A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma — HORIZON  

Asthma Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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 24-week open-label Treatment period prior to the 12-week post-treatment Follow-up period. ;

Related Conditions & MeSH terms

• Asthma

• NCT number: NCT06023589
• Study type: Interventional
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center@astrazeneca.com
• Status: Recruiting
• Phase: Phase 3
• Start date: August 24, 2023
• Completion date: December 31, 2027