Last updated: 07/17/2025 12:40:16
Long term special drug use investigation of Mepolizumab
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Nucala® Subcutaneous Injection Special Drug Use Investigation (Long-Term)
Trial description: This study is a special drug use investigation program of NUCALA (a brand name for Mepolizumab) administered subcutaneously (SC). In this study the information regarding the safety and effectiveness of long term use of NUCALA after subcutaneous injection will be collected from Asthma subjects in daily clinical practice. The observation period per subject will be 52 weeks from the initiation of NUCALA treatment with follow-up investigation for 2 years after the observation period. NUCALA is a registered trademark of the GlaxoSmithKline [GSK] group of companies
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of subjects whose data enetered on Electronic data capture (EDC) system
Timeframe: Up to 3 years
Incidence of adverse drug reaction
Timeframe: Up to 3 years
Number of subjects showing Response to the treatment
Timeframe: Up to Week 52
Number of subjects excluded from analysis due to exacerbation of asthma
Timeframe: Up to Week 52
Number of subjects having adverse drug reactions (ADR)
Timeframe: Up to 3 years
Number of subjects require priority investigation matter
Timeframe: Up to 3 years
Secondary outcomes:
Response rate assessed by global assessment of effectiveness
Timeframe: Up to Week 52
Frequency of exacerbation of asthma
Timeframe: Up to Week 52
Total score of Asthma Control Test (ACT)
Timeframe: Up to Week 52
Number of subjects having normal Peak Expiratory Flow (PEF) score
Timeframe: Up to Week 54
Interventions:
Drug: NUCALA Injection
Enrollment:
1061
Observational study model:
Case-Only
Primary completion date:
2023-22-11
Time perspective:
Prospective
Clinical publications:
Tsuboi E, Aoki H, Aizawa K, Komatsubara M, Howarth P. . Long-term safety and effectiveness of mepolizumab for patients with bronchial asthma in routine clinical practice in Japan - final report of special drug use investigation. Respir Investig. 2025;63(4): 651-659. doi:10.1016/j.resinv.2025.05.003 https://www.sciencedirect.com/science/article/pii/S221253452500067X
PMID: 40398189
DOI: 10.1016/j.resinv.2025.05.003
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
January 2017 to November 2023
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- Subjects receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications)
- No exclusion criteria
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications)
Exclusion criteria:
- No exclusion criteria
Trial location(s)
No location data available.
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2023-22-11
Actual study completion date
2023-22-11
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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