A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma
NCT ID: NCT06023589
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
231 participants
INTERVENTIONAL
2023-08-24
2030-08-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma
NCT03706079
Effectiveness and Safety Study of Tezepelumab in Adults & Adolescent Participants With Severe Asthma in the United States
NCT05329194
Study to Evaluate Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma
NCT05274815
Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma
NCT03406078
Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma
NCT03347279
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tezepelumab
Participants will be receiving tezepelumab subcutaneous injection
Tezepelumab
Participants will be receiving subcutaneous injection of tezepelumab
Placebo
Participants will be receiving placebo through a subcutaneous injection
Placebo
Participants will be receiving subcutaneous injection of matching placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tezepelumab
Participants will be receiving subcutaneous injection of tezepelumab
Placebo
Participants will be receiving subcutaneous injection of matching placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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 at Visit 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 medium or 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 controller medication is required according to local guidelines and standard of care; (long-acting beta agonist, leukotriene receptor antagonist, long-acting muscarinic antagonist) 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:
1. Post-BD (albuterol/salbutamol) responsiveness of FEV1 ≥ 10% during Screening (15 to 30 min after administration of 4 puffs of albuterol/salbutamol with a maximum of 12 puffs of reliever medication only if tolerated by the participant) at either Visit 1 or Visit 2.
If (a) is not achieved at Visit 1 or Visit 2, historical documentation by any of the below prior to Visit 1:
2. Post-BD responsiveness of FEV1 ≥ 10%.
3. Positive methacholine challenge defined as provocative concentration (PC20) of ≤ 16 mg/mL.
4. PEF average daily diurnal variability \> 13% over a 2-week period.
5. Variability of FEV1 ≥ 12% between any two clinical visits.
6. Positive exercise challenge test (defined as a fall in FEV1 of \> 12%).
7. FeNO ≥ 20 ppb despite confirmed ICS maintenance therapy.
7. History of at least 2 severe asthma exacerbation events OR 1 severe asthma exacerbation event resulting in hospitalisation within 12 months prior to Visit 1.
8. Pre-BD FEV1 \>50% and ≤ 95%PN OR FEV1/forced vital capacity (FVC) ratio ≤ 0.85 at either Visit 1 or Visit 2.
9. Evidence of uncontrolled asthma, with at least 1 of the below criteria:
1. 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.
2. Use of reliever medication, other than as a preventive for exercise induced bronchospasm, on 3 or more days per week for at least 1 week during the Screening/Run-in period.
3. Sleep awakening due to asthma symptoms requiring use of reliever medication at least once during the Screening/Run-in period.
4. Asthma symptoms 3 or more days per week in at least 1 week during the Screening/Run-in period.
10. Body weight ≥ 16 kg at Visit 1 (Screening) and Visit 3 (Randomisation).
Exclusion Criteria
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 because of participation in the study, or influence the results or the participant's ability to participate in the study.
3. History of a clinically significant deterioration in asthma or asthma exacerbation including those requiring use of systemic corticosteroids or increase in the maintenance 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 or requiring intubation.
5 Years
11 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amgen
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Montgomery, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
La Jolla, California, United States
Research Site
Long Beach, California, United States
Research Site
Orange, California, United States
Research Site
San Diego, California, United States
Research Site
Atlanta, Georgia, United States
Research Site
Savannah, Georgia, United States
Research Site
Boston, Massachusetts, United States
Research Site
Boston, Massachusetts, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Detroit, Michigan, United States
Research Site
Northfield, New Jersey, United States
Research Site
Schenectady, New York, United States
Research Site
Staten Island, New York, United States
Research Site
Chapel Hill, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Toledo, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Columbia, South Carolina, United States
Research Site
Coppell, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Frisco, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Temple, Texas, United States
Research Site
Buenos Aires, , Argentina
Research Site
Buenos Aires, , Argentina
Research Site
Buenos Aires, , Argentina
Research Site
CABA, , Argentina
Research Site
Florida, , Argentina
Research Site
Lanús, , Argentina
Research Site
Lobos, , Argentina
Research Site
Mendoza, , Argentina
Research Site
Quilmes, , Argentina
Research Site
Rosario, , Argentina
Research Site
Blumenau, , Brazil
Research Site
Curitiba, , Brazil
Research Site
Salvador, , Brazil
Research Site
São Paulo, , Brazil
Research Site
São Paulo, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Sorocaba, , Brazil
Research Site
Edmonton, Alberta, Canada
Research Site
Burlington, Ontario, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Windsor, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Beijing, , China
Research Site
Changchun, , China
Research Site
Lanzhou, , China
Research Site
Nanjing, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shenyang, , China
Research Site
Shenzhen, , China
Research Site
Wuxi, , China
Research Site
Bogotá, , Colombia
Research Site
Bogotá, , Colombia
Research Site
Medellín, , Colombia
Research Site
Brest, , France
Research Site
Bron, , France
Research Site
Créteil, , France
Research Site
Marseille, , France
Research Site
Paris, , France
Research Site
Paris, , France
Research Site
Paris, , France
Research Site
Rouen, , France
Research Site
Vandœuvre-lès-Nancy, , France
Research Site
Debrecen, , Hungary
Research Site
Szeged, , Hungary
Research Site
Szigetvár, , Hungary
Research Site
Genova, , Italy
Research Site
Pavia, , Italy
Research Site
Roma, , Italy
Research Site
Fukuoka, , Japan
Research Site
Fukuoka, , Japan
Research Site
Fukuyama, , Japan
Research Site
Funabashi-shi, , Japan
Research Site
Nara, , Japan
Research Site
Odawara, , Japan
Research Site
Ōtsu, , Japan
Research Site
Saga, , Japan
Research Site
Shimotsuga-gun, , Japan
Research Site
Yokohama, , Japan
Research Site
Chihuahua City, , Mexico
Research Site
Guadalajara, , Mexico
Research Site
Mexico City, , Mexico
Research Site
Veracruz, , Mexico
Research Site
Amsterdam, , Netherlands
Research Site
Rotterdam, , Netherlands
Research Site
Iloilo City, , Philippines
Research Site
Las Piñas, , Philippines
Research Site
Quezon, , Philippines
Research Site
Santa Rosa, , Philippines
Research Site
Lodz, , Poland
Research Site
Tarnów, , Poland
Research Site
Bucharest, , Romania
Research Site
Bucharest, , Romania
Research Site
Bellville, , South Africa
Research Site
Cape Town, , South Africa
Research Site
Durban, , South Africa
Research Site
Durban, , South Africa
Research Site
Middelburg, , South Africa
Research Site
Thabazimbi, , South Africa
Research Site
Vereeniging, , South Africa
Research Site
Welkom, , South Africa
Research Site
Seongnam-si, , South Korea
Research Site
Seongnam-si, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Badalona, , Spain
Research Site
Barcelona, , Spain
Research Site
Esplugues de Llobregat (Barc), , Spain
Research Site
Madrid, , Spain
Research Site
Sabadell, , Spain
Research Site
Valencia, , Spain
Research Site
Valencia, , Spain
Research Site
Villarreal, , Spain
Research Site
Bangkok, , Thailand
Research Site
Bangkoknoi, , Thailand
Research Site
Chiang Mai, , Thailand
Research Site
Muang, , Thailand
Research Site
Bursa, , Turkey (Türkiye)
Research Site
Istanbul, , Turkey (Türkiye)
Research Site
Izmir, , Turkey (Türkiye)
Research Site
Yenimahalle, , Turkey (Türkiye)
Research Site
Chernivtsi, , Ukraine
Research Site
Ivano-Frankivsk, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Birmingham, , United Kingdom
Research Site
Bradford, , United Kingdom
Research Site
Bristol, , United Kingdom
Research Site
Glasgow, , United Kingdom
Research Site
Leicester, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Nottingham, , United Kingdom
Research Site
Stoke-on-Trent, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D5180C00016
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.