Mepolizumab for the Treatment of Chronic Spontaneous Urticaria: An Open-label, Single-arm, Exploratory Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Reduction in Urticaria Activity Score (UAS7)
研究概览
简要总结
This is an exploratory study designed to generate preliminary data in evaluating the efficacy of Nucala in the treatment of chronic spontaneous urticaria.
详细描述
This is an open-label, single arm exploratory study of mepolizumab in the treatment of CSU. The primary endpoint will be the mean reduction in the seven day urticaria activity score (UAS7) before and after 10 weeks of treatment with mepolizumab. Secondary endpoints will be the mean reduction of the urticaria control test (UCT) score and the weekly itch severity score (ISS) before and after treatment. Enrollment examination will include a standardized history and examination, baseline UCT score, CBC with differential, serum IgE level, chronic urticaria index, IgE Fc receptor antibody functional assay, and a 4 mm punch biopsy of lesional skin to confirm the urticarial tissue reaction includes eosinophils and is not neutrophilic predominant. Patients will discontinue all anti-histamines and start cetirizine 10 mg PO BID which may be continued throughout the study duration. Patients will be provided with a log book to track daily urticaria signs and symptoms in a standardized manner for UAS scoring. At week 0 (enrollment visit +7 days), baseline UAS7 and ISS score will be assessed and skin biopsy results reviewed. Patients with a confirmatory skin biopsy will receive 200 mg SC of mepolizumab at week 0,2,4,6,and 8. UAS-7 and weekly ISS score will be calculated at week 0, 4, 8, and 10. UCT scoring will be calculated at week 0 and at week 10. Repeat CBC with differential, serum IgE level, and measures of basophil serum activation (chronic urticaria index, IgE FC Receptor antibody functional assay) will be assessed at week 10. Attached to this document is a protocol summary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male and female patients 18 years or older.
- •Clinical and/or histopathological diagnosis of conventional CSU
- •Unresponsive to oral antihistamine therapy
- •Good general health as confirmed by medical history
- •Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
- •Patients who read and sign an approved informed consent for this study
排除标准
- •Vulnerable study population
- •If you are female and pregnant
- •Biopsy proven neutrophilic rich urticaria
- •Known history of adverse reaction to mepolizumab (Nucala)
研究组 & 干预措施
Treatment Arm
This is an open-label pilot investigation and all study participants are assigned to active treatment. There is no placebo arm in this study.
干预措施: Nucala (Drug)
结局指标
主要结局
Reduction in Urticaria Activity Score (UAS7)
时间窗: Baseline to 10 Weeks
Study participants documented their chronic spontaneous urticaria (CSU) symptoms using a diary, daily scoring for a) the number of wheals \[none (=0 points), \<10 (=1 point), 10-50 (=2 points), or \>50 per day (=3 points)\], and b) the intensity of pruritus \[none (=0 points), mild (=1 point), moderate (=2 points), severe (=3 points)\]. The daily UAS score is summed over a week to calculate the UAS7 score (range: 0-42). Participants were considered responders if they had ≥ 95% reduction in baseline UAS7 score and non-responders if they had \<95% reduction in baseline UAS7 score.
次要结局
- Change in Short Form Urticaria Control Test Score (S-UCT)(Baseline to 10 weeks)
- Change in Long Form Urticaria Control Test (L-UCT) Score(Baseline to 10 Weeks)
- Change in Itch Severity Score (ISS)(Baseline to 10 weeks)
研究者
Jason Sluzevich MD
Principal Investigator
Mayo Clinic