WithdrawnNot Applicable

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

Stopped: Sponsor decision

South Korea0Started 2026-03-31

Plain-language 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.

Who can participate

Age range19 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Incidence of adverse events (AEs)

Timeframe: Up to 24 weeks

Incidence of adverse drug reactions (ADRs)

Timeframe: Up to 24 weeks

Incidence of serious adverse events (SAEs)

Timeframe: Up to 24 weeks

Incidence of serious adverse drug reactions (SADRs)

Timeframe: Up to 24 weeks

Incidence of unexpected adverse drug reactions

Timeframe: Up to 24 weeks

Incidence of adverse events of special interest (AESIs)

Timeframe: Up to 24 weeks

Incidence of adverse events leading to temporary or permanent discontinuation

Timeframe: Up to 24 weeks

Incidence of adverse events leading to death

Timeframe: Up to 24 weeks

Trial details

NCT IDNCT06886009

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-06-08

View on ClinicalTrials.gov More Generalized Pustular Psoriasis trials