A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma
NCT ID: NCT02161757
Last Updated: 2018-08-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1207 participants
INTERVENTIONAL
2014-06-13
2017-07-18
Brief Summary
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Detailed Description
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Approximately 1140 subjects will be randomized globally. Subjects will receive tralokinumab, or placebo, administered via subcutaneous injection at the study site, over a 52-week treatment period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Tralokinumab Dose Regimen 1
Tralokinumab subcutaneous injection
Tralokinumab
Subcutaneous injection
Placebo Dose Regimen 1
Placebo subcutaneous injection
Placebo
Subcutaneous injection
Tralokinumab Dose Regimen 2
Tralokinumab subcutaneous injection
Tralokinumab
Subcutaneous injection
Placebo Dose Regimen 2
Placebo subcutaneous injection
Placebo
Subcutaneous injection
Interventions
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Tralokinumab
Subcutaneous injection
Placebo
Subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
2. Documented physician-diagnosed asthma.
3. Documented treatment with ICS at a total daily dose corresponding to ≥500μg fluticasone propionate dry powder formulation equivalents) and a LABA
4. Morning pre-BD FEV1 value of ≥40 and \<80% value (\<90% for patients 12 to 17 years of age) of their PNV.
5. Post-BD reversibility of ≥12% and ≥200 mL in FEV1
6. ACQ-6 score ≥1.5
Exclusion Criteria
2. History of anaphylaxis following any biologic therapy
3. Hepatitis B, C or HIV
4. Pregnant or breastfeeding
5. History of cancer
6. Current tobacco smoking or a history of tobacco smoking for ≥ 10 pack-years
7. Previous receipt of tralokinumab
12 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Reynold A Panettieri, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Arcadia, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Poway, California, United States
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San Jose, California, United States
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Tustin, California, United States
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Wildomar, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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New Haven, Connecticut, United States
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Clearwater, Florida, United States
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Coral Gables, Florida, United States
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Cutler Bay, Florida, United States
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Fort Lauderdale, Florida, United States
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Hialeah, Florida, United States
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Hialeah, Florida, United States
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Homestead, Florida, United States
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Homestead, Florida, United States
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Jacksonville, Florida, United States
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Kissimmee, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Ormond Beach, Florida, United States
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Pembroke Pines, Florida, United States
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Winter Park, Florida, United States
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Albany, Georgia, United States
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Atlanta, Georgia, United States
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Lawrenceville, Georgia, United States
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Meridian, Idaho, United States
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Twin Falls, Idaho, United States
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Fort Wayne, Indiana, United States
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South Bend, Indiana, United States
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Bowling Green, Kentucky, United States
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Bangor, Maine, United States
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Brockton, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Farmington Hills, Michigan, United States
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Flint, Michigan, United States
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Ypsilanti, Michigan, United States
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Chesterfield, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Missoula, Montana, United States
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Las Vegas, Nevada, United States
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Union, New Jersey, United States
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Brooklyn, New York, United States
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Cornelius, North Carolina, United States
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Hickory, North Carolina, United States
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Shelby, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Columbus, Ohio, United States
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Middleburg Heights, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Monroeville, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Scottdale, Pennsylvania, United States
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Uniontown, Pennsylvania, United States
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Johnston, Rhode Island, United States
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Providence, Rhode Island, United States
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Warwick, Rhode Island, United States
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Anderson, South Carolina, United States
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Greenville, South Carolina, United States
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Myrtle Beach, South Carolina, United States
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Spartanburg, South Carolina, United States
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Boerne, Texas, United States
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Corsicana, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Lampasas, Texas, United States
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McKinney, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Murray, Utah, United States
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Provo, Utah, United States
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Salt Lake City, Utah, United States
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South Burlington, Vermont, United States
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Arlington, Virginia, United States
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Richmond, Virginia, United States
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Richland, Washington, United States
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Tacoma, Washington, United States
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Buenos Aires, , Argentina
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CABA, , Argentina
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Cap. Fed, , Argentina
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Ciudad Autonomade Buenos Aires, , Argentina
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Concepción del Uruguay, , Argentina
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Córdoba, , Argentina
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Mendoza, , Argentina
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Mendoza, , Argentina
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Quilmes, , Argentina
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Rosario, , Argentina
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San Miguel de Tucumán, , Argentina
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Brussels (Anderlecht), , Belgium
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Erpent, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Dupnitsa, , Bulgaria
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Kozloduy, , Bulgaria
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Pazardzhik, , Bulgaria
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Pernik, , Bulgaria
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Rousse, , Bulgaria
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Sliven, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Varna, , Bulgaria
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Veliko Tarnovo, , Bulgaria
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Vratsa, , Bulgaria
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Yambol, , Bulgaria
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Armenia, , Colombia
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Bogotá, , Colombia
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Bogotá, , Colombia
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Cali, , Colombia
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Aschaffenburg, , Germany
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Augsburg, , Germany
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Bad Lippspringe, , Germany
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Geesthacht, , Germany
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Herford, , Germany
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Landsberg, , Germany
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Leipzig, , Germany
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München-Pasing, , Germany
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Reinfeld, , Germany
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Rodgau-Dudenhofen, , Germany
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Warendorf, , Germany
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Balassagyarmat, , Hungary
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Edelény, , Hungary
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Farkasgyepü, , Hungary
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Komárom, , Hungary
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Létavértes, , Hungary
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Miskolc, , Hungary
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Pécs, , Hungary
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Pécs, , Hungary
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Százhalombatta, , Hungary
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Cusco, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Będzin, , Poland
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Bydgoszcz, , Poland
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Chorzów, , Poland
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Gdansk, , Poland
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Gdansk, , Poland
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Grudziądz, , Poland
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Kielce, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lubin, , Poland
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Lublin, , Poland
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Lublin, , Poland
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Mrozy, , Poland
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Olsztyn, , Poland
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Ostrowiec Świętokrzyski, , Poland
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Ostrów Wielkopolski, , Poland
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Oświęcim, , Poland
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Puławy, , Poland
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Racibórz, , Poland
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Skierniewice, , Poland
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Staszów, , Poland
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Warsaw, , Poland
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Wieluń, , Poland
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Wołomin, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Zamość, , Poland
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Zgierz, , Poland
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Humenné, , Slovakia
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Kežmarok, , Slovakia
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Prešov, , Slovakia
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Sabinov, , Slovakia
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Topoľčany, , Slovakia
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Bucheon-si, , South Korea
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Cheongju-si, , South Korea
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Daegu, , South Korea
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Incheon, , South Korea
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Incheon, , South Korea
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Jeju City, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Alicante, , Spain
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Badalona, , Spain
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Hospitalet de Llobregat(Barcel, , Spain
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Santander, , Spain
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Valencia, , Spain
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Changhua, , Taiwan
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Kaohsiung City, , Taiwan
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New Taipei City, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Yilan, , Taiwan
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Chernivtsi, , Ukraine
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Chernivtsi, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Lutsk, , Ukraine
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Lviv, , Ukraine
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Odesa, , Ukraine
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Vinnytsia, , Ukraine
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Zaporizhzhya, , Ukraine
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Zaporizhzhya, , Ukraine
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Can Tho, , Vietnam
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Hanoi, , Vietnam
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Hà Nội, , Vietnam
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Ho Chi Minh City, , Vietnam
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Hochiminh, , Vietnam
Countries
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References
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Gottlow M, Svensson DJ, Lipkovich I, Huhn M, Bowen K, Wessman P, Colice G. Application of structured statistical analyses to identify a biomarker predictive of enhanced tralokinumab efficacy in phase III clinical trials for severe, uncontrolled asthma. BMC Pulm Med. 2019 Jul 17;19(1):129. doi: 10.1186/s12890-019-0889-4.
Carlsson M, Braddock M, Li Y, Wang J, Xu W, White N, Megally A, Hunter G, Colice G. Evaluation of Antibody Properties and Clinically Relevant Immunogenicity, Anaphylaxis, and Hypersensitivity Reactions in Two Phase III Trials of Tralokinumab in Severe, Uncontrolled Asthma. Drug Saf. 2019 Jun;42(6):769-784. doi: 10.1007/s40264-018-00788-w.
Panettieri RA Jr, Sjobring U, Peterffy A, Wessman P, Bowen K, Piper E, Colice G, Brightling CE. Tralokinumab for severe, uncontrolled asthma (STRATOS 1 and STRATOS 2): two randomised, double-blind, placebo-controlled, phase 3 clinical trials. Lancet Respir Med. 2018 Jul;6(7):511-525. doi: 10.1016/S2213-2600(18)30184-X. Epub 2018 May 20.
Panettieri RA Jr, Wang M, Braddock M, Bowen K, Colice G. Tralokinumab for the treatment of severe, uncontrolled asthma: the ATMOSPHERE clinical development program. Immunotherapy. 2018 Mar 1;10(6):473-490. doi: 10.2217/imt-2017-0191. Epub 2018 Mar 14.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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D2210C00007
Identifier Type: -
Identifier Source: org_study_id
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