NCT01170936

Ilaris® in Urticarial Vasculitis - Investigation of Treatment Responses

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urticaria
• Vasculitis

Interventions

Type	Name	Description
DRUG	canakinumab	Single dose of canakinumab 300mg s.c. injection

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-09-01
• Completion: 2011-12-01
• First posted: 2010-07-28
• Last updated: 2012-05-31

Locations

1 site across 1 country: Germany