Efficacy Study of Canakinumab to Treat Urticaria (URTICANA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01635127
First received: July 3, 2012
Last updated: February 3, 2014
Last verified: July 2012
  Purpose

Evaluation whether canakinumab leads to improvement of urticaria


Condition Intervention Phase
Chronic Idiopathic Urticaria
Drug: Canakinumab
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Complete clinical remission [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Improvement of urticaria within 4 weeks, objective measurements daily wheal score and UAS7


Estimated Enrollment: 20
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Placebo

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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 < 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01635127

Contacts
Contact: Antonios Kolios, MD +41 (0)44 255 11 11 antonios.kolios@usz.ch
Contact: Alexander Navarini, MD PhD alexander.navarini@usz.ch

Locations
Switzerland
University Hospital Zurich, Division of Dermatology Recruiting
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Peter Schmid-Grendelmeier, Prof MD University Hospital Zurich, Division of Dermatology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01635127     History of Changes
Other Study ID Numbers: USZ-DER-AAN-017
Study First Received: July 3, 2012
Last Updated: February 3, 2014
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014