Skip to main content
Eligibility
for people ages 40 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

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

Official Title

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis Pirfenidone Antibodies, Monoclonal

Eligibility

You can join if…

Open to people ages 40 years and up

  • Have a diagnosis of IPF within the previous 5 years from time of screening and confirmed at baseline
  • FVC>/=40 % and less than or equal to (

  • Stable baseline lung function as evidenced by a difference of less than (<) 10% in FVC (liters) measurements between screening and Day 1/Visit 2 prior to randomization
  • Diffusion capacity of the lung for carbon monoxide>/=25% and

  • 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

    /=4 weeks required prior to randomization and throughout the placebo-controlled study period

You CAN'T join 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 (ILD)
  • 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 (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 human immunodeficiency virus(HIV) infection
  • Past use of any anti-interleukin (IL)-13 or anti-IL-14/IL-13 therapy, including lebrikizumab
  • Evidence of acute or chronic hepatitis or known liver cirrhosis

Exclusions 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 mL/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)

Locations

  • UCSD Medical Center
    La Jolla, California, 92093, USA

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT01872689
Phase
Phase 2
Lead Scientist
Jeffrey Golden
Study Type
Interventional
Last Updated
March 2017