NCT07210554尚未招募3 期
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Stapokibart Injection in Subjects With Moderate to Severe Bullous Pemphigoid
Chengdu Kangnuoxing Biopharma,Inc.1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年11月11日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Percentage of subjects achieving sustained complete remission (CR) at W36
研究概览
简要总结
This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of Stapokibart in subjects with Moderate to Severe Bullous Pemphigoid.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand the study content and voluntarily sign the Informed Consent Form (ICF).
- •Aged between 18 and 90 years, inclusive, regardless of gender.
- •Confirmed diagnosis of bullous pemphigoid prior to randomization.
- •Bullous Pemphigoid Disease Area Index (BPDAI) activity score ≥ 24 points at the screening visit and at randomization.
- •Weekly average of the Pruritus Numerical Rating Scale (NRS) score ≥ 4 points at randomization.
- •Karnofsky Performance Status score ≥50% at the screening visit.
排除标准
- •Diagnosis of other forms of pemphigoid or other autoimmune blistering diseases.
- •Presence of other active skin comorbidities that may interfere with the study evaluations, apart from bullous pemphigoid.
- •Insufficient washout period for prior treatments.
- •Any condition that, in the opinion of the investigator, would preclude the subject's participation in the study.
研究组 & 干预措施
Group 1
Experimental
干预措施: Stapokibart injection (Biological)
Group 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of subjects achieving sustained complete remission (CR) at W36
时间窗: Up to 36 weeks
Sustained complete remission (CR) defined as discontinuation of oral corticosteroid (OCS) therapy and achievement of CR on or before Week 16, no relapse during the period from OCS discontinuation up to Week 36, and no requirement for rescue therapy up to Week 36.
次要结局
未报告次要终点
研究者
研究点 (1)
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