EUCTR2021-002669-16-ES进行中（未招募）1 期
A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PILOT AND DOSE-RANGING STUDY OF MTPS9579A IN PARTICIPANTS WITH REFRACTORY CHRONIC SPONTANEOUS URTICARIA
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- •Body mass index (BMI) of 18-38 kg/m^2 and weight >=40 kg at screening
- •Diagnosis of CSU refractory to second-generation H1 antihistamine (sgH1-AHs) at the time of randomization
- •Demonstrated compliance with required use of the Urticaria eDiary
- •For patients on H2 antihistamines or leukotriene receptor antagonists (LTRAs) for non-CSU indications, treatment at a stable dose for >=2 weeks prior to screening, with no anticipated changes throughout duration of study, including the screening period
- •Use of contraceptive measures
- •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 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •Previous participation in a clinical trial of MTPS9579A
- •Chronic urticaria with known cause or other diseases with symptoms of urticaria or angioedema
- •Skin disease associated with chronic itching
- •Uncontrolled disease where flares are commonly treated with systemic corticosteroids
- •History or evidence of any clinically significant medical condition/disease or abnormalities in laboratory tests that, in the investigator's judgment, precludes the patient’s safe participation and completion of the study, or interferes with the conduct and interpretation of the study
研究者
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