Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512883
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 3 Open-label Trial to Evaluate Safety Pharmacokinetics and Efficacy of Benralizumab in Children With Eosinophilic Diseases CLIPS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLIPS
Brief Summary:
The main purpose of study is to assess the safety tolerability and pharmacokinetic PK of benralizumab
Detailed Description:
This study is open-label multicentre basket study to evaluate the safety PK pharmacodynamic PD efficacy and immunogenicity of repeat dosing of benralizumab subcutaneous SC every 4 weeks Q4W in male and female children with rare eosinophilic diseases
Paediatric participants with eosinophilic granulomatosis with polyangiitis EGPA will be enrolled in the first cohort Additional cohorts in other eosinophilic diseases may be added in future protocol amendments
The study consists of 3 periods
1 Screening period 1 to 4 weeks
2 Open-label treatment period 52 weeks
3 Open-label extension period at least 52 weeks plus safety follow-up SFU weeks after last investigational product IP administration
All eligible participants will receive benralizumab SC Q4W during the 52-week open-label treatment period
All participants who complete the 52-week open-label treatment period on IP will be offered the opportunity to continue into an extension period The extension period is intended to allow each participant at least an additional one year of treatment with benralizumab
Paediatric participants with eosinophilic granulomatosis with polyangiitis EGPA will be enrolled in the first cohort Additional cohorts in other eosinophilic diseases may be added in future protocol amendments
The study consists of 3 periods
1 Screening period 1 to 4 weeks
2 Open-label treatment period 52 weeks
3 Open-label extension period at least 52 weeks plus safety follow-up SFU weeks after last investigational product IP administration
All eligible participants will receive benralizumab SC Q4W during the 52-week open-label treatment period
All participants who complete the 52-week open-label treatment period on IP will be offered the opportunity to continue into an extension period The extension period is intended to allow each participant at least an additional one year of treatment with benralizumab
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None