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NCT05692180 | RECRUITING | Asthma

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)
Sponsor:

AstraZeneca

Brief 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 controller medication.

Condition or disease

Asthma

Intervention/treatment

Benralizumab

Placebo

Phase

PHASE3

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : Efficacy and Safety of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)
Actual Study Start Date : 2023-04-05
Estimated Primary Completion Date : 2030-05-05
Estimated Study Completion Date : 2032-05-16

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 6 Years to 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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/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.
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)

Location Details

NCT05692180

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

WITHDRAWN

United States, Albama

Research Site

Mobile, Albama, United States, 36608

WITHDRAWN

United States, Albama

Research Site

Montgomery, Albama, United States, 36106

RECRUITING

United States, Arizona

Research Site

Tucson, Arizona, United States, 85724

WITHDRAWN

United States, Arkansa

Research Site

Little Rock, Arkansa, United States, 72202

WITHDRAWN

United States, California

Research Site

Madera, California, United States, 93636

NOT YET RECRUITING

United States, California

Research Site

Torrance, California, United States, 90505

RECRUITING

United States, District of Columbia

Research Site

Washington, District of Columbia, United States, 20010

RECRUITING

United States, Florida

Research Site

Miami, Florida, United States, 33144

RECRUITING

United States, Florida

Research Site

Miami, Florida, United States, 33184

COMPLETED

United States, Florida

Research Site

Ocala, Florida, United States, 34471

RECRUITING

United States, Kentucky

Research Site

Owensboro, Kentucky, United States, 42301

RECRUITING

United States, Louisiana

Research Site

Lafayette, Louisiana, United States, 70508

WITHDRAWN

United States, Louisiana

Research Site

New Orleans, Louisiana, United States, 70112

RECRUITING

United States, Maryland

Research Site

Glenn Dale, Maryland, United States, 20769

NOT YET RECRUITING

United States, Massachusetts

Research Site

Boston, Massachusetts, United States, 02114

WITHDRAWN

United States, Mississippi

Research Site

Ridgeland, Mississippi, United States, 39157

COMPLETED

United States, Missouri

Research Site

Kansas City, Missouri, United States, 64108

WITHDRAWN

United States, Nebraska

Research Site

Lincoln, Nebraska, United States, 68510

WITHDRAWN

United States, New Jersey

Research Site

Brick, New Jersey, United States, 08724

RECRUITING

United States, New Jersey

Research Site

Northfield, New Jersey, United States, 08225

RECRUITING

United States, New York

Research Site

Bronx, New York, United States, 10459

RECRUITING

United States, Ohio

Research Site

Cincinnati, Ohio, United States, 45229

RECRUITING

United States, Ohio

Research Site

Cleveland, Ohio, United States, 44106

RECRUITING

United States, South Carolina

Research Site

Charleston, South Carolina, United States, 29425

RECRUITING

United States, Texas

Research Site

Dallas, Texas, United States, 75235

RECRUITING

United States, Texas

Research Site

San Antonio, Texas, United States, 78229

RECRUITING

United States, Texas

Research Site

Tyler, Texas, United States, 75708

RECRUITING

United States, West Virginia

Research Site

Morgantown, West Virginia, United States, 26506

RECRUITING

Argentina,

Research Site

Buenos Aires, Argentina, C1414AIF

RECRUITING

Argentina,

Research Site

Good Air City, Argentina, C1425DTG

RECRUITING

Argentina,

Research Site

Florencio Varela, Argentina, 1888

RECRUITING

Argentina,

Research Site

Florida, Argentina, B1602DQD

RECRUITING

Argentina,

Research Site

Lobos, Argentina, 7240

RECRUITING

Argentina,

Research Site

Mar del Plata, Argentina, B7600

RECRUITING

Argentina,

Research Site

Mendoza, Argentina, 5500

RECRUITING

Argentina,

Research Site

Mendoza, Argentina, M5500CCG

RECRUITING

Argentina,

Research Site

Rosario, Argentina, 2000

RECRUITING

Argentina,

Research Site

Santa Fe, Argentina, S3000ASF

RECRUITING

Canada, Alberta

Research Site

Edmonton, Alberta, Canada, T6G 1C9

RECRUITING

Canada, Ontario

Research Site

Burlington, Ontario, Canada, To solve Tout

WITHDRAWN

Canada, Ontario

Research Site

Hamilton, Ontario, Canada, L8S 1G5

RECRUITING

Canada, Quebec

Research Site

Montreal, Quebec, Canada, H3T 1C5

WITHDRAWN

Canada,

Research Site

Quebec, Canada, G1V 4W2

RECRUITING

France,

Research Site

Creteil, France, 94010

RECRUITING

France,

Research Site

Lyon, France, 69394

RECRUITING

France,

Research Site

Montpellier, France, 34295

RECRUITING

France,

Research Site

Nice, France, 06000

RECRUITING

France,

Research Site

Paris, France, 77019

RECRUITING

France,

Research Site

Rouen Cedex, France, 76031

RECRUITING

France,

Research Site

Toulouse Cedex 9, France, 31059

WITHDRAWN

Germany,

Research Site

Essen, Germany, 41469

WITHDRAWN

Germany,

Research Site

Wesel, Germany, 46483

RECRUITING

Italy,

Research Site

Genova, Italy, 16100

RECRUITING

Italy,

Research Site

Milano, Italy, 20142

RECRUITING

Italy,

Research Site

Pavia, Italy, 27100

RECRUITING

Italy,

Research Site

San Pietro bridge, Italy, 24036

WITHDRAWN

Italy,

Research Site

Roma, Italy, 00161

RECRUITING

Italy,

Research Site

Roma, Italy, 00165

RECRUITING

Italy,

Research Site

Verona, Italy, 37134

RECRUITING

Korea, Republic of,

Research Site

Cheongju-Si, Korea, Republic of, 28644

RECRUITING

Korea, Republic of,

Research Site

Young Gu, Korea, Republic of, 22332

RECRUITING

Korea, Republic of,

Research Site

Seoul, Korea, Republic of, 03080

RECRUITING

Korea, Republic of,

Research Site

Seoul, Korea, Republic of, 03722

RECRUITING

Korea, Republic of,

Research Site

Seoul, Korea, Republic of, 05505

RECRUITING

Poland,

Research Site

Bialystok, Poland, 15-879

RECRUITING

Poland,

Research Site

Krakow, Poland, 31-624

RECRUITING

Poland,

Research Site

Rzeszów, Poland, 35-612

RECRUITING

Poland,

Research Site

Skarżysko-Kamienna, Poland, 26-110

RECRUITING

Poland,

Research Site

Łódź, Poland, 90-302

RECRUITING

Spain,

Research Site

Badalona, Spain, 08916

RECRUITING

Spain,

Research Site

Barcelona, Spain, 8035

RECRUITING

Spain,

Research Site

Benalmádena, Spain, 29631

RECRUITING

Spain,

Research Site

Cartagena, Spain, 30203

RECRUITING

Spain,

Research Site

Esplugues de Llobregat, Spain, 8950

RECRUITING

Spain,

Research Site

Madrid, Spain, 28034

WITHDRAWN

Spain,

Research Site

Mérida, Spain, 06800

RECRUITING

Spain,

Research Site

Valencia, Spain, 46026

RECRUITING

Taiwan,

Research Site

Changhua, Taiwan, 500

RECRUITING

Taiwan,

Research Site

composed, Taiwan, 833

RECRUITING

Taiwan,

Research Site

Taichung, Taiwan, 402

RECRUITING

Taiwan,

Research Site

Taipei, Taiwan, 100

RECRUITING

Taiwan,

Research Site

taoyuan, Taiwan, 333

WITHDRAWN

United Kingdom,

Research Site

Glasgow, United Kingdom, GZ 8C

WITHDRAWN

United Kingdom,

Research Site

Leicester, United Kingdom, LE2 7LZ

RECRUITING

United Kingdom,

Research Site

London, United Kingdom, E1 4NS

RECRUITING

United Kingdom,

Research Site

London, United Kingdom, SE5 9RS

RECRUITING

United Kingdom,

Research Site

Manchester, United Kingdom, M13 9pl