Mechanism of action of Xolair (omalizumab) as treatment for hives

• Conditions: Chronic spontaneous urticaria; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-005127-27-NL
• Lead Sponsor: MC Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-27
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified