NCT06023589

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 231 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 5 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 104-week open-label Treatment period prior to the 12-week post-treatment Follow-up period.

Conditions

• Asthma

Interventions

Type	Name	Description
BIOLOGICAL	Tezepelumab	Participants will be receiving subcutaneous injection of tezepelumab
OTHER	Placebo	Participants will be receiving subcutaneous injection of matching placebo

Timeline

• Start date: 2023-08-24
• Primary completion: 2028-05-31
• Completion: 2030-08-23
• First posted: 2023-09-05
• Last updated: 2026-04-01

Locations

143 sites across 22 countries: United States, Argentina, Brazil, Canada, China, Colombia, France, Hungary, Italy, Japan, Mexico, Netherlands, Philippines, Poland, Romania, South Africa, South Korea, Spain, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study