A Phase 2, Randomized Dose-ranging Study To Evaluate The Efficacy Of Tralokinumab In Adults With Idiopathic Pulmonary Fibrosis
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 12-006817
NCT ID: NCT01629667
Sponsor Protocol Number: CD-RI-CAT-354-1066
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:
- IPF diagnosis for ≤ 5 years prior to Visit 1 (screening). Confirmation of diagnosis of IPF in accordance is required for subject inclusion
- Confirmed diagnosis of IPF by clinical characteristics, HRCT and surgical lung biopsy (if required)
- Mild to moderate IPF to include all of the following at screening:
- FVC ≥ 50% predicted normal
- 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
- Hemoglobin-corrected diffusion capacity for carbon monoxide (DLCO) ≥ 30% predicted normal 4) Be able to walk ≥ 100 meters unassisted
Key Exclusion Criteria:
- A FEV1/FVC ratio less than 0.70 at the time of screening (postbronchodilator)
- The extent of emphysema on the HRCT is greater than the extent of fibrosis.
- Currently listed for lung transplantation
- Use of the following medications:
- 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)
- Pirfenidone within 4 weeks prior to Visit 1 (screening)
- N-acetylcysteine within 4 weeks prior to Visit 1 (screening)
- 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