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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with flares with generalized pustular psoriasis (GPP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spevigo® | Drug | Intravenous |
|
| Measure | Description | 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 |
| 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. |
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Inclusion criteria:
Exclusion criteria:
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Patients diagnosed with generalized pustular psoriasis (GPP) in Korea
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Busan | 49241 | South Korea | |||
| Asan Medical Center |
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| Label | URL |
|---|---|
| Related Info | View source |
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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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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000712973 | spesolimab |
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| 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 |
| Seoul |
| 05505 |
| South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Ajou University Hospital | Suwon | 16499 | South Korea |