Ilaris® in Urticarial Vasculitis - Investigation of Treatment Responses (ILUVIT)
This is a single-center open label study to assess the efficacy and safety of single doses of canakinumab (trade name Ilaris®), a high-affinity monoclonal antibody that neutralizes IL-1β, in patients with active urticarial vasculitis. Efficacy is primarily assessed by a combined symptom score, the urticarial vasculitis activity score (UVAS). Following a baseline period of 2 weeks, patients will be dosed with two single s.c. injections of 150 mg (consistent with a total dose of 300 mg canakinumab). Visits for investigator's assessments will be scheduled at 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks post dose. Patient's self-assessment will be performed on a daily basis throughout the study. Overall a max. of 10 subjects with urticarial vasculitis will be enrolled.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label Pilot Study to Assess the Efficacy and Safety of a Single Dose Regime of Canakinumab (ACZ885) in Patients With Active, Refractory Urticarial Vasculitis|
- Effect of single doses of canakinumab on the clinical signs and symptoms of urticarial vasculitis measured by the urticarial vasculitis activity score (UVAS) [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]Change in the mean UV activity score (UVAS) from the baseline phase (day -14 to day 0) to the last 2 weeks of the first 4 weeks treatment phase (day 15 to 28) of the study (The UVAS combines the key symptoms of UV). Daily UVAS values will be documented using DHAFs (Daily Health Assessment Forms). Values for the Sum UVAS can range from 0 to 50 per day (5 symptoms, 0-10 each). Mean Daily UVAS will be calculated by dividing the sum of the daily activity scores by 5.
- Safety and tolerability following administration of canakinumab to patients with active urticarial vasculitis [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]Safety and tolerability: This includes physical examination, electrocardiogram, routine safety laboratory assessments, clinical observation, vital signs and adverse event reporting
|Study Start Date:||July 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Single dose of canakinumab 300mg s.c. injection
Other Name: Ilaris
|Berlin, Germany, 10117|
|Principal Investigator:||Marcus Maurer, MD||Charite University, Berlin, Germany|