EUCTR2021-006447-95-PL进行中（未招募）1 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose ranging Study to Assess the Efficacy and Safety of CDX-0159 in Patients with Chronic Inducible Urticaria
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
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
- •1.Males and females, >/= 18 years of age.
- •2.Diagnosis of ColdU or SD >/= 3 months.
- •3.Diagnosis of chronic ColdU or SD despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
- •a.The presence of recurrent pruritic wheals with or without angioedema for >/= 6 weeks at any time prior to Visit 1 despite the use of H1 antihistamines.
- •b.Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment.
- •c.UCT of < 12 during the 14 days prior to treatment.
- •4.Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
- •5.Willing and able to complete a daily symptom electronic diary and comply with study visits.
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •1.Women who are pregnant or nursing.
- •2.Chronic spontaneous urticaria or other forms of CIndU besides ColdU or SD.
- •3.Active, pruritic skin condition in addition to CIndU.
- •4.Medical condition that would cause additional risk or interfere with study procedures.
- •5.Known HIV, hepatitis B or hepatitis C infection.
- •6.Vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid vaccination during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine.
- •7.History of anaphylaxis
研究者
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