Chronic Idiopathic Urticaria | Efficacy Study of Canakinumab to Treat Urticaria
Chronic Idiopathic Urticaria research study
What is the primary objective of this study?
Evaluation whether canakinumab leads to improvement of urticaria
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Chronic Idiopathic Urticaria
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:PlaceboConstituent of canakinumab
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
CanakinumabMonoclonal antibody inhibiting interleukin 1 beta
Start Date: June 2012
Completed Date: May 2017
Phase: Phase 2
Primary Outcome: Complete clinical remission
Study sponsors, principal investigator, and references
Principal Investigator: Peter Schmid-Grendelmeier, Prof MD
Lead Sponsor: University of Zurich