At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Benralizumab (drug), Placebo (drug)
- How long the study runs
- Study runs about 44 months (dates as stated)
- About the drug or intervention
- Benralizumab — drug: Benralizumab active solution will be administered SC to the patients. · Placebo — drug: Placebo solution will be administered SC to the patients.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 6 Years to 18 Years
- Who
- All
- Number of participants
- 94
- Started
- 2023-04-05
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for asthma
- • Phase3 - 94 participants
- • 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
Who can take part?
- • Ages 6 Years to 18 Years
- • Diagnosed with asthma
Where?
- • London - Research Site
- • Manchester - Research Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
A randomised, double-blind, parallel-group, placebo-controlled, time-to-first-asthma-exacerbation event study designed. There will be a screening period of 2 months to allow adequate time for the eligibility criteria to be evaluated. The screening period may be reduced to not lesser than 4 weeks from Visit 2a. Furthermore, the Screening Period may be extended up to 12 weeks (or longer, if deemed necessary by the investigator), to accommodate treatment. Visit 2 will be split into Part A (Visit 2a) and Part B (Visit 2b) to reassess eligibility prior to randomisation and first dose of study treatment administration. Patients will be randomised 1:1 to receive benralizumab or placebo. The treatment period will consist of 2 parts: double-blind (DB) treatment period and open-label extension (OLE) period. The initial placebo-controlled, DB treatment period will be of variable duration. The minimum duration of treatment in the DB treatment period for each patient will be 16 weeks. Patient will continue in the DB treatment period until the patient experiences an exacerbation or the required number of events have been observed in the study, whichever occurs sooner. All patients who experience an asthma exacerbation in the DB treatment period will be offered the opportunity to continue into the OLE period. The OLE period is intended to allow each patient at least 48 weeks in the ≥ 12 to \< 18-year-old age group and at least 2 years (104 weeks) in the ≥ 6 to \< 12-year-old age group, of treatment with benralizumab. An end-of-the-treatment visit will occur 8 weeks after the last dose in the OLE.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 6 Years - 18 Years
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ at Visit 1
What the study is looking for
- ✓Patient and the caregiver (where applicable) must be willing to and be able to answer questionnaires that are part...
- ✓Male or female patients aged ≥ 6 to \< 18 years old.
- ✓Patients with physician-diagnosed severe eosinophilic asthma for at least 12 months prior to Visit 1.
- ✓Patients with a diagnosis of severe asthma confirmed, evaluated, and managed by the clinical site/site network for ≥...
- ✓Patients with an exacerbation history of asthma exacerbations (defined as a requirement for systemic corticosteroids...
Who cannot take part
- ✗Life-threatening asthma.
- ✗History of anaphylaxis to any biologic therapy.
- ✗Current cancer, or history of cancer.
- ✗A helminth parasitic infection.
- ✗Use of immunosuppressive medication.
See the full criteria
Where Is This Study? (2 UK sites)
Research Site
London SE5 9RS, United Kingdom
Research Site
Manchester M13 9PL, United Kingdom
