Asthma (Pediatric)
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Asthma (Pediatric)
D5180C00016 Enrolling

Research Trial for Severe Uncontrolled Asthma (94 Weeks)


Treatment: Injection Age: 5 Years


Recruiting children aged 5 to under 12 with severe uncontrolled asthma, to participate in this clinical research trial.  Must have documented treatment with a total daily dose of either medium or high dose inhaled corticosteroids (ICS) for at least 3 months, and documented treatment with at least one additional maintenance asthma controller medication.

Participants will receive investigational treatment (active study drug) or placebo, via subcutaneous injection.  Following the treatment period, participants may have the option to take part in the open-label extension period, and receive active study drug.  Study treatment and study-related assessments will be provided at no cost.  Reimbursement for study-related expenses may be provided.

Study participation will last up to 94 weeks and involve about 24 visits to the study centre, during that time.


Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Mariam Hanna

Pediatric Allergist

Dr. Douglas Mack

Pediatric Allergist

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The following information is from ClinicalTrials.gov

Last Update Posted: May 19, 2024

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)

ClinicalTrials.gov ID

NCT06023589

Sponsor

AstraZeneca

Study Description

  • Brief 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.

  • Condition or Disease:

    Asthma

  • Intervention/Treatment:

    Biological: Tezepelumab
    Other: Placebo
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    5 Years and 11 Years (Child)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

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.
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. Documented physician diagnosis of severe asthma for at least 6 months prior to Visit 1. Documented physician-prescribed treatment with a total daily dose of either medium or high dose, for at least 3 months with stable dose ≥ 1 month prior to Visit 1. Documented treatment with at least one additional maintenance asthma controller medication is required according to local guidelines and standard of care; (long-acting beta agonist, leukotriene receptor antagonist, long-acting muscarinic antagonist) for at least 3 months with stable dose ≥ 1 month prior to Visit 1. Evidence of asthma as documented by one of the following: Documented historical BD responsiveness of FEV1 ≥ 10% in the previous 12 months prior to Visit 1 OR Documented historical methacholine challenge result of ≤ 16 mg/mL in the previous 12 months prior to Visit 1 OR Post-BD (albuterol/salbutamol) responsiveness of FEV1 ≥ 10% during Screening (15 to 30 min after administration of 4 puffs of albuterol/salbutamol) at either Visit 1 or Visit 2. History of at least 2 severe asthma exacerbation events OR 1 severe asthma exacerbation event resulting in hospitalisation within 12 months prior to Visit 1. Pre-BD FEV-1 >50% and ≤ 95%PN OR FEV1/forced vital capacity (FVC) ratio ≤ 0.8 at either Visit 1 or Visit 2.

Evidence of uncontrolled asthma, with at least 1 of the below criteria:

ACQ-IA score ≥ 1.5 at least once during Screening/Run-in, including Visit 3 (prior to Randomisation) for participants ≥ 6 years old at Screening
Use of reliever medication, other than as a preventive for exercise induced bronchospasm, on 3 or more days per week for at least 1 week during the Screening/Run-in period
Sleep awakening due to asthma symptoms requiring use of reliever medication at least once during the Screening/Run-in period
Asthma symptoms 3 or more days per week in at least 1 week during the Screening/Run-in period
Body weight ≥ 16 kg at Visit 1 (Screening) and Visit 3 (Randomisation).

Exclusion Criteria:

History of cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitis with nasal polyposis.
History of any clinically significant disease or disorder other than asthma which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant’s ability to participate in the study.
History of a clinically significant deterioration in asthma or asthma exacerbation including those requiring use of systemic corticosteroids or increase in the maintenance dose of oral corticosteroids within 30 days prior to Visit 1.
Change in ICS dose within 1 month prior to Visit 1.
History of a life-threatening asthma exacerbation resulting in a hypoxic seizure or requiring intubation or mechanical ventilation.


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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