Post-marketing Surveillance of Spesolimab I.V. Infusion in improvement of Generalized Pustular Psoriasis (GPP) with acute symptoms in Japan (PMS for GPP with acute symptoms)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49954
• EU PAS number:
  EUPAS49953
• Study ID:
  49954
• Official title and acronym:
  Post-marketing Surveillance of Spesolimab I.V. Infusion in improvement of Generalized Pustular Psoriasis (GPP) with acute symptoms in Japan (PMS for GPP with acute symptoms)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  The primary outcome is the incidence of investigator/BI-defined drug reactions (including safety concerns: Serious infections, Serious hypersensitivity).
• Study status:
  Planned

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Planned: 22/09/2022

Actual: 22/09/2022

Study start date

Planned: 01/03/2023

Date of final study report

Planned: 31/12/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Nippon Boehringer Ingelheim Co., Ltd.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only