Schnitzler Syndrome Clinical Trial
Official title:
A Multi-center, Double-blind, Placebo-controlled Phase II Study of the Efficacy and Safety of Canakinumab in Subjects With Schnitzler Syndrome
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.
1. Amendment: After successful completion of the 16-week open-label phase patients will be
eligible to enter a one-year open-label extension of the study. During this part of the
study patients will be scheduled at bi-monthly intervals. Canakinumab dosing will be
performed upon relapse of symptoms comparable to the 16-week open-label phase.
2. Amendment: After successful completion of the 1-year open-label study extension patients
will be eligible to enter another 3-year open-label extension. Patients will be
scheduled at 3-month-intervals and Canakinumab dosing will be performed on an individual
basis with optimized dosing intervals to ensure a constant low disease activity.
n/a
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