A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: Lebrikizumab; Pirfenidone; Placebo
Intervention description: Lebrikizumab will be administered at a dose of 250 mg via SC injection once every 4 weeks.; Pirfenidone will be administered orally at a stable dose of 2403 mg per day or at MTD.; Placebo matched to lebrikizumab will be administered via SC injection once every 4 weeks.
Intervention MeSH terms: Pirfenidone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 505.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will
      evaluate the efficacy and safety of lebrikizumab as monotherapy in the absence of background
      IPF therapy and as combination therapy with pirfenidone background therapy in participants
      with IPF. Participants will be randomized to receive either lebrikizumab or placebo
      subcutaneously every 4 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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)