Single-arm Study to Assess a Potential Effect of Anti-IL-17 (Secukinumab) in the Treatment of Pyoderma Gangrenosum

Study Overview
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Brief Summary
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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.

Official Title
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Single-arm Study to Assess a Potential Effect of Anti-IL-17 (Secukinumab) in the Treatment of Pyoderma Gangrenosum

Conditions
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Pyoderma Gangrenosum

Intervention / Treatment
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* Drug: Secukinumab


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Confirmed diagnosis of Pyoderma gangrenosum Biopsy-proven, non-healing ulcer with primarily neutrophil infiltration, regardless of size and location Characterization of target lesion (size, PGA, duration) 18-75 years of age Body weight ≥ 40 kg and ≤ 160 kg Signed informed consent Key Exclusion Criteria: Permanent severe diseases, especially those affecting the immune system Pregnancy or breast feeding History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia Myocardial infarction or cardiac arrhythmia which requires drug therapy Evidence of severe renal dysfunction or significant hepatic disease History of irritable bowel disease History of lymphoproliferative disorders Evidence for active infection including but not limited to active tuberculosis, HIV or hepatitis B/C that in the opinion of the investigator would compromise the patient's ability to tolerate therapy History of malignancy of any organ system, treated or untreated, whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-label<br>300 mg secukinumab every week for 4 weeks followed by 300 mg secukinumab every 2 weeks until week 32. | Drug: Secukinumab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |