A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma

Last updated: May 29, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Asthma

Treatment

Tezepelumab

Placebo

Clinical Study ID

NCT06023589
D5180C00016
  • Ages 5-11
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent from (ICF) at least one parent/caregiver (as per localguidelines) and accompanying informed assent from the participant (where theparticipant is able to provide assent) prior to admission to the study.

  2. Participants must be 5 to < 12 years of age, at the time of signing the assent form (as applicable per local guidelines) and their caregivers signing the ICF and atVisit 3.

  3. Documented physician diagnosis of severe asthma confirmed and evaluated for at least 6 months prior to Visit 1.

  4. Documented physician-prescribed treatment with a total daily dose of either mediumor high dose, for at least 3 months with stable dose ≥ 1 month prior to Visit 1.

  5. Documented treatment with at least one additional maintenance asthma controllermedication is required according to local guidelines and standard of care; (long-acting beta agonist, leukotriene receptor antagonist, long-acting muscarinicantagonist) for at least 3 months with stable dose ≥ 1 month prior to Visit 1.

  6. Supportive evidence of asthma as documented by one of the following:

  7. Post-BD (albuterol/salbutamol) responsiveness of FEV1 ≥ 10% during Screening (15 to 30 min after administration of 4 puffs of albuterol/salbutamol with amaximum of 12 puffs of reliever medication only if tolerated by theparticipant) at either Visit 1 or Visit 2.If (a) is not achieved at Visit 1 or Visit 2, historical documentation by anyof the below prior to Visit 1:

  8. Post-BD responsiveness of FEV1 ≥ 10%.

  9. Positive methacholine challenge defined as provocative concentration (PC20) of ≤ 16 mg/mL.

  10. PEF average daily diurnal variability > 13% over a 2-week period.

  11. Variability of FEV1 ≥ 12% between any two clinical visits.

  12. Positive exercise challenge test (defined as a fall in FEV1 of > 12%).

  13. FeNO ≥ 20 ppb despite confirmed ICS maintenance therapy.

  14. History of at least 2 severe asthma exacerbation events OR 1 severe asthmaexacerbation event resulting in hospitalisation within 12 months prior to Visit 1.

  15. Pre-BD FEV1 >50% and ≤ 95%PN OR FEV1/forced vital capacity (FVC) ratio ≤ 0.85 ateither Visit 1 or Visit 2.

  16. Evidence of uncontrolled asthma, with at least 1 of the below criteria:

  17. ACQ-IA score ≥ 1.5 at least once during Screening/Run-in, including Visit 3 (prior to Randomisation) for participants ≥ 6 years old at Screening.

  18. Use of reliever medication, other than as a preventive for exercise inducedbronchospasm, on 3 or more days per week for at least 1 week during theScreening/Run-in period.

  19. Sleep awakening due to asthma symptoms requiring use of reliever medication atleast once during the Screening/Run-in period.

  20. Asthma symptoms 3 or more days per week in at least 1 week during theScreening/Run-in period.

  21. Body weight ≥ 16 kg at Visit 1 (Screening) and Visit 3 (Randomisation).

Exclusion

Exclusion Criteria:

  1. History of vocal cord dysfunction, cystic fibrosis, primary ciliary dyskinesia, orchronic rhinosinusitis with nasal polyposis.

  2. History of any clinically significant disease or disorder other than asthma which,in the opinion of the investigator, may either put the participant at risk becauseof participation in the study, or influence the results or the participant's abilityto participate in the study.

  3. History of a clinically significant deterioration in asthma or asthma exacerbationincluding those requiring use of systemic corticosteroids or increase in themaintenance dose of oral corticosteroids within 30 days prior to Visit 1.

  4. Change in ICS dose within 1 month prior to Visit 1.

  5. History of a life-threatening asthma exacerbation resulting in a hypoxic seizure orrequiring intubation.

Study Design

Total Participants: 231
Treatment Group(s): 2
Primary Treatment: Tezepelumab
Phase: 3
Study Start date:
August 24, 2023
Estimated Completion Date:
August 23, 2030

Study 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.

Connect with a study center

  • Research Site

    Buenos Aires, C1121ABE
    Argentina

    Active - Recruiting

  • Research Site

    Buenos Aires 3435910, C1122
    Argentina

    Active - Recruiting

  • Research Site

    CABA, C1028AAP
    Argentina

    Terminated

  • Research Site

    Caba, 1426
    Argentina

    Active - Recruiting

  • Research Site

    Florida, B1602DQD
    Argentina

    Active - Recruiting

  • Research Site

    Lanus, B1824KAJ
    Argentina

    Active - Recruiting

  • Research Site

    Lobos, 7240
    Argentina

    Active - Recruiting

  • Research Site

    Mendoza, M5500CCG
    Argentina

    Active - Recruiting

  • Research Site

    Quilmes, B1878FNR
    Argentina

    Terminated

  • Research Site

    Rosario, 2000
    Argentina

    Active - Recruiting

  • Research Site

    Blumenau, 89030-101
    Brazil

    Active - Recruiting

  • Research Site

    Curitiba, 80060-240
    Brazil

    Active - Recruiting

  • Research Site

    Salvador, 40060-330
    Brazil

    Site Not Available

  • Research Site

    Sao Paulo, 05403 000
    Brazil

    Active - Recruiting

  • Research Site

    Sorocaba, 18040-425
    Brazil

    Active - Recruiting

  • Research Site

    São Paulo, 05430-010
    Brazil

    Active - Recruiting

  • Research Site

    São Paulo 3448439, 04024-002
    Brazil

    Active - Recruiting

  • Research Site

    Edmonton, Alberta T6G 1C9
    Canada

    Active - Recruiting

  • Research Site

    Burlington, Ontario L7L 6W6
    Canada

    Active - Recruiting

  • Research Site

    Hamilton, Ontario L8S 1G5
    Canada

    Active - Recruiting

  • Research Site

    Windsor, Ontario N8X 2G1
    Canada

    Active - Recruiting

  • Research Site

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • Research Site

    Beijing, 100191
    China

    Active - Recruiting

  • Research Site

    Changchun, 130021
    China

    Active - Recruiting

  • Research Site

    Lanzhou, 730000
    China

    Active - Recruiting

  • Research Site

    Nanjing, 210008
    China

    Active - Recruiting

  • Research Site

    Shanghai, 200062
    China

    Active - Recruiting

  • Research Site

    Shanghai 1796236, 200127
    China

    Site Not Available

  • Research Site

    Shenyang, 110004
    China

    Active - Recruiting

  • Research Site

    Shenzhen, 518026
    China

    Active - Recruiting

  • Research Site

    Wuxi, 214023
    China

    Active - Recruiting

  • Research Site

    Bogotá,
    Colombia

    Site Not Available

  • Research Site

    Bogotá 3688689,
    Colombia

    Site Not Available

  • Research Site

    Medellín, 050034
    Colombia

    Site Not Available

  • Research Site

    Brest, 29609
    France

    Active - Recruiting

  • Research Site

    Bron, 69500
    France

    Suspended

  • Research Site

    Créteil, 94010
    France

    Active - Recruiting

  • Research Site

    Marseille, 13005
    France

    Active - Recruiting

  • Research Site

    Paris, 75015
    France

    Active - Recruiting

  • Research Site

    Paris 2988507, 75019
    France

    Active - Recruiting

  • Research Site

    Rouen, 76031
    France

    Active - Recruiting

  • Research Site

    Vandœuvre-lès-Nancy, 54511
    France

    Active - Recruiting

  • Research Site

    Debrecen, 4031
    Hungary

    Active - Recruiting

  • Research Site

    Szeged, 6720
    Hungary

    Active - Recruiting

  • Research Site

    Szigetvár, 7900
    Hungary

    Active - Recruiting

  • Research Site

    Genova, 16147
    Italy

    Active - Recruiting

  • Research Site

    Pavia, 27100
    Italy

    Active - Recruiting

  • Research Site

    Roma, 00165
    Italy

    Site Not Available

  • Research Site

    Fukuoka, 813-0017
    Japan

    Active - Recruiting

  • Research Site

    Fukuoka 1863967, 811-1394
    Japan

    Active - Recruiting

  • Research Site

    Fukuoka-shi, 811-1394
    Japan

    Active - Recruiting

  • Research Site

    Fukuyama, 720-8520
    Japan

    Active - Recruiting

  • Research Site

    Funabashi-shi, 273-8588
    Japan

    Active - Recruiting

  • Research Site

    Nara, 630-8581
    Japan

    Active - Recruiting

  • Research Site

    Nara 1855612, 630-8054
    Japan

    Active - Recruiting

  • Research Site

    Odawara, 250-0055
    Japan

    Active - Recruiting

  • Research Site

    Saga, 840-8571
    Japan

    Active - Recruiting

  • Research Site

    Shimotsuga-gun, 321-0293
    Japan

    Active - Recruiting

  • Research Site

    Yokohama, 223-0059
    Japan

    Site Not Available

  • Research Site

    Ōtsu, 520-0804
    Japan

    Active - Recruiting

  • Research Site

    Seongnam-Si, 463-712
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Chihuahua City, 31000
    Mexico

    Active - Recruiting

  • Research Site

    Guadalajara, 44100
    Mexico

    Active - Recruiting

  • Research Site

    Mexico City, 06100
    Mexico

    Site Not Available

  • Research Site

    Mexico City 3530597, 06760
    Mexico

    Site Not Available

  • Research Site

    Veracruz, 91910
    Mexico

    Active - Recruiting

  • Research Site

    Amsterdam, 1105 AZ
    Netherlands

    Active - Recruiting

  • Research Site

    Rotterdam, 3015 GD
    Netherlands

    Active - Recruiting

  • Research Site

    Iloilo,
    Philippines

    Active - Recruiting

  • Research Site

    Iloilo City, 5000
    Philippines

    Active - Recruiting

  • Research Site

    Las Piñas, 1740
    Philippines

    Active - Recruiting

  • Research Site

    Quezon, 1100
    Philippines

    Active - Recruiting

  • Research Site

    Santa Rosa, 4026
    Philippines

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  • Research Site

    Lodz, 90-329
    Poland

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    Tarnów, 33-100
    Poland

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    Łódź, 90-302
    Poland

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  • Research Site

    Bucharest, 050159
    Romania

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  • Research Site

    Bucharest 683506, 020395
    Romania

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  • Research Site

    Bellville, 7531
    South Africa

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    Cape Town, 7925
    South Africa

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    Durban, 4001
    South Africa

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  • Research Site

    Durban 1007311, 4001
    South Africa

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  • Research Site

    Middelburg, 1055
    South Africa

    Completed

  • Research Site

    Thabazimbi, 0380
    South Africa

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    Vereeniging, 1935
    South Africa

    Active - Recruiting

  • Research Site

    Welkom, 9460
    South Africa

    Active - Recruiting

  • Research Site

    Seongnam-si, 13496
    South Korea

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  • Research Site

    Seongnam-si 1897000, 13496
    South Korea

    Site Not Available

  • Research Site

    Seoul, 03722
    South Korea

    Active - Recruiting

  • Research Site

    Seoul 1835848, 03181
    South Korea

    Active - Recruiting

  • Research Site

    Badalona, 08916
    Spain

    Active - Recruiting

  • Research Site

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Research Site

    Esplugues de Llobregat (Barc), 08950
    Spain

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  • Research Site

    Madrid, 28009
    Spain

    Active - Recruiting

  • Research Site

    Sabadell, 08208
    Spain

    Active - Recruiting

  • Research Site

    Valencia, 46010
    Spain

    Active - Recruiting

  • Research Site

    Valencia 2509954, 46010
    Spain

    Active - Recruiting

  • Research Site

    Villarreal, 12540
    Spain

    Active - Recruiting

  • Research Site

    Bangkok, 10330
    Thailand

    Site Not Available

  • Research Site

    Bangkoknoi, 10700
    Thailand

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  • Research Site

    Chiang Mai, 50200
    Thailand

    Site Not Available

  • Research Site

    Muang, 40002
    Thailand

    Active - Recruiting

  • Research Site

    Bursa, 16059
    Turkey (Türkiye)

    Active - Recruiting

  • Research Site

    Istanbul, 34899
    Turkey (Türkiye)

    Active - Recruiting

  • Research Site

    Izmir, 35210
    Turkey (Türkiye)

    Active - Recruiting

  • Research Site

    Yenimahalle, 06500
    Turkey (Türkiye)

    Active - Recruiting

  • Research Site

    Chernivtsi, 58002
    Ukraine

    Active - Recruiting

  • Research Site

    Ivano-Frankivsk, 76000
    Ukraine

    Active - Recruiting

  • Research Site

    Kyiv, 03038
    Ukraine

    Active - Recruiting

  • Research Site

    Kyiv 703448, 03038
    Ukraine

    Active - Recruiting

  • Research Site

    Birmingham, B4 6NH
    United Kingdom

    Active - Recruiting

  • Research Site

    Bradford, BD9 6RJ
    United Kingdom

    Active - Recruiting

  • Research Site

    Bristol, BS2 8BJ
    United Kingdom

    Active - Recruiting

  • Research Site

    Glasgow, G3 8SJ
    United Kingdom

    Site Not Available

  • Research Site

    Leicester, LE1 5WW
    United Kingdom

    Active - Recruiting

  • Research Site

    London, SE5 9RS
    United Kingdom

    Active - Recruiting

  • Research Site

    Nottingham, NG7 2UH
    United Kingdom

    Active - Recruiting

  • Research Site

    Stoke-on-Trent, ST4 6QG
    United Kingdom

    Active - Recruiting

  • Research Site

    Montgomery, Alabama 36106
    United States

    Active - Recruiting

  • Research Site

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • Research Site

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Research Site

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Research Site

    Long Beach, California 90806
    United States

    Active - Recruiting

  • Research Site

    Orange, California 92868
    United States

    Site Not Available

  • Research Site

    San Diego, California 92123
    United States

    Active - Recruiting

  • Research Site

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Research Site

    Savannah, Georgia 31406
    United States

    Terminated

  • Research Site

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Research Site

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Research Site

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Active - Recruiting

  • Research Site

    Ann Arbor, Michigan 48105
    United States

    Terminated

  • Research Site

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Research Site

    Northfield, New Jersey 08225
    United States

    Active - Recruiting

  • Research Site

    Hawthorne, New York 10532
    United States

    Active - Recruiting

  • Research Site

    Schenectady, New York 12304
    United States

    Site Not Available

  • Research Site

    Staten Island, New York 10305
    United States

    Active - Recruiting

  • Research Site

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • Research Site

    Cincinnati, Ohio 45229-3039
    United States

    Active - Recruiting

  • Research Site

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Research Site

    Toledo, Ohio 43617
    United States

    Active - Recruiting

  • Research Site

    Oklahoma City, Oklahoma 73120
    United States

    Active - Recruiting

  • Research Site

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • Research Site

    Coppell, Texas 75019
    United States

    Terminated

  • Research Site

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • Research Site

    Frisco, Texas 75034
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Research Site

    San Antonio, Texas 78249
    United States

    Active - Recruiting

  • Research Site

    Temple, Texas 76508
    United States

    Site Not Available

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