原始来源记录
决策级临床试验登记变更
Dianthus：CAPTIVATE CIDP 3期试验中claseprubart的早期GO决定
该公司在CAPTIVATE试验中对CIDP的claseprubart做出早期GO决定，在完成开放标签Part A的参与者少于40人的情况下，确认应答者达到20人。该里程碑基于50%或更高的应答率标准，提前于此前指引的2026年第二季度时间表实现。公司现预计在2026年底前提供Part B的顶线指导。
关键事实
- 申报时间
- 2026年3月9日 11:19
- 事件
- 临床试验登记变更
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
- 应答者
- 20例确认应答者
- 参与者
- <40名计划参与者
来源摘录
EX-99.1 2 dnth-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 DIANTHUS THERAPEUTICS HIGHLIGHTS RECENT BUSINESS ACHIEVEMENTS, INCLUDING GO DECISION FOR PHASE 3 CAPTIVATE CIDP TRIAL, AND REPORTS Q4 AND FY 2025 FINANCIAL RESULTS Early GO decision reached in CAPTIVATE ahead of Q2’26 guidance based on GO criteria of 20 confirmed responders achieved with less than 40 planned participants completing open-label Part A Phase 3 registrational trial of claseprubart evaluating 300mg/2mL Q2W and 300mg/2mL Q4W in generalized Myasthenia Gravis (gMG) expected to initiate in mid-2026; top-line results anticipated in 2H’28 Phase 2 MoMeNtum trial of claseprubart in Multifocal Motor Neuropathy (MMN) ongoing; top-line results on track for 2H’26 Phase 1 healthy volunteer data for DNTH212 anticipated in 2H’26; updat