A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-17
SponsorAstraZeneca
About this trial
The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab.
Eligibility criteria
Qualifiers
Male or female participants 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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Benralizumab
Treatment groups
14 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov