corticosteroids. Inadequate response (resistance) to highly potent topical corticosteroids is defined as a history of failure to achieve and maintain remission or a low disease activity state (comparable to an IGA score of 0 [indicating clear] to 2 [indicating mild]) despite treatment with a daily regimen of highly potent topical corticosteroids applied for 14 days or for the maximum duration recommended for highly potent topical corticosteroids.
- •Patients who are able to understand the study procedures including the ability to complete patient-oriented questionnaires.
- •Patients who are able to apply a stable dose of emollients within 7 days before the baseline visit.
- •Patients who agree to sign the written informed consent.
排除标准
- •Hypersensitivity to dupilumab or to any of its ingredients
- •Patients under adult autonomy protection system
- •Any other condition (e;g., psoriasis) on the hands that according to the investigator will impair the ability to evaluate treatment effect.
- •Treatment with topical corticosteroids or topical calcineurin inhibitors within one week of baseline.
- •Treatment with oral immunosuppressants (including cyclosporine, methotrexate, azathioprine, mycophenolate mofetil), alitretinoin or phototherapy within 4 weeks of baseline visit.
- •Treatment with an investigational drug within 8 weeks (or 5 half-lives) of baseline.
- •Active chronic infection requiring the use of a systemic antibiotic within 2 weeks before study start.
- •Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis, aspergillosis) despite infection resolution; or unusually frequent, recurrent, or prolonged infections, per investigator judgment.
- •History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
- •Positive for hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody at the screening visit.
- •Patients with known helminth infections.
- •Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study. Women of childbearing potential who are sexually active and unwilling to use an adequate birth control method
研究组 & 干预措施
dupilumab group
patient receive dupilumab 300 mg every 2 weeks after a 600 mg-loading dose of dupilumab on day 0
干预措施: Dupilumab (Drug)
placebo group
patient receive placebo
干预措施: placebo (Drug)
结局指标
主要结局
severity score mTLSS (modified Total Lesion Symptom Score)
时间窗: Week 16
The primary outcome measure will be the 16-week percent change since baseline of the severity score mTLSS (modified Total Lesion Symptom Score) The mTLSS combines an evaluation of hand eczema lesions severity including 6 key signs (erythema, desquamation, lichenification/hyperkeratosis, vesiculae, oedema, fissures) and the intensity of pruritus and pain. The seven individual CHE symptoms; (erythema, scaling, lichenification or hyperkeratosis, vesiculation, edema, fissures, and pruritus/pain) form the composite scale of mTLSS' strength and each one of them scores from 0 (mild) to 3 (severe). The scores are summed, extending from a base estimation of 0 (no signs or symptoms) to the most extreme of 21 (more serious disease).
次要结局
- Evolution of pruritus(Week 16)
- Evolution of pain(Week 16)
- evolution of laboratory parameters - transaminases(Week 16)
- evolution of laboratory parameters - total immunoglobulin E(Week 16)
- Improvement of quality of life(Week 16)
- Incidence of Treatment-Emergent Adverse Event(Week 16)
- evolution of sleep loss(Week 16)
- IGA - Clearance(Week 16)
- PaGa - Clearance(Week 16)
- evolution of laboratory parameters - full blood count(Week 16)
- Improvement of quality of life by EQ-5D-5L(Week 16)
- Evolution of the Eczema Area and Severity Index (EASI)(Week 16)
- Improvement of work productivity(Week 16)
- evolution of laboratory parameters - specific immunoglobulin E(Week 16)