A randomized double-blinded pilot study of the efficacy and safety of dupilumab versus placebo in patients with Netherton syndrome - NS-Dupi

CHU de Toulouse0 个研究点目标入组 24 人开始时间: 2019年4月23日最近更新: 2024年6月3日

试验速览

暂无简介。

•- Adult patients (=18 years) affiliated to a social insurance protection regimen.
•-Clinical diagnosis of NS and absent or marked reduction of LEKTI staining.
•-Moderate to severe forms: NASA (Netherton Area Severity Assessment score) score = 5/12 at inclusion.
•-Patients able to understand the study procedures including the ability to complete patient-based self-assessment questionnaires.
•-Patients who agree to sign the written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 24
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•-Hypersensitivity to dupilumab or its excipients.
•-Modification of the usual treatment within 2 weeks before inclusion.
•-Treatment with topical calcineurin inhibitors 1 week before inclusion.
•-Treatment with oral immunosuppressant , oral retinoids or phototherapy within 4 weeks before inclusion.
•-Treatment with immunomodulating biologics 16 weeks before inclusion.
•-Treatment with another investigational drug within 8 weeks before inclusion.
•-Treatment with a systemic antibiotic within 1 week before inclusion.
•-Active skin infection requiring the use of a systemic therapy within 2 weeks before the inclusion.
•-Any other condition that according to the investigator will impair the ability to evaluate treatment effect.
•-Known or suspected history of immunosuppression, including history of invasive opportunistic infections
•-Current infections including infection with helminthes.
•-Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
•-Mental or physical incapacity to fill in the questionnaires.

发起方

CHU de Toulouse