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Efficacy Study of Canakinumab to Treat Urticaria — URTICANA  

Chronic Idiopathic Urticaria Clinical Trial

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

Clinical Trial Summary

Evaluation whether canakinumab leads to improvement of urticaria

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01635127
Study type Interventional
Source University of Zurich
Contact Antonios Kolios, MD
Phone +41 (0)44 255 11 11
Email antonios.kolios@usz.ch
Status Recruiting
Phase Phase 2
Start date June 2012
Completion date May 2017
View Details
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