EUCTR2020-004961-38-DE进行中（未招募）1 期
Phase 2a trial to assess the efficacy and safety of LEO 152020 in adult patients with cholinergic urticaria
EO Pharma A/S0 个研究点目标入组 28 人开始时间: 2021年1月21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
- 28
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
- •- Subject with a history of CholU diagnosis for = 6 months
- •- Subject has active and uncontrolled CholU disease at the time of screening and randomisation, as defined by the following:
- •a.Urticaria control test (UCT) < 12 at screening
- •b.UASprovo = 3
- •- Age 18 or older
- •- Recent history (within 6 months of screening) with documented inadequate response to standard dose of H1 antihistamines
- •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 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •- Other clearly dominating forms* of urticaria as etiology for wheal and flare type reactions
- •*These diseases are allowed as comorbidities, if cholinergic urticaria is the dominating form of chronic urticaria
- •- Systemic immunosuppressive medications within 4 weeks prior to screening
- •- Drugs with antihistamine properties including H1 antihistamines and H2 antihistamines 1 week prior to randomisation
研究者
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