Last updated: 01/30/2026 16:10:52

NUCALA® Special Drug Use Investigation (EGPA, Long-term)

GSK study ID
208505
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: NUCALA ® Subcutaneous Injection Special Drug Use Investigation (EGPA, Long-term)
Trial description: This study is a drug use investigation program of NUCALA. The objective of this study is to collect and assess information on the safety and effectiveness of the long-term use of NUCALA SC injection in daily clinical practice in subjects with Eosinophilic Granulomatosis with Polyangiitis (EGPA). All subjects who administered NUCALA for the treatment of EGPA after its approval of indication will be included in the study. In addition, after the approval, subjects who had already received NUCALA for EGPA prior to the conclusion of the contract will also be included. Approximately 300 subjects will be included in the study. The observation period per subject is up to 96 weeks (2 years) from the start of NUCALA administration for EGPA at a maximum. If a subject has withdrawn from/terminated administration of NUCALA, it will be until the withdrawal/termination. Additionally, to consider the safety and effectiveness of NUCALA administration in subjects who had withdrawn from/terminated due to symptom improvement, 48 weeks (1 year) follow-up investigation should be conducted as much as possible. The total study duration will be approximately 3 years (2 years observation period and 1 year follow-up) from the approval of EGPA indication to the lifting of approval condition. 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 participants with adverse drug reactions (ADRs)

Timeframe: Up to 96 Weeks

Response rate based on global assessment of effectiveness

Timeframe: Up to 96 Weeks

Time to EGPA relapse

Timeframe: Up to 96 Weeks

Secondary outcomes:
Not applicable
Interventions:
Drug: Nucala
Enrollment:
4115
Observational study model:
Case-Only
Primary completion date:
2025-30-07
Time perspective:
Prospective
Clinical publications:
Fujii T, Atsumi T, Okamoto N, Takahashi N, Tamura N, Nakajima A, Nakajima A, Matsuno H, Mukai I, Ishida A, Aizawa K, Kuwana M, Takagi M, Takeuchi T.Post-marketing surveillance of mepolizumab use in patients with eosinophilic granulomatosis with polyangiitis in Japan: Interim analysis.Ther Res.2021;42(6):403-422
Medical condition
Churg-Strauss Syndrome, Eosinophilic Granulomatosis with Polyangiitis
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
June 2018 to July 2025
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
  • All subjects who administered NUCALA for the treatment of EGPA after its approval of indication will be included in the study. In addition, after the approval, subjects who had already received NUCALA for EGPA prior to the conclusion of the contract will also be included.
  • Subjects who had been registered to NCT03028480 for bronchial asthma, but had a change in treatment purpose from bronchial asthma to EGPA during the observation period
  • Not applicable.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Tokyo, Japan, 107-0052
Status
Recruiting

Study documents

Protocol
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
2025-30-07
Actual study completion date
2025-30-07

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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