Informations générales (source: ClinicalTrials.gov)
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) (HORIZON)
Interventional
Phase 3
AstraZeneca (Voir sur ClinicalTrials)
août 2023
décembre 2027
17 octobre 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Ralph EPAUD | 29/03/2024 01:30:50 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Research Site - 29609 - Brest - France | Contact (sur clinicalTrials) | ||||
| Research Site - 54511 - Vandoeuvre les Nancy Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 69677 - Bron - France | Contact (sur clinicalTrials) | ||||
| Research Site - 75012 - Paris - France | Contact (sur clinicalTrials) | ||||
| Research Site - 75015 - Paris - France | Contact (sur clinicalTrials) | ||||
| Research Site - 76031 - Bois Guillaume - France | Contact (sur clinicalTrials) | ||||
| Research Site - 77019 - Paris - France | Contact (sur clinicalTrials) | ||||
| Research Site - 94010 - Creteil - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion 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. 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.