EUCTR2013-001163-24-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 IDIOPATHIC PULMONARY FIBROSIS.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 480
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
- •- Adult patient, >/= 40 years of age
- •- Have a definite IPF diagnosis according to the 2011 ATS/ARS/ERS/ALAT consensus statement on IPF within the previous 5 years from time of screening and confirmed at baseline
- •- Forced vital capacity (FVC) >/= 40% and - 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 >/= 25% and - Ability to walk >/= 100 meters unassisted in 6 minutes.
- •- Cohort A (monotherapy): No background IPF therapy for >=4 weeks
- •allowed prior to randomization and throughout the placebo controlled
- •study period
- •- Cohort B (combination therapy): Tolerated dose of pirfenidone
- •<=2403 milligrams/once daily (mg/QD) for >=4 weeks required prior to
- •randomization and throughout the placebo controlled study period
- •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 105
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 375
排除标准
- •- History of 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)
- •- Lung transplant expected within 12 months of screening
- •- Evidence of clinically significant lung disease other than IPF
- •- 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 FEV1 or FVC
- •- 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 4 weeks prior to or during screening
- •- Known current malignancy or current evaluation for potential malignancy
- •- An active upper or lower respiratory tract infection occurring at any
- •time within the screening period prior to the randomization visit
- •- Listeria monocytogenes infection or active parasitic infections within 6 months prior to Day 1, Visit 2
- •- Active tuberculosis requiring treatment within 12 months of screening
- •- Known immunodeficiency, including but not limited to HIV infection
- •- Past use of any anti-IL-13 or anti-IL-14/IL-13 therapy, including lebrikizumab
- •- Evidence of acute or chronic hepatitis or known liver cirrhosis.
- •Chronic treatment with pirfenidone within 4 weeks or five half lives
- •prior to screening (whichever is longer) to the end of the placebocontrolled
- •period (Day 365/Visit 16) (limited to Cohort A)
- •- For Cohort B: Known achalasia, esophageal stricture, or esophageal
- •dysfunction sufficient to limit the ability to swallow oral medication;
- •Tobacco smoking or use of tobacco-related products within 3 months of
- •screening or unwillingness to avoid smoking throughout the study; any
- •condition that, as assessed by the investigator, might be significantly
- •exacerbated by the known side effects associated with pirfenidone;
- •known or suspected peptic ulcer; use of strong CYP1A2 inhibitors (eg,
- •fluvoxamine or enoxacin) or moderate CYP1A2 inducers (limited to
- •tobacco smoking and tobacco related products) within 4 weeks of
- •randomization or during the study
研究者
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