Efficacy and Safety of Canakinumab in Schnitzler Syndrome

This is an interventional treatment trial for Schnitzler Syndrome focused on measuring Schnitzler syndrome, IL-1 beta, Canakinumab, Ilaris, Treatment, Efficacy, Safety Read More

Inclusion Criteria:

• Patients with a diagnosis of Schnitzler syndrome as per criteria (ref 1).
• Patients that have been / are treated with Anakinra must have demonstrated a partial or complete clinical response with an associated normalization of their biomarkers of inflammation (CRP).
• Male and female patients at least 18 years of age at the time of the screening visit.
• Patient's informed consent.
• Negative QuantiFERON test or negative Purified Protein Derivative (PPD) test (< 5 mm induration) at screening or within 1 month prior to the screening visit, according to the national guidelines. Patients with a positive PPD test (≥ 5 mm induration) at screening may be enrolled only if they have either a negative chest x-ray or a negative QuantiFERON test (QFT-TB G In-Tube).
• Adequate contraception in premenopausal females

Exclusion Criteria:

• Pregnant or nursing (lactating) women
• History of being immunocompromised, including a positive HIV at screening (ELISA and Western blot).
• Serologic evidence of hepatitis B or C infection
• Live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose
• History of significant medical conditions, which in the Investigator's opinion would exclude the patient from participating in this trial
• History of recurrent and/or evidence of active bacterial, fungal, or viral infection(s)

• Use of the following therapies:

  • Anakinra within 24 hours prior to Baseline visit XML File Identifier : tl8ybe8lI1o6DeawQocCBa8TF/w=
  • Corticosteroids (oral prednisone (or equivalent)) > 1.0 mg/kg/day (or greater than the maximum of 60 mg/day for children over 60 kg) within 3 days prior to the Baseline visit
  • Intra-articular, peri-articular or intramuscular corticosteroid injections within 4 weeks prior to the Baseline visit
  • Any other investigational biologics within 8 weeks prior to the Baseline visit
  • Any other investigational drugs, other than investigational biologic treatment, within 30 days (or 3 months for investigational monoclonal antibodies) or 5 half-lives prior to the Baseline visit, whichever is longer
• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes