2025-522642-44-00招募中2 期
B7981118 - A Phase 2b Randomized, Double Blind, 12-Week Placebo Controlled Study With a 12-Week Double-Blind Extension Period to Evaluate the Efficacy, Safety and Tolerability of Ritlecitinib (PF 06651600) in Adult Participants with Chronic Spontaneous Urticaria
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Pfizer Inc.
- 入组人数
- 7
- 试验地点
- 7
- 主要终点
- Change from baseline in UAS7 at Week 12
研究概览
简要总结
To compare the effect of ritlecitinib on improvement in UAS7 at Week 12.
To evaluate the safety and tolerability of ritlecitinib in participants with CSU
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •adults (aged ≥18 years old or minimum legal adult age as defined per local regulation, whichever is greater)
- •clinical diagnosis of CSU for ≥3 months at the time of screening who remain symptomatic despite treatment with second generation H1-antihistamines (sgAH) (at locally approved dose or higher) and are anti-IgEnaïve or anti-IgE-experienced (who stopped, could not tolerate, or did not adequately respond)
排除标准
- •Participants will not be eligible if their urticaria is solely due to inducible urticaria, have active dermatological diseases other than CSU with urticaria wheels or angioedema or other skin diseases associated with chronic itching.
结局指标
主要结局
Change from baseline in UAS7 at Week 12
Change from baseline in UAS7 at Week 12
Incidence of TEAEs, SAEs, and AEs leading to discontinuation
Incidence of TEAEs, SAEs, and AEs leading to discontinuation
次要结局
- Change from baseline in UAS7 at all timepoints except Week 12
- Change from baseline in ISS7 at Week 12
- Change from baseline in HSS7 at Week 12
- Achieving complete response defined as UAS7=0 at Week 12
- Achieving UAS7 ≤6 at Week 12
- Achieving complete response defined as ISS7=0 at Week 12
- Achieving complete response defined as HSS7=0 at Week 12
- Time to achieving UAS7 ≤6
- Time to achieving improvement from baseline ≥10 in UAS7
- Incidence of TEAEs, SAEs, and AEs leading to discontinuation
研究者
Clinical Medical Lead
Scientific
Pfizer Inc.
研究点 (7)
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