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중증 호산구성 천식 소아 환자에서 Benralizumab의 다기관, 무작위, 이중 맹검, 병렬 그룹, 위약 대조, 최초 천식 악화 3상 효능 및 안전성 연구(DOMINICA) (DOMINICA)

2026년 10월 27일 업데이트: AstraZeneca

중증 호산구성 천식 소아 환자에서 Benralizumab의 효능 및 안전성(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.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

94

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

6년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Benralizumab

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

Benralizumab active solution will be administered SC to the patients.
위약 비교기: Placebo

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

Placebo solution will be administered SC to the patients.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Time to first asthma exacerbation
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change from baseline, during the DB treatment period in Interviewer-Administered Version of the Asthma Control Questionnaire (ACQ-IA)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Number of patients with Adverse events (AEs) and Serious adverse events (SAEs)
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AstraZeneca

협력자

Parexel

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 4월 5일

기본 완료 (추정된)

2026년 12월 23일

연구 완료 (추정된)

2026년 12월 23일

연구 등록 날짜

최초 제출

2023년 1월 11일

QC 기준을 충족하는 최초 제출

2023년 1월 11일

처음 게시됨 (실제)

2023년 1월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 27일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • D3250C00024

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

IPD 공유 기간

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.

IPD 공유 액세스 기준

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.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다