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CIDP患者を対象としたリリプルバートの長期安全性および有効性試験

基本情報

NCT ID
NCT06859099
ステータス
招待制
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
300
治験依頼者名
Sanofi

概要

This study is a Phase 3 extension, global, multicenter open-label study. The purpose of this study is to evaluate long-term safety and efficacy of riliprubart in adult participants with chronic inflammatory demyelinating polyneuropathy (CIDP) who have completed Part B in 1 of 3 parent studies (PDY16744, EFC17236, or EFC18156) and wish to continue treatment with riliprubart. Up to approximately 300 participants will be enrolled to continue receiving treatment with riliprubart. The duration of participation for each participant will be up to approximately 4 years, including posttreatment follow-up. The treatment duration will be up to approximately 3 years. A participant who discontinues riliprubart treatment at any time during the study will be followed for safety for a minimum of 55 weeks after the last dose of riliprubart received.

対象疾患

炎症性脱髄性多発神経炎、慢性

介入

Riliprubart Prefilled Pen (PFP)(DRUG)

依頼者(Sponsor)