NCT04512339Unknown2 期
Dupilumab in Severe Chronic Hand Eczema With Inadequate Response or Intolerance to Alitretinoin
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Response to treatment/hand eczema severity (Hand Eczema Severity Index, HECSI)
研究概览
简要总结
The purpose of this study is to investigate the efficacy of dupilumab in hand eczema patients with an inadequate response or intolerance to alitretinoin.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and ≤ 75 years.
- •Severe or very severe chronic hand eczema as defined by a Physician Global Assessment (PGA) using a validated Photoguide.
- •Inflammatory subtypes of hand eczema: recurrent vesicular hand eczema or chronic fissured hand eczema.
- •An inadequate response to topical corticosteroids within 6 months before screening.
- •A history of prior alitretinoin exposure and inadequate response or intolerance to alitretinoin.
- •Patients has also received standard skin care, including emollients and barrier protection as appropriate, without significant improvement.
- •Patients has avoided irritants and contact allergens, if identified, without significant improvement.
- •Women of childbearing potential are required to use a highly effective (failure rate of <1% per year when used consistently and correctly) method of birth control, prior to receiving study intervention, during the study and for at least 10 weeks after receiving the last administration of study intervention. E.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal foam/gel/film/cream/suppository (if available in their locale); male partner sterilization (the vasectomized partner should be the sole partner for that participant); true abstinence (when this is in line with the preferred and usual lifestyle of the participant). NOTE: If a female participant's childbearing potential changes after start of the study (e.g., a woman who is not heterosexually active becomes active, a premenarchal woman experiences menarche), she must begin practicing a highly effective method of birth control, as described above.
- •A woman of childbearing potential must have a negative serum or urine pregnancy test (β-human chorionic gonadotropin [β-hCG]) at screening and at Week 0 prior to administration of study intervention;
- •Agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention.
- •Agree not to receive a Bacillus Calmette-Guérin (BCG) vaccination during the study, or within 12 months after the last administration of study intervention.
- •Be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
- •Must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to participate in the study.
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Other clinical subtypes of hand eczema, e.g. hyperkeratotic hand eczema, as defined by the Danish Contact Dermatitis Group
- •Treatment with alitretinoin, systemic immunosuppressive medication or UV radiation within the previous 4 weeks.
- •Patients with predominantly atopic dermatitis, in whom the hands are also involved, but no main concern. Patients with controlled atopic dermatitis, in which the hands are mainly affected, are eligible for inclusion.
- •Psoriasis of the hands.
- •Active bacterial, fungal, or viral infection of the hands.
- •Pregnant/lactating or planning to become pregnant during the study period.
- •Current malignancy (other than successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and⁄or localized carcinoma in situ of the cervix).
- •Participant has known allergies, hypersensitivity, or intolerance to dupilumab or its excipients: L-arginine hydrochloride, L-histidine, polysorbate 80, sodium acetate, acetic acid, sucrose, water for injections.
- •Participants with active helminth and other parasitic infections.
- •Patients infected with human immunodeficiency virus (HIV) (positive serology for HIV antibody).
- •Patients testing positive for hepatitis B virus (HBV) or hepatitis C (HCV) infection.
研究组 & 干预措施
Dupilumab
Active Comparator
Patients with severe hand eczema with an inadequate response or intolerance to alitretinoin. This group will receive dupilumab injections (600mg subcutaneously as a loading dose, followed by 300mg subcutaneously once every two weeks).
干预措施: Dupilumab (Drug)
Placebo
Placebo Comparator
Patients with severe hand eczema with an inadequate response or intolerance to alitretinoin. This group will receive placebo injections (600mg subcutaneously as a loading dose, followed by 300mg subcutaneously once every two weeks).
干预措施: Placebo (Drug)
结局指标
主要结局
Response to treatment/hand eczema severity (Hand Eczema Severity Index, HECSI)
时间窗: 16 weeks
HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs of hand eczema and the extent of the lesions on each of 5 hand areas by use of standard scales. The total HECSI score is based on a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and a 5-point scale rating the affected area(s) ranging from 0 (0% affected area) to 4 (76% to 100% affected area). A decrease in score relates to an improvement in signs and symptoms. Response is defined as HECSI-75: the proportion of patients wit a HECSI score of ≥75% improvement from baseline.
次要结局
- Response to treatment/hand eczema/foot eczema severity (Physician Global Assessment)(Week 4, 8, 12, 16)
- Response to treatment/hand eczema/foot eczema severity (modified Total Lesion Symptom Score, mTLSS)(Week 4, 8, 12, 16)
- Changeof quality of life (Dermatology Life Quality Index, DLQI)(Week 4, 8, 12, 16)
- Response to treatment/hand eczema severity (Photographic guide)(Week 4, 8, 12, 16)
- Response to treatment/hand eczema severity (Hand Eczema Severity Index, HECSI)(Week 4, 8, 12, 16)
- Changeof pruritus (Numerical Rating Scale, NRS)(Week 4, 8, 12, 16)
- Change of hand eczema related quality of life (Quality of Life in Hand Eczema Questionnaire, QOLHEQ)(Week 4, 8, 12, 16)
- Change of work productivity and impairment (Work Productivity and Activity Impairment, WPAI)(Week 4, 8, 12, 16)
- Cost-utility. Quality-adjusted life-years (QALY's): registered direct/indirect costs, combined with EQ-5D-5L outcome(Week 4, 8, 12, 16)
- Cost-effectiveness: registered direct/indirect costs combined with the primary and secondary effectiveness outcomes (HECSI and PG)(Week 4, 8, 12, 16)
- Safety and tolerability (adverse events)(Up to 16 weeks)
- Patient reported change (Patient Global Assessment, PaGA)(Week 4, 8, 12, 16)
- Change of pain (Numerical Rating Scale, NRS)(Week 4, 8, 12, 16)
- Change of anxiety and depression (Hospital Anxiety and Depression scale, HADS)(Week 4, 8, 12, 16)
研究者
Marie Louise A Schuttelaar, MD, PhD
Principal Investigator, Dermatologist
University Medical Center Groningen
研究点 (1)
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