Efficacy Study of Canakinumab to Treat Urticaria

• Register: ClinicalTrials.gov
• Last refreshed on: 10 October 2016
• Main ID: NCT01635127
• Date of registration: 03/07/2012
• Prospective Registration: No
• Primary sponsor: University of Zurich
• Public title: Efficacy Study of Canakinumab to Treat Urticaria URTICANA
• Scientific 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
• Date of first enrolment: June 2012
• Target sample size: 20
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT01635127
• 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
• Phase: Phase 2

Countries of recruitment

Switzerland

Contacts

• Name: Antonios Kolios, MD

• Name: Peter Schmid-Grendelmeier, Prof MD
• Affiliation: University Hospital Zurich, Division of Dermatology

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Idiopathic Urticaria

Intervention(s)

Drug: Canakinumab

Drug: Placebo

Primary Outcome(s)

Complete clinical remission [Time Frame: 4 weeks]

Secondary ID(s)

USZ-DER-AAN-017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors