Efficacy Study of Canakinumab to Treat Urticaria

NCT01635127 | Unknown Phase 2 DMC

• 1 other identifier: USZ-DER-AAN-017
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation whether canakinumab leads to improvement of urticaria

Conditions

Chronic Idiopathic Urticaria

Outcome Measures

Primary Outcomes (1)

• Complete clinical remission

  Improvement of urticaria within 4 weeks, objective measurements daily wheal score and UAS7

  4 weeks

Study Arms (2)

Canakinumab

EXPERIMENTAL

Monoclonal antibody inhibiting interleukin 1 beta

Drug: Canakinumab

Placebo

PLACEBO COMPARATOR

Constituent, inactive

Drug: Placebo

Interventions

Canakinumab DRUG

150mg s.c.

Also known as: Ilaris

Canakinumab

Placebo DRUG

Constituent of canakinumab

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Division of Dermatology

Zurich, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 32827729 DERIVED

MeSH Terms

Conditions

Chronic Urticaria

Interventions

canakinumab

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Schmid-Grendelmeier, Prof MD

  University Hospital Zurich, Division of Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonios Kolios, MD

CONTACT

+41 (0)44 255 11 11; antonios.kolios@usz.ch

Alexander Navarini, MD PhD

CONTACT

alexander.navarini@usz.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 6, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

CH (1)