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重症スギ花粉症成人および青年患者におけるオマリズマブの有効性と安全性に関する研究
基本情報
- NCT ID
- NCT03369704
- ステータス
- 完了
- 試験のフェーズ
- 第3相
- 試験タイプ
- 介入
- 目標被験者数
- 337
- 治験依頼者名
- Novartis
概要
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.
対象疾患
Seasonal Allergic Rhinitis
介入
Omalizumab(DRUG)
Placebo(DRUG)
依頼者(Sponsor)
ノバルティスファーマ株式会社(INDUSTRY)