Canakinumab for Pyoderma Gangrenosum
This study is a prospective open label evaluation of Canakinumab (Ilaris) for treatment of subjects with pyoderma gangrenosum.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Multi Center Open Label Pilot Study To Assess a Potential Effect of an Anti-Il-1-Beta Antagonist in the Treatment of Pyoderma Gangrenosum|
- Change of the Physician's global assessment (Grade 0-4) of the target lesion [ Time Frame: Week 2, 4, 8, 16 ] [ Designated as safety issue: No ]
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
- Almost completely healed target ulcer with only minimal signs of active PG
- Evidence of target ulcer healing which involves at least 50% of ulcer/ulcer margin
- Evidence of target ulcer healing which involves less than 50% of ulcer/ulcer margin
- No evidence of target healing ulcer
- Change in surface area of the target lesion of pyoderma gangrenosum [ Time Frame: Week 2, 4, 8, 16 ] [ Designated as safety issue: No ]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 [ Time Frame: Week 2, 4, 8, 16 ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||November 2012|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Canakinumab s.c. 150-300mg Week 0, (2), 8
Monoclonal antibody inhibiting interleukin 1 beta
Other Name: Ilaris
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.
|Contact: Alexander Navarini, MD PhDfirstname.lastname@example.org|
|Department of Dermatology, University Hospital Zurich||Recruiting|
|Zurich, Switzerland, 8091|
|Contact: Alexander Navarini, MD PhD +41442551111 email@example.com|
|Contact: Severine Buffoni, dipl. pharm. +41442551111 firstname.lastname@example.org|
|Principal Investigator:||Lars French, Prof MD||University Hospital Zurich, Division of Dermatology|