A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults with Uncontrolled, Severe Asthma

AstraZeneca AB0 个研究点目标入组 390 人开始时间: 2011年6月28日最近更新: 2013年10月28日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: AstraZeneca AB
入组人数: 390

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 clinical trial of medicinal product

入排标准

性别: All

入选标准

•1) Age 18-75 years of age at the time of screening (Visit 1).
•2) Written informed consent
•3) Body mass index (BMI) between 16-40 kg/m2 at Visit 1.
•4) Documented physician-diagnosed asthma for at least 12 months prior to Visit 1 and
•- Proof of postbronchodilator reversibility of FEV1 = 12% and = 200 mL to a
•SABA documented within 36 months prior to Visit 1; OR
•- Proof of a positive response (PC20 = 8 mg/mL) to a methacholine or histamine
•challenge documented within 36 months prior to Visit 1; OR
•- A postbronchodilator increase in FEV1 = 12% and = 200 mL at Visit 1.
•5) Subjects must have received an asthma controller regimen consistent with that
•described at Step 4 or 5 of the GINA guidelines (GINA, 2009) for at least 6 of the
•12 months prior to Visit 1 and must have used physician prescribed high-dose ICS in
•combination with LABA for at least 30 days prior to Visit 1
•6) For subjects receiving an alternative combination of ICS/LABA prior to Visit 1, a
•willingness to switch to fluticasone/salmeterol either as a DPI at a dose of 500/50 µg,
•one inhalation twice per day, or as an MDI at a dose of 230 µg/21 µg, 2 inhalations
•twice per day, once eligibility has been confirmed at Visit 2.
•7) Where applicable, the dose of other asthma controller medications (leukotriene
•modifiers, theophylline, OCS, or cromones) must have been stable for at least 30 days
•prior to Visit 1.
•8) Subjects must have a history of at least 2 but no more than 6 documented asthma
•exacerbation events within the 12 months prior to Visit 1.
•9) At both Visits 1 and 4, subjects must have at least one of the following; a morning
•prebronchodilator FEV1 value of between 40% and 80% predicted or an ACQ-6 score
•for the preceding week of = 1.5.
•10) A chest x-ray taken during the screening/run-in period or within the 12 months before
•Visit 1 that, according to the investigator, is normal for an asthmatic subject and
•excludes significant alternative respiratory disease.
•11) Females of childbearing potential who are sexually active with a nonsterilized male
•partner must use highly effective contraception from screening, and must agree to
•continue using such precautions through Week 75 of the study.
•- A highly effective method of contraception is defined as one that results in a
•low failure rate (ie, less than 1% per year) when used consistently and
•12) Nonsterilized males or sterilized males who are = 1 year post-vasectomy who are
•sexually active with a female partner of childbearing potential must use a highly
•effective method of contraception (see Table 4.2.1-1) from Day 1 through Week 75.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 350
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

排除标准

•1) Employee of the clinical study site or any other individuals directly involved with the
•conduct of the study, or immediate family members of such individuals.
•2) Pregnant or breastfeeding women.
•3) Individuals who are legally institutionalized.
•4) Subjects unable to demonstrate acceptable inhaler and peak flow meter/spirometry
•techniques as judged by the investigator.
•5) Any concomitant respiratory disease that in the opinion of the investigator and/or
•medical monitor will interfere with the evaluation of the investigational product.
•6) Concurrent enrollment in another clinical study where the subject is receiving an
•investigational product.
•7) Previous receipt of tralokinumab.
•8) Receipt of any marketed or investigational biologic agent within 4 months or
•5 half-lives prior to Visit 1, whichever is longer
•9) Receipt of any investigational nonbiologic agent within 3 months or 5 half-lives prior
•to Visit 1, whichever is longer
•10) Subjects who have received a live or live attenuated vaccine within 4 weeks prior to
•11) Use of systemic immunosuppressive medication within 3 months prior to Visit 1.
•12) Current use of any oral or ophthalmic ß-adrenergic antagonist.
•13) Occurrence of an asthma exacerbation event requiring a burst of systemic
•corticosteroids from 30 days prior to Visit 1, up to and including Visit 4.
•14) Known history of allergy or reaction to any component of the investigational product
•formulation or history of anaphylaxis following any biologic therapy.
•15) Known exposure to inhaled occupational agents or fumes with an established
•diagnosis of occupational asthma.
•16) Current tobacco smoking or a history of tobacco smoking = 10 pack-years.
•17) Previous medical history or evidence of an uncontrolled intercurrent illness that in the
•opinion of the investigator and/or medical monitor may compromise the safety of the
•subject in the study or interfere with evaluation of the investigational product or
•reduce the subject’s ability to participate in the study.
•18) Any clinically relevant abnormal findings in physical examination, electrocardiogram
•(ECG), vital signs, hematology, clinical chemistry, or urinalysis during screening/runin
•period, which in the opinion of the investigator or medical monitor may
•compromise the safety of the subject in the study or interfere with evaluation of the
•investigational product or reduce the subject’s ability to participate in the study.
•19) Evidence of active liver disease, including jaundice or aspartate transaminase, alanine
•transaminase, or alkaline phosphatase greater than twice the upper limit of normal.
•20) History of a clinically significant infection from 30 days prior to Visit 1, up to and including Visit 4.
•21) Subjects who in the opinion of the investigator have evidence of active TB, either
•treated or untreated, or latent TB without completion of an appropriate course of
•treatment or appropriate ongoing prophylactic treatment.
•22) A history of an untreated systemic helminth parasitic infestation; diagnosis of a
•helminth parasitic infestation within 6 months prior to Visit 1; history of living with a
•person known to have had a helminth parasitic infestation within 12 months prior to
•23) History of chronic alcohol or drug abuse within 12 months of Visit 1, or any condition
•associated with poor compliance as judged by the investigator.
•24) History of any known primary immunodeficiency disorder excluding asymptomatic

研究者

发起方

AstraZeneca AB

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