EUCTR2018-003429-27-DE进行中（未招募）1 期
A PHASE II, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF MSTT1041A IN PATIENTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 65
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
- •- Age 18-75 years
- •- Ability to comply with the study protocol
- •- Chronic AD that has been present for at least 3 years before the screening visit
- •- Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable
- •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 88
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •- Prior treatment with MSTT1041A
- •- Treatment with any investigational therapy (with the exception of biologics) within 8 weeks or within 5 half-lives whichever is longer, before screening
- •- Treatment with investigational or licensed biologics as follows:
- •Any cell-depleting agents including but not limited to rituximab: within 6 months before screening, or until lymphocyte count returns to normal, whichever is longer
- •Other biologics: within 3 months or 5 half-lives before screening, whichever is longer
- •- Certain other treatments and medical procedures undertaken within a particular time frame prior to the baseline visit
- •- Comorbid conditions that may interfere with evaluation of investigational medicinal product
- •- History or evidence of substance abuse that would pose a risk to patient safety, interfere with the conduct of the study, have an impact on the study results, or affect the patient's ability to participate in the study
- •- History of anaphylaxis, hypersensitivity to a biologic agent, or known hypersensitivity to any component of the MSTT1041A or placebo injection
- •- Planned surgical intervention during the course of the study
- •- Pregnant or breastfeeding, or intending to become pregnant during the study
- •- Patient who is a member of the investigational team or his/her immediate family
研究者
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