NL-OMON40255已完成2 期
An exploratory, open-label, single centre, phase II, proof of concept study of gevokizumab treatment in patients with Schnitzler syndrome. - open label study with gevokizumab in patients with Schnitzler syndrome.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Male or female, aged >= 18 years
- •- Weight >= 45 kg and <= 125 kg
- •- For subjects with reproductive potential, a willingness to use highly effective contraceptive measures, and for female subjects a negative serum pregnancy test
- •- Probable or definite Schnitzler syndrome according to Strasbourg criteria.
排除标准
- •- Differential diagnoses other than Schnitzler syndrome,
- •- Any prior treatment with systemic alkylating agents within the previous 6 months prior to selection,
- •- Active TB disease,
- •- History of severe allergic or anaphylactic reactions to monoclonal antibodies,
- •- History of malignancy within 5 years prior to selection,
- •- Known immunodeficiency,
- •- Infectious disease,
- •- Any live (attenuated) vaccine within 3 months prior to selection,
- •- Pregnancy, breastfeeding or possibility to become pregnant during the study
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