Evaluation of the Efficacy of Kallikrein Inhibition by Lanadelumab for Patients With Bradykinin Angioedema: a Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Evaluation of the efficacy of the kallikrein inhibition by lanadelumab in patients with bradykinin-angioedema
研究概览
简要总结
A multicenter observational study aiming to evaluate the efficacy of kallikrein inhibition by lanadelumab in patients with bradykinin- angioedema
详细描述
The bradykinin-angioedema (AE-BK) is characterized by recurrent and unpredictable episodes of swelling; it can be disabling and disfiguring and the attacks affecting the larynx can be life-threatening.
The clinical symptoms depend on accumulation of bradykinin (BK), a vasoactive peptide responsible for vasodilation and increase of vascular leakage. BK formation depends on activation of the kallikrein-kinin cascade leading to uncontrolled generation of plasma kallikrein and subsequent proteolysis of high molecular-weight kininogen (HK).
Lanadelumab is a fully human monoclonal antibody inhibitor of plasma kallikrein, thereby preventing BK production; it represents an attractive therapeutic strategy for BK-AE prophylaxis.
The aim of this study is to evaluate the kallikrein inhibition by assessing the levels of cleaved HK and the immunogenicity of the lanadelumab.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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/female >18 years old
- •Patient with hereditary or acquired angioedema
- •Patient treated by lanadelumab
- •Patient whose the biological explorations have been carried out or will be carried out at Laboratory of Immunology of CHUGA
- •Informed consent is obtained from the participant
排除标准
- •Absence of biological material at T0 and M3 (stored for routine analysis)
- •Person under guardianship or curatorship
- •Female who is pregnant, nursing
结局指标
主要结局
Evaluation of the efficacy of the kallikrein inhibition by lanadelumab in patients with bradykinin-angioedema
时间窗: 3 months
Levels of cleaved HK measured by Western Blot
次要结局
- Evaluation of the efficacy of kallikrein inhibition by lanadelumab in patients with bradykinin-angioedema between T0 and the others visits(Day 7; 6, 12 and if possible 24 months)
- Immunogenicity of lanadelumab(Months 3, 6, 12 (and 24 if possible))
- Evaluation of therapeutic escape(Months 3, 6, 12 and if possible 24)