2024-520031-33-00招募中2 期
A Phase 2 Study to Evaluate the Safety, Tolerability, and Clinical Activity of BLU-808, a Wild Type KIT Inhibitor, in Chronic Inducible Urticaria and Chronic Spontaneous Urticaria
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 57
- 试验地点
- 16
- 主要终点
- Part A/B: Overall safety profile as assessed by the type, frequency, severity, and causality of Adverse Events
研究概览
简要总结
Part A/B: To characterize the safety and tolerability of BLU-808
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Part A: Confirmed diagnosis of chronic inducible urticaria for ≥3 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines
- •Part B: Confirmed diagnosis of chronic spontaneous urticaria for ≥6 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines
- •Other protocol-defined criteria apply
排除标准
- •Part A: Any active urticaria that may interfere with study assessments
- •Part A: History of cold-induced anaphylaxis
- •Part B: Participant has a clearly defined predominant cause of chronic urticaria or sole trigger such as symptomatic dermographism and cold-induced urticaria
- •Part A/B: Any other skin disease associated with chronic itching or angioedema that might influence the study evaluations and results, skin diseases associated with only wheals and no itch, or autoinflammatory diseases with urticarial lesions
- •Part A/B: Significant medical, psychiatric, or surgical conditions, or physical findings that may affect participant safety, study drug metabolism, study participation, or assessment of study results
- •Part A/B: Abnormal laboratory values that may pose risks or interfere with study participation
- •Part A/B: Pregnancy or plans for pregnancy; breastfeeding
- •Other protocol-defined criteria apply
结局指标
主要结局
Part A/B: Overall safety profile as assessed by the type, frequency, severity, and causality of Adverse Events
Part A/B: Overall safety profile as assessed by the type, frequency, severity, and causality of Adverse Events
次要结局
- 1. Part A: Cold-induced urticaria: mean change in critical temperature threshold using TempTest from Baseline to the end of Week 12
- 2. Part A: Symptomatic dermographism: mean change in total Fric score using FricTest from Baseline to the end of Week 12
- 3. Part A: Complete response rate at the end of Week 12
- 4. Part B: Mean change from Baseline to the end of Week 12 in patient reported outcome(s)
- 5. Part B: Complete response rate at the end of Week 12
- 6. Part A/B: Absolute and percent change in pharmacodynamic markers from Baseline to the end of Week 12
- 7. Part A/B: Population pharmacokinetic parameters including but not limited to AUC, Cmax, Cmin, CL/F, Vc/F, and t1/2
研究者
EU Medical Information
Scientific
Blueprint Medicines Corp.
研究点 (16)
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