A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma
HORIZON
A Multicentre, Randomised, Double-Blind, Parallel-Group Placebo-Controlled, Phase 3, Efficacy and Safety Study of Tezepelumab in 5 to < 12 Year Old Children With Severe Uncontrolled Asthma (HORIZON)
1 other identifier
interventional
231
22 countries
143
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 asthma
Started Aug 2023
Longer than P75 for phase_3 asthma
143 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2023
CompletedStudy Start
First participant enrolled
August 24, 2023
CompletedFirst Posted
Study publicly available on registry
September 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 23, 2030
April 30, 2026
April 1, 2026
4.8 years
July 20, 2023
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annualized severe asthma exacerbation rate (AAER)
To assess the effect of tezepelumab on severe asthma exacerbations in children 5 to \< 12 years old with severe uncontrolled asthma compared with placebo.
From Baseline to Week 52
Secondary Outcomes (20)
Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) percent predicted normal (PN)
From Baseline to Week 52
AAER associated with allergic asthma
From Baseline to Week 52
Time to first severe asthma exacerbation
From Baseline to Week 52
Proportion of participants with ≥ 1 severe asthma exacerbation
From Baseline to Week 52
AAER associated with ER visit or hospitalisation
From Baseline to Week 52
- +15 more secondary outcomes
Study Arms (2)
Tezepelumab
EXPERIMENTALParticipants will be receiving tezepelumab subcutaneous injection
Placebo
PLACEBO COMPARATORParticipants will be receiving placebo through a subcutaneous injection
Interventions
Participants will be receiving subcutaneous injection of tezepelumab
Eligibility Criteria
You may qualify if:
- Written informed consent from (ICF) at least one parent/caregiver (as per local guidelines) and accompanying informed assent from the participant (where the participant is able to provide assent) prior to admission to the study.
- 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.
- Documented physician diagnosis of severe asthma confirmed and evaluated for at least 6 months prior to Visit 1.
- 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.
- 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.
- Supportive evidence of asthma as documented by one of the following:
- 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:
- Post-BD responsiveness of FEV1 ≥ 10%.
- Positive methacholine challenge defined as provocative concentration (PC20) of ≤ 16 mg/mL.
- PEF average daily diurnal variability \> 13% over a 2-week period.
- Variability of FEV1 ≥ 12% between any two clinical visits.
- Positive exercise challenge test (defined as a fall in FEV1 of \> 12%).
- FeNO ≥ 20 ppb despite confirmed ICS maintenance therapy.
- 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.
- +7 more criteria
You may not qualify if:
- History of vocal cord dysfunction, cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitis with nasal polyposis.
- 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.
- 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.
- Change in ICS dose within 1 month prior to Visit 1.
- History of a life-threatening asthma exacerbation resulting in a hypoxic seizure or requiring intubation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Amgencollaborator
Study Sites (143)
Research Site
Montgomery, Alabama, 36106, United States
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Phoenix, Arizona, 85016, United States
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Little Rock, Arkansas, 72202, United States
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La Jolla, California, 92037, United States
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Long Beach, California, 90806, United States
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Orange, California, 92868, United States
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San Diego, California, 92123, United States
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Atlanta, Georgia, 30322, United States
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Savannah, Georgia, 31406, United States
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Baltimore, Maryland, 21287, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02115, United States
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Ann Arbor, Michigan, 48105, United States
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Detroit, Michigan, 48201, United States
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Northfield, New Jersey, 08225, United States
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Hawthorne, New York, 10532, United States
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Schenectady, New York, 12304, United States
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Staten Island, New York, 10305, United States
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Chapel Hill, North Carolina, 27514, United States
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Cincinnati, Ohio, 45229-3039, United States
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Cleveland, Ohio, 44106, United States
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Toledo, Ohio, 43617, United States
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Oklahoma City, Oklahoma, 73120, United States
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Columbia, South Carolina, 29203, United States
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Coppell, Texas, 75019, United States
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Dallas, Texas, 75246, United States
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Frisco, Texas, 75034, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78249, United States
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Temple, Texas, 76508, United States
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Buenos Aires, 1426, Argentina
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Buenos Aires, C1121ABE, Argentina
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Buenos Aires, C1122, Argentina
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CABA, C1028AAP, Argentina
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Florida, B1602DQD, Argentina
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Lanus, B1824KAJ, Argentina
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Lobos, 7240, Argentina
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Mendoza, M5500CCG, Argentina
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Quilmes, B1878FNR, Argentina
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Rosario, 2000, Argentina
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Blumenau, 89030-101, Brazil
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Curitiba, 80060-240, Brazil
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Salvador, 40060-330, Brazil
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São Paulo, 01227-200, Brazil
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São Paulo, 04024-002, Brazil
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São Paulo, 05430-010, Brazil
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Sorocaba, 18040-425, Brazil
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Edmonton, Alberta, T6G 1C9, Canada
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Burlington, Ontario, L7L 6W6, Canada
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Hamilton, Ontario, L8S 1G5, Canada
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Windsor, Ontario, N8X 2G1, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Beijing, 100191, China
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Changchun, 130021, China
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Lanzhou, 730000, China
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Nanjing, 210008, China
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Shanghai, 200062, China
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Shanghai, 200127, China
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Shenyang, 110004, China
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Shenzhen, 518026, China
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Wuxi, 214023, China
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Bogotá, 110231, Colombia
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Bogotá, Colombia
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Medellín, 050034, Colombia
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Brest, 29609, France
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Bron, 69500, France
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Créteil, 94010, France
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Marseille, 13005, France
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Paris, 75012, France
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Paris, 75015, France
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Paris, 75019, France
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Rouen, 76031, France
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Vandœuvre-lès-Nancy, 54511, France
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Debrecen, 4031, Hungary
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Szeged, 6720, Hungary
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Szigetvár, 7900, Hungary
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Genova, 16147, Italy
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Pavia, 27100, Italy
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Roma, 00165, Italy
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Fukuoka, 811-1394, Japan
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Fukuoka, 813-0017, Japan
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Fukuyama, 720-8520, Japan
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Funabashi-shi, 273-8588, Japan
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Nara, 630-8581, Japan
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Odawara, 250-0055, Japan
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Ōtsu, 520-0804, Japan
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Saga, 840-8571, Japan
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Shimotsuga-gun, 321-0293, Japan
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Yokohama, 223-0059, Japan
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Chihuahua City, 31000, Mexico
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Guadalajara, 44100, Mexico
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Mexico City, 06100, Mexico
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Veracruz, 91910, Mexico
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Amsterdam, 1105 AZ, Netherlands
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Rotterdam, 3015 GD, Netherlands
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Iloilo City, 5000, Philippines
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Las Piñas, 1740, Philippines
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Quezon, 1100, Philippines
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Santa Rosa, 4026, Philippines
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Lodz, 90-329, Poland
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Tarnów, 33-100, Poland
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Bucharest, 020395, Romania
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Bucharest, 050159, Romania
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Bellville, 7531, South Africa
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Cape Town, 7925, South Africa
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Durban, 3630, South Africa
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Durban, 4001, South Africa
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Middelburg, 1055, South Africa
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Thabazimbi, 0380, South Africa
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Vereeniging, 1935, South Africa
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Welkom, 9460, South Africa
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Seongnam-si, 13496, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 03181, South Korea
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Seoul, 03722, South Korea
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Badalona, 08916, Spain
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Barcelona, 08035, Spain
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Esplugues de Llobregat (Barc), 08950, Spain
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Madrid, 28009, Spain
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Sabadell, 08208, Spain
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Valencia, 46010, Spain
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Valencia, 46026, Spain
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Villarreal, 12540, Spain
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Bangkok, 10330, Thailand
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Bangkoknoi, 10700, Thailand
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Chiang Mai, 50200, Thailand
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Muang, 40002, Thailand
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Bursa, 16059, Turkey (Türkiye)
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Istanbul, 34899, Turkey (Türkiye)
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Izmir, 35210, Turkey (Türkiye)
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Yenimahalle, 06500, Turkey (Türkiye)
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Chernivtsi, 58002, Ukraine
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Ivano-Frankivsk, 76000, Ukraine
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Kyiv, 03038, Ukraine
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Kyiv, 04050, Ukraine
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Birmingham, B4 6NH, United Kingdom
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Bradford, BD9 6RJ, United Kingdom
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Bristol, BS2 8BJ, United Kingdom
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Glasgow, G3 8SJ, United Kingdom
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Leicester, LE1 5WW, United Kingdom
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London, SE5 9RS, United Kingdom
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Nottingham, NG7 2UH, United Kingdom
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Stoke-on-Trent, ST4 6QG, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Double-Blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2023
First Posted
September 5, 2023
Study Start
August 24, 2023
Primary Completion (Estimated)
May 31, 2028
Study Completion (Estimated)
August 23, 2030
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.