NCT01635127

Efficacy Study of Canakinumab to Treat Urticaria

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chronic Idiopathic Urticaria

Interventions

Type	Name	Description
DRUG	Canakinumab	150mg s.c.
DRUG	Placebo	Constituent of canakinumab

Timeline

• Start date: 2012-06-01
• Primary completion: 2016-12-01
• Completion: 2017-05-01
• First posted: 2012-07-06
• Last updated: 2016-09-27

Locations

1 site across 1 country: Switzerland