A regulatory requirement non-interventional study to monitor the safety and effectiveness of Spesolimab in Korean patients with flares with generalized pustular psoriasis

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  SPEVIGO
• Study drug International non-proprietary name (INN) or common name:
  SPESOLIMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AC22) spesolimab

  spesolimab
• Medical condition to be studied:
  Pustular psoriasis

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Korean patients with flares with generalized pustular psoriasis

Study design details

• Study design:
  This is a single-arm, open-label, multi-center, observational and non-interventional study based on newly collected data.; ;
• Main study objective:
  The primary objective is to monitor the safety profile of Spesolimab IV in Korean patients ; with flares with GPP in routine medical practice.; The secondary objective is to monitor the effectiveness of Spesolimab IV by evaluating changes in the GPPGA pustulation sub-score (mandatory), GPPGA score (mandatory), GPPASI (if collected), pain VAS (if collected) and PSS (if collected) from baseline after 1 week and/or 4 weeks.