EUCTR2019-004647-74-DK进行中（未招募）1 期
Randomized, double blind, placebo controlled study to evaluate the effectof dupilumab on airway inflammation through assessments of lungfunction, mucus plugging and other lung imaging parameters in patientswith asthma - VESTIGE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 298
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
- •-18 to 70 years of age inclusive with the diagnosis of asthma based on Global Strategy for Asthma Management and Prevention (GINA) 2019 at the time of signing the informed consent
- •-History of =1 exacerbation (s) in the previous year
- •-Uncontrolled moderate to severe asthma (ACQ-5 =1.5) at V1 and V2, prior to randomization
- •-Pre-bronchodilator FEV1 =80% of predicted normal at V1 and V2, prior to randomization
- •-Exhibit bronchodilator reversibility (=12% and 200 mL improvement in FEV1 post SABA administration) during screening, prior to randomization
- •-Blood eosinophil =300 cells /µL and FeNO =25 ppb during screening, prior to randomization
- •-- Historical values of blood eosinophil count meeting the eligibility criterion measured
- •within 6 months prior to SV1 in the absence of OCS treatment are allowed.
- •-- FeNO value to be checked for eligibility at V2 as well.
- •-Existing treatment with medium to high dose ICS in combination with a second controller (e.g. LABA, LTRA) ± a third controller. The dose regimen should be stable =1 month prior V1 and during screening.
- •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 298
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Current smoker (cigarette or e-cigarette) or cessation of smoking
- •within 1 year prior randomization
- •-Previous smoker with a smoking history >10 pack-years
- •-Known hypersensitivity to dupilumab or any of its excipients
- •-A subject who experiences an asthma exacerbation (defined as a
- •deterioration of asthma that results in emergency treatment,
- •hospitalization due to asthma, or treatment with systemic steroids)
- •during screening
- •-Current acute bronchospasm or status asthmaticus
- •-Diagnosed pulmonary (other than asthma) or systemic disease
- •associated with elevated peripheral eosinophil counts
- •-History or clinical evidence of chronic obstructive pulmonary disease
- •(COPD) including Asthma-COPD Overlap Syndrome (ACOS) or any other
- •significant lung disease (eg, lung fibrosis, sarcoidosis, interstitial lung
- •disease, pulmonary hypertension, bronchiectasis, Churg-Strauss
- •Syndrome, etc)
- •-Active tuberculosis, latent untreated tuberculosis or a history of
- •incompletely treated tuberculosis or non-tuberculous mycobacterial
- •infection unless it is well documented by a specialist that the participant
- •has been adequately treated and the treatment with a biologic agent can
- •be initiated, in the medical judgment of the Investigator and/or
- •infectious disease specialist. Tuberculosis testing would only be
- •performed on a country by country basis according to the routine clinical
- •practice and the local guidelines, if required by regulatory authorities or
- •ethics committees
- •-History of or current evidence of clinically significant disease in any
- •non-respiratory system (e.g. cardiovascular, nervous system,
- •gastrointestinal, endocrinological, rheumatological, dermatological),
- •which, in the judgment of the Investigator, could interfere with the
- •study or require treatment that might interfere with the study
- •-Current evidence of clinically significant oncological disease, which in
- •the opinion of the investigator may interfere with the objectives of the
- •study or put the subject at undue risk
- •-Participants with any of the following results at Visit (V) 1:
- •-Positive (or indeterminate) hepatitis B surface antigen (HBs Ag) or
- •-Positive Hepatitis B IgM core antibody (IgM HBc Ab) or
- •-Positive total hepatitis B core antibody (total HBc Ab) confirmed by
- •positive HBV DNA or
- •-Positive hepatitis C antibody (HCV Ab) confirmed by positive HCV RNA
- •-History of human immunodeficiency virus (HIV) infection or positive
- •HIV serology at V 1
- •-Any biologic therapy (including experimental treatments and
- •dupilumab) or any other biologic therapy/immunosuppressant within 3
- •months prior to V1
- •-Treatment with live (attenuated) vaccine within 4 weeks before V1
- •For participants who have vaccination with live, attenuated vaccines
- •planned during the course of the study (based on national vaccination
- •schedule/local guidelines), it will be
- •determined, after consultation with a physician, whether the
- •administration of vaccine can be postponed until after the end of the
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研究者
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