A Phase 2a, Randomized, Double-blind, Study of TAS5315 in Chronic Spontaneous Urticaria Patients With an Inadequate Response to H1-antihistamines
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Mean change from baseline in weekly Urticaria Activity Score (UAS7) at week 12
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of TAS5315 in chronic spontaneous urticaria patients with an inadequate response to H1-antihistamines
详细描述
The main purpose of this study is to assess the efficacy of TAS5315 in chronic spontaneous urticaria patients with an inadequate response to H1-antihistamines compared with placebo as measured by the change from baseline in weekly Urticaria Activity Score (UAS7) at week 12
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
- •Aged 18 to 75 years
- •Diagnosis of chronic spontaneous urticaria (CSU)
- •Presence of itch and hives for at least 6 consecutive weeks prior to screening in spite of use of non-sedating H1-antihistamines for CSU
- •UAS7 score ≥ 16 and HSS7 score ≥ 8 during 7 days prior to study entry
- •In-clinic UAS ≥ 4 on study entry
- •Willing and able to complete and Participate Daily for the duration of the study
- •Key Exclusion Criteria
- •Diseases other than CSU with symptoms of urticaria or angioedema, including urticarial vasculitis, erythema multiforme, mastocytosis, or hereditary or acquired angioedema
- •Atopic dermatitis, psoriasis, ichthyosis, or other skin disease associated with chronic itching
- •Bleeding diathesis
- •Uncontrolled hypertension disease states
- •Treatment with omalizumab or other humanized anti-human IgE monoclonal antibody therapies used to treat CSU within 4 months prior to screening
- •Nonresponse to omalizumab or other humanized anti-human IgE monoclonal antibody therapies
- •Have been treated with other Bruton's Tyrosine Kinase inhibitors
- •Pregnant or lactating women
排除标准
- 未提供
研究组 & 干预措施
TAS5315 Dose 1
干预措施: TAS5315 Dose 1 (Drug)
TAS5315 Dose 2
干预措施: TAS5315 Dose 2 (Drug)
TAS5315 Dose 3
干预措施: TAS5315 Dose 3 (Drug)
AS5315 Dose 4
干预措施: TAS5315 Dose 4 (Drug)
TAS5315 Dose 5
干预措施: TAS5315 Dose 5 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change from baseline in weekly Urticaria Activity Score (UAS7) at week 12
时间窗: Week 12
The UAS7 is the sum of the HSS7 score (weekly Hives Severity Sore) and the ISS7 score (weekly Itch Severity Score). The range of the UAS7 score is 0 - 42. (Zuberbier et al. 1995; Zuberbier et al., 2014)
次要结局
- Complete absence of hives and itch (UAS7=0)(Over time from week 1 to week 12)
- Disease control (UAS7<=6)(Over time from week 1 to week 12)
- Mean change from baseline in weekly Angioedema Activity Score (AAS7)(Over time from week 1 to week 12)
- Mean change from baseline in Dermatology life quality index (DLQI)(Over time from week 1 to week 12)
- Mean change from baseline in Urticaria control test (UCT)(Over time from week 1 to week 12)
- Mean change from baseline in pharmacodynamics marker(Over time from week 1to week 12)