A Phase III Study to Evaluate the Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 418
- 试验地点
- 1
- 主要终点
- Change From Baseline of the Itch Severity Score (ISS7) Score After 12 Weeks of Treatment
研究概览
简要总结
The purpose of this study was to demonstrate the efficacy and safety of omalizumab, compared with placebo, as an add-on to H1 antihistamines (H1AH) therapy in adult patients suffering from Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite H1AH therapy.
详细描述
This was a randomized, multicenteric, double-blinded, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab as an add-on therapy for the treatment of patients of refractory CSU who remained symptomatic despite approved-dosed H1AH treatment.
The study consisted of three distinct epochs over 24 weeks: Screening epoch (Day -28 to Day -1), Randomized treatment epoch (Day 1 to Week 12) and Post-treatment follow-up epoch (Week 12 to Week 20). Patients were randomized into three treatment groups (omalizumab 300 mg s.c. omalizumab 150 mg s.c. and placebo) in a 2:2:1 ratio, stratified by latent tuberculosis (TB) status at Baseline (Yes/No).
On Day 1, eligible patients were randomly assigned to receive omalizumab (150 mg or 300 mg) or placebo by subcutaneous (s.c.) injection every 4 weeks (on Day 1, Week 4, and Week 8) during the 12-week double-blind randomized-treatment epoch. Patients visited the study center at 4-week intervals. Patients were instructed to stay on the same CSU H1AH treatment at stable dose that they were using during the pre-randomization period during the randomized treatment epoch. They were allowed to use diphenhydramine as rescue medication during all epochs. The last dose of the study drug during the randomized-treatment epoch was administered at Week 8 study visit, however, the last assessment was done at Week 12.
After the completion of the 12-week randomized-treatment epoch, all patients entered an 8-week post-treatment follow-up epoch.
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
- •Symptomatic CSU patients with CSU diagnosis for at least 6 months.
- •Patients must have been on an approved dose of an H1AH for CSU for at least the 3 consecutive days immediately prior to the Day -14 screening visit
- •Patients must have documented current use on the day of the initial screening visit
- •Main Exclusion Criteria
- •Clearly defined underlying etiology for chronic urticarias other than CSU (main manifestation being physical urticaria)
- •Other skin disease associated with itch Urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, or generalized cancer
排除标准
- 未提供
研究组 & 干预措施
Omalizumab 300mg
patients received a dose of omalizumab 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
干预措施: Omalizumab (Drug)
Omalizumab 150mg
patients received a dose of omalizumab 150 mg which consisted of one injection of omalizumab 150 mg vial and one injection of placebo 150 mg vial every 4 weeks (Day 1, Week 4 and Week 8)
干预措施: Omalizumab (Drug)
Placebo
patients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline of the Itch Severity Score (ISS7) Score After 12 Weeks of Treatment
时间窗: Baseline, Week 12
The severity of the itch was recorded by the patient twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). Baseline ISS7 was calculated 7 days prior to the first treatment date. A weekly score (ISS7) was derived by adding up the average daily scores of the seven days preceding the visit. The possible range of the weekly score was therefore 0 to 21, where 0 is the best score and 21 is the worst score. The complete itch response was defined as ISS7 = 0. Itch (Pruritus) Severity Score Scale: 0 = None 1. = Mild (minimal awareness, easily tolerated) 2. = Moderate (definite awareness, bothersome but tolerable) 3. = Severe (difficult to tolerate)
次要结局
- Percentage of Patients With UAS7≤6 at Week 12(Week 12)
- Percentage of Complete Responders (UAS7 = 0) at Week 12(Week 12)
- Change From Baseline of Dermatology Life Quality Index (DLQI) Score After 12 Weeks of Treatment(Week 12)
- Change From Baseline of Urticaria Activity Score (UAS7) After 12 Weeks of Treatment(Baseline, Week 12)
- Change From Baseline of Number of Hives Score (NHS7) After 12 Weeks of Treatment(Baseline, Week 12)
- Percentage of Patients With ISS7 Minimally Important Difference (MID) at Week 12(Week 12)
- Time to ISS7 MID Response by Week 12(12 weeks)