NL-OMON48247已完成2 期
Dupilumab in adults with severe chronic hand eczema with an inadequate response or intolerance to alitretinoin: a randomized, double-blind, placebo-controlled proof of concept efficacy study - Dupilumab in severe chronic hand eczema
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
- •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 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.
- •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 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
- •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
- •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)
研究者
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