A study to investigate the efficacy and safety of tezepelumab compared with placebo in children 5 to < 12 years old with severe asthma - HORIZON

Study identifier:D5180C00016

ClinicalTrials.gov identifier:NCT06023589

EudraCT identifier:N/A

CTIS identifier:2022-502984-39-00

Recruiting

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)

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

No

Study drug

-

Sex

All

Estimated Enrollment

372

Study type

Interventional

Age

5 Years - 11 Years

Date

Study Start Date: 24 Aug 2023
Estimated Primary Completion Date: 23 Apr 2027
Estimated Study Completion Date: 31 Dec 2027

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Amgen

Inclusion and exclusion criteria