An Open Label, Multicenter, Extension Study to Evaluate the Long-term Safety of QGE031 240 mg s.c. Given Every 4 Weeks for 52 Weeks in Chronic Spontaneous Urticaria Patients Who Completed Study CQGE031C2201
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 67
- 主要终点
- Number of Participants With at Least One Treatment Emergent Adverse Event (AE)
研究概览
简要总结
A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4 weeks for 52 weeks in Chronic Spontaneous Urticaria (CSU) patients who completed study CQGE031C2201
详细描述
A safety extension study to evaluate the long-term safety of QGE031 in Chronic Spontaneous Urticaria patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- •Written informed consent must be obtained before any assessment is performed.
- •Patients who complete the treatment epoch in study CQGE031C2201 and complete at least Visit 203 (Week 32 of the follow-up epoch, ≥16 weeks after last injection) and present with active disease as defined by UAS7 ≥
- •Patients must not have any missing eDiary entries in the 7 days prior to Visit 301 (patients are allowed to repeat until this criterion is met).
- •Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.
排除标准
- •Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria
- •Evidence of parasitic infection
- •Any other skin diseases than chronic spontaneous urticaria with chronic itching
- •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
Number of Participants With at Least One Treatment Emergent Adverse Event (AE)
时间窗: Within 16 weeks after Week 48
The primary objective of this study was to assess the long-term safety of one-year treatment of QGE031 in adult Chronic Spontaneous Urticaria (CSU) patients who completed the core study CQGE031C2201 using the following evaluations: number of participants with treatment emergent AEs of non-serious and serious nature including any events of special interest.
次要结局
- Percentage of Subjects Having Achieved UAS7 ≤ 6(Baseline, Week 52 and Week 100)
- Number and Proportion of Participants Who Achieved UAS7≤ 6(Baseline, Week 52, Week 100)