Mepolizumab Long-term Study to Assess Real World Safety and Effectiveness of Eosinophilic Granulomatosis With Polyangiitis (EGPA) in Japan

Study Overview
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Brief Summary
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Eosinophilic granulomatosis with polyangiitis (EGPA), formerly known as the Churg-Strauss syndrome, is a systemic necrotizing vasculitis that affects small and medium sized blood vessels. NUCALA® (mepolizumab 300 milligrams [mg], subcutaneous administration) was approved in Japan in 2018 for the treatment of EGPA in adult participants. This is a single-arm, multi-center, prospective, non-interventional study that aims to assess long-term (2 to 4 years) real-world safety and effectiveness of NUCALA. Approximately 120 participants who completed the NUCALA Post Marketing Surveillance (PMS) study (National Clinical Trial [NCT]03557060) will be enrolled in the study. NUCALA is a registered trademark of GlaxoSmithKline (GSK) group of companies.

Official Title
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A Single Arm, Multi-center Study to Assess the Long-term Real-world Safety and Effectiveness of Nucala in EGPA Patients Who Have Already Used Nucala for at Least 96 Weeks in Japan

Conditions
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Churg-Strauss Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult participants with EGPA of >=20 years of age inclusive, at the time of signing the informed consent. Participants must have a current clinical diagnosis of EGPA by physician. Participants have continuously used NUCALA for at least 96 weeks for the treatment of EGPA as mentioned in the current label in Japan. • Participants thus were registered and completed the NUCALA PMS study (special drug use investigation; Protocol Number 208505, NCT03557060) prior to be enrolled in this study. Physician's decision to continue treatment with NUCALA for the treatment of EGPA as mentioned in the current label in Japan. Prior to commencing any study related activities, participants must be able and willing to provide written informed consent. Exclusion Criteria: Participants who have previously discontinued NUCALA treatment for EGPA for more than 12 weeks. Participating in another clinical trial within the past 12 months, in which the participant has been exposed to an investigational or non-investigational pharmaceutical product. Participants with any reasons that in physician's opinion would place the participants at risk. Participants who are pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with EGPA who have received NUCALA treatment<br>Data will be collected of participants who have already received NUCALA for 96 weeks in routine clinical practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse events (AEs), Serious adverse events (SAEs) and Adverse events of special interest (AESI) | AEs, SAEs, and AESIs will be collected. | Up to 96 weeks | 
| Number of participants with Adverse drug reactions (ADRs) | ADRs related to NUCALA will be collected. | Up to 96 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with clinical symptoms | Clinical symptoms relevant to EGPA in systemic vasculitis will be assessed. | Up to 96 weeks | 
| Percentage of participants with EGPA relapse | EGPA relapse is defined as any of the following with worsening EGPA: increased dose of oral corticosteroids (OCS), initiation/increased dose of immuno-suppressive agents or EGPA treatment with hospitalization. | Up to 96 weeks | 
| Number of participants with hospitalization for EGPA-related events | Participants with hospitalization for EGPA-related events will be assessed. | Up to 96 weeks | 
| Number of participants with emergency room/unscheduled visits for EGPA-related events | Participants with emergency room/unscheduled visits for EGPA-related events will be assessed. | Up to 96 weeks | 
| Number of participants receiving prednisolone-equivalent of OCS over 96 weeks | Number of participants receiving prednisolone-equivalent of OCS over 96 weeks will be assessed. | Up to 96 weeks | 
| Percentage of participants in each category of average daily prednisolone-equivalent of OCS over 96 weeks | Percentage of participants in each category of average daily prednisolone-equivalent of OCS over 96 weeks will be assessed. The dosing categories will include: zero, greater than (>)0 to less than or equal to (<=)4.0 mg/day, >4.0 to <=7.5 mg/day, >7.5 mg/day. | Up to 96 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NUCALA, Eosinophilic granulomatosis with polyangiitis, Real world setting, Long term safety and efficacy