EUCTR2017-001262-25-DE进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, proof-of-concept, multicenter, 16-week treatment study with a 16 week follow-up period to assess the exploratory efficacy and safety of Dupilumab (anti-IL4Ra) in adult patients with cholinergic urticaria despite H1-antihistamine treatment.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
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.Patient is informed about study procedures and medications and has given written informed consent before any assessment.
- •2.Patient is able to communicate with the investigator, understands and complies with the requirements of the study.
- •3.Male or Female of any race
- •4.Patient is 18-70 years of age
- •5.Patient is diagnosed with moderate to severe CholU and refractory to standard of care treatment at the time of randomization, as defined by the following:
- •The presence of itch, hives and recurrent angioedema for = 6 consecutive weeks at any time prior to enrollment despite current use of licensed dose H1 antihistamine
- •UCT <12 prior to randomization (Day 1)
- •Patients must have been on standard of care for treatment of CholU for at least the 3 consecutive days immediately prior to the screening visit and must have documented current use on the day of the initial screening visit.
- •CholU diagnosis for >= 6 months
- •6.Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.
- •7.Patients must not have had any missing eDiary entries in the 7 days prior to randomization. Re-screening may be considered.
- •8.Women of childbearing potential have to agree to use an acceptable form of contraception (as determined by the site investigator) and have to continue its use for the duration of the study.
- •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 52
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. History of hypersensitivity to Dupilumab or their components.
- •2. Clearly dominating other form of urticaria as etiology for wheal and flare type reactions. This includes the following:
- •- Chronic spontaneous urticaria
- •- Inducible urticaria: urticaria factitia, cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, or contact-urticaria
- •These diseases are allowed a comorbidities, if cholinergic urticaria is the dominating form of chronic urticaria
- •3. Any other active severe skin disease associated with chronic itching that might confound the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus etc.)
- •4. Previous treatment with omalizumab within 3 months prior to screening.
- •5. History of anaphylactic shock.
- •6. Patients with confirmed active SARS-CoV-2 infection
研究者
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