Efficacy Study of Canakinumab to Treat Urticaria

Study Overview
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Brief Summary
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Evaluation whether canakinumab leads to improvement of urticaria

Detailed Description
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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

Official Title
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A Phase II Randomized Double-Blind Placebo Controlled Single Center Study of Canakinumab Treatment of Adult Patients With Moderate to Severe Chronic Idiopathic Urticaria

Conditions
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Chronic Idiopathic Urticaria

Intervention / Treatment
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* Drug: Canakinumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 < 18 or > 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Canakinumab<br>Monoclonal antibody inhibiting interleukin 1 beta | Drug: Canakinumab<br>* 150mg s.c.<br>* Other names: Ilaris;|
| Placebo Comparator: Placebo<br>Constituent, inactive | Drug: Placebo<br>* Constituent of canakinumab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete clinical remission | Improvement of urticaria within 4 weeks, objective measurements daily wheal score and UAS7 | 4 weeks |