Efficacy Study of Canakinumab to Treat Urticaria (URTICANA)

A Phase II Randomized Double-Blind Placebo Controlled Single Center Study of Canakinumab Treatment of Adult Patients With Moderate to Severe Chronic Idiopathic Urticaria

Evaluation whether canakinumab leads to improvement of urticaria

Study Overview

• Status: Unknown
• Conditions: Chronic Idiopathic Urticaria
• Intervention / Treatment: Drug: Canakinumab; Drug: 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

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Antonios Kolios, MD; Phone Number: +41 (0)44 255 11 11; Email: antonios.kolios@usz.ch
• Study Contact Backup: Name: Alexander Navarini, MD PhD; Email: alexander.navarini@usz.ch

Study Locations

• Switzerland
  • Zurich, Switzerland
    • Recruiting
    • University Hospital Zurich, Division of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Canakinumab; Monoclonal antibody inhibiting interleukin 1 beta	Drug: Canakinumab; 150mg s.c.; Other Names: Ilaris
Placebo Comparator: Placebo; Constituent, inactive	Drug: Placebo; Constituent of canakinumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete clinical remission	Improvement of urticaria within 4 weeks, objective measurements daily wheal score and UAS7	4 weeks

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Peter Schmid-Grendelmeier, Prof MD, University Hospital Zurich, Division of Dermatology

Publications and helpful links

General Publications

• Maul JT, Distler M, Kolios A, Maul LV, Guillet C, Graf N, Imhof L, Lang C, Navarini AA, Schmid-Grendelmeier P. Canakinumab Lacks Efficacy in Treating Adult Patients with Moderate to Severe Chronic Spontaneous Urticaria in a Phase II Randomized Double-Blind Placebo-Controlled Single-Center Study. J Allergy Clin Immunol Pract. 2021 Jan;9(1):463-468.e3. doi: 10.1016/j.jaip.2020.07.058. Epub 2020 Aug 20.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: July 3, 2012
• First Submitted That Met QC Criteria: July 3, 2012
• First Posted (Estimate): July 6, 2012

Study Record Updates

• Last Update Posted (Estimate): September 27, 2016
• Last Update Submitted That Met QC Criteria: September 26, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Skin Diseases, Vascular; Hypersensitivity; Urticaria; Chronic Urticaria
• Other Study ID Numbers: USZ-DER-AAN-017