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2歳から18歳未満の全身性重症筋無力症の小児におけるニポカリマブの試験

基本情報

NCT ID
NCT05265273
ステータス
募集中
試験のフェーズ
第2/第3相
試験タイプ
介入
目標被験者数
12
治験依頼者名
Janssen Research & Development, LLC

概要

The purpose of this study is to determine the effect of nipocalimab on total serum immunoglobulin G (IgG) in pediatric participants 2 to less than (\<) 18 years of age (globally) and 8 to \<18 years of age (for Unites Stated (US) sites only), the safety and tolerability of treatment with nipocalimab in children and adolescents and to evaluate the pharmacokinetics (PK) of nipocalimab in children and adolescents with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing, stable standard-of-care therapy.

対象疾患

重症筋無力症

介入

Nipocalimab(DRUG)

依頼者(Sponsor)

実施施設 (8)

東京女子医科大学病院

Shinjuku-ku, Japan(RECRUITING)

Saitama Prefecture Children's Medical Center

Saitama Shi, Japan(RECRUITING)

兵庫医科大学病院

Nishinomiya-Shi, Japan(RECRUITING)

Chiba University Hospital

Chiba, Japan(COMPLETED)

宮崎大学医学部附属病院

Miyazaki, Japan(RECRUITING)

Saitama Prefecture Children's Medical Center

Saitama Shi, Japan(RECRUITING)

千葉大学医学部附属病院

Chiba, Japan(COMPLETED)

長野県立こども病院

Azumino-shi, Japan(RECRUITING)