drugset / Trial / NCT02329223
Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This was a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult participants 12 - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and who remained symptomatic despite standard-dosed non-sedating H1 antihistamine treatment.
Timeline
- Start
- 2014-12
- Primary completion
- 2015-12
- Completion
- 2015-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omalizumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Omalizumab | Monoclonal antibody | 300 mg | Subcutaneous |