A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases

Study Purpose

The main purpose of study is to assess the safety, tolerability, and pharmacokinetic (PK) of benralizumab.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 6 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

All Cohorts:
  • - Male or female patients must be aged 6 to < 18 years of age at the time of signing the assent form and their caregiver signing the informed consent form.
  • - Body weight greater than (>=) 15 kilograms (kg).
EGPA Cohort:
  • - Therapy with corticosteroids: The prescribed dose of oral corticosteroids (OCS) (greater than [>] 0.1 milligrams per kilogram per day (mg/kg/day), max dose of 50 milligrams per day (mg/day) must be stable (that is, no adjustment of the dose) for at least 4 weeks prior to baseline (Visit 2).
  • - Immunosuppressive therapy: If receiving immunosuppressive therapy, the dosage must be stable for at least 4 weeks prior to baseline (Visit 2).

Exclusion Criteria:

All Cohorts:
  • - Any current malignancy or history of malignancy.
  • - History of anaphylaxis to any biologic therapy or vaccine.
  • - Known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological, respiratory, or any other system abnormalities.
  • - Previous receipt of benralizumab in an interventional clinical study.
EGPA Cohort:
  • - Diagnosed with granulomatosis with polyangiitis (previously known as Wegener'granulomatosis) or microscopic polyangiitis.
  • - EGPA relapse: any deterioration in EGPA and/or organ-threatening EGPA that per Investigator judgement renders patients unstable in their EGPA within 3 months prior to screening (Visit 1) and through first administration of IP at baseline (Visit 2).
  • - Life-threatening EGPA: imminently life-threatening EGPA disease within 3 months prior to screening (Visit 1) and through first administration of IP at baseline (Visit 2), as per Investigator judgement.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06512883
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AstraZeneca
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Brazil, Canada, Mexico, Turkey, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Granulomatosis With Polyangiitis (EGPA)
Additional Details

This study is open-label, multicentre, basket study to evaluate the safety, PK, pharmacodynamic (PD), efficacy, and immunogenicity of repeat dosing of benralizumab subcutaneous (SC) every 4 weeks (Q4W) in male and female children with rare eosinophilic diseases. Paediatric participants with eosinophilic granulomatosis with polyangiitis (EGPA) will be enrolled in the first cohort. Additional cohorts in other eosinophilic diseases may be added in future protocol amendments. The study consists of 3 periods: 1. Screening period: 1 to 4 weeks. 2. Open-label treatment period: 52 weeks. 3. Open-label extension period: at least 52 weeks (plus safety follow-up [SFU] weeks after last investigational product [IP] administration) All eligible participants will receive benralizumab SC Q4W during the 52-week open-label treatment period. All participants who complete the 52-week open-label treatment period on IP will be offered the opportunity to continue into an extension period. The extension period is intended to allow each participant at least an additional one year of treatment with benralizumab.

Arms & Interventions

Arms

Experimental: EGPA Cohort: Benralizumab

Participants with greater than or equal to (>=) 35 kg weight will receive benralizumab dose-1 and participants with less than (<) 35 kg weight will receive benralizumab dose-2 as SC injection Q4W during the 52-week treatment period. All participants, who complete the 52-week treatment period, will be offered the opportunity to continue into an extension period.

Interventions

Drug: - Benralizumab

Benralizumab will be administered as SC injection on Q4W.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Research Site, Aurora, Colorado

Status

Recruiting

Address

Research Site

Aurora, Colorado, 80045

International Sites

Research Site, Sao Paulo, Brazil

Status

Not yet recruiting

Address

Research Site

Sao Paulo, , 01232-010

Research Site, Toronto, Ontario, Canada

Status

Recruiting

Address

Research Site

Toronto, Ontario, M5G1X8

Research Site, Guadalajara, Mexico

Status

Recruiting

Address

Research Site

Guadalajara, , 44620

Research Site, Altındağ, Turkey

Status

Not yet recruiting

Address

Research Site

Altındağ, , 06230

Research Site, Istanbul, Turkey

Status

Not yet recruiting

Address

Research Site

Istanbul, , 34093