NCT02550106已完成4 期
A Phase IV, Multicenter, Single-arm and Open-label Study With Omalizumab (Xolair®) in Chronic Spontaneous Urticaria (CSU) Patients Who Remain Symptomatic Despite Antihistamine (H1) Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Percent of Participants With an Urticaria Control Test [UCT] Score of Greater Than or Equal to 12
研究概览
简要总结
Evaluate the proportion of patients with an urticaria control test [UCT] score of greater than or equal to 12 at Week 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Male or female patients aged between 18 and 75 years.
- •Diagnosis of CSU for ≥ 6 months and an inadequate response to nsH1 antihistamines at the time of the request, as defined by the following:
- •The presence of itch and hives for > 6 consecutive weeks at any time prior to enrollment, despite current use of H1 antihistamine therapy during this time period.
- •Weekly UAS7 score (range 0 to 42) 16 and UCT score (range 0 to 16) < 8 prior to enrollment (Day 1)
- •Current use of an H1 antihistamine for CSU on the day of the initial visit and Day
- •Informed consent
排除标准
- •Treatment with an investigational agent within 30 days before enrollment.
- •Routine (daily or every other day during 5 or more consecutive days) doses of the following medications within 30 days prior to Day -7: systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide.
- •Intravenous (i.v.) immunoglobulin G or plasmapheresis within 30 days prior to Day -7
- •Regular (daily/every other day) doxepin (oral) use within 14 days prior to Day -
- •Any H2 antihistamine use within 7 days prior to Day -
- •Any leukotriene receptor antagonist (LTRA) (montelukast or zafirlukast) within 7 days prior to Day
- •Concomitant use of cyclosporine or any other immunosuppressive agent.
- •Hypersensitivity to omalizumab or any component of the formulation.
- •History of anaphylactic shock.
研究组 & 干预措施
OMALIZUMAB
Experimental
sub cutaneous injections of 300 mg every 4 weeks until Week 8.
干预措施: OMALIZUMAB (Drug)
结局指标
主要结局
Percent of Participants With an Urticaria Control Test [UCT] Score of Greater Than or Equal to 12
时间窗: WEEK 12
Number of participants with an Urticaria Control Test score of greater than or equal to 12 at Week 12 The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control.
次要结局
- Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 28, With or Without the Presence of Angioedema(week 28)
- Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 20, With or Without the Presence of Angioedema(week 20)
- The Quality of Life Using the Chronic Urticaria Quality of Life (CU-QoL) Questionnaire(baseline and week 12)
- The Dermatology Life Quality Index (DLQI)(baseline and week 12)
- Percent of Participants With UAS7≤6 (Patients Achieving Disease Control), in Adult Patients With CSU, With or Without the Presence of Angioedema(WEEK 12)
- CSU Disease Activity Using the Urticaria Activity Score (UAS7), With or Without the Presence of Angioedema(baseline and week 12)
- Urticaria Control Test (UCT) Score According to the Presence of Angioedema at Baseline and Week 12(baseline and week 12)
- Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 16, With or Without the Presence of Angioedema(week 16)
- Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 24, With or Without the Presence of Angioedema(week 24)
- The Angioedema Quality of Life (AE-QoL)(baseline and week 12)
- Angioedema Activity Using the Angioedema Activity Score (AAS)(baseline and week 12)
研究者
研究点 (1)
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