RECRUITING

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

Conditions

Asthma Uncontrolled Asthma Severe Uncontrolled Asthma Human monoclonal antibody (IgG2λ) cytokine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2023-08-24

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06023589

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 11 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. 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. 2. 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. 3. Documented physician diagnosis of severe asthma for at least 6 months prior to Visit 1. 4. 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. 5. 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. 6. Evidence of asthma as documented by one of the following: 1. Documented historical BD responsiveness of FEV1 ≥ 10% in the previous 12 months prior to Visit 1 OR 2. Documented historical methacholine challenge result of ≤ 16 mg/mL in the previous 12 months prior to Visit 1 OR 3. 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. 7. 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. 8. Pre-BD FEV-1 \>50% and ≤ 95%PN OR FEV1/forced vital capacity (FVC) ratio ≤ 0.8 at either Visit 1 or Visit 2. 9. Evidence of uncontrolled asthma, with at least 1 of the below criteria: 1. 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 2. 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 3. Sleep awakening due to asthma symptoms requiring use of reliever medication at least once during the Screening/Run-in period 4. Asthma symptoms 3 or more days per week in at least 1 week during the Screening/Run-in period 10. Body weight ≥ 16 kg at Visit 1 (Screening) and Visit 3 (Randomisation).	1. History of cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitis with nasal polyposis. 2. 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. 3. 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. 4. Change in ICS dose within 1 month prior to Visit 1. 5. History of a life-threatening asthma exacerbation resulting in a hypoxic seizure or requiring intubation or mechanical ventilation.

Inclusion Criteria

Exclusion Criteria

1. 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.
2. 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.
3. Documented physician diagnosis of severe asthma for at least 6 months prior to Visit 1.
4. 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.
5. 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.
6. Evidence of asthma as documented by one of the following:
1. Documented historical BD responsiveness of FEV1 ≥ 10% in the previous 12 months prior to Visit 1 OR
2. Documented historical methacholine challenge result of ≤ 16 mg/mL in the previous 12 months prior to Visit 1 OR
3. 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.
7. 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.
8. Pre-BD FEV-1 \>50% and ≤ 95%PN OR FEV1/forced vital capacity (FVC) ratio ≤ 0.8 at either Visit 1 or Visit 2.
9. Evidence of uncontrolled asthma, with at least 1 of the below criteria:
1. 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
2. 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
3. Sleep awakening due to asthma symptoms requiring use of reliever medication at least once during the Screening/Run-in period
4. Asthma symptoms 3 or more days per week in at least 1 week during the Screening/Run-in period
10. Body weight ≥ 16 kg at Visit 1 (Screening) and Visit 3 (Randomisation).

1. History of cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitis with nasal polyposis.
2. 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.
3. 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.
4. Change in ICS dose within 1 month prior to Visit 1.
5. History of a life-threatening asthma exacerbation resulting in a hypoxic seizure or requiring intubation or mechanical ventilation.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479

information.center@astrazeneca.com

Study Locations (Sites)

Research Site

Montgomery, Alabama, 36106

United States

Research Site

Phoenix, Arizona, 85016

United States

Research Site

Little Rock, Arkansas, 72202

United States

Research Site

La Jolla, California, 92037

United States

Research Site

Orange, California, 92868

United States

Research Site

San Diego, California, 92123

United States

Research Site

Atlanta, Georgia, 30322

United States

Research Site

Savannah, Georgia, 31406

United States

Research Site

Boston, Massachusetts, 02115

United States

Research Site

Ann Arbor, Michigan, 48105

United States

Research Site

Detroit, Michigan, 48201

United States

Research Site

Northfield, New Jersey, 08225

United States

Research Site

Schenectady, New York, 12304

United States

Research Site

Staten Island, New York, 10305

United States

Research Site

Chapel Hill, North Carolina, 27514

United States

Research Site

Cincinnati, Ohio, 45229-3039

United States

Research Site

Cleveland, Ohio, 44106

United States

Research Site

Toledo, Ohio, 43617

United States

Research Site

Oklahoma City, Oklahoma, 73120

United States

Research Site

Coppell, Texas, 75019

United States

Research Site

Dallas, Texas, 75235

United States

Research Site

Temple, Texas, 76508

United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-24

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2023-08-24

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

Asthma
Uncontrolled Asthma
Severe Uncontrolled Asthma
Human monoclonal antibody (IgG2λ) cytokine

Additional Relevant MeSH Terms

Asthma