Informations générales (source: ClinicalTrials.gov)
Efficacy and Safety of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA) (DOMINICA)
Interventional
Phase 3
AstraZeneca (Voir sur ClinicalTrials)
avril 2023
mai 2032
21 décembre 2024
A study to evaluate the efficacy and safety of benralizumab administered subcutaneously
in patients ≥ 6 to < 18 years of age with severe eosinophilic asthma, including a
well-documented history of asthma exacerbations and uncontrolled asthma receiving
high-dose inhaled corticosteroid (ICS) plus at least one additional controller
medication.
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 01:30:43 | 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 - 06002 - Nice - France | Contact (sur clinicalTrials) | ||||
| Research Site - 31059 - Toulouse Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| Research Site - 34295 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Research Site - 69394 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Research Site - 76031 - Rouen Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 77019 - Paris - France | Contact (sur clinicalTrials) | ||||
| Research Site - 94010 - Creteil - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Capable of giving assent (signing the assent form) to participate in the study. The
caregiver of the patient must be capable of giving written informed consent for the
patient's participation in the study. Consent and assent forms must be completed
prior to any study specific procedures.
- Patient and the caregiver (where applicable) must be willing to and be able to
answer questionnaires that are part of the study procedures.
- Male or female patients aged ≥ 6 to < 18 years old.
- Patients with a diagnosis of eosinophilic asthma, defined by regional for at least
12 months prior to Visit 1.
- Patients with a diagnosis of severe asthma confirmed, evaluated, and managed by the
clinical site for ≥ 6 months prior to Visit 1.
- Patients with an exacerbation history of asthma exacerbations (defined as a
requirement for systemic corticosteroids and/or hospitalization) within 12 months
prior to Visit 1, OR,
1. 2 asthma exacerbations (defined as a requirement for systemic corticosteroids
and/or hospitalization) per year within the 2 years prior to Visit 1 AND, one
or more of the following:
2. Currently on stable maintenance oral corticosteroids (OCS) used for at least 3
months prior to Visit 1, OR,
3. At least one of the 2 exacerbations that occurred in the year prior to Visit 1
resulted in hospitalisation.
- Patients on well-documented, stable treatment for asthma with high dose ICS and at
least 1 additional controller medication, such as long-acting β2 agonists (LABA),
leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA),
or theophylline, since at least 6 months prior to Visit 1.
- Eosinophilic airway inflammation that is related to asthma characterised as
eosinophilic in nature as indicated by peripheral blood eosinophil count of ≥ 300
cells/μL during screening OR a blood eosinophil count of 150 to 299 cells/μL and
documentation of elevated eosinophils in bronchoalveolar lavage (BAL), sputum, or
bronchial biopsy within the 2 years prior to Visit 1.
- ≥ 70% compliance with maintenance asthma medication during the screening period
based on the Paediatric Asthma Symptom - Observer reported (PASO) or Asthma Daily
Diary.
- At least 70% daily PASO or Asthma Daily Diary completion during the entire screening
period, with at least 50% PASO or Asthma Daily Diary completion in the 14-day period
prior to randomisation.
- Pre-BD FEV1 ≤ 95% PN or pre-BD FEV1/FVC ratio < 0.85 required. Patients with ≥ 25 %
increase in mean pre-BD FEV1 value during the screening period will be screen
failed.
- ACQ-IA ≥ 1.5 with no meaningful improvement (ACQ-IA change ≤ -0.5) between screening
and Visit 2a.
- Body weight ≥ 15 kg.
- Females of childbearing potential (FOCBP) who are sexually active, as judged by the
investigator, must commit to consistent and correct use of a highly effective and
acceptable method of contraception
- Capable of giving assent (signing the assent form) to participate in the study. The
caregiver of the patient must be capable of giving written informed consent for the
patient's participation in the study. Consent and assent forms must be completed
prior to any study specific procedures.
- Patient and the caregiver (where applicable) must be willing to and be able to
answer questionnaires that are part of the study procedures.
- Male or female patients aged ≥ 6 to < 18 years old.
- Patients with a diagnosis of eosinophilic asthma, defined by regional for at least
12 months prior to Visit 1.
- Patients with a diagnosis of severe asthma confirmed, evaluated, and managed by the
clinical site for ≥ 6 months prior to Visit 1.
- Patients with an exacerbation history of asthma exacerbations (defined as a
requirement for systemic corticosteroids and/or hospitalization) within 12 months
prior to Visit 1, OR,
1. 2 asthma exacerbations (defined as a requirement for systemic corticosteroids
and/or hospitalization) per year within the 2 years prior to Visit 1 AND, one
or more of the following:
2. Currently on stable maintenance oral corticosteroids (OCS) used for at least 3
months prior to Visit 1, OR,
3. At least one of the 2 exacerbations that occurred in the year prior to Visit 1
resulted in hospitalisation.
- Patients on well-documented, stable treatment for asthma with high dose ICS and at
least 1 additional controller medication, such as long-acting β2 agonists (LABA),
leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA),
or theophylline, since at least 6 months prior to Visit 1.
- Eosinophilic airway inflammation that is related to asthma characterised as
eosinophilic in nature as indicated by peripheral blood eosinophil count of ≥ 300
cells/μL during screening OR a blood eosinophil count of 150 to 299 cells/μL and
documentation of elevated eosinophils in bronchoalveolar lavage (BAL), sputum, or
bronchial biopsy within the 2 years prior to Visit 1.
- ≥ 70% compliance with maintenance asthma medication during the screening period
based on the Paediatric Asthma Symptom - Observer reported (PASO) or Asthma Daily
Diary.
- At least 70% daily PASO or Asthma Daily Diary completion during the entire screening
period, with at least 50% PASO or Asthma Daily Diary completion in the 14-day period
prior to randomisation.
- Pre-BD FEV1 ≤ 95% PN or pre-BD FEV1/FVC ratio < 0.85 required. Patients with ≥ 25 %
increase in mean pre-BD FEV1 value during the screening period will be screen
failed.
- ACQ-IA ≥ 1.5 with no meaningful improvement (ACQ-IA change ≤ -0.5) between screening
and Visit 2a.
- Body weight ≥ 15 kg.
- Females of childbearing potential (FOCBP) who are sexually active, as judged by the
investigator, must commit to consistent and correct use of a highly effective and
acceptable method of contraception
- Clinically important pulmonary disease other than asthma or patients who have ever
been diagnosed with pulmonary or systemic disease, other than asthma, that are
associated with elevated peripheral eosinophil counts
- Life-threatening asthma,
- Asthma exacerbation requiring use of systemic corticosteroids or increase in
maintenance dose of OCS within 2 weeks prior to Visit 2a or acute upper/lower
respiratory infection that requires antibiotics or antiviral medication within 2
weeks prior to the first dose of the IP (Visit 2b).
- Any disorder that is not stable in the opinion of the investigator and could affect
the safety of the patient during the study, influence the findings of the studies or
their interpretations or impede the patient's ability to complete the entire
duration of the study.
- History of anaphylaxis to any biologic therapy.
- Current malignancy, or history of malignancy.
- A helminth parasitic infection
- Use of immunosuppressive medication
- Receipt of immunoglobulin or blood products within 30 days prior to Visit 1.
- Receipt of any marketed or investigational biologic within 4 months or 5 half-lives
prior to Visit 1
- Previously received benralizumab (MEDI-563).
- Participation in another interventional clinical study
- Patients with known hypersensitivity to benralizumab or any of the excipients of the
product.
- Currently pregnant, breastfeeding, or lactating females.
- Previous randomisation in the present study.