A Phase 2b, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous MEDI-528 in Adults With Uncontrolled Asthma

ASTRAZENECA PERU S.A.,0 个研究点目标入组 39 人开始时间: 2010年1月26日最近更新: 2023年9月4日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方: ASTRAZENECA PERU S.A.,
入组人数: 39

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 65（—）
性别: All

入选标准

•Male or female
•Age 18 through 65 years at the time of screening
•Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
•Female subjects of childbearing potential who are sexually active with non-sterilized male partner must use adequate contraception from screening through the end of the study. An acceptable method of contraception is defined as one that has no higher than a 1% failure rate. Sustained abstinence is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception
•Non-sterilized males who are sexually active with a female of child-bearing potential must use adequate contraception from screening through the end of the study
•Females or female partners not of childbearing potential must have been surgically sterilized (eg, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or postmenopausal (defined as at least 1 year since last regular menses)
•Sterilized males must be at least 1-year post vasectomy and have obtained documentation of the absence of sperm in the ejaculate
•Weight = 45 kg but = 120 kg and body mass index (BMI) between 18 and 35 kg/m2
•Physician-diagnosed asthma by medical chart
•Currently taking inhaled corticosteroids (ICS) or is a candidate to receive ICS per Expert Panel Report (EPR)-3
•Pre-bronchodilator forced expiratory volume in 1 second (FEV1) value = 40% at Day -28 and Day 1
•A post-bronchodilator increase in FEV1 and/or FVC = 12% and = 200 mL at Day -28
•Uncontrolled asthma consistent with EPR-3. In the 28 days before screening, subjects should have a history of one or more of the following:- Daytime asthma symptoms = 2 days/week- Nighttime awakening = 1 night/week- Albuterol/salbutamol use = 2 days/week
•An Asthma Control Questionnaire (ACQ) score = 1.5 at Day -28 and at Day 1.
•At least one asthma exacerbation in the 12 months before screening that required intake of systemic corticosteroids after an unscheduled medical encounter or as agreed with a physician based on an asthma action plan that defines when oral steroids can be taken by the subject
•Ability and willingness to complete the follow-up period through Day 323 as required by the protocol.

排除标准

•Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
•Concurrent enrollment in another clinical study
•Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
•Known history of allergy or reaction to any component of the investigational product formulation
•History of anaphylaxis to other biologic therapy
•Lung disease other than asthma (eg, chronic obstructive pulmonary disease [COPD], cystic fibrosis)
•Severe depression as measured by a depression score > 15 on the Hospital Anxiety and Depression Scale (HADS) at either Day-28 or Day 1.
•History of suicidal behavior in the previous 3 years as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) at Day -28.
•Acute illness other than asthma at the screening and randomization visits
•History of an active infection within 28 days before and during the screening period, or evidence of clinically significant active infection, including ongoing chronic infection
•History of ingestion of untreated water in a location known to be infected with parasites, resulting in acute or chronic diarrhea; history of recent travel to areas where parasite infestations are endemic within 6 months before screening; or a diagnosis of parasitic infection within 6 months before screening
•Use of immunosuppressive medication (except oral prednisone up to a dose of 20 mg every other day or equivalent [eg, 10 mg a day or 5 mg twice a day] and inhaled andtopical corticosteroids) within 28 days before randomization
•Receipt of immunoglobulin or blood products within 28 days before randomization
•Plans to donate blood during the entire study period
•Donated blood or has had a blood transfusion within 28 days before screening
•Receipt of any non-biological study drugs or interventional therapy (including surgical procedures) within 28 days of the first dose of investigational product in this study
•Receipt of any biologicals including MEDI-528 within 5 half-lives before the first dose of investigational product in this study
•History of any known immunodeficiency disorder
•A positive hepatitis B surface antigen, or hepatitis C virus antibody, as determined by medical history and/or subject´s verbal report
•A positive human immunodeficiency virus test or is taking antiretroviral medications, as determined by medical history and/or subject´s verbal report
•A live attenuated vaccination received within 28 days before screening
•History of clinically significant abnormality on electrocardiogram (ECG) in the opinion of the investigator
•Breastfeeding or lactating

研究者

发起方

ASTRAZENECA PERU S.A.,

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