hives urticaria
Conditions
Interventions
omalizumab 6 x 300 mg, per 4 weeks
basophils
complement
omalizumab
urticaria
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
Exclusion criteria: Other urticarias than CSU, including but not limited to CINDU Hypersensitivity to omalizumab or any component of the formulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The reduction of inflammatory characteristics in skin and blood in responders and non-responders of treatment with omalizumab, thereby exploring the reduction in inflammatory parameters by analysis of complement deposition and infiltration of basophils. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is the clinical efficacy of omalizumab, determined by the change from baseline in disease severity, quality of life and disease control. | — |
Countries
The Netherlands
Outcome results
None listed