NCT06886009

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
38mo left

Started Mar 2026

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Mar 2026Jun 2029

First Submitted

Initial submission to the registry

March 19, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
1 year until next milestone

Study Start

First participant enrolled

March 31, 2026

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2029

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

3.2 years

First QC Date

March 19, 2025

Last Update Submit

March 26, 2026

Conditions

Generalized Pustular Psoriasis

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (4)

  • Physician's Global Assessment for Generalized Pustular Psoriasis (GPPGA) pustulation sub-score of 0 indicating no visible pustules at Week 1

    At Week 1

  • A GPPGA pustulation sub-score of 0 indicating no visible pustules at Week 4

    At Week 4

  • A GPPGA score of 0 or 1 at Week 1

    At Week 1

  • A GPPGA score of 0 or 1 at Week 4

    At Week 4

Study Arms (1)

Patients with flares with generalized pustular psoriasis (GPP)

Drug: Spevigo®

Interventions

Spevigo®DRUG

Intravenous

Also known as: Spesolimab
Patients with flares with generalized pustular psoriasis (GPP)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with generalized pustular psoriasis (GPP) in Korea

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pusan National University Yangsan Hospital

Busan, 49241, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Ajou University Hospital

Suwon, 16499, South Korea

Location

Related Links

MeSH Terms

Conditions

Psoriasis

Interventions

spesolimab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2025

First Posted

March 20, 2025

Study Start

March 31, 2026

Primary Completion (Estimated)

June 8, 2029

Study Completion (Estimated)

June 8, 2029

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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

Locations

KR(4)