Chronic spontaneous urticaria
Conditions
Interventions
Trade Name: Xolair
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: OMALIZUMAB
CAS Number: 242138-07-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentra
Sponsors
UMC Utrecht
Eligibility
Sex/Gender
All
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). 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
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 |
|---|---|
| Main Objective: To relate the reduction of inflammatory characteristics in the skin and peripheral blood to clinical efficacy of Xolair (omalizumab) in patients with CSU.;Secondary Objective: To determine the clinical efficacy of Xolair (omalizumab), measured by disease activity, disease control and quality of life;Primary end point(s): The primary endpoint is the reduction of inflammatory characteristics in the skin in responders and non-responders of treatment with Xolair (omalizumab), thereby exploring the reduction in inflammatory parameters by analysis of complement deposition and infiltration of FceRI-bearing leukocytes such as basophils. Changes in inflammatory parameters in the skin will also be related to changes in levels of circulating complement components and the reduction of the in vitro activation state and numbers of basophils.;Timepoint(s) of evaluation of this end point: Skin biopsies will be performed at baseline, after 24 hours and after 2 weeks. Venipunctures will be performed at baseline, 1,2, 6 and 24 hours after the first dose of omalizumab, 1 and 2 weeks after the first dose of omalizumab, before and 2 hours after the second dose of omalizumab and subsequently every 4 weeks, before the next dose of omalizumab. Three months after the last (6th) dose, a last venipuncture will be performed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoint is the clinical efficacy of omalizumab. Disease severity (UAS7, AAS), Quality of life (CU-QoL, AE-QoL, DLQI), and disease control (UCT) will be measured for this purpose.;Timepoint(s) of evaluation of this end point: UAS7 and when applicable AAS will be used throughout the study. At baseline, after three months of treatment and at the last follow up visit, CU-QoL, DLQI and if applicable AE-QoL will be used. UCT will be used every visit where patients receive a dose of omalizumab, and at the last follow-up visit. | — |
Countries
Netherlands
Contacts
Public ContactDept. Dermatology/Allergology
UMC Utrecht
Outcome results
None listed