A PHASE II, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED, STUDY TO ASSESS THEEFFICACY AND SAFETY OF LEBRIKIZUMABIN PATIENTS WITH IDIOPATHIC PULMONARYFIBROSIS
- Conditions
- -J631 Bauxite fibrosis (of lung)-J633 Graphite fibrosis (of lung)Bauxite fibrosis (of lung)Graphite fibrosis (of lung)J631J633
- Registration Number
- PER-045-15
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 7
• Able and willing to provide written informed consent and to comply with the study protocol
• Age ≥ 40 years at Visit 1
• Have a diagnosis of IPF based on the ATS/ERS/JRS/ALAT consensus statement on IPF
(Raghu et al. 2011) within the previous 5 years from time of screening and confirmed at
baseline.
• Have a central review assessment of an HRCT performed during the screening period or
within 12 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.
• A Multidisciplinary Discussion of Diagnosis (MDD) based on 2011 ATS/ERS/JRS/ALAT
guidelines will be utilized to finalize the diagnosis in the event the initial central review
outcome results for HRCT and SLB are disparate (inconsistent with UIP/definite UIP). 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 mg/QD for ≥ 4 weeks required prior to
randomization and throughout the placebo-controlled study perio
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 (CTD), 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
Hospitalization due to an exacerbation of IPF within 4 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method