NUCALA® Special Drug Use Investigation (EGPA, Long-term)
NUCALA ® Subcutaneous Injection Special Drug Use Investigation (EGPA, Long-term)
NUCALA ® Subcutaneous Injection Special Drug Use Investigation (EGPA, Long-term)
Sponsor study identifier
observational
4,115
1 country
1
Study Start
June 25, 2018
Actual (reported)Primary Completion
July 30, 2025
Actual (reported)Study Completion
July 30, 2025
Actual (reported)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 If a subject has withdrawn from/terminated administration of NUCALA, it will be until the withdrawal/termination. Additionally, to consider the safety and effectiveness of NUCALA administration in subjects who had withdrawn from/terminated due to symptom improvement, 48 weeks (1 year) follow-up investigation should be conducted as much as possible.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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 30, 2025
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 4, 2018
Actual (reported)June 14, 2018
Actual (reported)June 25, 2018
Actual (reported)July 30, 2025
Actual (reported)July 30, 2025
Actual (reported)February 18, 2026
Actual (reported)Number of Participants With Adverse Drug Reactions (ADRs)
ADR is defined as adverse events for which a causal relationship with the drug was not ruled out.
Up to 96 Weeks
Response Rate Based on Global Assessment of Effectiveness
Response rate is the percentage of participants assessed as "effective" based on the course of subjective symptoms and clinical symptoms. Response rate was calculated as number of participants showing response to the NUCALA treatment divided by total number of participants on treatment\*100. Percentage values are rounded-off.
Up to 96 Weeks
Time to EGPA Relapse
EGPA relapse was defined as conditions meeting any of the following 3 criteria in participants presenting with worsening of EGPA (newly developed symptoms or worsening of existing symptoms), and the presence or absence of relapse and the time to the first relapse were evaluated: 1. corticosteroid administration newly started or a corticosteroid dose increased; 2. immunosuppressant administration newly started or an immunosuppressant dose increased; 3. hospitalization for the treatment of EGPA. Participants were considered responder for EGPA relapse if they met with any one of the three criteria mentioned above.
Up to 96 Weeks
Participants receiving NUCALA for the treatment of EGPA in clinical practice were enrolled in this study
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.
Subjects who administered NUCALA for the treatment of EGPA after its approval of indication will be included in the study.
GSK Investigational Site
Tokyo, 107-0052, Japan
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
GSK Clinical Trials
GlaxoSmithKline
4,115 participants (actual enrollment reported by the registry).
First Submitted
June 4, 2018
First Posted
June 14, 2018
Study Start
June 25, 2018
Actual (reported)Mepolizumab Long-term Study to Assess Real World Safety and Effectiveness of Eosinophilic Granulomatosis With Polyangiitis (EGPA) in Japan
Contact the study team to confirm eligibility.
Primary Completion
July 30, 2025
Actual (reported)Study Completion
July 30, 2025
Actual (reported)Last Updated
February 18, 2026
Results First Posted
February 18, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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