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AsthmaPhase 3DOMINICANCT05692180

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

A Phase 3 study testing Benralizumab in people with Asthma, run by AstraZeneca at 43 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 6 to 18 years
Conditions the study is for
Asthma
What is being tested?
Benralizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
94 participants
Where
43 sitesin 9 countries
Study dates
5 Apr 2023to 23 Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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 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 ≥ 6 months prior to Visit 1.
  • Patients with an exacerbation history of asthma exacerbations (defined as a requirement for systemic corticosteroids and/or hospitalisation) within 12 months prior to Visit 1, OR,
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  • 2 asthma exacerbations (defined as a requirement for systemic corticosteroids and/or hospitalisation) per year within the 2 years prior to Visit 1 AND, one or more of the following:
  • Currently on stable maintenance oral corticosteroids (OCS) used for at least 3 months prior to Visit 1, OR,
  • 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 one 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% of the predicted normal value or pre-BD FEV1/forced vital capacity (FVC) ratio < 0.85 required at Visit 1. 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.

Who cannot join

  • 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.
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  • 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 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.

Trial locations and contacts

43 sites in 9 countries.

43 sites in 9 countries

United States11 sites

  • Research Site

    Charleston, South Carolina, 29425

  • Research Site

    Cincinnati, Ohio, 45229

  • Research Site

    Kansas City, Missouri, 64108

  • Research Site

    Lafayette, Louisiana, 70508

  • Research Site

    Northfield, New Jersey, 08225

  • Research Site

    Ocala, Florida, 34471

  • Research Site

    Owensboro, Kentucky, 42301

  • Research Site

    San Antonio, Texas, 78229

  • Research Site

    The Bronx, New York, 10459

  • Research Site

    Torrance, California, 90505

  • Research Site

    Tyler, Texas, 75708

Other trials in United States

Argentina10 sites

  • Research Site

    Ciudad de Buenos Aire, C1425DTG

  • Research Site

    Ciudad de Buenos Aires, C1414AIF

  • Research Site

    Florida, B1602DQD

  • Research Site

    Lobos, 7240

  • Research Site

    Mar del Plata, B7600

  • Research Site

    Mendoza, 5500

  • Research Site

    Mendoza, M5500CCG

  • Research Site

    Rosario, 2000

  • Research Site

    San Juan Bautista, 1888

  • Research Site

    Santa Fe, S3000ASF

Other trials in Argentina

Poland5 sites

  • Research Site

    Bialystok, 15-879

  • Research Site

    Krakow, 31-624

  • Research Site

    Lodz, 90-302

  • Research Site

    Skarżysko-Kamienna, 26-110

  • Research Site

    Tarnów, 33-100

Other trials in Poland

South Korea4 sites

  • Research Site

    Cheongju-si, 28644

  • Research Site

    Junggu, 22332

  • Research Site

    Seoul, 03080

  • Research Site

    Seoul, 05505

Other trials in South Korea

Spain4 sites

  • Research Site

    Badalona, 08916

  • Research Site

    Barcelona, 8035

  • Research Site

    Benalmádena, 29631

  • Research Site

    Esplugues de Llobregat, 8950

Other trials in Spain

France3 sites

  • Research Site

    Créteil, 94010

  • Research Site

    Lyon, 69394

  • Research Site

    Rouen, 76031

Other trials in France

Italy2 sites

  • Research Site

    Milan, 20142

  • Research Site

    Roma, 00165

Other trials in Italy

Taiwan2 sites

  • Research Site

    Kaohsiung City, 833

  • Research Site

    Taoyuan, 333

Other trials in Taiwan

United Kingdom2 sites

  • Research Site

    London, SE5 9RS

  • Research Site

    Manchester, M13 9PL

Other trials in United Kingdom

About this study

Official 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.

Read the detailed description

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.

Conditions
Asthma
Being tested
Benralizumab, Placebo
Keywords
Eosinophilic asthma, Pediatric Patients, Severe asthma
Medical subject headings
Asthma, Pulmonary Eosinophilia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BenralizumabDrug

    Benralizumab active solution will be administered SC to the patients.

  • PlaceboDrug

    Placebo solution will be administered SC to the patients.

Study groups in NCT05692180
Study groupRoleWhat they receive
BenralizumabExperimentalPatients will receive Benralizumab as an active solution via a subcutaneous (SC) injection.
Receives: Drug: Benralizumab
PlaceboPlacebo comparatorPatients will receive a matching solution of the placebo via SC injection.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first asthma exacerbation

    The effect of benralizumab on asthma exacerbations in paediatric and adolescent patients with uncontrolled asthma will be evaluated.

    Measured: From Baseline (Week 0) to End of Treatment (EOT) in DB treatment period

Secondary outcomes (11)

  1. 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.

    Measured: From Baseline (Week 0) to EOT in DB treatment period

  2. Change from baseline, during the DB treatment period in Asthma symptom score

    The effect of benralizumab on asthma control and symptoms will be assessed.

    Measured: From Baseline (Week 0) to EOT in DB treatment period

  3. Change from baseline, during the DB treatment period in rescue medication use

    The effect of benralizumab on asthma control and symptoms will be assessed.

    Measured: From Baseline (Week 0) to EOT in DB treatment period

  4. 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.

    Measured: From Baseline (Week 0) to EOT in DB treatment period

  5. 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.

    Measured: From Baseline (Week 0) to EOT in DB treatment period

  6. Serum benralizumab trough concentration

    The pharmacokinetics of benralizumab will be characterised.

    Measured: During Day -7, Day 56, Day 112, every 16 weeks and at EOT DB treatment period

  7. Anti-benralizumab antibodies

    The immunogenicity of benralizumab will be characterised.

    Measured: During Day -7, Day 56, Day 112, every 16 weeks and at EOT DB treatment period

  8. 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.

    Measured: From Baseline (Week 0) to EOT in DB treatment period

  9. 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.

    Measured: From Baseline (Week 0) to EOT in DB treatment period

  10. 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.

    Measured: From Baseline (Week 0) to EOT in DB treatment period

  11. 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.

    Measured: From Screening until the EOT double blind treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2023
  2. Study start5 Apr 2023
  3. Primary completion23 Dec 2026 (estimated)
  4. Study completion23 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05692180
Sponsor's protocol ID
D3250C00024
Acronym
DOMINICA
Status last verified
Sep 2026
First submitted
11 Jan 2023
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Benralizumab in people with Asthma, run by AstraZeneca at 43 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Argentina, Poland, South Korea, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first asthma exacerbation (time frame: From Baseline (Week 0) to End of Treatment (EOT) in DB treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05692180.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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DOMINICA Clinical Trial NCT05692180 | AzTrials