EUCTR2015-001122-42-PL进行中（未招募）1 期
A Phase II, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lebrikizumab in patients with chronic obstructive pulmonary disease and a history of exacerbations
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •- Age 40-80 years old at Visit 1
- •- Able and willing to use the electronic device for patient-reported data collection
- •- Documented history of COPD diagnosis for >=12 months prior to Visit 1
- •- Post-bronchodilator FEV1/forced vital capacity (FVC) <0.70 at Visit 1 or Visit 2
- •- Post-bronchodilator FEV1 <80% predicted at Visit 1 or Visit 2
- •- The modified Medical Research Council (mMRC) score >=1 at Visit 1 or Visit 2
- •- Documented history of one or more acute COPD exacerbations that required treatment with systemic corticosteroids and/or antibiotics or hospitalization within 12 months prior to Visit 1
- •- Current tobacco smoker or former smoker (having stopped smoking for at least 6 months prior visit 1) with a history of smoking >=10 packyears (20 cigarettes/day for 10 years)
- •- On inhaled corticosteroids therapy for >=6 months prior to Visit 1
- •- On an eligible bronchodilator medication for >=6 months prior to Visit 1
- •- Chest X-ray or computed tomography scan within 3 months prior to Visit 1 or chest X-ray during the screening period (prior to Visit 2) that confirms the absence of clinically significant lung disease besides COPD
- •- Demonstrated adherence with background COPD inhaler medication during the screening period.
- •- For women who are not postmenopausal (>= 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year for the duration of the study
- •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 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
- •- History of clinically significant pulmonary disease other than COPD
- •- Diagnosis of alpha-1-antitrypsin deficiency
- •- Lung volume reduction surgery or procedure within 12 months prior to Visit 1
- •- Supplemental oxygen requirement >2 Liter/minute at rest or with exertion
- •- Current diagnosis of asthma
- •- Patients participating in, or scheduled for, an intensive COPD rehabilitation program
- •- Maintenance oral corticosteroid therapy, defined as daily or alternate-day oral corticosteroid maintenance therapy, within 3 months prior to Visit 1
- •- Treatment with systemic corticosteroids within 4 weeks prior to Visit 1 or during the screening period for any reason, including an acute exacerbation event
- •- Unstable ischemic heart disease, arrhythmia, cardiomyopathy, or other relevant cardiovascular disorder that, in the opinion of the investigator, may put the patient at risk or negatively affect the study outcome
- •- Any infection that resulted in hospital admission for >=24 hours and/or treatment with oral, intravenous (IV), or intramuscular (IM)
- •antibiotics within 4 weeks prior to Visit 1 or during screening
- •- Active tuberculosis requiring treatment within 12 months prior to Visit 1. Patients who have completed treatment for tuberculosis at least 12 months prior to Visit 1 and have no evidence of recurrent disease are permitted.
- •- Known immunodeficiency, including, but not limited to, HIV infection
- •- Evidence of acute or chronic hepatitis or known liver cirrhosis
- •- Aspartate transaminase, Alanine transaminase, or total bilirubin elevation >=2.0 × the upper limit of normal (ULN) during screening
- •- Clinically significant abnormality on screening electrocardiogram or laboratory tests (hematology, serum chemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the patient
- •- Known current malignancy or current evaluation for a potential malignancy
- •- Other clinically significant medical disease that is uncontrolled despite treatment, that is likely, in the opinion of the investigator, to impact the patient's ability to participate in the study or impact the study efficacy or safety assessments
- •- History of alcohol or drug abuse that would impair or risk the patient’s full participation in the study, in the opinion of the investigator
- •- Past and/or current use of any anti–interleukin 13 (IL-13) or anti–IL-4/IL-13 therapy, including lebrikizumab.
- •- Treatment with an immunomodulatory or immunosuppressive monoclonal antibody within 6 months or 5 drug half-lives prior to Visit 1 or during screening
- •- Use of an immunomodulatory or immunosuppressive therapy within 3 months or 5 drug half-lives prior to Visit 1 or during screening
- •- Use of other investigational therapy not described above within 4 weeks or 5 drug half-lives prior to Visit 1 or during screening
- •- Receipt of a live attenuated vaccine within 4 weeks prior to Visit 1 or during screening
- •- Pregnant or lactating
- •- Body mass index >38 kilogram/meter square
- •- Body weight <40 kilogram
研究者
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