None listed
Conditions
Interventions
For Cohort B/combination therapy, patients may initiate screening on a stable dose of
pirfenidone or free of background IPF therapy. After completing the initial screening
assessments (28d ± 14d
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: • 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 baseline. • 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
Exclusion criteria
Exclusion criteria: 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 screening • 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
Countries
Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Israel, Italy, Japan, Mexico, Peru, Poland, Singapore, Spain, United Kindgdom, United States
Contacts
Public ContactPatricia Matos
ROCHE FARMA (PERU) S.A.
Outcome results
None listed