JPRN-jRCT2080225049已完成3 期
A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- argenx
- 入组人数
- 151
研究概览
简要总结
ong-term treatment with repeated cycles of 1 infusion per week for 4 infusions of efgartigimod IV 10 mg/kg was safe and well tolerated, with most AEs being mild to moderate in severity. The overall benefit-risk profile was positive. The AChR-Ab seropositive, AChR-Ab seronegative, and overall populations had consistent improvements in MG-ADL and QMG scores over repeated cycles.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Patients with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.
- •2.Patients who participated in trial ARGX-113-1704 and are eligible for roll over, as specified in the protocol.
- •Other more specific inclusion criteria are further defined in the protocol.
排除标准
- •1.Patients who discontinued early from trial ARGX-113-1704 or patients who discontinued early from randomized treatment for pregnancy or rescue reasons or an (S)AE that might jeopardize the safety of the patient in that trial. 2.Pregnant and lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing. Women or childbearing potential should have a negative urine pregnancy test at SEB.
- •3.Male patients who are sexually active and do not intend to use effective methods of contraception during the trial or within 90 days after the last dosing or male patients who plan to donate sperm during the trial or within 90 days after the last dosing.
- •4.Patients with known Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) seropositivity. Other, more specific exclusion criteria are further defined in the protocol.
研究者
相似试验
Enrolling By Invitation
2 期
Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia GravisGeneralized Myasthenia GravisgMGNCT05374590argenx12
已完成
3 期
Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisNCT04818671argenx184
Enrolling By Invitation
3 期
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory MyopathyAntisynthetase SyndromeActive Idiopathic Inflammatory MyopathyPolymyositisImmune-Mediated Necrotizing MyopathyMyositisDermatomyositisNCT05979441argenx240
已完成
4 期
Anagre Cap. in Patients With High-Risk Essential ThrombocythemiaEssential ThrombocythemiaNCT03232177Yuhan Corporation70
招募中
3 期
A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune ThrombocytopeniaPrimary Immune Thrombocytopenia (ITP)NCT06544499argenx69