A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis

A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis

To study the safety and effectiveness of multiple-doses of tralokinumab on pulmonary function in adults with mild to moderate idiopathic pulmonary fibrosis (IPF). IPF is a chronic, progressive, irreversible, and usually fatal lung disease of unknown cause.

The primary objective of this study is to determine the effect of multiple doses of tralokinumab on pulmonary function in adults with mild to moderate IPF

Key Inclusion Criteria:

• 1) IPF diagnosis for <= 5 years prior to Visit 1 (screening). Confirmation of diagnosis of IPF in accordance is required for subject inclusion 2) Confirmed diagnosis of IPF by clinical characteristics, HRCT and surgical lung biopsy (if required) 3)Mild to moderate IPF to include all of the following at screening:

  1. FVC >= 50% predicted normal
  2. Partial pressure of oxygen in arterial blood (PaO2) of >= 55 mmHg on room air or 50 mmHg at high altitude (> 1500 meters), or oxygen saturation by pulse oximetry (SpO2) of >= 90%on room air at rest
  3. Hemoglobin-corrected diffusion capacity for carbon monoxide (DLCO) >= 30% predicted normal 4) Be able to walk >= 100 meters unassisted

Key Exclusion Criteria:

1. A FEV1/FVC ratio less than 0.70 at the time of screening (postbronchodilator)

2. The extent of emphysema on the HRCT is greater than the extent of fibrosis.

3. Currently listed for lung transplantation

4. Use of the following medications:

   1. Immunosuppressive medications (eg, methotrexate, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid) within 3 months prior to Visit 1 (screening). Oral prednisone <= 15 mg/day (or equivalent oral corticosteroid) is allowed for chronic use if subject was on a stable dose at least 30 days prior to Visit 1 (screening)
   2. Pirfenidone within 4 weeks prior to Visit 1 (screening)
   3. N-acetylcysteine within 4 weeks prior to Visit 1 (screening)
   4. Live attenuated vaccines within 4 weeks prior to Visit 1 (screening)