全身性重症筋無力症患者におけるプラセボと比較した経口クラドリビンの新製剤の有効性と安全性（MyClad）

基本情報

NCT ID: NCT06463587
ステータス: 募集中
試験のフェーズ: 第3相
試験タイプ: 介入
目標被験者数: 264
治験依頼者名: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

概要

The purpose of this clinical study is to determine the efficacy and safety of a new oral cladribine formulation in participants with Generalized Myasthenia Gravis (gMG) in comparison to placebo. It will also investigate the sustained efficacy, the need for retreatment, and the long-term safety of oral cladribine in gMG. An additional component is included to characterize the Pharmacokinetics (PK) of the new cladribine formulation in gMG participants. This study is divided into 3 periods: the double-blind placebo control (DBPC) pivotal period, and 2 extensions, the blinded extension (BE) and the retreatment (RT) period.

対象疾患

Generalized Myasthenia Gravis

介入

Placebo(OTHER)

Cladribine Low Dose(DRUG)

Cladribine High Dose(DRUG)

依頼者（Sponsor）

Merck Healthcare Kgaa, Darmstadt, Germany, An Affiliate Of Merck Kgaa, Darmstadt, Germany(INDUSTRY)

Emd Serono Research & Development Institute(INDUSTRY)

実施施設 (11)

一般財団法人　脳神経疾患研究所　附属　総合南東北病院

Koriyama-shi, Fukushima, Japan(RECRUITING)

Saitama Medical University Hospital - Dept of Neurology/Stroke Care Unit

Iruma-gun, Saitama, Japan(RECRUITING)

国際医療福祉大学成田病院

Narita-shi, Chiba, Japan(RECRUITING)

General Hanamaki Hospital - Dept of Neurology

Hanamaki-shi, Iwate, Japan(RECRUITING)

長崎大学病院

Nagasaki, Nagasaki, Japan(RECRUITING)

Hakodate Municipal Hospital - Dept of Neurology

Hakodate-shi, Hokkaido, Japan(RECRUITING)

東京医科大学病院

Shinjuku-ku, Tokyo-To, Japan(RECRUITING)

Kagawa University Hospital - Dept of Neurology

Kita-gun, Kagawa-ken, Japan(RECRUITING)

東邦大学医療センター大橋病院

Meguro-ku, Tokyo-To, Japan(RECRUITING)

千葉大学医学部附属病院

Chiba, Chiba, Japan(RECRUITING)

大阪大学医学部附属病院

Suita-shi, Japan(RECRUITING)