A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Completed · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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.

Key facts

Study ID

NCT01872689

Run by

Hoffmann-La Roche

People needed

505

Starts

2013-10-13

Expected to finish

2017-11-06

Last updated by the study team

2018-08-24

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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)

Where it is running

• Mayo Clinic- Scottsdale — Scottsdale, Arizona, United States
• Southern Arizona Veterans Administration Healthcare Systems — Tucson, Arizona, United States
• University of Arizona — Tucson, Arizona, United States
• UCSD Medical Center — La Jolla, California, United States
• University of California, San Francisco — San Francisco, California, United States
• National Jewish Health — Denver, Colorado, United States
• Rocky Mountain Center For Clinical Research — Wheat Ridge, Colorado, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Research Alliance Inc — Clearwater, Florida, United States
• Mayo Clinic-Jacksonville — Jacksonville, Florida, United States
• University Miami — Miami, Florida, United States
• Central Florida Pulmonary Group, PA — Orlando, Florida, United States
• USF Tampa General Hospital — Tampa, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Piedmont Healthcare Pulmonary and Critical Care Research — Austell, Georgia, United States
• Southeastern Lung Care — Decatur, Georgia, United States
• University of Chicago; Pulmonary and Critical Care — Chicago, Illinois, United States
• Loyola University Med Center — Maywood, Illinois, United States
• Univ of Iowa Hosp & Clinics; Pulmonary — Iowa City, Iowa, United States
• Uni of Kansas Medical Center — Kansas City, Kansas, United States
• Via Christi Hospital Inc. DBA Via Christi Research; Research Dept. — Wichita, Kansas, United States
• Maine Medical Center -Division of Pulmomary and Critical Care Medicine — Portland, Maine, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Johns Hopkins Bayview Medical Center - Johns Hopkins Asthma & Allergy Center — Baltimore, Maryland, United States
• University Alabama At Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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