Markers of Efficacy of Xolair (Omalizumab) in Chronic Spontaneous Urticaria

Phase 4

Completed

• Conditions: hives; urticaria; 10002426

• Registration Number: NL-OMON43836
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Age * 18 years
Diagnosis of CSU according to recent international guidelines
Moderate or severe disease activity (UAS7 * 16) despite current treatment with H1 antihistamines according to recent international guidelines
Sufficient washout of treatment with immunosuppressants (several washout periods are pre-defined).

Exclusion Criteria

Other urticarias than CSU, including but not limited to CINDU
Hypersensitivity to omalizumab or any component of the formulation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The reduction of inflammatory characteristics in skin and blood in responders<br /><br>and non-responders of treatment with omalizumab, thereby exploring the<br /><br>reduction in inflammatory parameters by analysis of complement deposition and<br /><br>infiltration of basophils. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoint is the clinical efficacy of omalizumab, determined by<br /><br>the change from baseline in disease severity, quality of life and disease<br /><br>control.</p><br>