PER-083-13未知未知
A PHASE II, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED, STUDY TO ASSESS THEEFFICACY AND SAFETY OF LEBRIKIZUMAB INPATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS
适应症
试验速览
- 阶段
- 未知
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
- 40 至 85（—）
入选标准
- •Age ≥40 years at Visit 1
- •Have a definite IPF diagnosis according to the 2011 ATS/ERS/JRS/ALAT consensus
- •statement on IPF within the previous 4 years from time of screening and confirmed at
- •Have a central review assessment of a screening HRCT performed during the screening
- •period or within 6 months prior to the start of screening.
- •All patients who have undergone a SLB as part of their initial workup should have
- •pathology slides sent in for SLB central review assessment.
- •Additionally, patients must meet the following criteria for study entry:
- •FVC ≥40% and ≤90% of predicted at screening
- •Stable baseline lung function as evidenced by a difference of <10% in FVC (L)
- •measurements between screening and Day 1/Visit 2 prior to randomization
- •Diffusion capacity of the lung for carbon monoxide (DLCO) ≥25% and ≤90% of predicted
- •at screening
- •Ability to walk ≥100 meters unassisted in 6 minutes.
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
- •Evidence of other known causes of interstitial lung disease (ILD) (e.g., domestic and
- •occupational environmental exposures, connective tissue disease, and drug toxicity)
- •Lung transplant expected within 12 months of screening
- •Evidence of clinically significant lung disease other than IPF (e.g., asthma or chronic
- •obstructive pulmonary disease [COPD])
- •Post bronchodilator forced expiratory volume in 1 second (FEV1)/FVC ratio <0.7 at screening
- •Positive bronchodilator response evidenced by an increase of ≥12% predicted and 200 mL
- •increase in either FEV1 or FVC
- •Any clinically significant medical disease (other than IPF) that is associated with an expected
- •survival of <12 months, likely to require a change in therapy during the study, or likely to
- •impact the ability of the patient to participate in the study in the opinion of the investigator, or
- •impact the study efficacy or safety assessments
- •Requirement for continuous medical care and assistance, or limited ability to self care that
- •would impact the ability of patient to participate in the study or to perform the study-related
- •assessments
- •Class IV New York Heart Association chronic heart failure or historical evidence of left
- •ventricular ejection fraction <35%
- •Hospitalization due to an exacerbation of IPF within four weeks prior to, or during screening
- •Known current malignancy or current evaluation for a potential malignancy
研究者
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