drugset / Trial / NCT01803763
Prospective Double-blind Placebo-controlled Study of the Effect of Xolair (Omalizumab) in Chronic Urticaria Patients
Phase 2/3
Completed
30 enrolled
Insel Gruppe AG, University Hospital Bern
Adverse Drug Reactions, Advice and Consulting ADR-AC · collabNovartis · collabUniversity of Bern · collab
RandomizedParallel-groupQuadruple-blindBasic science
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.
Timeline
- Start
- 2012-09
- Primary completion
- 2014-03
- Completion
- 2014-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Omalizumab | Monoclonal antibody | 300 mg | Subcutaneous |