NCT01987947已完成2 期
A Study of Quilizumab Versus Placebo in Patients With Refractory Chronic Spontaneous Urticaria
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Efficacy: Absolute change from baseline to Week 20 in the weekly itch score.
研究概览
简要总结
This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will assess the efficacy and safety of additional quilizumab therapy in adult patients with Chronic Spontaneous Urticaria resistant to antihistamine treatment.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CSU refractory to H1 antihistamines with/without LTRAs, as defined by the following:
- •The presence of itch and hives for > 6 consecutive weeks at any time prior to enrollment despite use of H1 antihistamines during this time period
- •UAS7 score greater than 16 and itch component of UAS7 greater than 8 during 7 days prior to Day
- •Patients must have been on daily stable doses of H1 antihistamine for at least 3 consecutive days immediately prior to the screening visit and must document current use at screening
- •CSU diagnosed for more than 6 months
- •Patients must have a minimum diary compliance (6 out of 7 consecutive days) prior to Day 1
排除标准
- •Treatment with an investigational agent within 30 days of screening, and previous treatment with monoclonal antibody therapies used to treat CSU 9 months prior to screening
- •Chronic urticarias other than CSU, including the following: Acute, solar, cholinergic, heat, cold, aquagenic, delayed pressure or contact.
- •Other diseases and conditions with symptoms of urticaria.
- •Routine doses of the following medications within 30 days prior to screening: systemic or topical corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide
- •IV immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to screening
- •Patients with cancer, history of cancer considered uncured or in complete remission for < 10 years, or currently under work-up for suspected cancer except non-melanoma skin cancer that has been treated or excised and is considered resolved
- •History of anaphylactic shock without clearly identifiable avoidable antigen
- •Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic or other pathological conditions.
- •Medical examination or laboratory findings that suggest the possibility of decompensation of co-existing conditions for the duration of the study.
- •Evidence of current drug or alcohol abuse
- •Nursing women and women of childbearing potential, unless using effective contraception as defined by protocol
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Quilizumab
Active Comparator
干预措施: Quilizumab (Drug)
结局指标
主要结局
Efficacy: Absolute change from baseline to Week 20 in the weekly itch score.
时间窗: 21 weeks
Safety: Incidence of anti-therapeutic antibodies.
时间窗: Approximately 30 weeks
Safety: Incidence & severity of adverse events.
时间窗: Approximately 30 weeks
次要结局
- Efficacy: Absolute change from baseline to Week 20 in the UAS7 aggregate score.(21 weeks)
- Efficacy: Absolute change from baseline to Week 4 in the weekly itch score.(5 weeks)
研究者
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