補体阻害薬による治療を受けていない、または最近受けていない発作性夜間ヘモグロビン尿症（PNH）の成人患者におけるポゼリマブ＋セムジシラン併用療法の安全性と有効性を評価する研究

基本情報

NCT ID

NCT05133531

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

190

治験依頼者名

Regeneron Pharmaceuticals

概要

This study is researching a clinical treatment combination with two experimental drugs called pozelimab and cemdisiran. The study is focused on people with paroxysmal nocturnal hemoglobinuria (PNH). The aim of the study is to see how safe and effective the pozelimab + cemdisiran combination is for people with PNH and how the combination compares with 2 existing treatments: ravulizumab and eculizumab. The pozelimab + cemdisiran combination may be referred to as "study drugs". Ravulizumab and eculizumab may also be called the "comparator drug". The study is looking at several research questions, including: * How effective is the pozelimab + cemdisiran combination compared to ravulizumab? * How effective is pozelimab + cemdisiran combination compared to eculizumab? * What side effects may happen from taking the study drugs? * How much study drugs are in the blood at different times? * Whether the body makes antibodies against the study drugs (which could make the study drugs less effective or could lead to side effects)

対象疾患

介入

依頼者（Sponsor）

実施施設 (5)