NCT07166211招募中2 期
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of CM512 Injection in Subjects With CSU
Keymed Biosciences Co.Ltd1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年11月27日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change from the baseline in 7-day urticaria activity score (UAS7) at 16 weeks of treatment (W16)
研究概览
简要总结
This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in subjects with CSU.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign the Informed Consent Form.
- •Age ≥ 18 years old and ≤ 75 years old.
- •Patients with a diagnosis of CSU before screening visit, and the duration was ≥6 months.
- •Pruritus and wheals existed for more than 6 weeks before screening, despite regular H1-Antihistamines(AH) treatment during this period.
- •A stable dose of the second-generation H1-Antihistamines(AH) has been continuously used for at least 7 days before randomization, and the individual is willing to continue to use it stably as stipulated in the protocol during the study period.
- •Within 7 days before randomization, UAS7≥16 and ISS7 ≥8.
排除标准
- •Not enough washing-out period for previous therapy.
- •Planned major surgical procedure during the patient's participation in this study.
- •Has ever experienced a systemic allergic reaction or immediate allergic reaction to any biological product (including any excipients).
- •CM512 has been used before.
- •Women who are pregnant or breastfeeding. During the study period, subjects who had plans to have children, or did not agree to contraception.
- •With any medical or non-medical conditions that are not suitable for participation in this study by investigators.
研究组 & 干预措施
Group 1
Experimental
干预措施: CM512 injection (Biological)
Group 2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change from the baseline in 7-day urticaria activity score (UAS7) at 16 weeks of treatment (W16)
时间窗: Up to 16 weeks
UAS7 is a verified and recognized Patient Reported Outcomes(PRO) scale for evaluating the activity of CSU, consisting of 7-day hives-severity score and 7-day itch-severity score (ISS7), ranging from 0 to 42 points. UAS7 score \< 7 indicates low urticaria activity, UAS7 score \> 28 suggests high urticaria activity and severe condition.
次要结局
未报告次要终点
研究者
研究点 (1)
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