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: April 2, 2025
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 for at least 6 months prior to Visit

  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. Evidence of asthma as documented by one of the following:

  7. Documented historical BD responsiveness of FEV1 ≥ 10% in the previous 12 monthsprior to Visit 1 OR

  8. Documented historical methacholine challenge result of ≤ 16 mg/mL in theprevious 12 months prior to Visit 1 OR

  9. Post-BD (albuterol/salbutamol) responsiveness of FEV1 ≥ 10% during Screening (15 to 30 min after administration of 4 puffs of albuterol/salbutamol) ateither Visit 1 or Visit 2.

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

  11. Pre-BD FEV-1 >50% and ≤ 95%PN OR FEV1/forced vital capacity (FVC) ratio ≤ 0.8 ateither Visit 1 or Visit 2.

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

  13. 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

  14. 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

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

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

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

Exclusion

Exclusion Criteria:

  1. History of cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitiswith 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 or mechanical ventilation.

Study Design

Total Participants: 372
Treatment Group(s): 2
Primary Treatment: Tezepelumab
Phase: 3
Study Start date:
August 24, 2023
Estimated Completion Date:
December 31, 2027

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 24-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

    Caba, C1028AAP
    Argentina

    Active - Recruiting

  • Research Site

    Capital Federal, C1122AAK
    Argentina

    Active - Recruiting

  • Research Site

    Florida, B1602DQD
    Argentina

    Active - Recruiting

  • Research Site

    Lanus Este, B1824KAJ
    Argentina

    Active - Recruiting

  • Research Site

    Lobos, 7240
    Argentina

    Active - Recruiting

  • Research Site

    Mendoza, M5500GIP
    Argentina

    Active - Recruiting

  • Research Site

    Quilmes, B1878FNR
    Argentina

    Active - Recruiting

  • Research Site

    Rosario, 2000
    Argentina

    Active - Recruiting

  • Research Site

    Blumenau, 89030-101
    Brazil

    Active - Recruiting

  • Research Site

    Curitiba, 80060-900
    Brazil

    Active - Recruiting

  • Research Site

    Salvador, 40060-330
    Brazil

    Active - Recruiting

  • Research Site

    Sao Paulo, 01227-200
    Brazil

    Active - Recruiting

  • Research Site

    Sorocaba, 18040-425
    Brazil

    Active - Recruiting

  • Research Site

    São Paulo, 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, 200127
    China

    Site Not Available

  • Research Site

    Shenyang, 110004
    China

    Active - Recruiting

  • Research Site

    Shenzhen, 518034
    China

    Active - Recruiting

  • Research Site

    Wuxi, 214023
    China

    Active - Recruiting

  • Research Site

    Bogota,
    Colombia

    Site Not Available

  • Research Site

    Bogotá, 110231
    Colombia

    Site Not Available

  • Research Site

    Medellín, 050034
    Colombia

    Site Not Available

  • Research Site

    Bois Guillaume, 76031
    France

    Active - Recruiting

  • Research Site

    Brest, 29609
    France

    Active - Recruiting

  • Research Site

    Bron, 69677
    France

    Active - Recruiting

  • Research Site

    Creteil, 94010
    France

    Active - Recruiting

  • Research Site

    Marseille, 13005
    France

    Active - Recruiting

  • Research Site

    Paris, 75015
    France

    Active - Recruiting

  • Research Site

    Vandoeuvre les Nancy Cedex, 54511
    France

    Active - Recruiting

  • Research Site

    Debrecen, 4031
    Hungary

    Active - Recruiting

  • Research Site

    Szeged, 7620
    Hungary

    Active - Recruiting

  • Research Site

    Szigetvár, 7900
    Hungary

    Active - Recruiting

  • Research Site

    Fukuoka-shi, 813-0017
    Japan

    Active - Recruiting

  • Research Site

    Fukuyama-shi,
    Japan

    Active - Recruiting

  • Research Site

    Funabashi-shi, 273-8588
    Japan

    Active - Recruiting

  • Research Site

    Nara-shi, 630-8581
    Japan

    Active - Recruiting

  • Research Site

    Odawara, 250-8558
    Japan

    Active - Recruiting

  • Research Site

    Otsu-shi, 520-0804
    Japan

    Active - Recruiting

  • Research Site

    Saga-shi, 840-8571
    Japan

    Active - Recruiting

  • Research Site

    Shimotsuga-gun, 321-0293
    Japan

    Active - Recruiting

  • Research Site

    Yokohama-shi, 223-0059
    Japan

    Site Not Available

  • Research Site

    SeongNam, 13620
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Seongnam-Si, 463-712
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Seoul, 110746
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Chihuahua, 31000
    Mexico

    Site Not Available

  • Research Site

    Guadalajara, 44100
    Mexico

    Active - Recruiting

  • Research Site

    Mexico City, 06100
    Mexico

    Site Not Available

  • Research Site

    Veracruz, 91910
    Mexico

    Site Not Available

  • Research Site

    Amsterdam, 1105 AZ
    Netherlands

    Active - Recruiting

  • Research Site

    Rotterdam, 3015 GD
    Netherlands

    Active - Recruiting

  • Research Site

    Iloilo,
    Philippines

    Active - Recruiting

  • Research Site

    Las Piñas, 1740
    Philippines

    Active - Recruiting

  • Research Site

    Quezon City, 1101
    Philippines

    Active - Recruiting

  • Research Site

    Santa Rosa, 4026
    Philippines

    Active - Recruiting

  • Research Site

    Tarnow, 33-100
    Poland

    Active - Recruiting

  • Research Site

    Tarnów, 33-100
    Poland

    Active - Recruiting

  • Research Site

    Łódź, 90-302
    Poland

    Active - Recruiting

  • Research Site

    Bucharest, 050159
    Romania

    Site Not Available

  • Research Site

    Bellville, 7531
    South Africa

    Active - Recruiting

  • Research Site

    Cape Town, 7925
    South Africa

    Active - Recruiting

  • Research Site

    Durban, 3630
    South Africa

    Active - Recruiting

  • Research Site

    Middelburg, 1050
    South Africa

    Active - Recruiting

  • Research Site

    Thabazimbi, 0380
    South Africa

    Site Not Available

  • Research Site

    Vereeniging, 1935
    South Africa

    Active - Recruiting

  • Research Site

    Welkom, 9460
    South Africa

    Active - Recruiting

  • Research Site

    Barcelona, 08208
    Spain

    Active - Recruiting

  • Research Site

    Esplugues De Llobregat (Barc), 08950
    Spain

    Active - Recruiting

  • Research Site

    Madrid, 28009
    Spain

    Active - Recruiting

  • Research Site

    Valencia, 46010
    Spain

    Active - Recruiting

  • Research Site

    Villarreal (Castellón), 12540
    Spain

    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

    Newcastle-Under-Lyme, ST4 6QG
    United Kingdom

    Site Not Available

  • Research Site

    Nottingham, NG7 2UH
    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

    Active - Recruiting

  • Research Site

    La Jolla, California 92037
    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

    Completed

  • Research Site

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Research Site

    Ann Arbor, Michigan 48105
    United States

    Active - Recruiting

  • Research Site

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Research Site

    Northfield, New Jersey 08225
    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

    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

    Coppell, Texas 75019
    United States

    Active - Recruiting

  • Research Site

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • Research Site

    Frisco, Texas 75034
    United States

    Site Not Available

  • Research Site

    San Antonio, Texas 78249
    United States

    Site Not Available

  • Research Site

    Temple, Texas 76508
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.