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Efficacy Study of Canakinumab to Treat Urticaria (URTICANA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01635127
Recruitment Status : Unknown
Verified September 2016 by University of Zurich.
Recruitment status was:  Recruiting
First Posted : July 6, 2012
Last Update Posted : September 27, 2016
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
Evaluation whether canakinumab leads to improvement of urticaria

Condition or disease Intervention/treatment Phase
Chronic Idiopathic Urticaria Drug: Canakinumab Drug: Placebo Phase 2

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Randomized Double-Blind Placebo Controlled Single Center Study of Canakinumab Treatment of Adult Patients With Moderate to Severe Chronic Idiopathic Urticaria
Study Start Date : June 2012
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives
Drug Information available for: Canakinumab

Arm Intervention/treatment
Experimental: Canakinumab
Monoclonal antibody inhibiting interleukin 1 beta
Drug: Canakinumab
150mg s.c.
Other Name: Ilaris

Placebo Comparator: Placebo
Constituent, inactive
Drug: Placebo
Constituent of canakinumab

Primary Outcome Measures :
  1. Complete clinical remission [ Time Frame: 4 weeks ]
    Improvement of urticaria within 4 weeks, objective measurements daily wheal score and UAS7

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01635127

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Contact: Antonios Kolios, MD +41 (0)44 255 11 11
Contact: Alexander Navarini, MD PhD

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University Hospital Zurich, Division of Dermatology Recruiting
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
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Principal Investigator: Peter Schmid-Grendelmeier, Prof MD University Hospital Zurich, Division of Dermatology
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Responsible Party: University of Zurich Identifier: NCT01635127    
Other Study ID Numbers: USZ-DER-AAN-017
First Posted: July 6, 2012    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System Diseases