NCT06509334招募中2 期
A Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled Phase II Clinical Study to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Adult Patients with Chronic Spontaneous Urticaria Inadequately Controlled by H1 Antihistamines
Jemincare1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2024年8月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Urticaria activity score used for 7 consecutive days(UAS7)
研究概览
简要总结
This Phase II Trial is Meant to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Patients With Chronic Spontaneous Urticaria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female adult subjects (≥18 years of age).
- •Diagnosis of Chronic Spontaneous Urticaria(CSU) ≥ 3 months prior to Screening Visit 1 and previously inadequately controlled with a second-generation H1 antihistamine.
- •Itching and hives lasting ≥ 6 weeks prior to Screening Visit
- •Have a UAS7 (range 0 - 42) ≥ 16, an ISS7 (range 0 - 21) ≥ 6, and an HSS7 (range 0 - 21) ≥ 6 within 7 days prior to randomization.
排除标准
- •Induced urticaria with a defined trigger, including artificial urticaria (cutaneous scratches), cold-contact, heat-contact, solar, pressure, delayed-pressure, water-source, cholinergic, or contact urticaria
- •Any other dermatological condition with chronic itching, such as atopic dermatitis, herpetic pemphigoid, herpetic dermatitis, senile itching, or psoriasis, which in the opinion of the investigator may affect the study assessment and study results
- •Other conditions with symptoms of urticaria or angioedema, including but not limited to urticarial vasculitis, pigmented urticaria, erythema multiforme, mastocytosis, hereditary urticaria, or acquired/drug-induced urticaria.
- •Previous allergic reaction or poor efficacy with omalizumab.
- •Contraindication or hypersensitivity to antihistamines (e.g., fexofenadine, loratadine, desloratadine, cetirizine, levocetirizine, rupatadine, bilastine) or any of the ingredients.
研究组 & 干预措施
JYB1904: Dose-1
Experimental
干预措施: JYB1904 (Drug)
JYB1904: Dose-2
Experimental
干预措施: JYB1904 (Drug)
Omalizumab
Active Comparator
干预措施: Omalizumab (Drug)
结局指标
主要结局
Urticaria activity score used for 7 consecutive days(UAS7)
时间窗: Baseline through 16 weeks
Change from baseline in urticaria activity score used for 7 consecutive days (UAS7) at weeks 8, 12, and 16.Score 0-42, UAS7=0 for complete remission
次要结局
- Urticaria activity score used for 7 consecutive days(UAS7)(Baseline through 32 weeks)
- Itch severity score used for 7 consecutive days(ISS7)(Baseline through 32 weeks)
- Hive severity score used for 7 consecutive days (HSS7)(Baseline through 32 weeks)
- Angioedema activity score used for 7 consecutive days(AAS7)(Baseline through 32 weeks)
- Dermatology Life Quality Index(DLQI)(Baseline through 32 weeks)
- Safety and tolerability(Baseline through 32 weeks)
- Trends in serum total immunoglobulin E(IgE)(Baseline through 32 weeks)
- Positive detection rate of anti-drug antibody (ADA)(Baseline through 32 weeks)
研究者
研究点 (1)
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