Generalized Pustular PsoriasisNCT06886009
Spesolimab Post-marketing Surveillance in Korean Patients With Flares With Generalized Pustular Psoriasis
An observational study of Generalized Pustular Psoriasis, run by Boehringer Ingelheim at 4 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Generalized Pustular Psoriasis
- What is being tested?
- Spevigo®
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 31 Mar 2026to 8 Jun 2029
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with generalized pustular psoriasis (GPP) in Korea
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Pusan National University Yangsan Hospital
Busan, 49241
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Ajou University Hospital
Suwon, 16499
About this study
Official title: 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.
- Conditions
- Generalized Pustular Psoriasis
- Being tested
- Spevigo®
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spevigo®Drug
Also called Spesolimab
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| Patients with flares with generalized pustular psoriasis (GPP) | Not described Receives: Drug: Spevigo® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Measured: Up to 24 weeks
Incidence of adverse drug reactions (ADRs)
Measured: Up to 24 weeks
Incidence of serious adverse events (SAEs)
Measured: Up to 24 weeks
Incidence of serious adverse drug reactions (SADRs)
Measured: Up to 24 weeks
Incidence of unexpected adverse drug reactions
Measured: Up to 24 weeks
Incidence of adverse events of special interest (AESIs)
Measured: Up to 24 weeks
Incidence of adverse events leading to temporary or permanent discontinuation
Measured: Up to 24 weeks
Incidence of adverse events leading to death
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start31 Mar 2026 (estimated)
- Primary completion8 Jun 2029 (estimated)
- Study completion8 Jun 2029 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Pustular PsoriasisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886009
- Sponsor's protocol ID
- 1368-0122
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Regulatory Requirement Non-interventional Study to Monitor the Safety and Effectiveness of Spesolimab in Korean Patients With Flares With Generalized Pustular Psoriasis
- ClinicalTrials.gov ID
- NCT06886009
- Acronym / sponsor ID
- 1368-0122
- Conditions
- Generalized Pustular Psoriasis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 8 Jun 2029 (estimated)
- Study completion
- 8 Jun 2029 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with flares with generalized pustular psoriasis (GPP) | – | Drug: Spevigo® |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with generalized pustular psoriasis (GPP) in Korea
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spevigo®Also: SpesolimabIntravenous | Drug | Patients with flares with generalized pustular psoriasis (GPP) |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Up to 24 weeks
Incidence of adverse drug reactions (ADRs)
Time frame: Up to 24 weeks
Incidence of serious adverse events (SAEs)
Time frame: Up to 24 weeks
Incidence of serious adverse drug reactions (SADRs)
Time frame: Up to 24 weeks
Incidence of unexpected adverse drug reactions
Time frame: Up to 24 weeks
Incidence of adverse events of special interest (AESIs)
Time frame: Up to 24 weeks
Incidence of adverse events leading to temporary or permanent discontinuation
Time frame: Up to 24 weeks
Incidence of adverse events leading to death
Time frame: Up to 24 weeks
4 secondary outcomes
Physician's Global Assessment for Generalized Pustular Psoriasis (GPPGA) pustulation sub-score of 0 indicating no visible pustules at Week 1
Time frame: At Week 1
A GPPGA pustulation sub-score of 0 indicating no visible pustules at Week 4
Time frame: At Week 4
A GPPGA score of 0 or 1 at Week 1
Time frame: At Week 1
A GPPGA score of 0 or 1 at Week 4
Time frame: At Week 4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Generalized Pustular Psoriasis, run by Boehringer Ingelheim at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: Up to 24 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.