efficacy study of canakinumab to treat urticaria

Conditions: Chronic Idiopathic Urticaria

Summary: evaluation whether canakinumab leads to improvement of urticaria

single center prospective placebo-controlled cross-over phase ii study. * to assess if canakinumab can induce clinical improvement and/or complete clinical remission of chronic idiopathic urticaria at week 4 as compared to placebo * to compare canakinumab and placebo treated patients in the percentage who achieve complete clinical remission at week 1, 2, 4, and 8. * to compare the percentage with clinical improvement as measured by uas7 score at week 1, 2, 4, and 8 in canakinumab and placebo treated patients * to compare the percentage of canakinumab and placebo treated patients with 75% and 100% improvement of their baseline (run-in-period) uas7 score at week 1,2,4,and 8 * to compare the daily wheal score for days 1 to 7 in canakinumab and placebo treated patients

Eligibility criteria:
inclusion criteria * diagnosis of chronic idiopathic urticaria for more than 6 weeks as confirmed by clinical and, if necessary, histological examination * ciu of moderate to severe severity defined by all of the following * physician severity score of 2 or 3 (on a scale from 0 - 3) * run-in period of the diary-based uas7 score of \> 21 (on a scale from 0 - 42) * symptomatic despite use of non-sedating antihistamine with or without concomitant leukotriene antagonist/corticosteroids * use of maintenance non-sedating antihistamine at a stable dose for at least 1 week prior to entering run-in period * maintenance corticosteroids at a dose of \<20 mg/day or \<0.4 mg/kg stable for at least the week prior to study entry for treatment of the patient's ciu will be allowed. * age: \> 18 years. * signed informed consent * negative or unreactive quantiferon test (qft-tb g in-tube) or history of adequate treatment of active or latent tuberculosis. exclusion criteria: * age \ 70 years * history of cancer except for treated basal cell carcinoma of the skin * with active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of human immunodeficiency virus (hiv) infection, hepatitis b and hepatitis c infection, active or untreated latent tuberculosis. * patients currently treated with systemic immunosuppressive agents or following treatments in the specified period before the baseline visit: * corticosteroids =20 mg/day or \>0.4 mg/kg for 1 week prior to study entry; * leukotriene antagonists for 1 week prior to study entry * colchicine, dapsone or mycophenolate mofetil for 3 weeks; * etanercept, leflunomide (documentation of a completion of a full cholestyramine elimination treatment after most recent leflunomide use will be required), thalidomide or ciclosporin for 4 weeks; * adalimumab or intravenous immunoglobulin for 8 weeks; * infliximab, 6-mercaptopurine, azathioprine, cyclophosphamide or chlorambucil for 12 weeks * live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose * contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product, * pregnant or lactating women, patients (men or women) planning a pregnancy during the duration of the study, lack of safe contraception. * safe contraception is defined as follows: * double-barrier contraception such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices together with condom use. * both men and women must use safe contraception (double-barrier as defined above) during the duration of the study and until 6 months after the study. * please note that female subjects who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential. * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the subject. * participation in another study with investigational drug within the 30 days preceding and during the present study. * previous enrolment into the current study. * enrolment of the investigator, his/her family members, employees and other dependent persons.