Status:
COMPLETED
A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 13 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2017
Estimated Enrollment :
505 Patients enrolled
Trial Details
Trial ID
NCT01872689
Start Date
October 13 2013
End Date
November 6 2017
Last Update
August 24 2018
Active Locations (112)
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1
University Alabama At Birmingham
Birmingham, Alabama, United States, 35294
2
Mayo Clinic- Scottsdale
Scottsdale, Arizona, United States, 85259
3
Southern Arizona Veterans Administration Healthcare Systems
Tucson, Arizona, United States, 85723
4
University of Arizona
Tucson, Arizona, United States, 85724-5030