NCT06931405进行中（未招募）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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 105
- 试验地点
- 86
- 主要终点
- Part A and Part B: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
This is a 2-part, proof-of-concept study to be conducted globally, designed to evaluate the safety, tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of BLU-808, a wild type KIT inhibitor, in participants with CIndU (Part A) or CSU (Part B).
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Arms A1 and A3 are non-randomized and open label. Arm B is randomized and double blind.
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
- •Part A: Confirmed diagnosis of CIndU for ≥3 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines.
- •Part B: Confirmed diagnosis of CSU for ≥3 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines.
排除标准
- •Part A: Any active urticaria that may interfere with study assessments.
- •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 and Part 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 and Part 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 and Part B: Abnormal laboratory values that may pose risks or interfere with study participation.
- •Part A and Part B: Pregnancy or plans for pregnancy; breastfeeding.
研究组 & 干预措施
Arm B (Part B): BLU-808/Placebo
Experimental
BLU-808 or matching placebo will be administered orally.
干预措施: Placebo (Drug)
Arm A1 (Part A): BLU-808
Experimental
BLU-808 will be administered orally.
干预措施: BLU-808 (Drug)
Arm A3 (Part A): BLU-808
Experimental
BLU-808 will be administered orally.
干预措施: BLU-808 (Drug)
Arm B (Part B): BLU-808/Placebo
Experimental
BLU-808 or matching placebo will be administered orally.
干预措施: BLU-808 (Drug)
结局指标
主要结局
Part A and Part B: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
时间窗: Day 1 through Week 16
次要结局
- Part A: Mean Change From Baseline in Critical Temperature Threshold (CTT) at Week 12(Baseline, Week 12)
- Part A: Mean Change From Baseline in Total Fric Score (TFS) at Week 12(Baseline, Week 12)
- Part A and Part B: Complete Response Rate(Week 12)
- Part A and Part B: Absolute Change From Baseline in Serum Tryptase Concentration at Week 12(Baseline, Week 12)
- Part A and Part B: Terminal Half-life (t½) of BLU-808(Day 1 to Day 57)
- Part A and Part B: Percent Change From Baseline in Serum Tryptase Concentration at Week 12(Baseline, Week 12)
- Part A and Part B: Area Under the Curve (AUC) of BLU-808(Day 1 to Day 57)
- Part A and Part B: Maximum Plasma Concentration (Cmax) of BLU-808(Day 1 to Day 57)
- Part A and Part B: Minimum Plasma Concentration (Cmin) of BLU-808(Day 1 to Day 57)
- Part A and Part B: Apparent Clearance (CL/F) of BLU-808(Day 1 to Day 57)
- Part A and Part B: Apparent Volume of Distribution for the Central Compartment (Vc/F) of BLU-808(Day 1 to Day 57)
- Part B: Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Week 12(Baseline, Week 12)
研究者
研究点 (86)
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