Extending omalizumab treatment intervals in patients with chronic spontaneous urticaria (EXOTIC trial): a multicentre, randomized, open-label, non-inferiority trial.

Bispebjerg Hospital0 个研究点目标入组 40 人开始时间: 2023年8月23日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•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

•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

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