Clinical Trial: Ilaris® in Urticarial Vasculitis - Investigation of Treatment Responses
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief Summary: 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.
Detailed Summary:
Sponsor: Charite University, Berlin, Germany
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Safety and tolerability following administration of canakinumab to patients with active urticarial vasculitis [ Time Frame: 18 weeks ]
Original Secondary Outcome: Same as current
Information By: Charite University, Berlin, Germany
Dates:
Date Received: July 26, 2010
Date Started: July 2010
Date Completion:
Last Updated: May 30, 2012
Last Verified: May 2012