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临床试验/NCT07151508
NCT07151508已完成不适用

Successful Treatment of Netherton Syndrome With Combination of Secukinumab and Dupilumab.

Federal Research Institute of Pediatric Hematology, Oncology and Immunology1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年12月19日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
overal survival Kaplan-Mayer method

研究概览

简要总结

In this study, we describe our experience with secukinumab (IL-17A inhibitor) and dupilumab (IL-4/IL-13 inhibitor) treatment of a group of pediatric patients with severe Neterton syndrome.

详细描述

Pediatric patients qualified for participation in the study if they had a documented diagnosis of Neterton syndrome and they received treatment with sekukinumab or dupilumab for at least 3 months.

All patients received treatment in the Department of Immunology at the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology from January 2021 to June 2024.

A total of 15 patients from 13 families with NS were enrolled in the study. The median age of the patients was 8 years (1;15), and the male/female ratio 9/6.

In this study, 14 patients initially received secukinumab therapy, for 12/14 patients dupilumab was added, and 2 patients continued secukinumab monotherapy. The median time to switch from secukinumab monotherapy to combination therapy was 4 months (3;27). One patient initially received dupilumab monotherapy and was switched to combination therapy (Fig. 1). Treatment duration for each type of treatment was at least 3 months at the time of this report.

Secukinumab was administered in a weight-adapted dosing regimen equivalent to that used in clinical trials for psoriasis: 75 mg for less than 25 kg,150 mg for 25 to 50 kg, and 300 mg for greater than 50 kg at baseline and weeks1,2,3, and 4 and monthly there after.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients with Neterton syndrome
  • Treatment with secukinumab and/or dupilumab for at least 3 months

排除标准

  • Irregular administration of therapy
  • Development of a serious adverse event

结局指标

主要结局

overal survival Kaplan-Mayer method

时间窗: 3 and 6 months from the start of each type of therapy

Evaluation of the efficacy and safety of dupilumab and secukinumab therapy in patients with Netherton syndrome

次要结局

  • event free survival(3 and 6 months from the start of each type of therapy)

研究者

研究点 (1)

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