Efficacy Study of Canakinumab to Treat Urticaria (URTICANA)

This study is currently recruiting participants.
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
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 April 23, 2014