EUCTR2020-005541-16-DE进行中（未招募）1 期
A phase 2a, randomised, double-blind, placebo-controlled, multi-site, proof of concept trial to evaluate the efficacy and safety of LEO 138559 in adult subjects with moderate to severe atopic dermatitis (AD).
EO Pharma A/S0 个研究点目标入组 52 人开始时间: 2021年3月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •18 – 64 years old (both included) at baseline.
- •Diagnosis of AD [as defined by the AAD Consensus Criteria] that has been present for =1 year prior to screening.
- •Subjects who have a recent history (within 6 months before screening) of inadequate response to treatment with topical medication, or for whom topical treatments are otherwise medically inadvisable.
- •EASI score =12 at screening and =16 at baseline.
- •vIGA-AD score =3 at screening and baseline.
- •Body surface area (BSA) of AD involvement =10% at screening and baseline.
- •Worst Daily Pruritus NRS (weekly average) of =3 points at baseline.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 52
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Treatment with systemic immunosuppressive/immunomodulating medication, immunoglobulin/blood products, or phototherapy within 4 weeks or 5 half-lives prior to randomisation, whichever is longer.
- •Treatment with biologics within 5 half-lives (if known) or 16 weeks prior to randomisation, whichever is longer.
- •Treatment with TCS, TCI, topical PDE-4 inhibitor, or other topical prescription treatments within 1 week prior to randomisation.
- •Treatment with a live (attenuated) vaccine within 12 weeks prior to randomisation.
- •Clinically significant active chronic or acute infection requiring systemic treatment within 4 weeks prior to randomisation that may compromise the safety of the subject.
- •Skin infection within 1 week prior to the baseline visit.
- •Presence of hepatitis B or C infection at screening.
- •History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
- •Subject has a positive test for tuberculosis at screening.
- •Subject is pregnant or lactating.
研究者
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