A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma
Start Date
8/24/2023
Completion Date
8/23/2030
Summary
To assess the efficacy and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.
Detailed Description
This is a phase-3 multicentre, double-blind, parallel-group placebo-controlled, randomised study. The study will comprise of: 1. Screening/Run-in period of 4 to 6 weeks, 2. 52-week double-blind Treatment period, 3. Post-treatment Follow-up period of 12 weeks. Participants will be randomised 2:1 to receive either tezepelumab or placebo administered by (SC) Subcutaneous injections for 52 weeks (double-blind Treatment period). There will then be a 12-week off-treatment Follow-up period for participants who do not continue in the optional open-label Active Treatment Extension period. An optional open-label Active Treatment Extension will allow all eligible participants the opportunity to receive active treatment with tezepelumab. The Active Treatment Extension period of the study will start following the 52-week double-blind Treatment period and will consist of a 104-week open-label Treatment period prior to the 12-week post-treatment Follow-up period.
Eligibility Criteria
Age Range: 5 years to 11 years
Interventions
Tezepelumab
Placebo
Conditions
Locations
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Montgomery, Alabama 36106
United States
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Phoenix, Arizona 85016
United States
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Little Rock, Arkansas 72202
United States
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La Jolla, California 92037
United States
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Long Beach, California 90806
United States
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Orange, California 92868
United States
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San Diego, California 92123
United States
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Atlanta, Georgia 30322
United States
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Savannah, Georgia 31406
United States
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Baltimore, Maryland 21287
United States
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Boston, Massachusetts 02114
United States
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Boston, Massachusetts 02115
United States
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Ann Arbor, Michigan 48105
United States
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Detroit, Michigan 48201
United States
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Northfield, New Jersey 08225
United States
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Hawthorne, New York 10532
United States
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Schenectady, New York 12304
United States
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Staten Island, New York 10305
United States
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Chapel Hill, North Carolina 27514
United States
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Cincinnati, Ohio 45229-3039
United States
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Cleveland, Ohio 44106
United States
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Toledo, Ohio 43617
United States
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Oklahoma City, Oklahoma 73120
United States
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Columbia, South Carolina 29203
United States
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Coppell, Texas 75019
United States
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Dallas, Texas 75246
United States
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Frisco, Texas 75034
United States
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Houston, Texas 77030
United States
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San Antonio, Texas 78249
United States
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Temple, Texas 76508
United States
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Buenos Aires, 1426
Argentina
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Buenos Aires, C1121ABE
Argentina
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Buenos Aires, C1122
Argentina
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CABA, C1028AAP
Argentina
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Florida, B1602DQD
Argentina
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Lanus, B1824KAJ
Argentina
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Lobos, 7240
Argentina
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Mendoza, M5500CCG
Argentina
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Quilmes, B1878FNR
Argentina
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Rosario, 2000
Argentina
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Blumenau, 89030-101
Brazil
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Curitiba, 80060-240
Brazil
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Salvador, 40060-330
Brazil
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São Paulo, 01227-200
Brazil
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São Paulo, 04024-002
Brazil
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São Paulo, 05430-010
Brazil
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Sorocaba, 18040-425
Brazil
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Edmonton, Alberta T6G 1C9
Canada
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Burlington, Ontario L7L 6W6
Canada
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Hamilton, Ontario L8S 1G5
Canada
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Windsor, Ontario N8X 2G1
Canada
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Montreal, Quebec H4A 3J1
Canada
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Beijing, 100191
China
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Changchun, 130021
China
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Lanzhou, 730000
China
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Nanjing, 210008
China
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Shanghai, 200062
China
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Shanghai, 200127
China
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Shenyang, 110004
China
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Shenzhen, 518026
China
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Wuxi, 214023
China
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Bogotá, 110231
Colombia
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Bogotá,
Colombia
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Medellín, 050034
Colombia
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Brest, 29609
France
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Bron, 69500
France
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Créteil, 94010
France
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Marseille, 13005
France
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Paris, 75012
France
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Paris, 75015
France
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Paris, 75019
France
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Rouen, 76031
France
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Vandœuvre-lès-Nancy, 54511
France
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Debrecen, 4031
Hungary
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Szeged, 6720
Hungary
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Szigetvár, 7900
Hungary
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Genova, 16147
Italy
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Pavia, 27100
Italy
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Roma, 00165
Italy
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Fukuoka, 811-1394
Japan
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Fukuoka, 813-0017
Japan
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Fukuyama, 720-8520
Japan
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Funabashi-shi, 273-8588
Japan
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Nara, 630-8581
Japan
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Odawara, 250-0055
Japan
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Ōtsu, 520-0804
Japan
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Saga, 840-8571
Japan
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Shimotsuga-gun, 321-0293
Japan
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Yokohama, 223-0059
Japan
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Chihuahua City, 31000
Mexico
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Guadalajara, 44100
Mexico
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Mexico City, 06100
Mexico
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Veracruz, 91910
Mexico
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Amsterdam, 1105 AZ
Netherlands
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Rotterdam, 3015 GD
Netherlands
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Iloilo City, 5000
Philippines
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Las Piñas, 1740
Philippines
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Quezon, 1100
Philippines
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Santa Rosa, 4026
Philippines
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Lodz, 90-329
Poland
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Tarnów, 33-100
Poland
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Bucharest, 020395
Romania
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Bucharest, 050159
Romania
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Bellville, 7531
South Africa
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Cape Town, 7925
South Africa
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Durban, 3630
South Africa
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Durban, 4001
South Africa
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Middelburg, 1055
South Africa
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Thabazimbi, 0380
South Africa
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Vereeniging, 1935
South Africa
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Welkom, 9460
South Africa
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Seongnam-si, 13496
South Korea
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Seongnam-si, 13620
South Korea
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Seoul, 03181
South Korea
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Seoul, 03722
South Korea
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Badalona, 08916
Spain
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Barcelona, 08035
Spain
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Esplugues de Llobregat (Barc), 08950
Spain
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Madrid, 28009
Spain
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Sabadell, 08208
Spain
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Valencia, 46010
Spain
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Valencia, 46026
Spain
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Villarreal, 12540
Spain
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Bangkok, 10330
Thailand
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Bangkoknoi, 10700
Thailand
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Chiang Mai, 50200
Thailand
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Muang, 40002
Thailand
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Bursa, 16059
Turkey (Türkiye)
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Istanbul, 34899
Turkey (Türkiye)
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Izmir, 35210
Turkey (Türkiye)
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Yenimahalle, 06500
Turkey (Türkiye)
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Chernivtsi, 58002
Ukraine
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Ivano-Frankivsk, 76000
Ukraine
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Kyiv, 03038
Ukraine
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Kyiv, 04050
Ukraine
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Birmingham, B4 6NH
United Kingdom
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Bradford, BD9 6RJ
United Kingdom
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Bristol, BS2 8BJ
United Kingdom
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Glasgow, G3 8SJ
United Kingdom
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Leicester, LE1 5WW
United Kingdom
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London, SE5 9RS
United Kingdom
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Nottingham, NG7 2UH
United Kingdom
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Stoke-on-Trent, ST4 6QG
United Kingdom