Efficacy Study of Canakinumab to Treat Urticaria
- Registration Number
- NCT01635127
- Lead Sponsor
- University of Zurich
- Brief Summary
Evaluation whether canakinumab leads to improvement of urticaria
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Constituent, inactive Canakinumab Canakinumab Monoclonal antibody inhibiting interleukin 1 beta
- Primary Outcome Measures
Name Time Method Complete clinical remission 4 weeks Improvement of urticaria within 4 weeks, objective measurements daily wheal score and UAS7
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital Zurich, Division of Dermatology
🇨🇭Zurich, Switzerland