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

3상 완료 NCT05958407

대상 질환Atopic Dermatitis, Atopic Hand Eczema
임상 단계3상
스폰서LEO Pharma
상태완료
참여자 수235 명
중재(약물)Tralokinumab
시작일2023년 8월 28일
완료일2025년 5월 5일
결과 공개일2026년 8월 5일

요약

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)

BENITIONS에서 보기 ClinicalTrials.gov 원문 보기

같은 질환의 다른 임상

전체 임상

이 페이지는 ClinicalTrials.gov의 공개 데이터를 정리한 것입니다. 의학적 조언이 아니며 투자 권유나 자문도 아닙니다. 반드시 전문의와 상담하세요.