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
- 1
- 主要终点
- Absolute difference in average Urticaria Control Test (UCT) score at week 36
研究概览
简要总结
This study is a multicentre, randomized, open-label, non-inferiority clinical trial.
The purpose and aim of this study is to investigate if patients with well controlled (UCT score score ≥ 12) chronic spontaneous urticaria (CSU) on omalizumab 300 mg every four weeks can extend treatment intervals and maintain disease control.
详细描述
Newly referred patients with CSU who are well-treated (UCT score ≥ 12) 12 weeks after initiating standard treatment with omalizumab 300 mg every four weeks, are randomized into two treatment arms.The first arm will continue standard treatment with omalizumab 300 mg every four weeks for 24 weeks. The second arm will receive treatment in an extended interval of omalizumab 300 mg every six weeks for 24 weeks.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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.
- •Omalizumab-naïve prior to initiating treatment with omalizumab.
- •Background treatment with four antihistamines daily.
- •Candidate for omalizumab treatment according to Danish guidelines.
排除标准
- •Pregnant or breastfeeding women.
- •Planned pregnancy within the next 6 months.
- •Weight ≥ 100 kilograms.
- •Presence of any other active skin disease or condition that may interfere with the assessment of CSU, such as atopic dermatitis, bullous pemphigoid, senile pruritus, or psoriasis.
- •Use of immunosuppressive drugs, such as prednisolone, azathioprine, methotrexate, or cyclosporine.
- •Predominantly experience symptoms from chronic inducible urticaria (CIndU).
- •Inability to complete study or comply with study procedures.
- •Patients with a positive basophil histamine release assay (BHRA) are not eligible for the study. Patients may therefore be withdrawn from the trial after enrolment, if they are found to have a positive BHRA test in the initial blood work.
研究组 & 干预措施
omalizumab 300 mg every six weeks
20 subjects are randomized to receive omalizumab 300 mg every six weeks from week 12 to week 36.
干预措施: omalizumab 300 mg every six weeks (Drug)
omalizumab 300 mg every four weeks
20 subjects are randomized to receive omalizumab 300 mg every four weeks from week 12 to week 36.
干预措施: omalizumab 300 mg every four weeks (Drug)
结局指标
主要结局
Absolute difference in average Urticaria Control Test (UCT) score at week 36
时间窗: Through study completion, an average of 36 weeks
The Urticaria Control Test (UCT) is a retrospective questionnaire that gathers information regarding the past 4 weeks. It consists of four questions, each with four possible answer options. A score ranging from 0 to 4 is assigned to each answer option. Consequently, the UCT score ranges from 0 to 16, with higher scores indicating lower control of the disease. A UCT score of 12 or higher suggests well-controlled urticaria, while a score of 16 indicates complete control.
次要结局
- Proportion of well-controlled patients (UAS7 score < 7) at week 24 and 36(Through study completion, an average of 36 weeks)
- Proportion of well-controlled patients (UCT score ≥ 12) at week 24 and 36(Through study completion, an average of 36 weeks)
- Proportion of completely controlled patients (UAS7 score = 0) at week 24 and 36(Through study completion, an average of 36 weeks)
- Differences in average Chronic Urticaria Quality of Life (CU-QoL) at week 24 and 36(Through study completion, an average of 36 weeks)
- Proportion of patients in the two treatment arms who experience flares(Through study completion, an average of 36 weeks)
- Absolute difference in average Urticaria Control Test (UCT) score at week 24(Through study completion, an average of 36 weeks)
- Proportion of completely controlled patients (UCT score = 16) at week 24 and 36(Through study completion, an average of 36 weeks)
- Differences in average dermatology life quality index (DLQI) at week 24 and 36(Through study completion, an average of 36 weeks)
- Difference in absolute UCT score measured as area under the curve (AUC)(Through study completion, an average of 36 weeks)
- Absolute difference in average weekly urticaria activity score (UAS7) at week 24 and 36(Through study completion, an average of 36 weeks)
- Adverse event (AEs) and serious advese events (SAEs)(Through study completion, an average of 36 weeks)
研究者
Simon Francis Thomsen
DM, PhD, DMSc
Bispebjerg Hospital