drugset / Trial / NCT03369704
Study of Efficacy and Safety of Omalizumab in Severe Japanese Cedar Pollinosis Adult and Adolescent Patients
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study was to demonstrate the efficacy and safety of omalizumab compared with placebo, on top of SoC (anti-histamine and nasal corticosteroid) in adult and adolescent patients with severe Japanese cedar pollinosis, whose symptoms were inadequately controlled despite the current recommended therapies (nasal corticosteroids plus one or more medications out of anti-histamine, leukotriene receptor antagonist, or prostaglandin D2/thromboxane A2 receptor antagonist) in the previous 2 Japanese cedar pollen seasons.
Timeline
- Start
- 2017-12-15
- Primary completion
- 2018-05-11
- Completion
- 2018-10-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omalizumab | Monoclonal antibody | 75 mg | Subcutaneous |
| Subject | Omalizumab | Monoclonal antibody | 600 mg | Subcutaneous |