EUCTR2014-002666-76-GB进行中（未招募）1 期
An open-label study to characterize the pharmacokinetics and pharmacodynamics of mepolizumab administered subcutaneously in children from 6 to 11 years of age with severe eosinophilic asthma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 28
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
- •Inclusion Criteria for Part A
- •1. Between 6 and 11 years of age inclusive, at the time of screening.
- •2. Diagnosis of severe asthma, defined by the regional asthma guidelines (i.e., NIH, GINA, etc.), for at least 12 months prior to Visit 1. If the subject is naïve to the study site, the subject/guardian must self-report a physician diagnosis of asthma and the investigator must confirm by review of medical history with the subject/guardian.
- •3. Eosinophilic airway inflammation that is related to asthma characterized as eosinophilic in nature as indicated by:
- •- elevated peripheral blood eosinophil count of =300 cells/µL demonstrated in the past 12 months OR
- •- elevated peripheral blood eosinophil count of =150 cells/µL at visit 1.
- •4. A well-documented requirement for regular treatment with inhaled corticosteroid (=400 µg/day fluticasone propionate (DPI) or equivalent daily) in the 12 months prior to Visit 1 with or without maintenance oral corticosteroids (OCS).
- •5. Current treatment with an additional controller medication for at least 3 months or a documented failure in the past 12 months of an additional controller medication for at least 3 successive months. [e.g., long-acting beta-2-agonist (LABA), leukotriene receptor antagonist (LTRA), or theophylline.]
- •6. FEV1: Persistent airflow obstruction at either visit 1 or Visit 2 (FEV1 performed prior to first dose of study medication) as indicated by:
- •- A pre-bronchodilator FEV1 <110% predicted OR
- •- FEV1:FVC ratio < 0.8 recorded at visit 1
- •7. Previously confirmed history of two or more exacerbations requiring treatment with systemic CS (intramuscular (IM), intravenous, or oral), in the 12 months prior to visit 1, despite the use of high-dose inhaled corticosteroids (ICS). For subjects receiving maintenance CS, the CS treatment for the exacerbations must have been a two-fold increase or greater in the dose.
- •No changes in the dose or regimen of baseline ICS and/or additional controller medication during the run-in period.
- •8. Male or female: Females of childbearing potential must commit to consistent and correct use of an acceptable method of contraception (see Appendix 6) for the duration of the trial and for 4 months after the last dose of investigational product. A urine pregnancy test is required of girls of childbearing potential. This test will be performed at the initial screening visit (Visit 1) and will be performed at each scheduled study visit prior to the administration of investigational product, and during the Early Withdrawal and Follow-up Visits.
- •9. Parent(s)/guardian able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. If applicable, the subject must be able and willing to give assent to take part in the study according to the local requirement.
- •Eligibility Criteria for Part B
- •-The subject has completed all study assessments up-to and including Visit 8 and
- •received all 3 doses of IP in Part A
- •-The PI has performed a benefit/risk assessment and this assessment supports
- •continued therapy with mepolizumab.
- •-The subject’s parents (or guardian) have given consent and the subject has given
- •assent for continued treatment
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 28
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
排除标准
- •Exclusion Criteria for Part A
- •1. Subjects with any history of life threatening asthma (e.g. requiring intubation), immunosuppressive medications intake or immunodeficiency disorder
- •2. Subjects with any medical condition or circumstance making the volunteer unsuitable for participation in the study.
- •3. Significant abnormality of rate, interval, conduction or rhythm in the 12-lead ECG, determined by the investigator in conjunction with the age and gender of the child at Visit 1.
- •4. ALT, and bilirubin > 2xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) at Visit 1.
- •5. Parent/guardian has a history of psychiatric disease, intellectual deficiency, substance abuse, or other condition (e.g. inability to read, comprehend and write) which will limit the validity of consent to participate in this study.
- •6. Unwillingness or inability of the subject or parent/guardian to follow the procedures outlined in the protocol.
- •7. Subject who is mentally or legally incapacitated.
- •8. Children who are wards of the state or government.
- •9. A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
- •10. Xolair: Subjects who have received omalizumab [Xolair] within 130 days of Visit 1.
- •11. Other Biologics: Subjects who have received any biological (other than Xolair) to treat inflammatory disease within 5 half-lives of visit 1.
- •12. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
- •13. Hypersensitivity: Subjects with allergy/intolerance to a monoclonal antibody or biologic.
- •14. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
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