Last updated: 06/13/2025 10:50:08
A Study of Nucala (Mepolizumab) Autoinjector in Korean Participants
GSK study ID
221408
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Trial overview
Official title: An Open Label, Multi-centre, Observational Study to Monitor the Safety of Nucala Autoinjector Administered in Korean Subjects for Treatment of the Indication as Condition of License Approval in Real-world Practice
Trial description: The purpose of this study is to observe the safety profile of Nucala autoinjector when it is used according to its approved label. This study will also monitor important identified and potential risks according to the risk management plan (RMP) in a real-world practice. Researchers will guide the participants to follow their treatment regimen, including the prescribed medications, during routine clinical practice.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Percentage of Participants with Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious AEs (SAEs), or Unexpected ADRs
Timeframe: Up to 48 weeks after first administration of mepolizumab
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2029-30-09
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
May 2026 to December 2030
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Severe Eosinophilic Asthma (SEA)
- As add-on maintenance treatment of SEA in participants 12 years and older.
- Hypersensitivity to mepolizumab or to any of the excipients.
Inclusion and exclusion criteria
Inclusion criteria:
- Severe Eosinophilic Asthma (SEA) As add-on maintenance treatment of SEA in participants 12 years and older.
- Blood eosinophil counts greater than or equal to (>=) 150 cells per microliter (cells/µL) at screening; or
- blood eosinophils >= 300 cells/µL in the past 12 months Eosinophilic Granulomatosis with Polyangiitis (EGPA) As add-on maintenance treatment of EGPA in adult participants. Hypereosinophilic Syndrome (HES) As add-on maintenance treatment of HES in adult participants (Except FIP1L1-PDGFRα kinase-positive participants).
Exclusion criteria:
- Hypersensitivity to mepolizumab or to any of the excipients.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Will be 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
Not applicable
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