Predictive Signature of Benralizumab Response
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 20
- 主要终点
- Predictive value of early blood gene expression signature of Benralizumab
研究概览
简要总结
The objective of the study is to establish the predictive value of early blood gene expression signature of Benralizumab response associated with a significant reduction of the number of exacerbations in treated severe asthmatic patients.
This trial is a French, multicenter and no-randomized trial. Patients enrolled will be clinically followed for 16 months (the treatment period: 12 months and 1 month follow-up; 6 clinical visit on site and in phone call at 13 months)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Patients between 18 and 75 years old.
- •Patients diagnosed with severe asthma (Chung and al, Eur Respir J 2014), i.e.:
- •asthma requiring high doses of ICS (>1000 microgram per day of Beclomethasone or equivalent) associated with LABA and/or systemic corticosteroids to be controlled over one year,
- •and/or uncontrolled asthma despite the later medications,
- •and/or a controlled asthma worsening after decreasing medications,
- •Documented historical reversibility of FEV1 ≥12% and FEV1 gain ≥ 200 milliliter
- •ACQ-7 score ≥ 1,5 at M
- •≥ 3 exacerbations in the 12 months prior to screening visit M-
- •Eosinophil blood count ≥ 0,3 G/L at inclusion visit or in the 12 months prior to the inclusion visit. If eosinophil blood count is ≥ 0,15 G/L and < 0,3 G/L, an eosinophilic phenotype defined by at least 1 of the following criteria will be required:
- •Fractional Exhaled Nitric Oxide (FeNO) > 25 ppm at inclusion visit or in the 12 months prior to the inclusion visit.
- •Sputum eosinophils ≥ 3% at inclusion visit or in the 12 months prior to the inclusion visit.
- •Patients who provide written informed consent prior to participation in the study
排除标准
- •Patients diagnosed with difficult-to-treat asthma and/or with uncontrolled asthma differential diagnosis according to the judgment of the investigator (e.g., vocal cord dysfunction, gastroesophageal reflux disease, granulomatous eosinophilic vasculitis, obstructive sleep apnea syndrome, hyperventilation syndrome, allergic broncho-pulmonary aspergillosis, Carrington disease, DIPNECH, asthma/COPD overlap syndrome).
- •Non-adherent patients to inhaled treatment (ICS + LABA).
- •Active smokers or former smokers exceeding 20 packs year.
- •Exacerbation at inclusion visit M
- •Active malignancy or malignancy in remission over less than 5 years.
- •Active parasitic infection or parasitic infection in the past 24 weeks.
- •Hypersensitivity to Benralizumab or to any of the excipients of Fasenra® (histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 20)
- •Patients requiring other immunosuppressive and immunomodulator drugs
- •Patients requiring other biotherapy than Benralizumab, with or without French's marketing authorisation in severe asthma
- •Patients requiring other biotherapy than Benralizumab that affects the immune system
- •SARS-COV2 infection
- •Pregnancy, lactation, or patients with childbearing potential refusing efficient contraceptive method.
- •Patients under psychiatric condition altering their comprehension and their ability to give informed consent.
- •Patients already enrolled in a clinical interventional research.
- •Patients not affiliated to a health insurance plan
- •Patients under guardianship, curators or safeguard of justice
研究组 & 干预措施
BENRALIZUMAB
Patients receive BENRALIZUMAB if they meet the criteria for inclusion and non-inclusion at the inclusion visit. Injections take place at the inclusion visit, at 1 month, 2 months, 4 months, 6 months, 8 months, 10 months and 12 months.
干预措施: Benralizumab Prefilled Syringe (Drug)
结局指标
主要结局
Predictive value of early blood gene expression signature of Benralizumab
时间窗: 12 months
To establish the predictive value of early blood gene expression signature of Benralizumab response associated with a significant reduction of the number of exacerbations in treated severe asthmatic patients. We will evaluate an early blood gene expression signature of Benralizumab response through a clinically relevant reduction of the number of exacerbations at month 12 (M12).
次要结局
- Molecular signature predictive of stabilization(12 months)
- The stability of the signature over time(0 month, 3 months, 6 months and 9 months)
- The association of gene expression patterns(12 months)
- Association of gene expression patterns and clinical characteristics(0 months)
- Stratification value of gene expression in severe asthma(12 months)
- Scenario-based cost-utility analysis(12 months)