A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases

Part of paid clinical trials in Aurora, Colorado.

Sponsor
AstraZeneca
Study ID
NCT06512883
Phase
PHASE3
Status
Recruiting
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Conditions

  • Eosinophilic Granulomatosis With Polyangiitis (EGPA)
  • Hypereosinophilia Syndrome (HES)

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Benralizumab — DRUG
    Benralizumab will be administered as SC injection on Q4W.

Study Details

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

Key Dates

Start date
Apr 17, 2025
Status verified
May 2026
Primary completion
Feb 21, 2028
Completion
May 14, 2029

Study Design

Enrollment
14 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: EGPA/HES 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.

Primary Outcome Measure

Number of Participants with Adverse Events (AEs) [ Time Frame: From screening (Week -4 to -1) until Week 52 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Research SiteAuroraColorado80045-
Research SiteCincinnatiOhio45229-
Research SiteHighland HillsOhio44106-2624-

Find similar trials in Aurora, CO

By research site
Research Site· Aurora, COResearch Site· Cincinnati, OHResearch Site· Highland Hills, OH

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