スペソリマブがネザートン症候群と呼ばれる皮膚疾患の患者に効果があるかどうかを検証する研究

基本情報

NCT ID

NCT05856526

ステータス

中止

試験のフェーズ

第2/第3相

試験タイプ

介入

目標被験者数

43

治験依頼者名

Boehringer Ingelheim

概要

This study is open to people with a skin disease called Netherton syndrome (NS). People can join the study if they are 12 years or older. The purpose of this study is to find out whether a medicine called spesolimab helps people with NS. Participants are divided into a spesolimab and a placebo group. Placebo injections look like spesolimab injections but do not contain any medicine. Every participant has a 2 in 3 chance of being in the spesolimab group. In the beginning, participants get the study medicine as an injection into a vein. Afterwards, they get it as an injection under the skin every month. After 4 months, participants in the placebo group switch to spesolimab treatment. Participants are in the study for up to 3 years. During this time, they visit the study site up to 42 times. The doctors regularly check participants' NS symptoms. The results are compared between the groups to see whether spesolimab works. The doctors also regularly check participants' general health and take note of any unwanted effects.

対象疾患

介入

依頼者（Sponsor）

実施施設 (3)