None listed
Conditions
Interventions
Lebrikizumab 125mg/mL inyectable, the drug will be administered by SC injection every 4 weeks. For pacients are ≥
40 years.
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: 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 baseline. • 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.
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, 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
Countries
Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Israel, Italy, Japan, Mexico, Peru, Poland, Singapore, Spain, United Kindgdom, United States
Contacts
Public ContactRoberto Carrasco
ROCHE FARMA (PERU) S.A.
Outcome results
None listed