A Randomized, 24 Weeks, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Omalizumab in Adult Patients With Chronic Urticaria Who Exhibit IgE Against Thyroperoxidase
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24)
研究概览
简要总结
This study evaluated the safety and efficacy of omalizumab in adult patients with moderate to severe chronic urticaria who exhibit IgE against thyroperoxidase.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Omalizumab 75-375 mg
Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
干预措施: Omalizumab 75-375 mg (Drug)
Omalizumab 75-375 mg
Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
干预措施: Loratadine (Drug)
Placebo to omalizumab
Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
干预措施: Placebo to omalizumab (Drug)
Placebo to omalizumab
Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
干预措施: Loratadine (Drug)
Placebo to omalizumab
Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
干预措施: Clemastine (Drug)
结局指标
主要结局
Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24)
时间窗: Baseline to end of the study (Week 24)
The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. Because of variations in chronic urticaria disease intensity, assessment of disease activity was based on a weekly (7 days) UAS score called UAS7, that is, the sum of the daily UASs, ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change score (Week 24 score minus Baseline score) indicates improvement.
次要结局
- Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study(At the end of the study (Week 24))
- Standardized (With Respect to Length of Time) Area Under the Curve (AUC) for the Urticaria Activity Score (UAS) From Baseline to the End of the Study (Week 24)(Baseline to the end of the study (Week 24))
- Use of Concomitant and Rescue Medications(At Weeks 4, 8, 12, 16, 20, and 24)
- Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24)(Baseline to the end of the study (Week 24))
- Change in the Skindex Score From Baseline to the End of the Study (Week 24)(Baseline to the end of the study (Week 24))
- Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)(Baseline to the end of the study (Week 24))
- Patient's Global Assessment of Their Chronic Urticaria Symptoms(At Baseline and at the end of the study (Week 24))
- Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms(At Baseline and at the end of the study (Week 24))