Spesolimab Post-marketing Surveillance in Korean Patients With Flares With Generalized Pustular Psoriasis

A Regulatory Requirement Non-interventional Study to Monitor the Safety and Effectiveness of Spesolimab in Korean Patients With Flares With Generalized Pustular Psoriasis

The primary and secondary objectives are to respectively monitor the safety and effectiveness of Spesolimab IV in Korean patients with flares with generalized pustular psoriasis (GPP) in a routine medical practice.

Study Overview

• Status: Withdrawn
• Conditions: Generalized Pustular Psoriasis
• Intervention / Treatment: Drug: Spevigo®

• Study Type: Observational

Contacts and Locations

Study Locations

• South Korea
  • Busan, South Korea, 49241
    • Pusan National University Yangsan Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Suwon, South Korea, 16499
    • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with generalized pustular psoriasis (GPP) in Korea

Description

Inclusion criteria:

• Patients starting Spesolimab IV for the first time in accordance with the approved label in Korea (complete enumeration for the first 2 years after product launch)
• Patients with generalized pustular psoriasis (GPP) flare
• Age >/=19 years at enrolment
• Patients who have signed the data release consent form

Exclusion criteria:

• Patients with Severe or life-threatening hypersensitivity to Spesolimab or to any of the excipients
• Patients with clinically important active infections (e.g. active tuberculosis)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with flares with generalized pustular psoriasis (GPP)	Drug: Spevigo®; Intravenous; Other Names: Spesolimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events (AEs)	Up to 24 weeks
Incidence of adverse drug reactions (ADRs)	Up to 24 weeks
Incidence of serious adverse events (SAEs)	Up to 24 weeks
Incidence of serious adverse drug reactions (SADRs)	Up to 24 weeks
Incidence of unexpected adverse drug reactions	Up to 24 weeks
Incidence of adverse events of special interest (AESIs)	Up to 24 weeks
Incidence of adverse events leading to temporary or permanent discontinuation	Up to 24 weeks
Incidence of adverse events leading to death	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician's Global Assessment for Generalized Pustular Psoriasis (GPPGA) pustulation sub-score of 0 indicating no visible pustules at Week 1	The GPPGA is a modified the Physician's Global Assessment (PGA), a physician's assessment of psoriatic lesions, which was adapted to the evaluation of Generalized Pustular Psoriasis (GPP) patients. The investigator scores the erythema, pustules, and scaling of all GPP lesions from 0 to 4. Each component is graded separately, the average is calculated, and the final GPPA is determined from this composite score. A lower score indicates a lesser severity, with 0 being clear and 1 being almost clear.	At Week 1
A GPPGA pustulation sub-score of 0 indicating no visible pustules at Week 4	The GPPGA is a modified the Physician's Global Assessment (PGA), a physician's assessment of psoriatic lesions, which was adapted to the evaluation of Generalized Pustular Psoriasis (GPP) patients. The investigator scores the erythema, pustules, and scaling of all GPP lesions from 0 to 4. Each component is graded separately, the average is calculated, and the final GPPA is determined from this composite score. A lower score indicates a lesser severity, with 0 being clear and 1 being almost clear.	At Week 4
A GPPGA score of 0 or 1 at Week 1	The GPPGA is a modified the Physician's Global Assessment (PGA), a physician's assessment of psoriatic lesions, which was adapted to the evaluation of Generalized Pustular Psoriasis (GPP) patients. The investigator scores the erythema, pustules, and scaling of all GPP lesions from 0 to 4. Each component is graded separately, the average is calculated, and the final GPPA is determined from this composite score. A lower score indicates a lesser severity, with 0 being clear and 1 being almost clear.	At Week 1
A GPPGA score of 0 or 1 at Week 4	The GPPGA is a modified the Physician's Global Assessment (PGA), a physician's assessment of psoriatic lesions, which was adapted to the evaluation of Generalized Pustular Psoriasis (GPP) patients. The investigator scores the erythema, pustules, and scaling of all GPP lesions from 0 to 4. Each component is graded separately, the average is calculated, and the final GPPA is determined from this composite score. A lower score indicates a lesser severity, with 0 being clear and 1 being almost clear.	At Week 4

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2026
• Primary Completion (Estimated): June 8, 2029
• Study Completion (Estimated): June 8, 2029

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 20, 2025

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis; spesolimab
• Other Study ID Numbers: 1368-0122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

• IPD Sharing Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• IPD Sharing Access Criteria: For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor'spublication plan); 2. and upon signing of a legal agreement.