Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist
30 novembre 2016 mis à jour par: AstraZeneca
A Multicentre, Randomized, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Asthmatic Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist (CALIMA)
The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA with or without oral corticosteroids and additional asthma controllers.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
2508
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Aschaffenburg, Allemagne
- Research Site
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Bamberg, Allemagne
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Berlin, Allemagne
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Bonn, Allemagne
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Frankfurt, Allemagne
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Frankfurt/Main, Allemagne
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Geesthacht, Allemagne
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Gelsenkirchen, Allemagne
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Hamburg, Allemagne
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Hannover, Allemagne
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Herford, Allemagne
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Leipzig, Allemagne
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Mainz, Allemagne
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München, Allemagne
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Neu-Isenburg, Allemagne
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Rostock, Allemagne
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Rüdersdorf, Allemagne
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Witten, Allemagne
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Buenos Aires, Argentine
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Caba, Argentine
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Ciudad Autónoma de Bs. As., Argentine
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Ciudad de Buenos Aires, Argentine
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Concepción del Uruguay, Argentine
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Corrientes, Argentine
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Córdoba, Argentine
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Florida, Argentine
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Godoy Cruz, Argentine
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La Plata, Argentine
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Mar del Plata, Argentine
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Mendoza, Argentine
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Ranelagh, Argentine
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Rosario, Argentine
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San Miguel de Tucuman, Argentine
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Quebec, Canada
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Alberta
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Calgary, Alberta, Canada
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Sherwood Park, Alberta, Canada
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British Columbia
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Vancouver, British Columbia, Canada
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New Brunswick
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Moncton, New Brunswick, Canada
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Ontario
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Burlington, Ontario, Canada
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Hamilton, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Quebec
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Montreal, Quebec, Canada
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St Charles Borromee, Quebec, Canada
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Concepcion, Chili
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Quillota, Chili
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Santiago, Chili
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Talcahuano, Chili
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Valparaiso, Chili
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Viña del Mar, Chili
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Asahi-shi, Japon
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Chiyoda-ku, Japon
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Chuo-ku, Japon
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Fukuoka-shi, Japon
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Himeji-shi, Japon
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Hiroshima-shi, Japon
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Itabashi-ku, Japon
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Kagoshima-shi, Japon
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Kishiwada-shi, Japon
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Kobe-shi, Japon
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Kokubunji-shi, Japon
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Matsue-shi, Japon
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Minato-ku, Japon
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Mizunami-shi, Japon
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Niigata-shi, Japon
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Obihiro-shi, Japon
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Oita-shi, Japon
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Ota-shi, Japon
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Sagamihara-shi, Japon
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Sakai-shi, Japon
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Sakaide-shi, Japon
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Sapporo-shi, Japon
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Sendai-shi, Japon
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Setagaya-ku, Japon
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Shibuya-ku, Japon
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Shinagawa-ku, Japon
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Sumida-ku, Japon
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Takamatsu-shi, Japon
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Toshima-ku, Japon
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Tsukubo-gun, Japon
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Yokohama-shi, Japon
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Iloilo City, Philippines
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Lipa City, Philippines
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Quezon City, Philippines
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Aleksandrów Łódzki, Pologne
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Białystok, Pologne
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Bielsko Biala, Pologne
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Bydgoszcz, Pologne
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Bystra Śląska, Pologne
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Gdańsk, Pologne
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Gorzów Wlkp, Pologne
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Karczew, Pologne
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Katowice, Pologne
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Koszalin, Pologne
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Kraków, Pologne
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Lubin, Pologne
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Lublin, Pologne
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Ostrów Wielkopolski, Pologne
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Poznań, Pologne
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Ruda Slaska, Pologne
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Rzeszów, Pologne
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Skierniewice, Pologne
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Szczecin, Pologne
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Tarnów, Pologne
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Toruń, Pologne
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Trzebnica, Pologne
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Warszawa, Pologne
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Wieluń, Pologne
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Wroclaw, Pologne
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Wrocław, Pologne
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Zabrze, Pologne
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Łódź, Pologne
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Łęczna, Pologne
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Żnin, Pologne
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Bragadiru, Roumanie
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Brasov, Roumanie
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Bucharest, Roumanie
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Constanta, Roumanie
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Deva, Roumanie
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Iasi, Roumanie
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Timisoara, Roumanie
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Goteborg, Suède
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Luleå, Suède
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Lund, Suède
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Chernivtsi, Ukraine
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Dnipropetrovsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Lutsk, Ukraine
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Mykolayiv, Ukraine
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Uzhgorod, Ukraine
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Vinnytsia, Ukraine
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Vinnytsya, Ukraine
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Zaporizhzhia, Ukraine
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Zaporozhye, Ukraine
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Alabama
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Andalusia, Alabama, États-Unis
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Birmingham, Alabama, États-Unis
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Arizona
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Flagstaff, Arizona, États-Unis
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Glendale, Arizona, États-Unis
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Phoenix, Arizona, États-Unis
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Tucson, Arizona, États-Unis
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California
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Alhambra, California, États-Unis
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Anaheim, California, États-Unis
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Beverly Hills, California, États-Unis
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Garden Grove, California, États-Unis
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Lakewood, California, États-Unis
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North Hollywood, California, États-Unis
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Northridge, California, États-Unis
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Palmdale, California, États-Unis
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Rancho Mirage, California, États-Unis
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Redondo Beach, California, États-Unis
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Rolling Hills Estate, California, États-Unis
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Sacramento, California, États-Unis
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Stockton, California, États-Unis
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Thousand Oaks, California, États-Unis
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Upland, California, États-Unis
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Ventura, California, États-Unis
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Walnut Creek, California, États-Unis
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Westminister, California, États-Unis
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Woodland, California, États-Unis
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Colorado
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Centennial, Colorado, États-Unis
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Colorado Springs, Colorado, États-Unis
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Wheat Ridge, Colorado, États-Unis
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Florida
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Celebration, Florida, États-Unis
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Fort Lauderdale, Florida, États-Unis
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Hialeah, Florida, États-Unis
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Homestead, Florida, États-Unis
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Jacksonville, Florida, États-Unis
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Lehigh Acres, Florida, États-Unis
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Miami, Florida, États-Unis
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Ocala, Florida, États-Unis
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Orlando, Florida, États-Unis
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Ormond Beach, Florida, États-Unis
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Virginia Gardens, Florida, États-Unis
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Georgia
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Gainesville, Georgia, États-Unis
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Smyrna, Georgia, États-Unis
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Idaho
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Eagle, Idaho, États-Unis
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Illinois
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Shiloh, Illinois, États-Unis
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Kansas
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Lenexa, Kansas, États-Unis
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Kentucky
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Fort Mitchell, Kentucky, États-Unis
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Louisiana
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Covington, Louisiana, États-Unis
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Maine
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Bangor, Maine, États-Unis
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Michigan
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Farmington Hills, Michigan, États-Unis
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Flint, Michigan, États-Unis
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Traverse City, Michigan, États-Unis
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Minnesota
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Minneapolis, Minnesota, États-Unis
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Missouri
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St Louis, Missouri, États-Unis
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Nevada
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Las Vagas, Nevada, États-Unis
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New Jersey
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Union, New Jersey, États-Unis
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New York
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Bronx, New York, États-Unis
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North Carolina
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Durham, North Carolina, États-Unis
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Wilmington, North Carolina, États-Unis
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Ohio
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Cincinnati, Ohio, États-Unis
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Columbus, Ohio, États-Unis
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Dayton, Ohio, États-Unis
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Middleburg Heights, Ohio, États-Unis
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis
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Oregon
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Corvallis, Oregon, États-Unis
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Portland, Oregon, États-Unis
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Pennsylvania
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Jefferson Hills, Pennsylvania, États-Unis
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Pittsburgh, Pennsylvania, États-Unis
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South Carolina
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Indian Land, South Carolina, États-Unis
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South Dakota
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Rapid City, South Dakota, États-Unis
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Tennessee
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Knoxville, Tennessee, États-Unis
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Texas
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Arlington, Texas, États-Unis
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Austin, Texas, États-Unis
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Boerne, Texas, États-Unis
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Dallas, Texas, États-Unis
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Houston, Texas, États-Unis
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San Antonio, Texas, États-Unis
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Utah
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Midvale, Utah, États-Unis
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Murray, Utah, États-Unis
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Virginia
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Fairfax, Virginia, États-Unis
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Falls Church, Virginia, États-Unis
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Wisconsin
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Madison, Wisconsin, États-Unis
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Milwaukee, Wisconsin, États-Unis
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
12 ans à 75 ans (Enfant, Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures
- Female and male aged 12 to 75 years, inclusively, at the time of Visit 1
- History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (>250µg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1.
- Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or without oral corticosteroids and additional asthma controllers. The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily. For ICS/LABA combination preparations, the mid-strength approved maintenance dose in the local country will meet this ICS criterion.
Exclusion criteria:
- Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome)
Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
- Affect the safety of the patient throughout the study
- Influence the findings of the studies or their interpretations
- Impede the patient's ability to complete the entire duration of study
- Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
- Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Benralizumab 30 mg toutes les 4 semaines
Benralizumab administré par voie sous-cutanée toutes les 4 semaines
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Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
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Expérimental: Benralizumab 30 mg toutes les 8 semaines
Benralizumab administré par voie sous-cutanée toutes les 8 semaines
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Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
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Comparateur placebo: Placebo
Placebo administré par voie sous-cutanée
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Placebo subcutaneously on study week 0 until study week 52 inclusive.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL
Délai: Immediately following the first administration of study drug through Study Week 56.
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The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.
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Immediately following the first administration of study drug through Study Week 56.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL
Délai: Immediately following the first administration of study drug through Study Week 56.
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The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.
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Immediately following the first administration of study drug through Study Week 56.
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Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils >=300/uL
Délai: Immediately following the first administration of study drug through Study Week 56.
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Immediately following the first administration of study drug through Study Week 56.
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Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils <300/uL
Délai: Immediately following the first administration of study drug through Study Week 56.
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Immediately following the first administration of study drug through Study Week 56.
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Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils >=300/uL
Délai: Immediately following the first administration of study drug through Study Week 56.
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Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary.
Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma).
Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1.
Each timepoint is calculated as bi-weekly means based on daily diary data.
If more than 50% of scores are missing in a 14 day period then this is considered as missing.
Symptom score lower is better.
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Immediately following the first administration of study drug through Study Week 56.
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Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils <300/uL
Délai: Immediately following the first administration of study drug through Study Week 56.
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Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary.
Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma).
Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1.
Each timepoint is calculated as bi-weekly means based on daily diary data.
If more than 50% of scores are missing in a 14 day period then this is considered as missing.
Symptom score lower is better.
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Immediately following the first administration of study drug through Study Week 56.
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Change in Asthma Rescue Medication Use
Délai: Immediately following the first administration of study drug through Study Week 56.
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Change from Baseline to Week 56 in number of Rescue medication use (puffs/day)
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Immediately following the first administration of study drug through Study Week 56.
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Home Lung Function Assessments Based on PEF
Délai: Immediately following the first administration of study drug through Study Week 56.
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Change from Baseline to Week 56 in Home lung function (morning and evening Peak expiratory flow [PEF])
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Immediately following the first administration of study drug through Study Week 56.
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Proportion of Nights With Awakening Due to Asthma
Délai: Immediately following the first administration of study drug through Study Week 56.
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Change from Baseline to Week 56 on Proportion of Nights with awakening due to asthma
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Immediately following the first administration of study drug through Study Week 56.
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Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils >=300/uL
Délai: Immediately following the first administration of study drug through Study Week 56.
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ACQ-6 contains one bronchodilator question and 5 symptom questions.
Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled).
Mean ACQ-6 score is the average of the responses.
Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.
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Immediately following the first administration of study drug through Study Week 56.
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Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils <300/uL
Délai: Immediately following the first administration of study drug through Study Week 56.
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ACQ-6 contains one bronchodilator question and 5 symptom questions.
Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled).
Mean ACQ-6 score is the average of the responses.
Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.
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Immediately following the first administration of study drug through Study Week 56.
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Number of Patients With >=1 Asthma Exacerbation
Délai: Immediately following the first administration of study drug through Study Week 56
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Immediately following the first administration of study drug through Study Week 56
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Time to First Asthma Exacerbation
Délai: Immediately following the first administration of study drug through Study Week 56
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Immediately following the first administration of study drug through Study Week 56
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Annual Rate of Asthma Exacerbation Resulting Emergency Room Visits and Hospitalizations
Délai: Immediately following the first administration of study drug through Study Week 56.
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Annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalization (adjudicated)
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Immediately following the first administration of study drug through Study Week 56.
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Pharmacokinetics of Benralizumab
Délai: Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60
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Mean PK Concentration at each visit
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Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60
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Immunogenicity of Benralizumab
Délai: Pre-treatment until end of follow-up
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Anti-drug antibodies (ADA) responses at baseline and post baseline.
Persistently positive is defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment.
Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.
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Pre-treatment until end of follow-up
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Extent of Exposure
Délai: Immediately following the first administration of study drug through Study Week 56
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Extent of exposure is defined as the duration of treatment in days
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Immediately following the first administration of study drug through Study Week 56
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Mean Change From Baseline to Week 56 in AQLQ(S)+12
Délai: Immediately following the first administration of study drug through Study Week 56
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AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire.
AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment).
Total or domain score change of >=0.5 are considered clinically meaningful.
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Immediately following the first administration of study drug through Study Week 56
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Change From Baseline to Week 56 in EQ-5D-5L VAS
Délai: Immediately following the first administration of study drug through Study Week 56
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EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.
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Immediately following the first administration of study drug through Study Week 56
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Mean Work Productivity Loss Due to Asthma
Délai: Immediately following the first administration of study drug through Study Week 56
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WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions.
Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working.
Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked.
This is only applicable to patients who were employed.
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Immediately following the first administration of study drug through Study Week 56
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Mean Productivity Loss Due to Asthma in Classroom
Délai: Immediately following the first administration of study drug through Study Week 56
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WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions.
Classroom productivity loss is derived by sum of percentage of missed classes due to asthma and product of percentage of actual hours attending classes times degree of asthma affecting classroom productivity.
Percentage of missed classes due to asthma is calculated by number of hours missed classes due to asthma divided by total number of hours missed classes plus number of hours actually attending classes.
This is only applicable for patients who took classes.
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Immediately following the first administration of study drug through Study Week 56
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Number of Participants That Utilized Health Care Resources
Délai: Immediately following the first administration of study drug through Study Week 56
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Immediately following the first administration of study drug through Study Week 56
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Patient and Clinician Assessment of Response to Treatment
Délai: Immediately following the first administration of study drug through Study Week 56
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CGIC (clinician global impression of change), and PGIC (patient global impression of change) are overall evaluation of response to treatment, conducted separately by investigator and patient using a 7-point rating scale, ranging from 1 (Very much Improved), to 7 (Very much Worse).
This endpoint was added after the second protocol amendment, thus not all patients had data to be analyzed.
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Immediately following the first administration of study drug through Study Week 56
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Mark Fitzgerald, MD, PhD, Professor of Medicine, The Lung Centre, Gordon and Leslie Diamond Health Care Centre, Vancouver Canada
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Menzies-Gow A, Hoyte FL, Price DB, Cohen D, Barker P, Kreindler J, Jison M, Brooks CL, Papeleu P, Katial R. Clinical Remission in Severe Asthma: A Pooled Post Hoc Analysis of the Patient Journey with Benralizumab. Adv Ther. 2022 May;39(5):2065-2084. doi: 10.1007/s12325-022-02098-1. Epub 2022 Mar 14.
- Lugogo NL, Kreindler JL, Martin UJ, Cook B, Hirsch I, Trudo FJ. Blood eosinophil count group shifts and kinetics in severe eosinophilic asthma. Ann Allergy Asthma Immunol. 2020 Aug;125(2):171-176. doi: 10.1016/j.anai.2020.04.011. Epub 2020 Apr 22.
- Jackson DJ, Humbert M, Hirsch I, Newbold P, Garcia Gil E. Ability of Serum IgE Concentration to Predict Exacerbation Risk and Benralizumab Efficacy for Patients with Severe Eosinophilic Asthma. Adv Ther. 2020 Feb;37(2):718-729. doi: 10.1007/s12325-019-01191-2. Epub 2019 Dec 14.
- Chipps BE, Hirsch I, Trudo F, Alacqua M, Zangrilli JG. Benralizumab efficacy for patients with fixed airflow obstruction and severe, uncontrolled eosinophilic asthma. Ann Allergy Asthma Immunol. 2020 Jan;124(1):79-86. doi: 10.1016/j.anai.2019.10.006. Epub 2019 Oct 15.
- Chupp G, Lugogo NL, Kline JN, Ferguson GT, Hirsch I, Goldman M, Zangrilli JG, Trudo F. Rapid onset of effect of benralizumab on morning peak expiratory flow in severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2019 May;122(5):478-485. doi: 10.1016/j.anai.2019.02.016. Epub 2019 Feb 23.
- Bleecker ER, Wechsler ME, FitzGerald JM, Menzies-Gow A, Wu Y, Hirsch I, Goldman M, Newbold P, Zangrilli JG. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018 Oct 18;52(4):1800936. doi: 10.1183/13993003.00936-2018. Print 2018 Oct.
- DuBuske L, Newbold P, Wu Y, Trudo F. Seasonal variability of exacerbations of severe, uncontrolled eosinophilic asthma and clinical benefits of benralizumab. Allergy Asthma Proc. 2018 Sep 4;39(5):345-349. doi: 10.2500/aap.2018.39.4162. Epub 2018 Aug 4.
- Chipps BE, Newbold P, Hirsch I, Trudo F, Goldman M. Benralizumab efficacy by atopy status and serum immunoglobulin E for patients with severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2018 May;120(5):504-511.e4. doi: 10.1016/j.anai.2018.01.030. Epub 2018 Feb 1.
- Ohta K, Adachi M, Tohda Y, Kamei T, Kato M, Mark Fitzgerald J, Takanuma M, Kakuno T, Imai N, Wu Y, Aurivillius M, Goldman M. Efficacy and safety of benralizumab in Japanese patients with severe, uncontrolled eosinophilic asthma. Allergol Int. 2018 Apr;67(2):266-272. doi: 10.1016/j.alit.2017.10.004. Epub 2017 Nov 8.
- FitzGerald JM, Bleecker ER, Nair P, Korn S, Ohta K, Lommatzsch M, Ferguson GT, Busse WW, Barker P, Sproule S, Gilmartin G, Werkstrom V, Aurivillius M, Goldman M; CALIMA study investigators. Benralizumab, an anti-interleukin-5 receptor alpha monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2128-2141. doi: 10.1016/S0140-6736(16)31322-8. Epub 2016 Sep 5.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 août 2013
Achèvement primaire (Réel)
1 mars 2016
Achèvement de l'étude (Réel)
1 mars 2016
Dates d'inscription aux études
Première soumission
31 juillet 2013
Première soumission répondant aux critères de contrôle qualité
31 juillet 2013
Première publication (Estimation)
2 août 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
25 janvier 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
30 novembre 2016
Dernière vérification
1 novembre 2016
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- D3250C00018
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .