2023-506187-14-00招募中4 期
Extending omalizumab treatment intervals in patients with chronic spontaneous urticaria (EXOTIC trial): a multicentre, randomized, open-label, non-inferiority trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Absolute difference in average urticaria control test (UCT) score between treatment arms at week 36.
研究概览
简要总结
To investigate if adult patients with well controlled chronic spontaneous urticaria (CSU) treated with omalizumab can extend treatment intervals and maintain disease control.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of CSU according to the EAACI/GA2LEN/EDF/WAO guidelines
- •Age ≥ 18 years
- •A UCT score ≥ 12 at week 12 after initiating treatment with 300 mg omalizumab every four weeks.
- •Omalizumab naïve prior to initiating treatment with omalizumab.
- •Background treatment of 4 antihistamines daily
- •Type 1 CSU (negative BHRA)
- •Candidate for omalizumab treatment according to Danish practice
排除标准
- •Pregnant or breastfeeding women
- •Planned pregnancy within 6 months
- •Body mass index (BMI) ≥ 100 kilograms
- •Any other active skin disease or condition that may interfere with assessment of CSU e.g., atopic dermatitis, bullous pemphigoid, senile pruritus, or psoriasis.
- •Use of immunosuppressive drugs e.g., prednisolone, azathioprine, methotrexate, and cyclosporine.
- •Predominantly symptoms from chronic inducible urticaria (CIndU)
- •Positive BHRA
- •Inability to complete study or comply with study procedures
结局指标
主要结局
Absolute difference in average urticaria control test (UCT) score between treatment arms at week 36.
Absolute difference in average urticaria control test (UCT) score between treatment arms at week 36.
次要结局
未报告次要终点
研究者
Ditte Georgina Zhang
Scientific
Bispebjerg Hospital
研究点 (2)
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