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

  • STATUS
    Recruiting
  • End date
    Apr 3, 2023
  • participants needed
    120
  • sponsor
    GlaxoSmithKline
Updated on 14 June 2021
Investigator
US GSK Clinical Trials Call Center
Primary Contact
GSK Investigational Site (8.1 mi away) Contact
+14 other location

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.

Details
Condition Churg-Strauss Syndrome
Clinical Study IdentifierNCT04551989
SponsorGlaxoSmithKline
Last Modified on14 June 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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