A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases

Description

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

Conditions

Eosinophilic Granulomatosis With Polyangiitis (EGPA)

Study Overview

Study Details

Study overview

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

Phase 3, Open-label Trial to Evaluate Safety, Pharmacokinetics, and Efficacy of Benralizumab in Children With Eosinophilic Diseases (CLIPS)

A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases

Condition
Eosinophilic Granulomatosis With Polyangiitis (EGPA)
Intervention / Treatment

-

Contacts and Locations

Aurora

Research Site, Aurora, Colorado, United States, 80045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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).
  • * 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).
  • * 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.
  • * 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.

Ages Eligible for Study

6 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2028-05-30