Lebrikizumab in Patients with IPF

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 or as combination therapy with pirfenidone background therapy in patients with idiopathic pulmonary fibrosis. Patients will be randomized to receive either lebrikizumab or placebo subcutaneously (SC) every 4 weeks.

  • Study Sponsor: Hoffmann-La Roche

  • Start Date: October 2013

    Estimated Primary Completion Date: May 2017

  • Phase 2 randomized, double blind, placebo controlled study to access the efficacy and safety of lebrikizumab in patients with Idiopathic Pulmonary Fibrosis

Inclusion Criteria:

  • Adult patinet, ≥ 40 years of age
  • Forced vital capacity (FVC) ≥ 40% and ≤ 100% 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 ≥ 25% and ≤ 90% 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 mg/QD 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 IPFPost 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 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 infections within 6 months prior to randomization
  • Active tuberculosis requiring treatment within 12 months of screening
  • Known immunodeficiency, including but not limited to HIV infection
  • Past use of any anti-IL-13 or anti-IL-14/IL-13 therapy, including lebrikizumab

Exclusions Limited to Combination Therapy Lebrikizumab:

  • Known achalasia, esophageal stricture, or esophageal dysfunction sufficient to limit the ability to swallow oral medication
  • Tobacco smoking 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 mL/min, calculated using the Cockcroft-Gault formula
  • Use or following therapies within 4 weeks of randomization (Day 1/Visit 2) or during the study
  • Strong inhibitors of CYP1A2 (eg, fluvoxamine or enoxacin)
  • Moderate inducers of CYP1A2 (eg, tobacco smoking)

Participating Clinics at Partner ILD Centers