EUCTR2021-000404-37-Outside-EU/EEA进行中（未招募）1 期
A phase 1 open-label, multi-centre, single-arm trial to evaluate the safety and pharmacokinetics (including MUsT) of twice daily topical application of delgocitinib cream for 8 weeks in adults, adolescents, and children with moderate to severe atopic dermatitis (AD).
EO Pharma A/S0 个研究点开始时间: 2021年4月14日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Key Inclusion criteria (Part 1: adults and adolescents; 12 years and above)
- •- Diagnosis of atopic dermatitis (AD) as defined by the Hanifin and Rajka (1980) criteria for AD
- •- Age 12 years and above at baseline
- •- AD involvement of 25-50% treatable body surface area (BSA) at screening and at baseline
- •- Moderate to severe AD (Validated Investigator Global Assessment scale for Atopic Dermatitis [vIGA-AD] score of at least 3) at screening and at baseline
- •Key Inclusion criteria (Part 2: children; 2-11 years)
- •- Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD
- •- Age 2-11 years at baseline
- •- History of AD for at least 3 months (children aged 2-5 years), and at least 12 months (children aged 6-11 years)
- •- AD involvement of =35% treatable BSA at screening and at baseline
- •- Moderate to severe AD (vIGA-AD score of at least 3) at screening and at baseline
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 32
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Key Exclusion criteria (Part 1 and 2: subjects aged 2 years and above)
- •- Active dermatologic conditions that may interfere with the diagnosis of AD
- •- Use of tanning beds or phototherapy within 4 weeks prior to baseline
- •- Systemic treatment with immunosuppressive/modulating drugs or corticosteroids within 4 weeks prior to baseline or 3 or more bleach baths any week within 4 weeks prior to baseline
- •- Treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCIs), topical phosphodiesterase-4, or oral antibiotics within 1 week prior to baseline
- •- Clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to baseline
- •- Any disorder, which is not stable, and in the investigator's opinion could affect the safety of the subject, influence the results of the trial or impede the subject's ability to complete the trial
研究者
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