A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)
Recruiting · 40 sites across 21 states
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
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.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
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 this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Children or teens aged 6 to under 18
- •A doctor has diagnosed severe eosinophilic asthma and it has been diagnosed/managed for at least 12 months (and confirmed and managed by the study site for at least 6 months)
- •In the last 12 months, you had asthma flare-ups that needed systemic (by mouth or IV) steroids and/or hospital care (or you meet an alternative flare-up pattern described in the study)
- •You are on stable asthma medicines, including high-dose inhaled corticosteroids plus at least one other controller medicine, for at least 6 months
- •You meet the study’s asthma inflammation and symptom score requirements (eosinophil levels and ACQ-IA score at screening)
🚫 You may not be able to join if…
- •You have an important lung disease other than asthma, or you’ve been diagnosed with a non-asthma lung/systemic disease linked to high eosinophil counts
- •You have life-threatening asthma
- •You recently had an asthma flare needing systemic corticosteroids or an increase in oral corticosteroids within 2 weeks before starting the study, or you had a recent infection needing antibiotics or antivirals within 2 weeks before the first dose
- •You had anaphylaxis (severe allergic reaction) to any biologic therapy, or you have a known allergy to benralizumab or its ingredients
- •You are currently pregnant, breastfeeding, or lactating; or you recently used certain biologic medicines/immunosuppressive medicines, received immunoglobulin/blood products, or have active cancer or certain infections
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 6–18
- ✓Have Asthma
- !Not for people who are pregnant or breastfeeding
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
What you need to know before you apply
What is this study testing?+
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.
Is it safe? Who makes sure of that?+
This is a late-stage study (Phase 3), testing how well the treatment works in more people. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT05692180 · Locations: Alabama · Arizona · Arkansas · California · District of Columbia · Florida · Kentucky · Louisiana · Maryland · Massachusetts · Mississippi · Missouri · Nebraska · New Jersey · New York · Ohio · South Carolina · Texas · West Virginia · Alberta · Ontario