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

NCT05692180 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: D3250C00024
• Study Type: interventional
• Target: 94
• Locations: 9 countries
• Sites: 43

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.

Conditions

Asthma

Keywords

Eosinophilic asthma; Pediatric Patients; Severe asthma

Outcome Measures

Primary Outcomes (1)

• Time to first asthma exacerbation

  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

Secondary Outcomes (11)

• Change from baseline, during the DB treatment period in Interviewer-Administered Version of the Asthma Control Questionnaire (ACQ-IA)

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

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

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

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

  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

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

• Change from baseline, during the DB treatment period in peak expiratory flow (PEF) measurement at home

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

Other Outcomes (2)

• Number of patients with Adverse events (AEs) and Serious adverse events (SAEs)

  From Screening period until EOT DB treatment period

• The AAER in the OLE period

  From Week 0 until the EOT OLE period

Study Arms (2)

Benralizumab

EXPERIMENTAL

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

Drug: Benralizumab

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Benralizumab DRUG

Benralizumab active solution will be administered SC to the patients.

Benralizumab

Placebo DRUG

Placebo solution will be administered SC to the patients.

Placebo

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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,
• 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 during screening and documentation of elevated eosinophils in bronchoalveolar lavage (BAL), sputum, bronchial biopsy, or historical eosinophil count ≥ 300 cells/μL 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 50% 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.
• ACQ-IA ≥ 1.5 at screening and Visit 2a.
• Body weight ≥ 15 kg.

You may not qualify if:

• 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 2.
• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (43)

Research Site

Torrance, California, 90505, United States

Location

Research Site

Ocala, Florida, 34471, United States

Location

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Owensboro, Kentucky, 42301, United States

Location

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Lafayette, Louisiana, 70508, United States

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Kansas City, Missouri, 64108, United States

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Northfield, New Jersey, 08225, United States

Location

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The Bronx, New York, 10459, United States

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Cincinnati, Ohio, 45229, United States

Location

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Charleston, South Carolina, 29425, United States

Location

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San Antonio, Texas, 78229, United States

Location

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Tyler, Texas, 75708, United States

Location

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Ciudad de Buenos Aires, C1414AIF, Argentina

Location

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Ciudad de Buenos Aire, C1425DTG, Argentina

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Florida, B1602DQD, Argentina

Location

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Lobos, 7240, Argentina

Location

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Mar del Plata, B7600, Argentina

Location

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Mendoza, 5500, Argentina

Location

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Mendoza, M5500CCG, Argentina

Location

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Rosario, 2000, Argentina

Location

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San Juan Bautista, 1888, Argentina

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Santa Fe, S3000ASF, Argentina

Location

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Créteil, 94010, France

Location

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Lyon, 69394, France

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Rouen, 76031, France

Location

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Milan, 20142, Italy

Location

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Roma, 00165, Italy

Location

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Bialystok, 15-879, Poland

Location

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Krakow, 31-624, Poland

Location

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Lodz, 90-302, Poland

Location

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Skarżysko-Kamienna, 26-110, Poland

Location

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Tarnów, 33-100, Poland

Location

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Cheongju-si, 28644, South Korea

Location

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Junggu, 22332, South Korea

Location

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Seoul, 03080, South Korea

Location

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Seoul, 05505, South Korea

Location

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Badalona, 08916, Spain

Location

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Barcelona, 8035, Spain

Location

Research Site

Benalmádena, 29631, Spain

Location

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Esplugues de Llobregat, 8950, Spain

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Kaohsiung City, 833, Taiwan

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Taoyuan, 333, Taiwan

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London, SE5 9RS, United Kingdom

Location

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Manchester, M13 9PL, United Kingdom

Location

MeSH Terms

Conditions

Asthma; Pulmonary Eosinophilia

Interventions

benralizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 20, 2023
• Study Start: April 5, 2023
• Primary Completion (Estimated): May 5, 2030
• Study Completion (Estimated): May 16, 2032
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 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.
• Access Criteria: 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.

Locations

IT (2); PL (5); KR (4); GB (2); AR (10); US (11); FR (3); ES (4); TW (2)