Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Multi-center, Double-blind, Placebo-controlled Phase II Study of the Efficacy and Safety of Canakinumab in Subjects With Schnitzler Syndrome
Brief Summary:
This is a multi-center double-blind placebo-controlled study to assess the efficacy and safety of canakinumab (trade name Ilaris®), a high-affinity monoclonal antibody that neutralizes IL-1β, in patients with Schnitzler syndrome. Efficacy is assessed by physician's global assessment (a combined clinical symptom score) and inflammation markers. Following a baseline period of 1-4 weeks, patients will be randomized to receive single s.c. injections of either 150 mg canakinumab or placebo (day 0). Treatment response will be assessed on day 7. Patients will then be eligible to enter the 16-week open-label phase and receive canakinumab injections (150-300mg, dose depends on clinical response on day 7) upon relapse of symptoms. Visits for investigator's assessments will be scheduled at 4-weekly intervals following day 7. Overall a max. of 20 subjects with Schnitzler syndrome will be enrolled.