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N/A N=4,115

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

Churg-Strauss Syndrome · Eosinophilic Granulomatosis With Polyangiitis

Enrolled (actual)
4,115
Serious AEs
1.8%
Results posted
Feb 2026
Primary outcome: Primary: Number of Participants With Adverse Drug Reactions (ADRs) — 57 Participants

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Nucala (Drug)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Jul 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Adverse Drug Reactions (ADRs)
57
PRIMARY
Response Rate Based on Global Assessment of Effectiveness
95.1
PRIMARY
Time to EGPA Relapse
133.7

Summary

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 If a subject has withdrawn from/terminated administration of NUCALA, it will be until the withdrawal/termination. Additionally, to consider the safety and effectiveness of NUCALA administration in subjects who had withdrawn from/terminated due to symptom improvement, 48 weeks (1 year) follow-up investigation should be conducted as much as possible.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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Not applicable.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03557060). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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