A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis
NCT ID: NCT01629667
Last Updated: 2017-05-15
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
409 participants
INTERVENTIONAL
2012-10-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tralokinumab 400 milligram (mg)
Participants will receive Tralokinumab 400 mg intravenous (IV) infusion Q4W for 68 Weeks.
Tralokinumab
Participants will receive Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab 800 mg
Participants will receive Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Tralokinumab
Participants will receive Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Placebo
Participants will receive placebo IV once every 4 Weeks (Q4W) for 68 Weeks.
Placebo
Participants will receive placebo IV once every 4 Weeks (Q4W) for 68 Weeks.
Interventions
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Tralokinumab
Participants will receive Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
Tralokinumab
Participants will receive Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
Placebo
Participants will receive placebo IV once every 4 Weeks (Q4W) for 68 Weeks.
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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)
50 Years
79 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Joseph Parker, MD
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Research Site
Phoenix, Arizona, United States
Research Site
La Jolla, California, United States
Research Site
Sacramento, California, United States
Research Site
Tampa, Florida, United States
Research Site
Winter Park, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Honolulu, Hawaii, United States
Research Site
Chicago, Illinois, United States
Research Site
Louisville, Kentucky, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Rochester, Minnesota, United States
Research Site
Chesterfield, Missouri, United States
Research Site
Summit, New Jersey, United States
Research Site
Durham, North Carolina, United States
Research Site
Hershey, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Charleston, South Carolina, United States
Research Site
Nashville, Tennessee, United States
Research Site
McAllen, Texas, United States
Research Site
McKinney, Texas, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Box Hill, , Australia
Research Site
Camperdown, , Australia
Research Site
Concord, , Australia
Research Site
Darlinghurst, , Australia
Research Site
Frankston, , Australia
Research Site
Glen Osmond, , Australia
Research Site
New Lambton, , Australia
Research Site
Parkville, , Australia
Research Site
Prahran, , Australia
Research Site
Woodville South, , Australia
Research Site
Edmonton, Alberta, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Windsor, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Ashkelon, , Israel
Research Site
Haifa, , Israel
Research Site
Jerusalem, , Israel
Research Site
Petah Tikva, , Israel
Research Site
Rehovot, , Israel
Research Site
Tel Aviv, , Israel
Research Site
Lima, , Peru
Research Site
Lima Cercado, , Peru
Research Site
Seoul, , South Korea
Countries
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References
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Parker JM, Glaspole IN, Lancaster LH, Haddad TJ, She D, Roseti SL, Fiening JP, Grant EP, Kell CM, Flaherty KR. A Phase 2 Randomized Controlled Study of Tralokinumab in Subjects with Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2018 Jan 1;197(1):94-103. doi: 10.1164/rccm.201704-0784OC.
Other Identifiers
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CD-RI-CAT-354-1066
Identifier Type: -
Identifier Source: org_study_id
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