EUCTR2018-000993-31-DK进行中（未招募）1 期
A multicenter, randomized, double-blind, placebo- controlled phase 2b dose-finding study to investigate the efficacy, safety and tolerability of LOU064 in adult chronic spontaneous urticaria patients inadequately controlled by H1-antihistamines
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 308
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. Signed informed consent must be obtained prior to participation in the study
- •2. Male and female subjects aged =18 years of age
- •3. CSU diagnosis for = 6 months prior to screening
- •4. Diagnosis of CSU inadequately controlled by second generation H1-antihistamines at the time of randomization as defined in the following:
- •- The presence of itch and hives for =6 consecutive weeks prior to screening in spite of use of non-sedating H1-antihistamines according to local treatment guidelines during this time period
- •- UAS7 score (range 0-42) =16 and HSS7 score (range 0-21) = 8 during 7 days prior to randomization (Day 1)
- •5. Willing and able to complete an Urticaria Participant Daily eDiary (UPDD) for the duration of the study
- •Other protocol-defined inclusion criteria may apply
- •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 286
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •1. Hypersensitivity to any of the study treatments
- •2. Clearly defined, predominant or sole trigger of their chronic urticaria (chronic inducible urticaria)
- •3. Other diseases with symptoms of urticaria or angioedema
- •4. Other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results
- •5. Known or suspected history of an ongoing, chronic or recurrent infectious disease
- •including but not limited to opportunistic infections (eg tuberculosis, atypical
- •mycobacterioses, listeriosis or aspergillosis), HIV, Hepatitis B/C.
- •6. Pregnant or nursing (lactating) women
- •7. Women of child-bearing potential not using highly effective methods of contraception
- •Other protocol-defined exclusion criteria may apply
研究者
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