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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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The purpose of this study is to explore the efficacy and safety of anti-Interleukin-(IL)17 therapy (secukinumab, administered weekly for 4 weeks followed by four-weekly administration until week 16) for the treatment of pyoderma gangrenosum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label | Experimental | 300 mg secukinumab every week for 4 weeks followed by 300 mg secukinumab every 2 weeks until week 32. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of the Physician's global assessment | The primary response parameter change of the physician global assessment (PGA) 5-point scale at week 16 as compared to week 0. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in surface area of lesions of pyoderma gangrenosum (two-dimensional surface in mm²) | Week 2,3,8,16,28,40 | |
| Assessment of patient's quality of life | Patient's quality of life is assessed by the Dermatology Life Quality Index (DLQI) questionnaire. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kilian Eyerich, MD, PhD | Technical University of Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Technical University of Munich | Munich | 80802 | Germany |
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| ID | Term |
|---|---|
| D017511 | Pyoderma Gangrenosum |
| ID | Term |
|---|---|
| D011711 | Pyoderma |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017445 | Skin Diseases, Vascular |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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| Week 2, 4, 8, 16, 28, 40 |
| Measurement of serum C reactive protein (mg/dl) | Week 2, 4, 8, 16, 28, 40 |
| Measurement of leukocyte counts (x10.e3/µl) | Week 2, 4, 8, 16, 28, 40 |
| Measurement of blood sedimentation rate (mm/h) | Week 2, 4, 8, 16, 28, 40 |
| Immunohistochemical analysis of IL-17+ immune cells | The number of IL-17+ immune cells is counted in two high-power-fields (400x) and mean in calculated. | Week 16 |
| D012883 |
| Skin Ulcer |