A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma
NCT ID: NCT02194699
Last Updated: 2018-05-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
856 participants
INTERVENTIONAL
2014-10-30
2017-09-21
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
TRIPLE
Study Groups
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Tralokinumab
Tralokinumab subcutaneous injection
Experimental: Tralokinumab
Tralokinumab subcutaneous injection
Placebo
Placebo subcutaneous injection
Placebo
Placebo subcutaneous injection
Interventions
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Experimental: Tralokinumab
Tralokinumab subcutaneous injection
Placebo
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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Christopher Brightling, MD
Role: PRINCIPAL_INVESTIGATOR
Institute for Lung Health, United Kingdom
Locations
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Research Site
Birmingham, Alabama, United States
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Hoover, Alabama, United States
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Huntsville, Alabama, United States
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Scottsdale, Arizona, United States
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Little Rock, Arkansas, United States
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Bakersfield, California, United States
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Buena Park, California, United States
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Encinitas, California, United States
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Lakewood, California, United States
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Lomita, California, United States
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Northridge, California, United States
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Palmdale, California, United States
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Roseville, California, United States
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Sacramento, California, United States
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San Francisco, California, United States
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Thousand Oaks, California, United States
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Ventura, California, United States
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Walnut Creek, California, United States
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Centennial, Colorado, United States
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Celebration, Florida, United States
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DeLand, Florida, United States
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Gainesville, Florida, United States
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Hialeah, 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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New Port Richey, Florida, United States
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Orlando, Florida, United States
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Palmetto Bay, Florida, United States
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Port Charlotte, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Winter Park, Florida, United States
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Columbus, Georgia, United States
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Gainesville, Georgia, United States
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Savannah, Georgia, United States
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Eagle, Idaho, United States
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Evergreen Park, Illinois, United States
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Kenilworth, Illinois, United States
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Peoria, Illinois, United States
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White Marsh, Maryland, United States
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Fall River, Massachusetts, United States
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Reno, Nevada, United States
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Northfield, New Jersey, United States
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Ocean City, New Jersey, United States
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Teaneck, New Jersey, United States
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Toms River, New Jersey, United States
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Verona, New Jersey, United States
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Albuquerque, New Mexico, United States
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Larchmont, New York, United States
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The Bronx, New York, United States
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The Bronx, New York, United States
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Wappingers Falls, New York, United States
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Burlington, North Carolina, United States
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Charlotte, North Carolina, United States
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Greensboro, North Carolina, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Rock Hill, South Carolina, United States
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Arlington, Texas, United States
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Baytown, Texas, United States
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Frisco, 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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Kingwood, 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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Orem, Utah, United States
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Salt Lake City, Utah, United States
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Fairfax, Virginia, United States
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Greenfield, Wisconsin, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Sherwood Park, Alberta, Canada
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Vancouver, British Columbia, Canada
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Ajax, Ontario, Canada
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Ajax, Ontario, Canada
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Burlington, Ontario, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Talcahuano, , Chile
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Brandýs nad Labem, , Czechia
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Jindřichův Hradec, , Czechia
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Prague, , Czechia
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Praha 10 - Strasnice, , Czechia
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Rokycany, , Czechia
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Teplice, , Czechia
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Catania, , Italy
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Genova, , Italy
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Legnago, , Italy
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Messina, , Italy
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Milan, , Italy
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Napoli, , Italy
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Palermo, , Italy
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Pisa, , Italy
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Salerno, , Italy
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Verona, , Italy
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Asahi-shi, , Japan
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Chūōku, , Japan
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Fukui-shi, , Japan
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Fukushima, , Japan
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Habikino-shi, , Japan
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Himeji-shi, , Japan
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Hiroshima, , Japan
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Itabashi-ku, , Japan
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Izumo-shi, , Japan
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Kagoshima, , Japan
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Kanazawa, , Japan
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Kanuma-shi, , Japan
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Kasuga-shi, , Japan
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Kishiwada-shi, , Japan
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Kobe, , Japan
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Kobe, , Japan
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Kochi, , Japan
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Maebashi, , Japan
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Matsue, , Japan
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Matsusaka-shi, , Japan
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Meguro-ku, , Japan
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Minatoku, , Japan
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Morioka, , Japan
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Nagasaki, , Japan
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Nagoya, , Japan
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Nishinomiya-shi, , Japan
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Sagamihara-shi, , Japan
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Sakaide-shi, , Japan
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Sapporo, , Japan
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Sasebo-shi, , Japan
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Seto-shi, , Japan
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Shibuya-ku, , Japan
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Shinagawa-ku, , Japan
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Shinjuku-ku, , Japan
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Sumida-ku, , Japan
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Takamatsu, , Japan
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Toshima-ku, , Japan
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Touon-shi, , Japan
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Toyama, , Japan
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Tsu, , Japan
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Tsukubo-gun, , Japan
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Uozu-shi, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Guadalajara, , Mexico
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México, , Mexico
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Monterrey, , Mexico
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Monterrey, , Mexico
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Villahermosa, , Mexico
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Caloocan City, , Philippines
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Iloilo City, , Philippines
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Lipa City, , Philippines
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Pasig, , Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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San Fernando City, , Philippines
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Chelyabinsk, , Russia
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Izhevsk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Novosibirsk, , Russia
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Novosibirsk, , Russia
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Omsk, , Russia
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Perm, , Russia
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Petrozavodsk, , Russia
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Pyatigorsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Ulyanovsk, , Russia
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Vladikavkaz, , Russia
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Volgograd, , Russia
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Yaroslavl, , Russia
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Yekaterinburg, , Russia
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Boksburg North, , South Africa
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Durban, , South Africa
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KwaDukuza, , South Africa
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Mount Edgecombe, , South Africa
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Mowbray, , South Africa
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Port Elizabeth, , South Africa
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Kaohsiung Hsien, , Taiwan
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Keelung, , Taiwan
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New Taipei City, , Taiwan
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Cherkasy, , Ukraine
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Dnipropetrovsk, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kremenchuk, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Lviv, , Ukraine
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Odesa, , Ukraine
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Sumy, , Ukraine
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Sumy, , Ukraine
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Uzhhorod, , Ukraine
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Zaporizhzhya, , Ukraine
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Zaporizhzhya, , Ukraine
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Bradford, , United Kingdom
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Cambridge, , United Kingdom
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Chertsey, , United Kingdom
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Glasgow, , United Kingdom
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Leicester, , United Kingdom
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Liverpool, , United Kingdom
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Manchester, , United Kingdom
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Northwood, , United Kingdom
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Sidcup, , United Kingdom
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Wishaw, , United Kingdom
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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D2210C00008
Identifier Type: -
Identifier Source: org_study_id
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