Actively Recruiting
A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma
Led by AstraZeneca · Updated on 2026-04-30
231
Participants Needed
143
Research Sites
365 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
A
Amgen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent from a parent or caregiver and assent from the child when appropriate
- Age between 5 and under 12 years at time of consent and assent
- Physician-diagnosed severe asthma for at least 6 months before screening
- On a stable medium or high daily dose of inhaled corticosteroids for at least 3 months prior to screening
- Using at least one additional maintenance asthma controller medication for at least 3 months prior to screening
- Evidence of asthma confirmed by lung function tests or other clinical measures
- History of at least 2 severe asthma exacerbations or 1 exacerbation leading to hospitalisation in the past 12 months
- Pre-bronchodilator lung function showing FEV1 over 50% and up to 95% predicted or FEV1/FVC ratio 0.85 or less at screening
- Evidence of uncontrolled asthma based on asthma control questionnaire scores, reliever medication use, or asthma symptoms during screening
- Body weight of at least 16 kg at screening and randomisation
You will not qualify if you...
- History of vocal cord dysfunction, cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitis with nasal polyposis
- Any other clinically significant disease or disorder that may risk participant safety or affect study results
- Recent worsening of asthma or exacerbation requiring systemic corticosteroids within 30 days before screening
- Change in inhaled corticosteroid dose within 1 month prior to screening
- History of life-threatening asthma exacerbation causing hypoxic seizure or requiring intubation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 143 locations
1
Research Site
Montgomery, Alabama, United States, 36106
Actively Recruiting
2
Research Site
Phoenix, Arizona, United States, 85016
Actively Recruiting
3
Research Site
Little Rock, Arkansas, United States, 72202
Withdrawn
4
Research Site
La Jolla, California, United States, 92037
Actively Recruiting
5
Research Site
Long Beach, California, United States, 90806
Not Yet Recruiting
6
Research Site
Orange, California, United States, 92868
Withdrawn
7
Research Site
San Diego, California, United States, 92123
Actively Recruiting
8
Research Site
Atlanta, Georgia, United States, 30322
Actively Recruiting
9
Research Site
Savannah, Georgia, United States, 31406
Terminated
10
Research Site
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
11
Research Site
Boston, Massachusetts, United States, 02114
Actively Recruiting
12
Research Site
Boston, Massachusetts, United States, 02115
Actively Recruiting
13
Research Site
Ann Arbor, Michigan, United States, 48105
Terminated
14
Research Site
Detroit, Michigan, United States, 48201
Actively Recruiting
15
Research Site
Northfield, New Jersey, United States, 08225
Actively Recruiting
16
Research Site
Hawthorne, New York, United States, 10532
Not Yet Recruiting
17
Research Site
Schenectady, New York, United States, 12304
Withdrawn
18
Research Site
Staten Island, New York, United States, 10305
Actively Recruiting
19
Research Site
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
20
Research Site
Cincinnati, Ohio, United States, 45229-3039
Actively Recruiting
21
Research Site
Cleveland, Ohio, United States, 44106
Actively Recruiting
22
Research Site
Toledo, Ohio, United States, 43617
Actively Recruiting
23
Research Site
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
24
Research Site
Columbia, South Carolina, United States, 29203
Withdrawn
25
Research Site
Coppell, Texas, United States, 75019
Terminated
26
Research Site
Dallas, Texas, United States, 75246
Actively Recruiting
27
Research Site
Frisco, Texas, United States, 75034
Withdrawn
28
Research Site
Houston, Texas, United States, 77030
Not Yet Recruiting
29
Research Site
San Antonio, Texas, United States, 78249
Actively Recruiting
30
Research Site
Temple, Texas, United States, 76508
Withdrawn
31
Research Site
Buenos Aires, Argentina, 1426
Actively Recruiting
32
Research Site
Buenos Aires, Argentina, C1121ABE
Actively Recruiting
33
Research Site
Buenos Aires, Argentina, C1122
Actively Recruiting
34
Research Site
CABA, Argentina, C1028AAP
Terminated
35
Research Site
Florida, Argentina, B1602DQD
Actively Recruiting
36
Research Site
Lanus, Argentina, B1824KAJ
Actively Recruiting
37
Research Site
Lobos, Argentina, 7240
Actively Recruiting
38
Research Site
Mendoza, Argentina, M5500CCG
Actively Recruiting
39
Research Site
Quilmes, Argentina, B1878FNR
Terminated
40
Research Site
Rosario, Argentina, 2000
Actively Recruiting
41
Research Site
Blumenau, Brazil, 89030-101
Actively Recruiting
42
Research Site
Curitiba, Brazil, 80060-240
Actively Recruiting
43
Research Site
Salvador, Brazil, 40060-330
Withdrawn
44
Research Site
São Paulo, Brazil, 01227-200
Actively Recruiting
45
Research Site
São Paulo, Brazil, 04024-002
Actively Recruiting
46
Research Site
São Paulo, Brazil, 05430-010
Actively Recruiting
47
Research Site
Sorocaba, Brazil, 18040-425
Actively Recruiting
48
Research Site
Edmonton, Alberta, Canada, T6G 1C9
Actively Recruiting
49
Research Site
Burlington, Ontario, Canada, L7L 6W6
Actively Recruiting
50
Research Site
Hamilton, Ontario, Canada, L8S 1G5
Actively Recruiting
51
Research Site
Windsor, Ontario, Canada, N8X 2G1
Actively Recruiting
52
Research Site
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
53
Research Site
Beijing, China, 100191
Actively Recruiting
54
Research Site
Changchun, China, 130021
Actively Recruiting
55
Research Site
Lanzhou, China, 730000
Actively Recruiting
56
Research Site
Nanjing, China, 210008
Actively Recruiting
57
Research Site
Shanghai, China, 200062
Actively Recruiting
58
Research Site
Shanghai, China, 200127
Withdrawn
59
Research Site
Shenyang, China, 110004
Actively Recruiting
60
Research Site
Shenzhen, China, 518026
Actively Recruiting
61
Research Site
Wuxi, China, 214023
Actively Recruiting
62
Research Site
Bogotá, Colombia, 110231
Withdrawn
63
Research Site
Bogotá, Colombia
Withdrawn
64
Research Site
Medellín, Colombia, 050034
Withdrawn
65
Research Site
Brest, France, 29609
Actively Recruiting
66
Research Site
Bron, France, 69500
Suspended
67
Research Site
Créteil, France, 94010
Actively Recruiting
68
Research Site
Marseille, France, 13005
Actively Recruiting
69
Research Site
Paris, France, 75012
Actively Recruiting
70
Research Site
Paris, France, 75015
Actively Recruiting
71
Research Site
Paris, France, 75019
Actively Recruiting
72
Research Site
Rouen, France, 76031
Actively Recruiting
73
Research Site
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
74
Research Site
Debrecen, Hungary, 4031
Actively Recruiting
75
Research Site
Szeged, Hungary, 6720
Actively Recruiting
76
Research Site
Szigetvár, Hungary, 7900
Actively Recruiting
77
Research Site
Genova, Italy, 16147
Actively Recruiting
78
Research Site
Pavia, Italy, 27100
Actively Recruiting
79
Research Site
Roma, Italy, 00165
Not Yet Recruiting
80
Research Site
Fukuoka, Japan, 811-1394
Actively Recruiting
81
Research Site
Fukuoka, Japan, 813-0017
Actively Recruiting
82
Research Site
Fukuyama, Japan, 720-8520
Actively Recruiting
83
Research Site
Funabashi-shi, Japan, 273-8588
Actively Recruiting
84
Research Site
Nara, Japan, 630-8581
Actively Recruiting
85
Research Site
Odawara, Japan, 250-0055
Actively Recruiting
86
Research Site
Ōtsu, Japan, 520-0804
Actively Recruiting
87
Research Site
Saga, Japan, 840-8571
Actively Recruiting
88
Research Site
Shimotsuga-gun, Japan, 321-0293
Actively Recruiting
89
Research Site
Yokohama, Japan, 223-0059
Withdrawn
90
Research Site
Chihuahua City, Mexico, 31000
Actively Recruiting
91
Research Site
Guadalajara, Mexico, 44100
Actively Recruiting
92
Research Site
Mexico City, Mexico, 06100
Not Yet Recruiting
93
Research Site
Veracruz, Mexico, 91910
Actively Recruiting
94
Research Site
Amsterdam, Netherlands, 1105 AZ
Actively Recruiting
95
Research Site
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
96
Research Site
Iloilo City, Philippines, 5000
Actively Recruiting
97
Research Site
Las Piñas, Philippines, 1740
Actively Recruiting
98
Research Site
Quezon, Philippines, 1100
Actively Recruiting
99
Research Site
Santa Rosa, Philippines, 4026
Actively Recruiting
100
Research Site
Lodz, Poland, 90-329
Actively Recruiting
101
Research Site
Tarnów, Poland, 33-100
Actively Recruiting
102
Research Site
Bucharest, Romania, 020395
Actively Recruiting
103
Research Site
Bucharest, Romania, 050159
Actively Recruiting
104
Research Site
Bellville, South Africa, 7531
Actively Recruiting
105
Research Site
Cape Town, South Africa, 7925
Actively Recruiting
106
Research Site
Durban, South Africa, 3630
Actively Recruiting
107
Research Site
Durban, South Africa, 4001
Actively Recruiting
108
Research Site
Middelburg, South Africa, 1055
Completed
109
Research Site
Thabazimbi, South Africa, 0380
Withdrawn
110
Research Site
Vereeniging, South Africa, 1935
Actively Recruiting
111
Research Site
Welkom, South Africa, 9460
Actively Recruiting
112
Research Site
Seongnam-si, South Korea, 13496
Withdrawn
113
Research Site
Seongnam-si, South Korea, 13620
Actively Recruiting
114
Research Site
Seoul, South Korea, 03181
Actively Recruiting
115
Research Site
Seoul, South Korea, 03722
Actively Recruiting
116
Research Site
Badalona, Spain, 08916
Actively Recruiting
117
Research Site
Barcelona, Spain, 08035
Actively Recruiting
118
Research Site
Esplugues de Llobregat (Barc), Spain, 08950
Actively Recruiting
119
Research Site
Madrid, Spain, 28009
Actively Recruiting
120
Research Site
Sabadell, Spain, 08208
Actively Recruiting
121
Research Site
Valencia, Spain, 46010
Actively Recruiting
122
Research Site
Valencia, Spain, 46026
Withdrawn
123
Research Site
Villarreal, Spain, 12540
Actively Recruiting
124
Research Site
Bangkok, Thailand, 10330
Not Yet Recruiting
125
Research Site
Bangkoknoi, Thailand, 10700
Not Yet Recruiting
126
Research Site
Chiang Mai, Thailand, 50200
Not Yet Recruiting
127
Research Site
Muang, Thailand, 40002
Actively Recruiting
128
Research Site
Bursa, Turkey (Türkiye), 16059
Actively Recruiting
129
Research Site
Istanbul, Turkey (Türkiye), 34899
Actively Recruiting
130
Research Site
Izmir, Turkey (Türkiye), 35210
Actively Recruiting
131
Research Site
Yenimahalle, Turkey (Türkiye), 06500
Not Yet Recruiting
132
Research Site
Chernivtsi, Ukraine, 58002
Actively Recruiting
133
Research Site
Ivano-Frankivsk, Ukraine, 76000
Actively Recruiting
134
Research Site
Kyiv, Ukraine, 03038
Actively Recruiting
135
Research Site
Kyiv, Ukraine, 04050
Actively Recruiting
136
Research Site
Birmingham, United Kingdom, B4 6NH
Actively Recruiting
137
Research Site
Bradford, United Kingdom, BD9 6RJ
Actively Recruiting
138
Research Site
Bristol, United Kingdom, BS2 8BJ
Actively Recruiting
139
Research Site
Glasgow, United Kingdom, G3 8SJ
Withdrawn
140
Research Site
Leicester, United Kingdom, LE1 5WW
Actively Recruiting
141
Research Site
London, United Kingdom, SE5 9RS
Actively Recruiting
142
Research Site
Nottingham, United Kingdom, NG7 2UH
Actively Recruiting
143
Research Site
Stoke-on-Trent, United Kingdom, ST4 6QG
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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