2022-501344-14-00
Recruiting
Phase 3
A Multicentre, Randomised, Double-blind, Parallel Group, Placebocontrolled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients with Severe Eosinophilic Asthma (DOMINICA)
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Astrazeneca AB
- Enrollment
- 72
- Locations
- 29
- Primary Endpoint
- Time to first asthma exacerbation defined as a worsening of asthma requiring: • Use of systemic corticosteroid (or a temporary increase) for at least 3 days; a single depo-injectable dose, OR • An emergency room visit due to asthma OR • Hospitalisation due to asthma
Overview
Brief Summary
To evaluate the effect of benralizumab on asthma exacerbations in paediatric and adolescent patients with uncontrolled asthma.
Study Design
- Allocation
- Non-randomized
- Primary Purpose
- Open-label extension period
- Masking
- None
Eligibility Criteria
- Ages
- 0 years to 17 years (0-17 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Capable of giving assent (signing the assent form) to participate in the study, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. 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.
- •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% of the predicted normal value or pre-BD FEV1/FVC ratio < 0.85 required at Visit
- •Patients with ≥ 25 % increase in 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 method of contraception (confirmed by the investigator) for the duration of the study and for 12 weeks after the last dose of IP. Highly effective methods defined in protocol
- •Patient and the caregiver (where applicable) must be willing to and be able to answer questionnaires that are part of the study procedures, as listed in the ICF, the assent form, and the CSP.
- •Male or female patients aged ≥ 6 to < 18 years old at the time of signing the assent form and their caregivers signing the informed consent form.
- •Patients with physician-diagnosed severe eosinophilic asthma for at least 12 months prior to Visit
Exclusion Criteria
- •Clinically important pulmonary disease other than asthma as defined in protocol.
- •A helminth parasitic infection as defined in protocol.
- •A history of known immunodeficiency including HIV infection.
- •Active liver disease.
- •Current use of any oral or ophthalmic non-selective β adrenergic antagonist (eg, propranolol).
- •Use of immunosuppressive as defined in protocol. Chronic maintenance corticosteroid for the treatment of asthma is allowed.
- •Receipt of immunoglobulin or blood products as defined in protocol.
- •Receipt of any marketed or investigational biologic as defined in protocol.
- •Previously received benralizumab (MEDI-563).
- •Receipt of live attenuated vaccines as defined in protocol.
Outcomes
Primary Outcomes
Time to first asthma exacerbation defined as a worsening of asthma requiring: • Use of systemic corticosteroid (or a temporary increase) for at least 3 days; a single depo-injectable dose, OR • An emergency room visit due to asthma OR • Hospitalisation due to asthma
Time to first asthma exacerbation defined as a worsening of asthma requiring: • Use of systemic corticosteroid (or a temporary increase) for at least 3 days; a single depo-injectable dose, OR • An emergency room visit due to asthma OR • Hospitalisation due to asthma
Secondary Outcomes
- Change from baseline, during the DB treatment period, in the following measures: ACQ-IA, Asthma symptom score, Rescue medication use, Night-time awakenings due to asthma, PEF
- • Serum benralizumab trough concentration • Anti-benralizumab antibodies
- Change from baseline, during the DB treatment period, in PAQLQ-IA total score
- Change from baseline, during the DB treatment period, in spirometry, including pre-dose/pre-bronchodilator FEV1 and post-bronchodilator FEV1
- The AAER in the DB treatment period
- Safety: AEs/SAEs : Occurrence/frequency ; Relationship to the IP as assessed by the investigator ; Intensity ; Seriousness ; Death ; AEs leading to discontinuation of IP ; Vital signs ; Clinical laboratory parameters
- the Open-Label Extension;Period: AEs and SAEs
- the Open-Label Extension: The AAER in the OLE period
Investigators
AstraZeneca Clinical Study Information Center
Scientific
Astrazeneca AB
Study Sites (29)
Loading locations...
Similar Trials
Completed
Phase 3
A Study of the Safety and Effectiveness of Benralizumab to Treat Patients With Severe Uncontrolled Asthma.AsthmaNCT03170271AstraZeneca660
Recruiting
Phase 2/3
A study to learn if rozanolixizumab is safe, how it moves through the body, and if it works in children with myasthenia gravis2022-502074-16-00UCB Biopharma7
Terminated
Phase 3
Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled AsthmaAsthmaNCT01947946AstraZeneca13
Completed
Phase 3
Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled AsthmaAsthmaNCT01928771AstraZeneca2,681
Recruiting
Phase 1/2
A multicentre trial evaluating the combination of a MEK inhibitor and a
PDL1 inhibitor in pediatric and adult patients with locally advanced and/or
metastatic soft tissue sarcoma2024-510712-75-00Centre Leon Berard80