Asthma Clinical Trial
— DOMINICAOfficial title:
Efficacy and Safety of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | May 16, 2032 |
Est. primary completion date | May 5, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 18 Years |
Eligibility | 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 ß2 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Argentina | Research Site | Buenos Aires | |
Argentina | Research Site | Ciudad de Buenos Aire | |
Argentina | Research Site | Florencio Varela | |
Argentina | Research Site | Florida | |
Argentina | Research Site | Lobos | |
Argentina | Research Site | Mar del Plata | |
Argentina | Research Site | Mendoza | |
Argentina | Research Site | Mendoza | |
Argentina | Research Site | Rosario | |
Argentina | Research Site | Santa Fe | |
Canada | Research Site | Burlington | Ontario |
Canada | Research Site | Edmonton | Alberta |
Canada | Research Site | Hamilton | Ontario |
Canada | Research Site | Montreal | Quebec |
Canada | Research Site | Quebec | |
France | Research Site | Creteil | |
France | Research Site | Lyon | |
France | Research Site | Montpellier | |
France | Research Site | Nice cedex 1 | |
France | Research Site | Paris | |
France | Research Site | Rouen Cedex | |
France | Research Site | Toulouse Cedex 9 | |
Germany | Research Site | Essen | |
Germany | Research Site | Wesel | |
Italy | Research Site | Genova | |
Italy | Research Site | Milano | |
Italy | Research Site | Pavia | |
Italy | Research Site | Ponte San Pietro | |
Italy | Research Site | Roma | |
Italy | Research Site | Roma | |
Italy | Research Site | Verona | |
Korea, Republic of | Research Site | Cheongju-si | |
Korea, Republic of | Research Site | Jung-gu | |
Korea, Republic of | Research Site | Seoul | |
Korea, Republic of | Research Site | Seoul | |
Korea, Republic of | Research Site | Seoul | |
Poland | Research Site | Bialystok | |
Poland | Research Site | Krakow | |
Poland | Research Site | Lódz | |
Poland | Research Site | Rzeszów | |
Poland | Research Site | Skarzysko-Kamienna | |
Spain | Research Site | Badalona | |
Spain | Research Site | Barcelona | |
Spain | Research Site | Benalmádena | |
Spain | Research Site | Cartagena | |
Spain | Research Site | Esplugues de Llobregat | |
Spain | Research Site | Madrid | |
Spain | Research Site | Mérida | |
Spain | Research Site | Valencia | |
Taiwan | Research Site | Changhua | |
Taiwan | Research Site | Kaohsiung | |
Taiwan | Research Site | Taichung | |
Taiwan | Research Site | Taipei | |
Taiwan | Research Site | Taoyuan | |
United Kingdom | Research Site | Glasgow | |
United Kingdom | Research Site | Leicester | |
United Kingdom | Research Site | London | |
United Kingdom | Research Site | London | |
United Kingdom | Research Site | Manchester | |
United States | Research Site | Brick | New Jersey |
United States | Research Site | Bronx | New York |
United States | Research Site | Charleston | South Carolina |
United States | Research Site | Cincinnati | Ohio |
United States | Research Site | Cleveland | Ohio |
United States | Research Site | Dallas | Texas |
United States | Research Site | Glenn Dale | Maryland |
United States | Research Site | Kansas City | Missouri |
United States | Research Site | Lafayette | Louisiana |
United States | Research Site | Lincoln | Nebraska |
United States | Research Site | Little Rock | Arkansas |
United States | Research Site | Madera | California |
United States | Research Site | Miami | Florida |
United States | Research Site | Miami | Florida |
United States | Research Site | Mobile | Alabama |
United States | Research Site | Montgomery | Alabama |
United States | Research Site | Morgantown | West Virginia |
United States | Research Site | New Orleans | Louisiana |
United States | Research Site | Northfield | New Jersey |
United States | Research Site | Ocala | Florida |
United States | Research Site | Owensboro | Kentucky |
United States | Research Site | San Antonio | Texas |
United States | Research Site | Tucson | Arizona |
United States | Research Site | Tyler | Texas |
United States | Research Site | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca | Parexel |
United States, Argentina, Canada, France, Germany, Italy, Korea, Republic of, Poland, Spain, Taiwan, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of patients with Adverse events (AEs) and Serious adverse events (SAEs) | The safety and tolerability of benralizumab will be evaluated. | From Screening period until EOT DB treatment period | |
Other | The AAER in the OLE period | The annualised rate of severe exacerbations in the OLE period will be assessed. | From Week 0 until the EOT OLE period | |
Primary | Time to first asthma exacerbation | The effect of benralizumab on asthma exacerbations in paediatric and adolescent patients with uncontrolled asthma will be evaluated. | From Baseline (Week 0) to End of Treatment (EOT) in DB treatment period | |
Secondary | Change from baseline, during the DB treatment period in Interviewer-Administered Version of the Asthma Control Questionnaire (ACQ-IA) | The effect of benralizumab on asthma control and symptoms will be assessed. | From Baseline (Week 0) to EOT in DB treatment period | |
Secondary | Change from baseline, during the DB treatment period in Asthma symptom score | The effect of benralizumab on asthma control and symptoms will be assessed. | From Baseline (Week 0) to EOT in DB treatment period | |
Secondary | Change from baseline, during the DB treatment period in rescue medication use | The effect of benralizumab on asthma control and symptoms will be assessed. | From Baseline (Week 0) to EOT in DB treatment period | |
Secondary | Change from baseline, during the DB treatment period in night-time awakenings due to asthma | The effect of benralizumab on asthma control and symptoms will be assessed. | From Baseline (Week 0) to EOT in DB treatment period | |
Secondary | Change from baseline, during the DB treatment period in peak expiratory flow (PEF) | The effect of benralizumab on asthma control and symptoms will be assessed. | From Baseline (Week 0) to EOT in DB treatment period | |
Secondary | Serum benralizumab trough concentration | The pharmacokinetics of benralizumab will be characterised. | During Day -7, Day 56, Day 112, every 16 weeks and at EOT DB treatment period | |
Secondary | Anti-benralizumab antibodies | The immunogenicity of benralizumab will be characterised. | During Day -7, Day 56, Day 112, every 16 weeks and at EOT DB treatment period | |
Secondary | Change from baseline, during the DB treatment period in Paediatric Asthma Quality of Life Questionnaire-Interviewer Administered (PAQLQ-IA) total score | The effect of benralizumab on asthma health-related quality of life will be assessed. | From Baseline (Week 0) to EOT in DB treatment period | |
Secondary | Change from baseline, during the DB treatment period, in spirometry, for pre-dose/pre-bronchodilator forced expiratory volume in one second (FEV1) | The effect of benralizumab on pulmonary function (FEV1) will be assessed. | From Baseline (Week 0) to EOT in DB treatment period | |
Secondary | Change from baseline, during the DB treatment period, in spirometry, for post-bronchodilator FEV1 | The effect of benralizumab on pulmonary function (FEV1) will be assessed. | From Baseline (Week 0) to EOT in DB treatment period | |
Secondary | The Annualised asthma exacerbation rate (AAER) in the DB treatment period | The asthma exacerbations reported during the DB treatment period of the study will be described. | From Screening until the EOT double blind treatment period |
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