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

Churg-Strauss Syndrome Clinical Trial

— MARS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04551989
• Other study ID #: 213684
• Status: Active, not recruiting
• Start date: December 11, 2020
• Est. completion date: April 3, 2023

Study information

• Verified date: September 2022
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: April 3, 2023
• Est. primary completion date: April 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Churg-Strauss Syndrome
• Granulomatosis with Polyangiitis

Locations

Country	Name	City	State
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Gunma
Japan	GSK Investigational Site	Hyogo
Japan	GSK Investigational Site	Hyogo
Japan	GSK Investigational Site	Hyogo
Japan	GSK Investigational Site	Hyogo
Japan	GSK Investigational Site	Ishikawa
Japan	GSK Investigational Site	Ishikawa
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kochi
Japan	GSK Investigational Site	Mie
Japan	GSK Investigational Site	Mie
Japan	GSK Investigational Site	Miyagi
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Saitama
Japan	GSK Investigational Site	Shiga
Japan	GSK Investigational Site	Shizuoka
Japan	GSK Investigational Site	Shizuoka
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tottori
Japan	GSK Investigational Site	Wakayama
Japan	GSK Investigational Site	Yamaguchi

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of participants with Adverse drug reactions (ADRs)	ADRs related to NUCALA will be collected.	Up to 96 weeks
Secondary	Percentage of participants with clinical symptoms	Clinical symptoms relevant to EGPA in systemic vasculitis will be assessed.	Up to 96 weeks
Secondary	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
Secondary	Number of participants with hospitalization for EGPA-related events	Participants with hospitalization for EGPA-related events will be assessed.	Up to 96 weeks
Secondary	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
Secondary	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
Secondary	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