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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Benralizumab
DrugBenralizumab will be administered as SC injection on Q4W.
Treatment groups
14 Participants
are divided into 1 treatment groupGroup A: EGPA/HES Cohort: BenralizumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Adverse Events (AEs)
The safety and tolerability of benralizumab will be evaluated.
Time frame
From screening (Week -4 to -1) until Week 522
Serum Concentrations of Benralizumab
The PK of benralizumab will be evaluated.
Time frame
Weeks 0, 12, 24, 25, 36, and 52Secondary outcomes
1
EGPA Cohort: Percentage of Participants with Remission at Week 24
Remission defined as Paediatric Vasculitis Activity Score (PVAS) = 0 and oral corticosteroid (OCS) intake less than or equal to (\<=) 0.1 mg/kg/day.
Time frame
At Week 242
Number of Participants with Positive Antidrug Antibody (ADA)
The immunogenicity of benralizumab will be evaluated.
Time frame
Weeks 0, 12, 24, 36, 48, and 523
Change From Baseline in Peripheral Blood Eosinophil Count
The PD effect of benralizumab on peripheral blood eosinophil count will be evaluated.
Time frame
From Baseline to Weeks 0, 12, 24, 36, 524
EGPA Cohort: Time to First EGPA Relapse
The efficacy of benralizumab on time to first relapse will be assessed. EGPA relapse will be defined as worsening or persistence of active disease since the last visit characterized by: a) Active vasculitis (PVAS \> 0); OR b) Worsening of asthma symptoms (based on Asthma Control Questionnaire - Interviewer Administered \[ACQ-IA\]); OR c) Active nasal and/or sinus disease with worsening in at least one sino-nasal symptom question warranting any of the following: 1) Increase OCS; OR 2) Increase/addition of immunosuppressive medication; OR 3) Hospitalisation related to EGPA worsening.
Time frame
Up to 52 weeksSponsors and contacts
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Source ClinicalTrials.gov