A Multi-center, Randomized, Double-blind, Placebo, and Active-controlled Phase 2b Dose-finding Study of QGE031 as add-on Therapy to Investigate the Efficacy and Safety in Patients With Chronic Spontaneous Urticaria (CSU)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 382
- 试验地点
- 83
- 主要终点
- Percentage of Participants With Complete Hives Response (HSS7=0)
研究概览
简要总结
This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic Spontaneous Urticaria.
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)
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
- •Diagnosis of chronic spontaneous urticaria for at least 6 months
- •Diagnosis of chronic spontaneous urticaria refractory to standard of care at time of randomization
排除标准
- •Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria
- •Evidence of parasitic infection
- •Any other skin disease with chronic itching
- •Previous treatment with omalizumab or QGE031
- •Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or epinephrine
- •History of anaphylaxis
- •History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
- •History of hypersensitivity to any of the study drugs or its components of similar chemical classes
- •Pregnant or nursing (lactating) women
- •Other protocol defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Percentage of Participants With Complete Hives Response (HSS7=0)
时间窗: Week 12
The primary objective was to establish the dose-response relationship of ligelizumab (24, 72 and 240 mg every 4 weeks) with respect to achievement of complete hives response (HSS7=0) at Week 12 and select an appropriate dose (or range of doses) which is likely to be superior to omalizumab at the highest approved dose (300 mg every 4 weeks). Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days, with a possible range of 0 - 21. Hives Severity Score scale: 0 - None 1. - Mild (1-6 hives/12 hours) 2. - Moderate (7-12 hives/12 hours) 3. - Severe (\>12 hives/12 hours) To confirm an overall dose-response signal based on MCP-Mod, and to estimate the minimal ligelizumab dose that shows a relevant superior effect over omalizumab, based on the selected dose response model, the lowest ligelizumab dose that provides a response rate 15% higher than the response of omalizumab 300 mg.
次要结局
- HSS7=0 Response: at Week 20 Measured Over 7 Days(Week 20)
- UAS7=0 Response: at Week 20 Measured Over 7 Days(Week 20)
- Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days(Week 12)
- Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days(Week 20)
- Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days(Week 20)
- Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days(Week 20)
- ISS7=0 Response: at Week 20 Measured Over 7 Days(Week 20)
- Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days(Week 12)
- Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days(Week 12)
- Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days(Week 12)
- Complete Urticaria Activity Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days(Week 12)
- Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days(Week 12)