drugset / Trial / NCT00866788
A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
RandomizedParallel-groupDouble-blindTreatment
Summary
The study is a Phase II, dose-ranging, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of a single subcutaneously administered omalizumab dose as add-on therapy for the treatment of adolescent and adult patients 12-75 years old who have been diagnosed with CIU and remain symptomatic despite treatment with therapeutic doses of an H1 antihistamine. The study will enroll approximately 76 patients at approximately 45 study centers in the United States and Germany.
Timeline
- Start
- 2009-03
- Primary completion
- 2010-01
- Completion
- 2010-01
Outcome
Met primary endpoint
registry analysis (superiority or other test); Placebo vs Omalizumab 300 mg; p = 0.0003; van Elteren test; NCT00866788 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omalizumab | Monoclonal antibody | 75 mg | Subcutaneous |
| Subject | Omalizumab | Monoclonal antibody | 300 mg | Subcutaneous |
| Subject | Omalizumab | Monoclonal antibody | 600 mg | Subcutaneous |
| Background | Cetirizine | Other / unclassified | 10 mg | — |
| Background | Desloratadine | Small molecule | 5 mg | — |
| Background | Diphenhydramine | Small molecule | 25 mg | — |
| Background | Fexofenadine | Unknown | 60 mg | — |
| Background | Fexofenadine | Unknown | 180 mg | — |
| Background | Levocetirizine | Unknown | 5 mg | — |
| Background | Loratadine | Small molecule | 10 mg | — |