EUCTR2020-005976-36-SE进行中（未招募）1 期
An investigator-initiated, open label trial to correlate efficacy oftralokinumab in subjects with atopic dermatitis to molecular signatures(PRECision in TRAlokinumab therapy) - PRECTRA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
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
- •Confirmed diagnosis of AD defined by UK Working Criteria with an EASI
- •score = 16, age 18-80 years, body weight = 40 kg and = 160 kg, signed
- •informed consent from patient.
- •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 42
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnancy or breast feeding, women of child-bearing potential unless
- •they use effective contraception during the study and for 4 weeks after
- •study completion or discontinuation, history or presence of epilepsy,
- •significant neurological disorders, cerebrovascular attacks or ischemia,
- •myocardial infarction or cardiac arrhythmia which requires drug therapy,
- •evidence of severe renal dysfunction or significant hepatic disease,
- •history of lymphoproliferative disorders, patients who are considered
- •potentially unreliable or where it is envisaged the patient may not
- •consistently attend scheduled study visits, inability or unwillingness to
- •undergo repeated venipuncture or skin punch biopsies, any
- •immuneactive
- •systemic treatment within 4 weeks or 5 biologic half-lifes
- •(whichever is longer) or immune-active topical treatment within one
- •week before inclusion, history of clinical significant medical condition or
- •any other reason, which the investigator determines, would interfere with the subject´s participation in this study or would make the subject an unsuitable candidate to receive study drug or would put the subject at risk by participating in the study.
研究者
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