A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma
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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 5 Years to 11 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 52 weeks
- Procedures mentioned: Injections
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants will be randomised 2:1 to receive either tezepelumab or placebo administered by (SC) Subcutaneous injections for 52 weeks (double-blind Treatment period)."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well tezepelumab works and how safe it is compared with a placebo (a treatment with no active drug). It is for children ages 5 to 11 with severe asthma that is not controlled by medium- or high-dose inhaled steroids and at least one other asthma control medicine.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be ages 5 to 11 when joining and at Visit 3. A parent or caregiver must give written consent, and the child must agree if able.
- Weigh at least 16 kg (about 35 pounds) at the first visit and Visit 3.
- Have severe asthma diagnosed and checked by a doctor for at least 6 months before the first visit.
- Have used medium- or high-dose inhaled steroids and at least one other regular asthma control medicine for at least 3 months. Both doses must be unchanged for at least 1 month before the first visit.
- Have breathing tests or other test results that support the asthma diagnosis.
- Have had at least 2 severe asthma attacks, or 1 severe attack that led to a hospital stay, in the year before the first visit.
- Meet the study’s breathing test limits at Visit 1 or 2, before taking a medicine that opens the airways.
- Have signs of poor asthma control during screening: a high asthma survey score (ages 6 and older), symptoms or rescue medicine use on at least 3 days in a week, or waking at night and needing rescue medicine. Rescue medicine used only to prevent exercise symptoms does not count.
Who can't join
- Have a history of vocal cord problems, cystic fibrosis, a disorder of the tiny hairs that clear mucus from the lungs, or long-term nose and sinus swelling with nasal growths.
- Have another serious health condition that the study doctor thinks could make joining unsafe, affect the results, or make participation difficult.
- Have had major asthma worsening or an asthma attack within 30 days before the first visit, including one needing steroid pills or shots or a higher dose of regular steroid pills.
- Have changed the inhaled steroid dose within 1 month before the first visit.
- Have ever had a life-threatening asthma attack that caused a seizure from low oxygen or required a breathing tube.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. 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. 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: 1. History of vocal cord dysfunction, cystic fibrosis, primary ciliary dyskinesia, or chronic 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 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.
Study sites (30)
AL
- Research Site · Montgomery, AL 36106More trials in Montgomery
AR
- Research Site · Little Rock, AR 72202More trials in Little Rock
AZ
- Research Site · Phoenix, AZ 85016More trials in Phoenix
CA
- Research Site · La Jolla, CA 92037More trials in La Jolla
- Research Site · Long Beach, CA 90806More trials in Long Beach
- Research Site · Orange, CA 92868More trials in Orange
- Research Site · San Diego, CA 92123More trials in San Diego
GA
- Research Site · Atlanta, GA 30322More trials in Atlanta
- Research Site · Savannah, GA 31406More trials in Savannah
MA
- Research Site · Boston, MA 02114More trials in Boston
- Research Site · Boston, MA 02115More trials in Boston
MD
- Research Site · Baltimore, MD 21287More trials in Baltimore
MI
- Research Site · Ann Arbor, MI 48105More trials in Ann Arbor
- Research Site · Detroit, MI 48201More trials in Detroit
NC
- Research Site · Chapel Hill, NC 27514More trials in Chapel Hill
NJ
- Research Site · Northfield, NJ 08225More trials in Northfield
NY
- Research Site · Hawthorne, NY 10532More trials in Hawthorne
- Research Site · Schenectady, NY 12304More trials in Schenectady
- Research Site · Staten Island, NY 10305More trials in Staten Island
OH
- Research Site · Cincinnati, OH 45229-3039More trials in Cincinnati
- Research Site · Cleveland, OH 44106More trials in Cleveland
- Research Site · Toledo, OH 43617More trials in Toledo
OK
- Research Site · Oklahoma City, OK 73120More trials in Oklahoma City
SC
- Research Site · Columbia, SC 29203More trials in Columbia
TX
- Research Site · Coppell, TX 75019More trials in Coppell
- Research Site · Dallas, TX 75246More trials in Dallas
- Research Site · Frisco, TX 75034More trials in Frisco
- Research Site · Houston, TX 77030More trials in Houston
- Research Site · San Antonio, TX 78249More trials in San Antonio
- Research Site · Temple, TX 76508More trials in Temple