Prospective Double-blind Placebo-controlled Study of the Effect of Xolair (Omalizumab) in Chronic Urticaria Patients

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to investigate the pathophysiological mechanism of omalizumab in patients with documented chronic urticaria who have complaints under standard antihistamine treatment. With this study the investigators will assess the correlation between Fc-IgE receptor downregulation as well as functionality and clinical response to omalizumab treatment in patients with chronic urticaria. This may be an approach for other diseases as well, where Fc-IgE receptor crosslinking are essential. The treatment time is set for a total of 4 monthly applications of omalizumab. According to the dosage recommendations of recent studies, fixed doses of 300 mg omalizumab are administered subcutaneously.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborators: Adverse Drug Reactions, Advice and Consulting ADR-AC; Novartis; University of Bern
• Treatments: Omalizumab

Criteria

Inclusion Criteria:

• 1. Diagnosis of chronic urticaria made by clinical symptoms and clinical investigations

• 2. Patients with chronic urticaria were defined as having symptoms for at least 6 weeks, with hives present at least twice weekly, refractory to H1 antihistaminics at time of randomization

• 3. Signed informed consent documenting understanding of the study procedures and the investigational nature of the study

Exclusion Criteria

• Age <18 or >70 year

• Patients with pure physical or cold urticaria, delayed pressure or cholinergic urticaria

• Patients with a clearly defined allergic urticaria (food, drugs etc.)

• Previous treatment with omalizumab within one year prior to randomization

• Known hypersensitivity to omalizumab or any of its components

• History of cancer in the previous 5 years

• Patients with parasitic infections

• Patients with documented active tuberculosis or undergoing anti-TB therapy

• Patients currently or recently (in the preceding 4 weeks) treated with systemic immunosuppressive agents according to medical history

• Pregnant or nursing women

• Known intolerance to any protocol intervention

• Patient's lack of accountability, inability to appreciate the nature, meaning and consequences of the study and to formulate his/her own wishes correspondingly