drugset / Trial / NCT03369704

Study of Efficacy and Safety of Omalizumab in Severe Japanese Cedar Pollinosis Adult and Adolescent Patients

NCT03369704

Phase 3 Completed 337 enrolled Novartis Pharmaceuticals
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

EvaluationDrugModalityDoseRoute
Subject Omalizumab Monoclonal antibody 75 mg Subcutaneous
Subject Omalizumab Monoclonal antibody 600 mg Subcutaneous