NCT07402213招募中3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety 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 240 人开始时间: 2026年3月9日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Urticaria Activity Score Over 7 Consecutive Days(UAS7)
研究概览
简要总结
This Phase III Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.
详细描述
This study is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of JYB1904 injection compared to placebo in patients with CSU inadequately controlled by second-generation H1 antihistamines.
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 participant must be ≥18 years old at the time of signing the informed consent.
- •Participants are diagnosed with CSU for ≥6 months before screening.
- •Participants suffer from itching and hives for at least 6 consecutive weeks at any time before screening.
- •UAS7 (range 0~42) ≥16, ISS7 (range 0~21) ≥8 during 7 days before randomization.
- •Participants treated with stable dose of second-generation H1 antihistamines (up to 4x approved dose) for at least 6 consecutive weeks before randomization, switching medications, or changing drug dosage or frequency is not allowed within 3 weeks before randomization.
- •Participants have ≥6 days record of UAS7 before randomization.
排除标准
- •Participants who suffer from inducible urticaria with definite inducements, including urticaria factitia (dermatographism), cold contact, heat contact, solar, pressure, delayed pressure, aquagenic, cholinergic or contact urticaria, etc.
- •Participants who suffer from any other skin diseases with chronic itching, such as atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis, etc.
- •Participants who suffer from other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria or acquired/drug-induced urticaria.
- •Participants who are contraindicated or hypersensitive to antihistamines or any of its component (such as fexofenadine, loratadine, desloratadine, cetirizine, levocetirizine, rupatadine, bilastine).
- •History of anaphylactic shock.
研究组 & 干预措施
Placebo Group
Placebo Comparator
Placebo and 300 mg JYB1904 injection administered SC
干预措施: Placebo+JYB1904 (Drug)
JYB1904 Injection Group
Experimental
300 mg JYB1904 injection administered SC
干预措施: JYB1904 (Drug)
结局指标
主要结局
Urticaria Activity Score Over 7 Consecutive Days(UAS7)
时间窗: Up to 12 weeks
Change from baseline in UAS7 at W12. The UAS7 is a composite score derived from the ISS7 and the HSS7, i.e., the sum of ISS7 and HSS7, ranging from 0 to 42 points. UAS7 = 0 indicates complete resolution of urticaria.
次要结局
- Itch Severity Score Over 7 Consecutive Days(ISS7)(Up to 12 weeks)
- Urticaria Activity Score Over 7 Consecutive Days(UAS7)(Up to 12 weeks)
- Urticaria Activity Score Over 7 Consecutive Days(UAS7)(Up to 24 weeks)
- Itch Severity Score Over 7 Consecutive Days(ISS7)(Up to 24 weeks)
- Hive Severity Score Over 7 Consecutive Days (HSS7)(Up to 24 weeks)
- Angioedema Activity Score Over 7 Consecutive Days(AAS7)(Up to 24 weeks)
- Dermatology Life Quality Index(DLQI)(Up to 24 weeks)
- Efficacy Assessment Scale(Through study completion, an average of 72 weeks)
- Urticaria Activity Score Over 7 Consecutive Days(UAS7)(Through study completion, an average of 72 weeks)
- Dermatology Life Quality Index(DLQI)(Through study completion, an average of 72 weeks)
- Rescue Therapy(Up to 24 weeks)
- Safety and tolerability(Through study completion, an average of 72 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
A Study to Evaluate the Efficacy and Safety of JNJ-88545223 for the Treatment of Participants With Active Psoriatic ArthritisNCT07321873Janssen Research & Development, LLC240
招募中
2 期
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic PainNCT07285018Eli Lilly and Company150
招募中
2 期
A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple MyelomaMultiple MyelomaNCT07266441Janssen Research & Development, LLC157
尚未招募
2 期
This is a Clinical Study to Assess Whether the Combination of SJ733 and Tafenoquine Will be a Safe and Rapidly Acting Anti-malarial for the Radical Cure of P. Vivax MalariaMalariaNCT07430592R. Kiplin Guy104
尚未招募
2 期
Safety and Efficacy of PSMA-Targeted Fluorescent Contrast Agent DGPR1008 for Intraoperative Imaging in Robot-Assisted Radical ProstatectomyProstate CancerNCT07415135Zhu Yinjie18