EUCTR2016-001717-24-Outside-EU/EEA进行中（未招募）1 期
Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Potential Effect of Benralizumab on the Humoral Immune Response to the Seasonal Influenza Vaccination in Adolescent and Young Adult Patients with Severe Asthma (ALIZE) - ALIZE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent/assent as appropriate with local guidance for study
- •2. Female and male patients aged 12 to 21 years, inclusively
- •3. Documented history of current treatment with ICS and LABA. The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 µg/day fluticasone propionate dry powder formulation or equivalent daily
- •4. Women of childbearing potential (WOCBP) must use an effective form of birth
- •control (confirmed by the Investigator)
- •5. All male patients who are sexually active must agree to use a double barrier method of
- •contraception (condom with spermicide) from the first dose of IP until 16 weeks after
- •their last dose
- •6. Weight of =40 kg
- •7. Evidence of asthma as documented by either:
- •– Airway reversibility (FEV1 =12% and 200 ml) demonstrated at Visit 1 or Visit 2
- •using the Maximum Post-bronchodilator Procedure OR
- •– Airway reversibility documented in the previous 12 months prior to Visit 1
- •8. Morning pre-bronchodilator forced expiratory volume in 1 second (FEV1) of >50%
- •predicted at Visit 1 or Visit 2
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Clinically important pulmonary disease other than asthma (eg, active lung infection,
- •bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome)
- •2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
- •?- Affect the safety of the patient throughout the study
- •?- Influence the findings of the studies or their interpretations
- •?- Impede the patient’s ability to complete the entire duration of study
- •3. Any clinically significant abnormal findings in physical examination, vital signs, baseline ECG, hematology, clinical chemistry, or urinalysis during 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 entire duration of the study
- •4. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology, or a positive medical history for hepatitis B or C. Patients with a history of hepatitis B vaccination without history of hepatitis B are allowed to enroll
- •5. Current smokers
- •6. History of cancer
- •7. Use of immunosuppressive medication (including but not limited to: oral corticosteroid [for reasons other than asthma], methotrexate, troleandomycin, cyclosporine, azathioprine, tacrolimus, mycofenolate mofetil, intramuscular longacting depot corticosteroid [for reasons other than asthma], or any experimental anti-inflammatory therapy) within 3 months prior to the date informed consent/assent
- •8. Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent/assent is obtained
- •9. Receipt of any marketed (eg, omalizumab) or investigational biologic within 4 months or 5 half-lives prior to the date informed consent/assent is obtained, whichever is longer
- •10. Receipt of an influenza vaccine within 90 days prior to randomization
- •11. Previously received benralizumab (MEDI-563)
- •12. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level =2.5 times the upper limit of normal (ULN) confirmed during screening period
- •13. Life threatening asthma defined as episodes requiring intubation associated with
- •hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episodes
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