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進行性骨化性線維異形成症(FOP)の成人患者を対象に、ガレトスマブとプラセボを静脈内(IV)投与した場合の安全性、忍容性、有効性を評価する試験
基本情報
- NCT ID
- NCT05394116
- ステータス
- 実施中(募集終了)
- 試験のフェーズ
- 第3相
- 試験タイプ
- 介入
- 目標被験者数
- 63
- 治験依頼者名
- Regeneron Pharmaceuticals
概要
This study is researching an experimental drug called garetosmab. The study is focused on adult patients with fibrodysplasia ossificans progressiva (FOP). The aim of the study is to see how safe and effective the study drug is in patients with FOP. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
対象疾患
Fibrodysplasia Ossificans Progressiva
介入
Garetosmab(DRUG)
Placebo(DRUG)
依頼者(Sponsor)
Regeneron(INDUSTRY)
実施施設 (3)
名古屋大学医学部附属病院
Nagoya, Aichi-ken, Japan
九州大学病院
Fukuoka, Japan
大分大学医学部附属病院
Yufu, Oita Prefecture, Japan