A PHASE II, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED, STUDY TO ASSESS THEEFFICACY AND SAFETY OF LEBRIKIZUMAB INPATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS

Not Applicable

• Conditions: -J631 Bauxite fibrosis (of lung)-J633 Graphite fibrosis (of lung); Bauxite fibrosis (of lung); Graphite fibrosis (of lung); J631; J633

• Registration Number: PER-083-13
• Lead Sponsor: F. HOFFMANN-LA ROCHE LTD.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-08
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Age ≥40 years at Visit 1
• Have a definite IPF diagnosis according to the 2011 ATS/ERS/JRS/ALAT consensus
statement on IPF within the previous 4 years from time of screening and confirmed at
baseline.
• Have a central review assessment of a screening HRCT performed during the screening
period or within 6 months prior to the start of screening.
• All patients who have undergone a SLB as part of their initial workup should have
pathology slides sent in for SLB central review assessment.
Additionally, patients must meet the following criteria for study entry:
• FVC ≥40% and ≤90% of 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 (DLCO) ≥25% and ≤90% of predicted
at screening
• Ability to walk ≥100 meters unassisted in 6 minutes.

Exclusion Criteria

History of a 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) (e.g., domestic and
occupational environmental exposures, connective tissue disease, and drug toxicity)
Lung transplant expected within 12 months of screening
• Evidence of clinically significant lung disease other than IPF (e.g., asthma or chronic
obstructive pulmonary disease [COPD])
• 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 mL
increase in either FEV1 or FVC
• Any clinically significant medical disease (other than IPF) that is associated with an expected
survival of <12 months, likely to require a change in therapy during the study, or likely to
impact the ability of the patient to participate in the study in the opinion of the investigator, or
impact the study efficacy or safety assessments
• Requirement for continuous medical care and assistance, or limited ability to self care that
would impact the ability of patient to participate in the study or to perform the study-related
assessments
• 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 four weeks prior to, or during screening
• Known current malignancy or current evaluation for a potential malignancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified