Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Have a diagnosis of IPF within the previous 5 years from time of screening and confirmed at baseline
FVC \>/=40 percent (%) and \</=100% of predicted at screening
Stable baseline lung function as evidenced by a difference of less than (\<) 10% in FVC (in liters) measurements between screening and Day 1, Visit 2 prior to randomization
DLco \>/=25% and \</=90% of predicted at screening
Ability to walk \>/=100 meters unassisted in 6 minutes
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 milligrams once daily (mg/day) for \>/=4 weeks required prior to randomization and throughout the placebo-controlled study period
You may not be if
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
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 milliliters 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
Listeria monocytogenes infection or active parasitic infection 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 human immunodeficiency virus infection
Past use of any anti-interleukin (IL)-13 or anti-IL-4/IL-13 therapy, including lebrikizumab
Evidence of acute or chronic hepatitis or known liver cirrhosis
Exclusions Criteria Limited to 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 period
Known or suspected peptic ulcer
Any condition that, as assessed by the investigator, might be significantly exacerbated by the known side effects associated with pirfenidone
Creatinine clearance \<40 milliliters/minute, calculated using the Cockcroft-Gault formula
Use of following therapies within 4 weeks of randomization (Day 1, Visit 2) or during the study: Strong inhibitors of CYP1A2 (Cytochrome P450 Family 1 Subfamily A Member 2) (example: fluvoxamine or enoxacin); Moderate inducers of CYP1A2 (limited to tobacco smoking and tobacco-related products)
Clareo Health | A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
