A PHASE II, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED, STUDY TO ASSESS THEEFFICACY AND SAFETY OF LEBRIKIZUMABIN PATIENTS WITH IDIOPATHIC PULMONARYFIBROSIS

F. HOFFMANN-LA ROCHE LTD.,0 个研究点目标入组 7 人开始时间: 2015年11月20日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•Able and willing to provide written informed consent and to comply with the study protocol
•Age ≥ 40 years at Visit 1
•Have a diagnosis of IPF based on the ATS/ERS/JRS/ALAT consensus statement on IPF
•(Raghu et al. 2011) within the previous 5 years from time of screening and confirmed at
•Have a central review assessment of an HRCT performed during the screening period or
•within 12 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.
•A Multidisciplinary Discussion of Diagnosis (MDD) based on 2011 ATS/ERS/JRS/ALAT
•guidelines will be utilized to finalize the diagnosis in the event the initial central review
•outcome results for HRCT and SLB are disparate (inconsistent with UIP/definite UIP). Cohort A: No background IPF therapy for ≥ 4 weeks allowed prior to randomization and
•throughout the placebo-controlled study period
•Cohort B: Tolerated dose of pirfenidone ≤ 2403 mg/QD for ≥ 4 weeks required prior to
•randomization and throughout the placebo-controlled study perio

•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 (CTD), 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
•Positive bronchodilator response evidenced by an increase of ≥ 12% predicted and 200 mL
•increase in either FEV1 or FVC
•Hospitalization due to an exacerbation of IPF within 4 weeks prior to or during screening
•Known current malignancy or current evaluation for a potential malignancy

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