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

Not yet recruiting

• Conditions: Generalized Pustular Psoriasis
• Interventions: Drug: Spevigo®

• Registration Number: NCT06886009
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-19
• Study First Posted: 2025-03-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-08
• Study Start: 2025-06-27
• Primary Completion: 2029-06-08
• Study Completion: 2029-06-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with flares with generalized pustular psoriasis (GPP)	Spevigo®	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Physician's Global Assessment for Generalized Pustular Psoriasis (GPPGA) pustulation sub-score of 0 indicating no visible pustules at Week 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.
A GPPGA pustulation sub-score of 0 indicating no visible pustules at Week 4	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.
A GPPGA score of 0 or 1 at Week 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.
A GPPGA score of 0 or 1 at Week 4	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.