2025-521130-28-00招募中3 期
Efficacy and Safety of Nipocalimab vs Efgartigimod in a Randomized, Open-label, Phase 3b, Interventional Trial Including Within Class Switching From Efgartigimod to Nipocalimab
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Averaged mean percent change from baseline in total IgG over Weeks 8 to 12 between Arms 1 and 2.
研究概览
简要总结
To evaluate the efficacy of nipocalimab vs efgartigimod in participants initiating neonatal Fc receptor (FcRn) treatment for generalized myasthenia gravis (gMG).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age and <75 years of age
- •AChR antibody positive
- •MG-ADL ≥5 with ≥50% as non-ocular
- •Has suboptimal response to current stable therapy for generalized Myasthenia Gravis according to the investigator, (specific to arms 1 and 2)
- •Total IgG ≥6 g/L, (specific to arms 1 and 2)
- •Treatment with efgartigimod intravenously or subcutaneously for ≥1 cycles, (specific to arm 3)
- •Participant and HCP agree it is appropriate for the participant to switch to nipocalimab, (specific to arm 3)
排除标准
- •Has received treatment for MG with an FcRn-targeting therapy, (specific to arms 1 and 2)
- •Is currently taking IgG monoclonal antibody therapeutics, or Fc-conjugated therapeutic agents, including factor or enzyme replacement, (specific to arms 1 and 2)
- •Current efgartigimod dosing is inconsistent with the label, (specific to arm 3)
结局指标
主要结局
Averaged mean percent change from baseline in total IgG over Weeks 8 to 12 between Arms 1 and 2.
Averaged mean percent change from baseline in total IgG over Weeks 8 to 12 between Arms 1 and 2.
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen Cilag International
研究点 (4)
Loading locations...
相似试验
招募中
3 期
Open-Label followed by a Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Infigratinib in Children with HypochondroplasiaHypochondroplasia2024-516822-67-00Qed Therapeutics Inc.32
招募中
4 期
Aflibercept 8mg for high-frequent Faricimab and prior Aflibercept 2mg treated Neovascular age-related macular degeneration: a monocenter, single-arm, open-label extension study (A-FAN)2024-515497-26-00Medical University Of Graz33
招募中
2 期
Tuvonralimab and Iparomlimab Based Regimens for the Neoadjuvant Treatment of Biliary Tract CancerNCT07267078Peking Union Medical College Hospital45
招募中
不适用
Real-World Efgartigimod Effectiveness in CIDP: A Prospective StudyCIDPNCT07264426argenx200
招募中
2 期
EFFICACY AND SAFETY TRIAL OF EPCORITAMAB WITH OR WITHOUT LENALIDOMIDE AS FIRST LINE THERAPY FOR SUBJECTS WITH DIFFUSE LARGE B-CELL LYMPHOMA.2023-504832-16-00Genmab A/S102