Ilaris® in Urticarial Vasculitis - Investigation of Treatment Responses

Sponsor
Charite University, Berlin, Germany
Study ID
NCT01170936
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • canakinumab — DRUG
    Single dose of canakinumab 300mg s.c. injection

Study Details

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.

Key Dates

Start date
Jul 31, 2010
Status verified
May 2012
Primary completion
Sep 30, 2011
Completion
Dec 31, 2011

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Canakinumab

Primary Outcome Measure

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 ]

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