Idiopathic Pulmonary Fibrosis
Conditions
Interventions
investigational material(s)
Generic name etc : Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 r
Sponsors
AstraZeneca
MedImmune LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Privision of informed consent prior to any study specific procedures -Confirmed IPF diagnosis for 5 years or less prior to Visit 1 (screening). Confirmation of diagnosis of IPF -Mild to moderate IPF to include all of the following at Visit 1 a. FVC 50% or more and 90% predicted normal or less b. Partial pressure of oxygen in arterial blood (PaO2) of 55 mmHg on room air or more, or oxygen saturation by pulse oximetry (SpO2) of 90% on room air at rest or more c. Hemoglobin-corrected diffusion capacity for carbon monoxide (DLCO) 30% or moreand 90% predicted normal or less
Exclusion criteria
Exclusion criteria: -History of clinically significant environmental exposure (eg, domestic and occupational) to a known cause of pulmonary fibrosis -Diagnosis of connective tissue disease or drug toxicity as the likely cause of the interstitial disease -A suspected IPF exacerbation not fully resolved and treatment completed 14 days or less prior to Visit 1 -A suspected IPF exacerbation during the screening period -A FEV1/FVC ratio < 0.70 at the time of Visit 1 (postbronchodilator) -The extent of emphysema on the HRCT is greater than the extent of fibrosis
Outcome results
None listed