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Evaluation whether canakinumab leads to improvement of urticaria
Full description
Single center prospective placebo-controlled cross-over phase II study.
Enrollment
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Inclusion and exclusion 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
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:
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.
Primary purpose
Allocation
Interventional model
Masking
20 participants in 2 patient groups, including a placebo group
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Central trial contact
Antonios Kolios, MD; Alexander Navarini, MD PhD
Data sourced from clinicaltrials.gov
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