NCT03557060

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,115 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 If a subject has withdrawn from/terminated administration of NUCALA, it will be until the withdrawal/termination. Additionally, to consider the safety and effectiveness of NUCALA administration in subjects who had withdrawn from/terminated due to symptom improvement, 48 weeks (1 year) follow-up investigation should be conducted as much as possible.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

Conditions

• Churg-Strauss Syndrome
• Eosinophilic Granulomatosis With Polyangiitis

Interventions

Type	Name	Description
DRUG	Nucala	NUCALA injections will be administered to eligible subjects with diagnosis of EGPA. Dose unit, daily dose frequency, date of administration will be at the investigator discretion.

Timeline

• Start date: 2018-06-25
• Primary completion: 2025-07-30
• Completion: 2025-07-30
• First posted: 2018-06-14
• Last updated: 2026-02-18
• Results posted: 2026-02-18

Locations

1 site across 1 country: Japan