A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4
研究概览
简要总结
The study is a Phase II, dose-ranging, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of a single subcutaneously administered omalizumab dose as add-on therapy for the treatment of adolescent and adult patients 12-75 years old who have been diagnosed with CIU and remain symptomatic despite treatment with therapeutic doses of an H1 antihistamine. The study will enroll approximately 76 patients at approximately 45 study centers in the United States and Germany.
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
- Double (Participant, Investigator)
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
- •CIU diagnosis > 3 months (by history)
- •No underlying etiology clearly defined for urticaria (main manifestation cannot be physical urticaria)
排除标准
- •Pregnant, breastfeeding, or women not taking contraception
- •Patients < 40kg
- •Treatment with any investigational agent within 30 days of screening
- •Recent history of drug or alcohol abuse
- •Atopic dermatitis or other skin disease associated with pruritus
- •Clinically relevant major systemic disease (making interpretation of the study results difficult)
- •Previously treated with omalizumab (< 12 months since last injection)
- •Patients may not take during treatment period or have been taking within the past 3 months any of the following medications/treatments: regular (daily/every other day) hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, IVIG, or plasmapheresis
- •Patients may not have been taking doxepin within the past 6 weeks regular (daily/every other day).
研究组 & 干预措施
Omalizumab 75 mg
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.).
干预措施: omalizumab (Drug)
Omalizumab 75 mg
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.).
干预措施: H1 antihistamines (Drug)
Omalizumab 75 mg
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.).
干预措施: Diphenhydramine (Drug)
Omalizumab 300 mg
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
干预措施: omalizumab (Drug)
Omalizumab 300 mg
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
干预措施: H1 antihistamines (Drug)
Omalizumab 300 mg
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
干预措施: Diphenhydramine (Drug)
Omalizumab 600 mg
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
干预措施: omalizumab (Drug)
Omalizumab 600 mg
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
干预措施: H1 antihistamines (Drug)
Omalizumab 600 mg
Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
干预措施: Diphenhydramine (Drug)
Placebo
Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
干预措施: omalizumab (Drug)
Placebo
Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
干预措施: placebo (Drug)
Placebo
Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
干预措施: H1 antihistamines (Drug)
Placebo
Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
干预措施: Diphenhydramine (Drug)
结局指标
主要结局
Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4
时间窗: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
The UAS is a composite diary-recorded score, which is the sum of the numeric severity intensity ratings (0 = none to 3 = intense) for 1) the number of wheals (hives) and 2) the intensity of the pruritus (itch). The UAS7 is the sum of the daily average UAS (morning and evening values) for 7 days. The maximum UAS7 score is 42.
次要结局
- Number of Participants With Immunogenicity(16 weeks)
- Area Under the Concentration-time Curve From Time of Dosing Extrapolated to Infinity (AUC-Inf)(Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16))
- Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4(Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27))
- Terminal Half-Life (t1/2) of Omalizumab(Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16))
- Change in the Weekly Pruritus Score From Baseline to Week 4(Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27))
- Change in the Weekly Score for Number of Hives From Baseline to Week 4(Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27))
- Change in the Weekly Score for Sleep Interference From Baseline to Week 4(Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27))
- Number of Patients With Adverse Events by Severity(16 weeks overall (data reported separately for "up to 4 weeks" and "Weeks 5 to 16"))
- Time to Maximum Concentration (Tmax) of Omalizumab(Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16))
- Maximum Observed Concentration (Cmax) of Omalizumab(Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16))