A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Omalizumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite H1 Antihistamine Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 39
- 主要终点
- Change From Baseline in the Weekly Itch Severity Score at Week 12
研究概览
简要总结
This was a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult participants 12 - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and who remained symptomatic despite standard-dosed non-sedating H1 antihistamine treatment.
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
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamine at the time of randomization
- •Chronic spontaneous urticaria diagnosis for 6 months
排除标准
- •Weight less than 20 kg
- •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
- •Previous treatment with omalizumab
- •Contraindications to diphenhydramine
- •History of anaphylactic shock
- •History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
- •History of hypersensitivity to omalizumab or to drugs of similar chemical classes
- •Pregnant or nursing (lactating) women
研究组 & 干预措施
Omalizumab 150 mg
Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
干预措施: Omalizumab (Biological)
Placebo
Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
干预措施: Placebo (Other)
Omalizumab 300 mg
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
干预措施: Omalizumab (Biological)
结局指标
主要结局
Change From Baseline in the Weekly Itch Severity Score at Week 12
时间窗: Baseline to Week 12
The weekly itch severity score is a component of the Urticaria Activity Score 7 (UAS7) composite score. The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score from baseline indicates improvement.
次要结局
- Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12(Baseline to Week 12)
- Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12(Baseline to Week 12)
- Change From Baseline in the Weekly Number of Hives Score at Week 12(Baseline to Week 12)
- Percentage of Participants With Production of Anti-omalizumab Antibody(Week 24)
- Percentage of Weekly Itch Severity Score Minimally Important Difference (MID) Responders at Week 12(Week 12)
- Percentage of Complete Responders (UAS7 = 0) at Week 12(Week 12)
- Percentage of Participants With a UAS7 Score ≤ 6 at Week 12(Week 12)
- Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12(Baseline to Week 12)