A Randomized, Double-blind, Placebo-controlled, 28-week Treatment With a 8 Week Follow-up to Investigate the Impact of Omalizumab on Quality of Life Measures and the Incidence and Severity of Angioedema Despite H1-antihistamine Therapy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline Using Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Total Scores During the Study: Unadjusted Analysis and ANCOVA (LOCF) (FAS)
研究概览
简要总结
This study will assess the impact of omalizumab on the quality of life improvement when added to the standard therapy in refractory patients suffering from chronic spontaneous urticaria and angioedema.
详细描述
This study will be conducted using a double-blind, placebo-controlled, randomized, multicenter design to investigate the impact of omalizumab on Quality of Life (QoL) in Chronic Spontaneous Urticaria (CSU) and will assess its effectiveness in reducing and/or inhibiting the occurrence, time-course and severity of angioedema episodes.
Omalizumab is administered subcutaneously every 4 weeks as an add-on therapy to the current approved treatment of adult CSU patients. The treatment period is 28 weeks which is followed by an 8-week follow-up. The study aims to enroll approximately 70 patients.
The study is divided into a 2-week screening period, a 28-week double-blind treatment phase with omalizumab or placebo-omalizumab, and an 8-week follow-up phase.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic spontaneous urticaria (CSU) refractory to H1-antihistamine treatment
- •Presence of itch an hives for more than 6 weeks
- •UAS7 score of more than 14 (range 0-42)
- •Patient has history of insufficient response to 4x of the approved dose of H1-antihistamines
- •CSU diagnosis for more than 6 months
- •Angioedema at least 4x in the last 6 months
排除标准
- •Patients with non urticaria associated angioedema
- •History of hypersensitivity to omalizumab or the rescue medication or to drugs of similar chemical structure
- •Evidence of parasitic infection
- •Previous treatment with omalizumab within the last 6 months prior to screening
- •History of anaphylactic shock
- •Woman who are pregnant or breast feeding
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
1 Omalizumab
omalizumab once a month via subcutaneous injection.
干预措施: Omalizumab (Biological)
2 Placebo
placebo of omalizumab once a month via subcutaneous injection
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline Using Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Total Scores During the Study: Unadjusted Analysis and ANCOVA (LOCF) (FAS)
时间窗: Baseline, 4, 12, 20, 28 and 36 weeks
The CU-Q2oL is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It consists of 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Participants are asked to respond how much they are troubled by each problem on a 5-point Likert scale (1= not at all to 5= very much). An overall score is calculated and normalized to a scale of 1 to 100.
次要结局
- Diameter: Acute Swelling Episodes at End of Treatment (Weeks 25 to 28)(weeks 25 to 28)
- Diameter: Acute Swelling Episodes at End of Follow-up(Weeks 33 to 36)(weeks 33 to 36)
- Number of Angioedema Burdened Days by Study Phase (Observed Cases With Imputation)(Baseline, week 28; and the follow-up period (weeks 29-36))
- Mean Time Interval Between Successive Angioedema Episodes of the First 15 Episodes(Baseline to week 28)
- Change of Angioedema Activity Score (AAS) Total Week Sum Scores: Unadjusted Analysis and ANCOVA (Observed Cases With Imputation)(Baseline to week 28; and follow-up period (to week 36))
- Shortness of Breath: Acute Swelling Episodes Within the Screening Period (Weeks -2 to -1)(weeks -2 to -1)
- Shortness of Breath: Acute Swelling Episodes at End of Treatment Period (Weeks 25 to 28)(weeks 25 to 28)
- Change of DLQI Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)(baseline to week 28; and follow-up to week 36)
- Diameter: Acute Swelling Episodes Within the Screening Period (Week -2 to -1)(week -2 to -1)
- Change of AE-Q2oL Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)(baseline to week 28; and then follow-up to week 36)
- Rescue Medication During the Treatment Period(baseline to 28 weeks)
- Days of Rescue Medication During the Follow-up Period(weeks 33 to 36)
- Shortness of Breath: Acute Swelling Episodes at End of Follow-up Period (Weeks 33 to 36)(weeks 33 to 36)
- Days of Rescue Medication During the Treatment Period(baseline to 28 weeks)
- Change of UAS7 Total Scores From Baseline to Week 28: Unadjusted Analysis and ANCOVA (Observed Cases)(baseline to week 28; and then follow-up to week 36)