Phase 2 Multicentric Study Evaluating the Efficacy of Omalizumab in Idiopathic Severe and Refractory Solar Urticaria
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 13
- 主要终点
- Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting)
研究概览
简要总结
Solar urticaria is a rare disease, with a usual favourable outcome with photoprotection and with anti H1 histamines. Nevertheless, some cases can be severe and refractory to this usual treatment, leading to a large impact on quality of life. New treatment options are warranted. The investigators aim to test the efficacy and the safety of omalizumab, an anti-IgE antibody recently approved in chronic spontaneous urticaria, in this setting.
详细描述
This is an open-labelled multicentric phase II study testing the efficacy and the safety of omalizumab 300 mg (W0, W4 and W8) in patients affected with severe and refractory solar urticaria.
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
- •Age > or equal to 18 years,
- •Appearance of wheals within 15 min after sun exposure and lasting < 2 hr in the shade,
- •Wheals reproducible with phototesting: appearance after exposure to UVB, UVA or visible light less than 30 min after exposure and lasting < 2 hr,
- •Severity criteria:
- •Very large effect on quality of life, with Dermatology Life Quality Index (DLQI) > 10, and
- •At least 1 of the following: involvement of the face, per annual eruption, extension of wheals on the non-photoexposed skin, SU triggered by artificial light, SU flares accompanied by bronchospasm or syncope.
- •Refractory criteria:
- •Resistance to photoprotection with sunscreen with sun protection factor ≥ 50, and
- •Resistance to administration of an association of 2 different antihistamines during 3 months or to photodesensitization.
排除标准
- •Contra indication to omalizumab
- •Previous treatment with omalizumab
研究组 & 干预措施
Omalizumab
Omalizumab 300 mg W0, W4 and W8
干预措施: Omalizumab (Drug)
结局指标
主要结局
Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting)
时间窗: 4 weeks after the end of treatment
Proportion of patients with minimal urticarial dose (MUD) increased compared to baseline, under experimental conditions (assessed by phototesting). A small area of skin is exposed to increasing UVA doses with a solar simulator until an allergic reaction appears. The lower UVA dose triggering the urticaria is the MUD.
次要结局
- Proportion of Patients for Whom the Treatment Allowed Achieving Dermatology Life Quality Index< 6(4 and 12 weeks after the end of treatment)
- Proportion of Patients With Solar Urticaria Remission Under Experimental Conditions (Phototesting)(12 weeks after the end of treatment)
- Proportion of Patients Achieving 50% Improvement in Solar Urticaria Intensity(4 and 12 weeks after the end of treatment)
- Proportion of Patients Achieving Clinical Remission of Solar Urticaria(4 and 12 weeks after the end of treatment)