HORIZON
Research type
Research Study
Full 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)
IRAS ID
1008165
Contact name
Asa Rosqvist
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
This research study is organised and supported by AstraZeneca. The study purpose is to learn more about the study medication, Tezepelumab, to determine how safe and effective Tezepelumab is compared with placebo in children 5 to < 12 years old with severe asthma.
Asthma is the most common long-term medical condition in children in the UK, with around 1 in 11 children and young people living with asthma. The UK has one of the highest prevalence, emergency admission and death rates for childhood asthma in Europe. It is estimated that 1 million children in the UK are receiving treatment for asthma. Asthma is a long-term condition that affects the airways carrying air in and out of the lungs. It usually causes symptoms such as coughing, wheezing and breathlessness. If asthmatics come into contact with one of their asthma triggers, it can make symptoms worse and even bring on an asthma attack. These asthma exacerbations can be life-threatening, can significantly impact the participant’s quality of life, and result in significant healthcare costs. It is estimated that 5% to 10% of asthmatics have asthma symptoms despite treatment with current therapies, highlighting the need to develop new therapies.
This study consists of two parts. In the first part Tezepelumab will be evaluated over a 52-week period. It will be compared to a placebo that has no active ingredients. Participants will have a 50/50 chance of receiving Tezepelumab or placebo. This part is double−blind. In the second part there is an optional open label active treatment extension period. In this part all participants will receive Tezepelumab during the period of 24 weeks. The study consists of a Screening/Run-in period of 4 to 6 weeks, a 52-week double-blind treatment period, a 24-week optional open label active treatment extension period and a post-treatment follow-up period of 12 weeks.
Approximately 100 sites in approximately 17 countries will be included in this study.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
23/EM/0177
Date of REC Opinion
17 Oct 2023
REC opinion
Further Information Favourable Opinion