Efficacy and Safety of Canakinumab in Schnitzler Syndrome (NCT01276522) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of Canakinumab in Schnitzler Syndrome
Netherlands8 participantsStarted 2011-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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 visi…