Last updated: 10/21/2025 05:40:21
Pediatric eosinophilic granulomatosis with polyangiitis participants treated with Mepolizumab in Europe
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: A post-authorisation safety study (PASS) to describe real-world safety and effectiveness of NUCALA (mepolizumab) in paediatric eosinophilic granulomatosis with polyangiitis (EGPA) patients in Europe
Trial description: The purpose of this study is to describe real-world safety and effectiveness in pediatric EGPA participants treated with mepolizumab in Europe. Participants will be followed for up to 24 months after the initiation of mepolizumab treatment. Index date is defined as the date of the first (non-missing) dose of mepolizumab. NUCALA is a trademark of GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with adverse events and serious adverse events
Timeframe: Up to 24 months
Number of participants with adverse drug reactions
Timeframe: Up to 24 months
Number of pregnant participants with exposure of mepolizumab
Timeframe: Up to 24 months
Number of participants with medical device incidents
Timeframe: Up to 24 months
Secondary outcomes:
Number of participants with effect of mepolizumab on oral corticosteriods (OCS) dosage
Timeframe: Up to 24 months
Summary of demographics, clinical characteristics, medical and treatment history of participants treated with mepolizumab
Timeframe: Up to 12 months prior to Index date
Interventions:
Not applicable
Enrollment:
10
Primary completion date:
2029-20-07
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Churg-Strauss Syndrome, Eosinophilic Granulomatosis with Polyangiitis
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
June 2024 to July 2029
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
6 - 17 Years
Accepts healthy volunteers
No
- Participants with written informed assent and parent/caregiver consent
- Male or female, aged 6 to 17 years at the start of mepolizumab treatment
- Participants with concurrent enrollment and/or participation in an interventional clinical trial involving either an investigational medicinal product or medical device
- Participants who received treatment with mepolizumab more than 12 months prior to enrollment start date
Inclusion and exclusion criteria
Inclusion criteria:
- Participants with written informed assent and parent/caregiver consent
- Male or female, aged 6 to 17 years at the start of mepolizumab treatment
- Participants with confirmed diagnosis of EGPA
- Participants who initiated mepolizumab up to 12 months prior to enrollment start date (regardless of whether they continue treatment following study enrollment or not) or scheduled to receive treatment with mepolizumab at or after enrollment per routine clinical care
Exclusion criteria:
- Participants with concurrent enrollment and/or participation in an interventional clinical trial involving either an investigational medicinal product or medical device
- Participants who received treatment with mepolizumab more than 12 months prior to enrollment start date
- Participants who received other biologics within 3 months of the first dose of mepolizumab
Trial location(s)
Showing 1 - 6 of 7 Results
Study documents
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
No study documents available
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Additional information
Not applicable
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