Schnitzler Syndrome Clinical Trial
Official title:
Efficacy and Safety of Canakinumab in Schnitzler Syndrome
Schnitzler syndrome is a disabling inflammatory disease, characterized by chronic urticaria,
fever, arthralgia, bone pain and gammopathy, which can so far only be effectively treated
with anakinra, an interleukin-1 receptor antagonist. However, this drug is not registered
for use in Schnitzler syndrome, and it needs to be injected daily, which is uncomfortable
and unpractical. Therefore other treatments targeting IL-1 are needed. Canakinumab is a
long-acting monoclonal antibody against IL-1β that has been registered for bimonthly use in
the rare autoinflammatory disease Cryopyrin-associated periodic syndrome (CAPS). We
hypothesize that it will be effective in Schnitzler syndrome too in view of clinical
similarities to CAPS and the targeting of IL-1B, which is also blocked by anakinra (which
blocks both IL-1B and IL-1A).
This is a 6-month open-label, single treatment arm study of canakinumab 150 or 300 mg (in
case of insufficient response to 150 mg) subcutaneous injection once per month in patients
with active Schnitzler syndrome, in which efficacy and safety will be assessed.
More on Canakinumab:
Canakinumab is a high-affinity human monoclonal anti-human interleukin-1β (IL-1β)antibody of
the IgG1/k isotype), developed for the treatment of IL-1β driven inflammatory diseases.
Canakinumab binds human IL-1β and functionally neutralizes the bioactivity of this
pro-inflammatory cytokine. IL-1β is produced mainly by mononuclear phagocytes in response to
injury and infection and plays a dominant role in the pathobiology of autoinflammatory
syndromes (e.g. Cryopyrin associated periodic syndrome, CAPS), systemic Juvenile Idiopathic
Arthritis and gout. Canakinumab is expected to treat the signs and symptoms of inflammation
and the underlying structural damage of disease. Canakinumab has been administered in
clinical trials as an intravenous (i.v.) infusion or as a subcutaneous (sc) injection and
has been approved under the trade name ILARIS® in the US for patients ≥ 4 years of age with
CAPS and in the European Union and Switzerland for CAPS patients ≥ 4 years of age.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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