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: March 31, 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, 1426
    Argentina

    Active - Recruiting

  • Research Site

    Buenos Aires 3435910, 1426
    Argentina

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  • Research Site

    CABA, C1028AAP
    Argentina

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    Caba, 1426
    Argentina

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    Capital Federal, C1122AAK
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    Florida, B1602DQD
    Argentina

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    Florida 3433908, B1602DQD
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    Lanus, B1824KAJ
    Argentina

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    Lanus Este, B1824KAJ
    Argentina

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    Lanús, B1824KAJ
    Argentina

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  • Research Site

    Lanús 3432135, B1824KAJ
    Argentina

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  • Research Site

    Lobos, 7240
    Argentina

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  • Research Site

    Lobos 3431313, 7240
    Argentina

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    Mendoza, M5500CCG
    Argentina

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    Mendoza 3844421, M5500CCG
    Argentina

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    Quilmes, B1878FNR
    Argentina

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    Quilmes 3429652, B1878FNR
    Argentina

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    Rosario, 2000
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    Rosario 3838583, 2000
    Argentina

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    Blumenau, 89030-101
    Brazil

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    Blumenau 3469968, 89030-101
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    Curitiba, 80060-240
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    Curitiba 3464975, 80060-240
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    Salvador, 40060-330
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    Salvador 3450554, 40060-330
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    Sao Paulo, 01227-200
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    Sorocaba, 18040-425
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    Sorocaba 3447399, 18040-425
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    São Paulo, 04024-002
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    São Paulo 3448439, 05430-010
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    Edmonton, Alberta T6G 1C9
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    Edmonton 5946768, Alberta 5883102 T6G 1C9
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    Beijing, 100191
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    Beijing 1816670, 100191
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    Changchun, 130021
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    Changchun 2038180, 130021
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    Lanzhou, 730000
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    Lanzhou 1804430, 730000
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    Nanjing, 210008
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    Nanjing 1799962, 210008
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    Shanghai, 200127
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    Shanghai 1796236, 200062
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    Medellín 3674962, 050034
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    Brest, 29609
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    Bron, 69500
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    Genova 8969657, 16147
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    Pavia 3171366, 27100
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    Roma, 00165
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    Roma 8957247, 00165
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    Fukuoka, 813-0017
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    Fukuoka 1863967, 813-0017
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    Fukuyama, 720-8520
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    Fukuyama 1863917, 720-8520
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    Odawara, 250-0055
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    Odawara 1854747, 250-0055
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    Otsu, 520-0804
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    Saga, 840-8571
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    Shimotsuga-gun, 321-0293
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    Chihuahua City, 31000
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    Guadalajara, 44100
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    Guadalajara 4005539, 44100
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    Mexico City, 06100
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    Mexico City 3530597, 06100
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    Veracruz, 91910
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    Veracruz 3514783, 91910
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    Amsterdam, 1105 AZ
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    Amsterdam 2759794, 1105 AZ
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    Rotterdam, 3015 GD
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    Rotterdam 2747891, 3015 GD
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    Iloilo, 5000
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    Iloilo City, 5000
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    Iloilo City 1711005, 5000
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    Las Piñas, 1740
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    Las Piñas 1707174, 1740
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    Quezon, 1100
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    Quezon 1692214, 1100
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    Quezon City, 1101
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    Santa Rosa, 4026
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    Santa Rosa 1687894, 4026
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    Lodz, 90-329
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    Lodz 3093133, 90-329
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    Tarnow, 33-100
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    Tarnów, 33-100
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    Tarnów 757026, 33-100
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    Bucharest 683506, 050159
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    Bellville 3370141, 7531
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    Durban 1007311, 3630
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    Middelburg, 1055
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    Middelburg 976361, 1055
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    Thabazimbi, 0380
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    Thabazimbi 949683, 0380
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    Vereeniging, 1935
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    Vereeniging 944385, 1935
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    Welkom, 9460
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    United States

    Site Not Available

  • Research Site

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • Research Site

    Phoenix 5308655, Arizona 5551752 85016
    United States

    Site Not Available

  • Research Site

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Research Site

    Little Rock 4119403, Arkansas 4099753 72202
    United States

    Site Not Available

  • Research Site

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Research Site

    Long Beach, California 90806
    United States

    Site Not Available

  • Research Site

    Orange, California 92868
    United States

    Site Not Available

  • Research Site

    San Diego, California 92123
    United States

    Active - Recruiting

  • Research Site

    La Jolla 5363943, California 5332921 92037
    United States

    Site Not Available

  • Research Site

    Long Beach 5367929, California 5332921 90806
    United States

    Site Not Available

  • Research Site

    Orange 5379513, California 5332921 92868
    United States

    Site Not Available

  • Research Site

    San Diego 5391811, California 5332921 92123
    United States

    Site Not Available

  • Research Site

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Research Site

    Savannah, Georgia 31406
    United States

    Completed

  • Research Site

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Site Not Available

  • Research Site

    Savannah 4221552, Georgia 4197000 31406
    United States

    Site Not Available

  • Research Site

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Research Site

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Site Not Available

  • Research Site

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Research Site

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • Research Site

    Ann Arbor, Michigan 48105
    United States

    Completed

  • Research Site

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Research Site

    Ann Arbor 4984247, Michigan 5001836 48105
    United States

    Site Not Available

  • Research Site

    Detroit 4990729, Michigan 5001836 48201
    United States

    Site Not Available

  • Research Site

    Northfield, New Jersey 08225
    United States

    Active - Recruiting

  • Research Site

    Northfield 4503316, New Jersey 5101760 08225
    United States

    Site Not Available

  • Research Site

    Hawthorne, New York 10532
    United States

    Site Not Available

  • Research Site

    Schenectady, New York 12304
    United States

    Site Not Available

  • Research Site

    Staten Island, New York 10305
    United States

    Active - Recruiting

  • Research Site

    Schenectady 5136454, New York 5128638 12304
    United States

    Site Not Available

  • Research Site

    Staten Island 5139568, New York 5128638 10305
    United States

    Site Not Available

  • Research Site

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • Research Site

    Chapel Hill 4460162, North Carolina 4482348 27514
    United States

    Site Not Available

  • 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

    Cincinnati 4508722, Ohio 5165418 45229-3039
    United States

    Site Not Available

  • Research Site

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Site Not Available

  • Research Site

    Toledo 5174035, Ohio 5165418 43617
    United States

    Site Not Available

  • Research Site

    Oklahoma City, Oklahoma 73120
    United States

    Active - Recruiting

  • Research Site

    Oklahoma City 4544349, Oklahoma 4544379 73120
    United States

    Site Not Available

  • Research Site

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • Research Site

    Columbia 4575352, South Carolina 4597040 29203
    United States

    Site Not Available

  • Research Site

    Coppell, Texas 75019
    United States

    Completed

  • 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

  • Research Site

    Coppell 4683217, Texas 4736286 75019
    United States

    Site Not Available

  • Research Site

    Dallas 4684888, Texas 4736286 75246
    United States

    Site Not Available

  • Research Site

    Frisco 4692559, Texas 4736286 75034
    United States

    Site Not Available

  • Research Site

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Research Site

    San Antonio 4726206, Texas 4736286 78249
    United States

    Site Not Available

  • Research Site

    Temple 4735966, Texas 4736286 76508
    United States

    Site Not Available

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