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Wieloośrodkowe, randomizowane, prowadzone metodą podwójnie ślepej próby, w grupach równoległych, kontrolowane placebo, badanie fazy III dotyczące czasu do pierwszego zaostrzenia astmy, dotyczące skuteczności i bezpieczeństwa stosowania benralizumabu u dzieci i młodzieży z ciężką astmą eozynofilową (DOMINICA) (DOMINICA)

27 października 2026 zaktualizowane przez: AstraZeneca

Skuteczność i bezpieczeństwo benralizumabu u dzieci i młodzieży z ciężką astmą eozynofilową (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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

94

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Argentyna
      • Ciudad de Buenos Aire, Argentyna, C1425DTG
        • Research Site
      • Ciudad de Buenos Aires, Argentyna, C1414AIF
        • Research Site
      • Florida, Argentyna, B1602DQD
        • Research Site
      • Lobos, Argentyna, 7240
        • Research Site
      • Mar del Plata, Argentyna, B7600
        • Research Site
      • Mendoza, Argentyna, 5500
        • Research Site
      • Mendoza, Argentyna, M5500CCG
        • Research Site
      • Rosario, Argentyna, 2000
        • Research Site
      • San Juan Bautista, Argentyna, 1888
        • Research Site
      • Santa Fe, Argentyna, S3000ASF
        • Research Site
  • Francja
      • Créteil, Francja, 94010
        • Research Site
      • Lyon, Francja, 69394
        • Research Site
      • Rouen, Francja, 76031
        • Research Site
  • Hiszpania
      • Badalona, Hiszpania, 08916
        • Research Site
      • Barcelona, Hiszpania, 8035
        • Research Site
      • Benalmádena, Hiszpania, 29631
        • Research Site
      • Esplugues de Llobregat, Hiszpania, 8950
        • Research Site
  • Korea Południowa
      • Cheongju-si, Korea Południowa, 28644
        • Research Site
      • Junggu, Korea Południowa, 22332
        • Research Site
      • Seoul, Korea Południowa, 03080
        • Research Site
      • Seoul, Korea Południowa, 05505
        • Research Site
  • Polska
      • Bialystok, Polska, 15-879
        • Research Site
      • Krakow, Polska, 31-624
        • Research Site
      • Lodz, Polska, 90-302
        • Research Site
      • Skarżysko-Kamienna, Polska, 26-110
        • Research Site
      • Tarnów, Polska, 33-100
        • Research Site
  • Stany Zjednoczone
    • California
      • Torrance, California, Stany Zjednoczone, 90505
        • Research Site
    • Florida
      • Ocala, Florida, Stany Zjednoczone, 34471
        • Research Site
    • Kentucky
      • Owensboro, Kentucky, Stany Zjednoczone, 42301
        • Research Site
    • Louisiana
      • Lafayette, Louisiana, Stany Zjednoczone, 70508
        • Research Site
    • Missouri
      • Kansas City, Missouri, Stany Zjednoczone, 64108
        • Research Site
    • New Jersey
      • Northfield, New Jersey, Stany Zjednoczone, 08225
        • Research Site
    • New York
      • The Bronx, New York, Stany Zjednoczone, 10459
        • Research Site
    • Ohio
      • Cincinnati, Ohio, Stany Zjednoczone, 45229
        • Research Site
    • South Carolina
      • Charleston, South Carolina, Stany Zjednoczone, 29425
        • Research Site
    • Texas
      • San Antonio, Texas, Stany Zjednoczone, 78229
        • Research Site
      • Tyler, Texas, Stany Zjednoczone, 75708
        • Research Site
  • Tajwan
      • Kaohsiung City, Tajwan, 833
        • Research Site
      • Taoyuan, Tajwan, 333
        • Research Site
  • Włochy
      • Milan, Włochy, 20142
        • Research Site
      • Roma, Włochy, 00165
        • Research Site
  • Zjednoczone Królestwo
      • London, Zjednoczone Królestwo, SE5 9RS
        • Research Site
      • Manchester, Zjednoczone Królestwo, M13 9PL
        • Research Site

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

6 lat do 18 lat (Dziecko, Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 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,

    1. 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:
    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 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.

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 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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Benralizumab

Patients will receive Benralizumab as an active solution via a subcutaneous (SC) injection.
Lek: Benralizumab

Benralizumab active solution will be administered SC to the patients.
Komparator placebo: Placebo

Patients will receive a matching solution of the placebo via SC injection.
Lek: Placebo

Placebo solution will be administered SC to the patients.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Time to first asthma exacerbation
Ramy czasowe: From Baseline (Week 0) to End of Treatment (EOT) in DB treatment period

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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change from baseline, during the DB treatment period in Interviewer-Administered Version of the Asthma Control Questionnaire (ACQ-IA)
Ramy czasowe: From Baseline (Week 0) to EOT in DB treatment period

The effect of benralizumab on asthma control and symptoms will be assessed.
From Baseline (Week 0) to EOT in DB treatment period
Change from baseline, during the DB treatment period in Asthma symptom score
Ramy czasowe: From Baseline (Week 0) to EOT in DB treatment period

The effect of benralizumab on asthma control and symptoms will be assessed.
From Baseline (Week 0) to EOT in DB treatment period
Change from baseline, during the DB treatment period in rescue medication use
Ramy czasowe: From Baseline (Week 0) to EOT in DB treatment period

The effect of benralizumab on asthma control and symptoms will be assessed.
From Baseline (Week 0) to EOT in DB treatment period
Change from baseline, during the DB treatment period in night-time awakenings due to asthma
Ramy czasowe: From Baseline (Week 0) to EOT in DB treatment period

The effect of benralizumab on asthma control and symptoms will be assessed.
From Baseline (Week 0) to EOT in DB treatment period
Change from baseline, during the DB treatment period in peak expiratory flow (PEF)
Ramy czasowe: From Baseline (Week 0) to EOT in DB treatment period

The effect of benralizumab on asthma control and symptoms will be assessed.
From Baseline (Week 0) to EOT in DB treatment period
Serum benralizumab trough concentration
Ramy czasowe: During Day -7, Day 56, Day 112, every 16 weeks and at EOT DB treatment period

The pharmacokinetics of benralizumab will be characterised.
During Day -7, Day 56, Day 112, every 16 weeks and at EOT DB treatment period
Anti-benralizumab antibodies
Ramy czasowe: During Day -7, Day 56, Day 112, every 16 weeks and at EOT DB treatment period

The immunogenicity of benralizumab will be characterised.
During Day -7, Day 56, Day 112, every 16 weeks and at EOT DB treatment period
Change from baseline, during the DB treatment period in Paediatric Asthma Quality of Life Questionnaire-Interviewer Administered (PAQLQ-IA) total score
Ramy czasowe: From Baseline (Week 0) to EOT in DB treatment period

The effect of benralizumab on asthma health-related quality of life will be assessed.
From Baseline (Week 0) to EOT in DB treatment period
Change from baseline, during the DB treatment period, in spirometry, for pre-dose/pre-bronchodilator forced expiratory volume in one second (FEV1)
Ramy czasowe: From Baseline (Week 0) to EOT in DB treatment period

The effect of benralizumab on pulmonary function (FEV1) will be assessed.
From Baseline (Week 0) to EOT in DB treatment period
Change from baseline, during the DB treatment period, in spirometry, for post-bronchodilator FEV1
Ramy czasowe: From Baseline (Week 0) to EOT in DB treatment period

The effect of benralizumab on pulmonary function (FEV1) will be assessed.
From Baseline (Week 0) to EOT in DB treatment period
The Annualised asthma exacerbation rate (AAER) in the DB treatment period
Ramy czasowe: From Screening until the EOT double blind 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Number of patients with Adverse events (AEs) and Serious adverse events (SAEs)
Ramy czasowe: From Screening period until EOT DB treatment period

The safety and tolerability of benralizumab will be evaluated.
From Screening period until EOT DB treatment period
The AAER in the OLE period
Ramy czasowe: From Week 0 until the EOT OLE period

The annualised rate of severe exacerbations in the OLE period will be assessed.
From Week 0 until the EOT OLE period

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

AstraZeneca

Współpracownicy

Parexel

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

5 kwietnia 2023

Zakończenie podstawowe (Szacowany)

23 grudnia 2026

Ukończenie studiów (Szacowany)

23 grudnia 2026

Daty rejestracji na studia

Pierwszy przesłany

11 stycznia 2023

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 stycznia 2023

Pierwszy wysłany (Rzeczywisty)

20 stycznia 2023

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

28 października 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 października 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • D3250C00024

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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

Ramy czasowe udostępniania IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Kryteria dostępu do udostępniania IPD

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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