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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Study closed to enrollment

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)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Andrew Limper, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Non-cancer trials contact form

Phone: 800-664-4542 (toll-free)

International patient clinical studies questions