Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Over 40 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Monotherapy (Cohort A): Placebo
Participants will receive monotherapy with placebo matched to lebrikizumab administered via subcutaneous (SC) injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants will be allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
  • Drug: Lebrikizumab
    Lebrikizumab will be administered at a dose of 250 mg via SC injection once every 4 weeks.
    Other names:
    • RO5490255
  • Drug: Placebo
    Placebo matched to lebrikizumab will be administered via SC injection once every 4 weeks.
Experimental
Monotherapy (Cohort A): Lebrikizumab
Participants will receive monotherapy with lebrikizumab at a dose of 250 milligrams (mg) administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period. Participants will be allowed to receive treatment with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to additional 52 weeks (that is, up to Week 104) in the open-label period.
  • Drug: Lebrikizumab
    Lebrikizumab will be administered at a dose of 250 mg via SC injection once every 4 weeks.
    Other names:
    • RO5490255
Placebo Comparator
Combination Therapy (Cohort B): Placebo + Pirfenidone
Participants will receive pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at maximum tolerated dose (MTD) administered orally along with placebo matched to lebrikizumab administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
  • Drug: Pirfenidone
    Pirfenidone will be administered orally at a stable dose of 2403 mg per day or at MTD.
  • Drug: Placebo
    Placebo matched to lebrikizumab will be administered via SC injection once every 4 weeks.
Experimental
Combination Therapy (Cohort B): Lebrikizumab + Pirfenidone
Participants will receive pirfenidone at a stable dose of 2403 mg per day (three 267 mg capsules three times a day [9 capsules daily] for a total of 2403 mg/day) or at MTD administered orally along with lebrikizumab at a dose of 250 mg administered via SC injection once every 4 weeks up to 52 weeks during the placebo-controlled treatment period.
  • Drug: Lebrikizumab
    Lebrikizumab will be administered at a dose of 250 mg via SC injection once every 4 weeks.
    Other names:
    • RO5490255
  • Drug: Pirfenidone
    Pirfenidone will be administered orally at a stable dose of 2403 mg per day or at MTD.

Recruiting Locations

More Details

NCT ID
NCT01872689
Status
Completed
Sponsor
Hoffmann-La Roche

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.