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 질환 | Atopic Dermatitis, Atopic Hand Eczema |
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| 임상 단계 | 3상 |
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| 스폰서 | LEO Pharma |
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| 상태 | 완료 |
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| 참여자 수 | 235 명 |
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| 중재(약물) | Tralokinumab |
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| 시작일 | 2023년 8월 28일 |
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| 완료일 | 2025년 5월 5일 |
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| 결과 공개일 | 2026년 8월 5일 |
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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
| Tralokinumab | 40.0 percentage of responders |
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| Placebo | 10.6 percentage of responders |
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| p-value | <.001 |
| treatment difference in percentage | 29.7 (95% CI 19.0–40.4) |
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