A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 336
- 主要终点
- Percentage of Participants With Adverse Events
研究概览
简要总结
The study is a global Phase III, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the safety and efficacy of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with chronic idiopathic urticaria (CIU) who remain symptomatic despite standard-dosed H1 antihistamine treatment (including doses up to 4 times above the approved dose level), H2 blockers, and/or leukotriene receptor antagonists (LTRA).
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
- 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 idiopathic urticaria (CIU) refractory to H1 antihistamines, H2 blockers, and/or leukotriene receptor antagonists (LTRA) at the time of randomization.
- •The presence of itch and hives for > 6 consecutive weeks at any time prior to enrollment despite current use of H1 antihistamine (up to 4 times the approved dosage), H2 blocker, and/or LTRA treatment during this time.
- •Urticaria activity score over 7 days (UAS7) score (range 0-42) ≥ 16 and itch component of UAS7 (range 0-21) ≥ 8 during 7 days prior to randomization (Week 0).
- •In-clinic UAS ≥ 4 on at least one of the screening visit days (Day -14, Day -7, or Day 1).
- •For women of childbearing potential, agreement to use an acceptable form of contraception and to continue its use for the duration of the study.
排除标准
- •Treatment with an investigational agent within 30 days prior to screening.
- •Weight less than 20 kg (44 lbs).
- •Clearly defined underlying etiology for chronic urticarias other than CIU.
- •Evidence of parasitic infection.
- •Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or other skin disease associated with itch.
- •Previous treatment with omalizumab within a year prior to screening.
- •Routine doses of the following medications within 30 days prior to screening: Systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide.
- •Intravenous (IV) immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to screening.
- •Regular (daily/every other day) doxepin (oral) use within 6 weeks prior to screening.
- •Patients with current malignancy, history of malignancy, or currently under work-up for suspected malignancy except non-melanoma skin cancer that has been treated or excised and is considered resolved.
- •Hypersensitivity to omalizumab or any component of the formulation.
- •History of anaphylactic shock.
- •Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic, or other pathological conditions that could interfere with the interpretation of the study results and or compromise the safety of the patients.
- •Evidence of current drug or alcohol abuse.
研究组 & 干预措施
Placebo
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
干预措施: Placebo (Drug)
Placebo
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
干预措施: H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist (Drug)
Placebo
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
干预措施: Diphenhydramine (Drug)
Omalizumab 300 mg
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
干预措施: Omalizumab (Drug)
Omalizumab 300 mg
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
干预措施: H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist (Drug)
Omalizumab 300 mg
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
干预措施: Diphenhydramine (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events
时间窗: Baseline to the end of study (up to 40 weeks)
The percentage of participants with serious adverse events and other adverse events is summarized by MedDRA preferred terms and organ classes in the Reported Adverse Events section below.
次要结局
- Percentage of Participants With a UAS7 Score ≤ 6 at Week 12(Week 12)
- Percentage of Weekly Itch Severity Score MID Responders at Week 12(Baseline to Week 12)
- Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12(Baseline to Week 12)
- Change From Baseline to Week 12 in the Weekly Itch Severity Score(Baseline to Week 12)
- Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7)(Baseline to Week 12)
- Change From Baseline to Week 12 in the Weekly Number of Hives Score(Baseline to Week 12)
- Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12(Baseline to Week 12)
- Change From Baseline to Week 12 in the Weekly Size of the Largest Hive Score(Baseline to Week 12)
- Percentage of Angioedema-free Days From Week 4 to Week 12(Week 4 to Week 12)
- Percentage of Complete Responders (UAS7 = 0) at Week 12(Week 12)