Pyoderma Gangrenosum
Conditions
Keywords
Interleukin 1 beta, Canakinumab, autoinflammatory syndrome
Brief summary
This study is a prospective open label evaluation of Canakinumab (Ilaris) for treatment of subjects with pyoderma gangrenosum.
Detailed description
At the start of the study (week 0), all patients will receive one subcutaneous injection of 150mg Canakinumab. Patients are then going to be examined at weeks 2, 4, 8, 12 and 16. At 2 weeks, all patients are going to be evaluated for response by Physician's global assessment (PGA) of the target lesion. Patients with PGA 0-1 are not going to receive another injection at this timepoint, while patients with PGA 2-4 are going to receive another 150mg Canakinumab. At 4 weeks, in case of PGA 4, patients are going to be offered a first or second line drug as an alternative therapy (corticosteroids, cyclosporin A or infliximab, dosage see below Alternative therapy in case of missing response) and stay within the trial (due to the long half-life of canakinumab) until week 8. At week 8, patients with PGA 0 receive another 150mg Canakinumab only, and patients with PGA 4 are not going to receive additional study drug, but are strongly encouraged to attend following medical visits for observation until the end of the study and/or switch to a first or second line drug as alternative therapy (see below). All other patients with PGA 1-3 receive the total accumulative dose of Canakinumab that they had received on week 0 and 2, namely 150 or 300mg. The study duration for each individual is going to be 16 weeks. At week 8 and 16, safety laboratory investigations with blood differential (Neutrophil granulocytes, monocytes, eosinophils, basophils, lymphocytes, thrombocytes, erythrocytes, hemoglobin), AST, ALT, y-GT, AP, Bilirubin (total), Creatinine, Na, K, CRP are going to be determined.
Interventions
DRUGCanakinumab
Monoclonal antibody inhibiting interleukin 1 beta
Sponsors
University of Zurich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Patients fulfilling all of the following inclusion criteria may be enrolled in the study 1. Age = 18 years of age at visit 0 and 2. Subjects are capable of giving informed consent 3. Non-healing ulcer with primarily neutrophil infiltration, regardless of size and location 4. Diagnosis of pyoderma gangrenosum as confirmed by clinical and histological examination (see
Exclusion criteria
). In case of doubt, a steering committee consisting of experts of the participating centers is going to evaluate whether inclusion is possible or not
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the Physician's global assessment (Grade 0-4) of the target lesion | Week 2, 4, 8, 16 | The primary response parameter change of the physician global assessment (PGA) 5-point scale at week 2, 4, 8, 16 as compared to week 0 : 0= Total resolution of target ulcer with no signs of active PG 1. Almost completely healed target ulcer with only minimal signs of active PG 2. Evidence of target ulcer healing which involves at least 50% of ulcer/ulcer margin 3. Evidence of target ulcer healing which involves less than 50% of ulcer/ulcer margin 4. No evidence of target healing ulcer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in surface area of the target lesion of pyoderma gangrenosum | Week 2, 4, 8, 16 | As secondary parameter, the change in surface area of the target lesion of pyoderma gangrenosum at week 2, 4, 8, 16 as compared to week 0 will be assessed by measuring the two-dimensional surface by tracing the border of the lesions on transparent foil as well as with Canfield photography. |
| Change in surface area of the non-target lesions | Week 2, 4, 8, 16 | As secondary parameter, the change in surface area of the non-target lesions of pyoderma gangrenosum at week 2, 4, 8, 16 as compared to week 0 will be assessed by measuring the two-dimensional surface by tracing the border of the lesions on transparent foil as well as with Canfield photography. |
Countries
Switzerland
Outcome results
None listed