2022-501344-14-00招募中3 期
A Multicentre, Randomised, Double-blind, Parallel Group, Placebocontrolled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients with Severe Eosinophilic Asthma (DOMINICA)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 29
- 主要终点
- Time to first asthma exacerbation defined as a worsening of asthma requiring: • Use of systemic corticosteroid (or a temporary increase) for at least 3 days; a single depo-injectable dose, OR • An emergency room visit due to asthma OR • Hospitalisation due to asthma
研究概览
简要总结
To evaluate the effect of benralizumab on asthma exacerbations in paediatric and adolescent patients with uncontrolled asthma.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Open-label extension period
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Capable of giving assent (signing the assent form) to participate in the study, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. The caregiver of the patient must be capable of giving written informed consent for the patient’s participation in the study. Consent and assent forms must be completed prior to any study specific procedures.
- •At least 70% daily PASO or Asthma Daily Diary completion during the entire screening period, with at least 50% PASO or Asthma Daily Diary completion in the 14-day period prior to randomisation.
- •Pre-BD FEV1 ≤ 95% of the predicted normal value or pre-BD FEV1/FVC ratio < 0.85 required at Visit
- •Patients with ≥ 25 % increase in pre-BD FEV1 value during the screening period will be screen failed.
- •ACQ-IA ≥ 1.5 with no meaningful improvement (ACQ-IA change ≤ -0.5) between screening and Visit 2a.
- •Body weight ≥ 15 kg.
- •Females of childbearing potential (FOCBP) who are sexually active, as judged by the investigator, must commit to consistent and correct use of a highly effective method of contraception (confirmed by the investigator) for the duration of the study and for 12 weeks after the last dose of IP. Highly effective methods defined in protocol
- •Patient and the caregiver (where applicable) must be willing to and be able to answer questionnaires that are part of the study procedures, as listed in the ICF, the assent form, and the CSP.
- •Male or female patients aged ≥ 6 to < 18 years old at the time of signing the assent form and their caregivers signing the informed consent form.
- •Patients with physician-diagnosed severe eosinophilic asthma for at least 12 months prior to Visit
- •See inclusion criteria 6, 7, 8, and 12 for further details.
- •Patients with a diagnosis of severe asthma confirmed, evaluated, and managed by the clinical site/site network for ≥ 6 months prior to Visit
- •Patients with an exacerbation history as defined in protocol.
- •Patients on well-documented, stable treatment for asthma with high dose ICS as specified in GINA guideline/local guidelines/label requirements and at least one additional controller medication, such as LABA, LTRA, LAMA, or theophylline, since at least 6 months prior to Visit 1
- •Eosinophilic airway inflammation that is related to asthma characterised as eosinophilic in nature as indicated by peripheral blood eosinophil count of ≥ 300 cells/μL during screening OR a blood eosinophil count of 150 to 299 cells/μL and documentation of elevated eosinophils in BAL, sputum, or bronchial biopsy within the 2 years prior to Visit
- •≥ 70% compliance with maintenance asthma medication during the screening period based on the PASO or Asthma Daily Diary.
排除标准
- •Clinically important pulmonary disease other than asthma as defined in protocol.
- •A helminth parasitic infection as defined in protocol.
- •A history of known immunodeficiency including HIV infection.
- •Active liver disease.
- •Current use of any oral or ophthalmic non-selective β adrenergic antagonist (eg, propranolol).
- •Use of immunosuppressive as defined in protocol. Chronic maintenance corticosteroid for the treatment of asthma is allowed.
- •Receipt of immunoglobulin or blood products as defined in protocol.
- •Receipt of any marketed or investigational biologic as defined in protocol.
- •Previously received benralizumab (MEDI-563).
- •Receipt of live attenuated vaccines as defined in protocol.
- •Change to allergen immunotherapy or new allergen immunotherapy as defined in protocol.
- •Life-threatening asthma, as defined in protocol.
- •Participation in another interventional clinical study with an IP administered as defined in protocol.
- •Patients with known hypersensitivity to benralizumab or any of the excipients of the product.
- •Any clinically significant abnormal findings in physical examination, vital signs, ECG, haematology, or clinical chemistry during the screening period, which in the opinion of the investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient’s ability to complete the entire duration of the study.
- •Currently pregnant, breastfeeding, or lactating females as defined in protocol.
- •Involvement of the caregiver of the patient in the planning and/or conduct of the study.
- •Judgment by the investigator that the patient should not participate in the study if he/she is unlikely to comply with study procedures, restrictions, and requirements.
- •Previous randomisation in the present study.
- •Asthma exacerbation requiring use of systemic corticosteroids or increase in maintenance dose of OCS or acute upper/lower respiratory infection that requires antibiotics or antiviral medication as defined in protocol.
- •Any disorder as defined in protocol or major physical impairment that is not stable in the opinion of the investigator and could: Affect the safety of the patient during the study/ Influence the study findings/ Impede the patient’s ability to complete the entire duration of the study.
- •Current smokers or as defined in protocol.
- •Alcohol or drug abuse / any conditions associated with poor compliance.
- •Patients who are scheduled to be admitted to hospital / undergoing inpatient surgery during the study.
- •History of anaphylaxis to any biologic therapy.
- •Current malignancy, or history of malignancy.
结局指标
主要结局
Time to first asthma exacerbation defined as a worsening of asthma requiring: • Use of systemic corticosteroid (or a temporary increase) for at least 3 days; a single depo-injectable dose, OR • An emergency room visit due to asthma OR • Hospitalisation due to asthma
Time to first asthma exacerbation defined as a worsening of asthma requiring: • Use of systemic corticosteroid (or a temporary increase) for at least 3 days; a single depo-injectable dose, OR • An emergency room visit due to asthma OR • Hospitalisation due to asthma
次要结局
- Change from baseline, during the DB treatment period, in the following measures: ACQ-IA, Asthma symptom score, Rescue medication use, Night-time awakenings due to asthma, PEF
- • Serum benralizumab trough concentration • Anti-benralizumab antibodies
- Change from baseline, during the DB treatment period, in PAQLQ-IA total score
- Change from baseline, during the DB treatment period, in spirometry, including pre-dose/pre-bronchodilator FEV1 and post-bronchodilator FEV1
- The AAER in the DB treatment period
- Safety: AEs/SAEs : Occurrence/frequency ; Relationship to the IP as assessed by the investigator ; Intensity ; Seriousness ; Death ; AEs leading to discontinuation of IP ; Vital signs ; Clinical laboratory parameters
- the Open-Label Extension;Period: AEs and SAEs
- the Open-Label Extension: The AAER in the OLE period
研究者
AstraZeneca Clinical Study Information Center
Scientific
Astrazeneca AB
研究点 (29)
Loading locations...
相似试验
已完成
3 期
A Study of the Safety and Effectiveness of Benralizumab to Treat Patients With Severe Uncontrolled Asthma.AsthmaNCT03170271AstraZeneca660
招募中
3 期
A study to learn if rozanolixizumab is safe, how it moves through the body, and if it works in children with myasthenia gravisGeneralized Myasthenia Gravis2022-502074-16-00UCB Biopharma7
终止
3 期
Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled AsthmaAsthmaNCT01947946AstraZeneca13
已完成
3 期
Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled AsthmaAsthmaNCT01928771AstraZeneca2,681
招募中
2 期
A multicentre trial evaluating the combination of a MEK inhibitor and a
PDL1 inhibitor in pediatric and adult patients with locally advanced and/or
metastatic soft tissue sarcoma2024-510712-75-00Centre Leon Berard80