BENITIONSClinical Trial Intelligence

A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy

第3相 完了 NCT05958407

対象疾患Atopic Dermatitis, Atopic Hand Eczema
第3相
スポンサーLEO Pharma
ステータス完了
参加者数235 名
介入(薬剤)Tralokinumab
開始日2023年8月28日
完了日2025年5月5日
結果公開日2026年8月5日

概要

The purpose of this study is to test if treatment with tralokinumab is safe and efficacious in treating moderate-to-severe atopic hand eczema. This will be judged by a range of assessments that rate the severity and extent of atopic hand eczema and its symptoms, as well as general health status and quality of life. The trial will last for up to 40 weeks for each participant. There will be up to 15 visits for each participant, 3 of which will be conducted by phone. The first part of the trial is called a screening period and will last up to 4 weeks. For the first 16 weeks after screening, trial participants will receive either tralokinumab or dummy injections every two weeks. After the first 16 weeks, all trial participants will receive tralokinumab injections every two weeks for 16 weeks. The last part of the trial is a period of 4 weeks after the end of treatment period, where trial participants will not receive tralokinumab but are monitored for safety.

Percentage of Participants With IGA-AHE Score of 0 (Clear) or 1 (Almost Clear)

At Week 16 · percentage of responders

Tralokinumab40.0 percentage of responders
Placebo10.6 percentage of responders
p-value<.001
treatment difference in percentage29.7 (95% CI 19.0–40.4)

BENITIONS で見る ClinicalTrials.gov の原文を見る

同じ疾患の他の治験

すべての治験

このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。