Pyoderma Gangrenosum
Conditions
Brief summary
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.
Interventions
DRUGSecukinumab
Sponsors
Novartis
Technical University of Munich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the Physician's global assessment | Week 16 | The primary response parameter change of the physician global assessment (PGA) 5-point scale at week 16 as compared to week 0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunohistochemical analysis of IL-17+ immune cells | Week 16 | The number of IL-17+ immune cells is counted in two high-power-fields (400x) and mean in calculated. |
| Change in surface area of lesions of pyoderma gangrenosum (two-dimensional surface in mm²) | Week 2,3,8,16,28,40 | — |
| Measurement of blood sedimentation rate (mm/h) | 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 | — |
| Assessment of patient's quality of life | Week 2, 4, 8, 16, 28, 40 | Patient's quality of life is assessed by the Dermatology Life Quality Index (DLQI) questionnaire. |
Countries
Germany
Outcome results
None listed