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好酸球性胃炎(好酸球性十二指腸炎の有無を問わず)の成人および青年患者におけるデュピルマブの効果と副作用を検討する研究

基本情報

NCT ID
NCT05831176
ステータス
実施中(募集終了)
試験のフェーズ
第2相
試験タイプ
介入
目標被験者数
22
治験依頼者名
Regeneron Pharmaceuticals

概要

This study is researching an experimental drug called dupilumab. The study is focused on participants with active eosinophilic gastritis (EoG) with or without eosinophilic duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EoG and EoD are uncommon, persistent, allergic/immune diseases in which eosinophils (a type of white blood cell) gather in large numbers in the stomach and small intestine and cause inflammation and damage. The aim of the study is to evaluate the effect of dupilumab on relieving EoG (with or without EoD) symptoms and reducing inflammation in the stomach and, if applicable, small intestine in adults and adolescents aged 12 years and older after at least 24 weeks (about 6 months) and up to 52 weeks (1 year) of treatment. The study is looking at several other research questions, including: * What side effects may happen from taking 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

Eosinophilic Gastritis (EoG)Eosinophilic Duodenitis (EoD)Eosinophilic Gastrointestinal Disease (EGID)Eosinophilic Gastroenteritis

介入

Dupilumab(DRUG)

依頼者(Sponsor)

実施施設 (9)

兵庫県立はりま姫路総合医療センター

Himeji, Hyōgo, Japan

国家公務員共済組合連合会 虎の門病院

Minato-ku, Tokyo, Japan

大垣市民病院

Ōgaki, Gifu, Japan

公立大学法人横浜市立大学附属病院

Yokohama, Kanagawa, Japan

神戸元町呼吸器内科・アレルギークリニック

Kobe, Hyōgo, Japan

川崎医科大学附属病院

Kurashiki, Okayama-ken, Japan

国家公務員共済組合連合会 呉共済病院

Kure, Hiroshima, Japan

株式会社 麻生 飯塚病院

Iizuka, Fukuoka, Japan

国立大学法人山形大学医学部附属病院

Yamagata, Japan