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)
AstraZeneca
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.
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 optio…
Eligibility
- Age range
- 5–11 years
- Sex
- All
- Healthy volunteers
- No
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 to…
Interventions
- BiologicalTezepelumab
Participants will be receiving subcutaneous injection of tezepelumab
- OtherPlacebo
Participants will be receiving subcutaneous injection of matching placebo
Locations (143)
- Research SiteMontgomery, Alabama
- Research SitePhoenix, Arizona
- Research SiteLittle Rock, Arkansas
- Research SiteLa Jolla, California
- Research SiteLong Beach, California
- Research SiteOrange, California