At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 30 enrolled
Drug / intervention
Benralizumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Study to Evaluate the Pharmacokinetics and Pharmacodynamics and Long-term Safety of Benralizumab Administered Subcutaneously in Children With Severe Eosinophilic Asthma
In Brief
A Phase 3 clinical trial evaluating Benralizumab for Severe Uncontrolled Asthma. Completed, enrolled 30 participants across 15 sites in 2 countries.
Detailed Summary
This study will evaluate the PK, PD and long-term safety of Benralizumab administered subcutaneously in 30 children aged 6 to 11 years with severe eosinophilic asthma. Up to an additional 3 Japanese patients aged 12 to 14 years will be enrolled to meet local regulatory requirements.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Uncontrolled Asthma
CountriesJapan, United States
CollaboratorsIQVIA Pty Ltd, Parexel, Covance, PPD Development, LP
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartNov 2019
First PostedMar 2020
Primary CompletionSep 2022
TodayJul 2026
First PostedMar 12, 2020
Enrollment StartNov 21, 2019
Primary CompletionSep 12, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 6.3 years ago
Interventions
Benralizumabdrug
Dose will be stratified by body weight at screening: Patients will receive Dose 1 or Dose 2 of Benralizumab administered by SC injection at Day 0 and Weeks 4, 8, and 16, 24, 32, and 40.