Phase 2a Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change From Baseline in Post-provocation Urticaria Activity Score (UASprovo)
研究概览
简要总结
Phase 2a trial to assess the efficacy and safety of LEO 152020 in adult patients with cholinergic urticaria
详细描述
This is a phase 2a, randomised, double-blind, placebo-controlled, cross-over trial conducted in Germany at 3-6 sites. Subjects will be randomised to one of two treatment sequences (A and B). Each treatment period will last 7 days with a wash-out period of 7 days between treatments. Half of the subjects will start with treatment A followed by treatment B while the other half will start with treatment B followed by treatment A. A safety follow-up visit will be performed 3 days after last dose of the tested medication.
The main assessment is an urticaria activity score. After a Pulse-controlled ergometry (PCE) provocation test subjects will be rated on their number of wheals and their itch severity, resulting in a sum score ranging from 0 to 6 points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Placebo-controlled
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with a history of Cholinergic urticaria diagnosis for ≥ 6 months
- •Subject has active and uncontrolled Cholinergic urticaria disease at the time of screening and randomisation, as defined by the following:
- •Urticaria control test < 12 at screening
- •Urticaria Activity Score post-provocation ≥ 3
- •Recent history (within 6 months of screening) with documented inadequate response to standard dose as to marketing authorization of H1 antihistamines.
排除标准
- •Other clearly dominating forms* of urticaria as aetiology 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,
- •Systemic drugs (e.g. oral drug) with antihistamine properties including H1 antihistamines and some antidepressants (e.g. tricyclic antidepressants) and H2 antihistamines 1 week prior to randomisation and throughout the trial. However, topical antihistamines in the form of nasal spray and eyedrops are allowed in the standard prescribed dose.
研究组 & 干预措施
Active - Placebo
Patients will receive active treatment for 7 days, followed by a washout period of 7 days and then placebo for 7 days
干预措施: LEO 152020 (Drug)
Active - Placebo
Patients will receive active treatment for 7 days, followed by a washout period of 7 days and then placebo for 7 days
干预措施: LEO 152020 placebo (Drug)
Placebo - Active
Patients will receive placebo for 7 days, followed by a washout period of 7 days and then active treatment for 7 days
干预措施: LEO 152020 (Drug)
Placebo - Active
Patients will receive placebo for 7 days, followed by a washout period of 7 days and then active treatment for 7 days
干预措施: LEO 152020 placebo (Drug)
结局指标
主要结局
Change From Baseline in Post-provocation Urticaria Activity Score (UASprovo)
时间窗: Baseline to Day 7
The Urticaria Activity Score (UAS) rates a participants' number of wheals and their itch severity on a scale from 0 to 6, with 6 being the most severe. UAS is assessed after provocation of urticaria by moderate exercise to cause sweating.
次要结局
- Number of Treatment Emergent Adverse Events(From start of each treatment period (day 1 for the 1st treatment period or day 15 or 22 for the 2nd treatment period) until 3 days after end of each treatment period (day 11 for the 1st treatment period or day 25 or 32 for the 2nd treatment period))