2025-522939-33-00招募中2 期
Master Protocol Full Title- A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis. ISA 2 to Master Protocol ARGX-999-2-MG-2000 – an Exploratory, Phase 2a, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Argenx
- 入组人数
- 29
- 试验地点
- 24
- 主要终点
- MP - 1. Incidence, severity, and relatedness of AEs and SAEs
研究概览
简要总结
MP - To determine the safety and tolerability of multiple regimens (monotherapy or add-on therapy to backbone therapy) in MG subtypes.
ISA 2 - To evaluate the safety and tolerability of empasiprubart IV as a monotherapy
研究设计
- 分配方式
- Na
- 主要目的
- Safety follow-up period
- 盲法
- None
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
- •MP Main inclusion criteria: o Is at least 18 years of age and the local legal age of consent for clinical studies o Has been diagnosed with MG consistent with MG's clinical features and with symptom severity appropriate for currently enrolling ISAs, per the investigator’s clinical judgment o If receiving MG therapy, including nonsteroidal immunosuppressive drugs (NSIDs), corticosteroids, or acetylcholinesterase (AChE) inhibitors either in combination or alone, the participant should receive a stable dosage before master protocol screening
- •ISA 2- - Is seropositive for anti-acetylcholine receptor antibodies (AChR-Ab) - Has confirmed diagnosis of gMG and is Myasthenia Gravis Foundation of America (MGFA) Class II, III, IVa, or IVb - Has documented immunization against encapsulated bacterial pathogens (Neisseria meningitidis and Streptococcus pneumoniae) within 5 years before ISA screening or will complete immunization at least 14 days before the first IMP administration
排除标准
- •MP Main exclusion criteria: o Known autoimmune disease or any medical condition other than the indication under study that would interfere with an accurate assessment of clinical symptoms of MG or puts the participant at undue risk. o Is MGFA (Myasthenia Gravis Foundation of America) Class V
- •ISA 2- - Clinical diagnosis of systemic lupus erythematosus (SLE) - Is receiving concurrent complement inhibitors (eg, eculizumab, zilucoplan, ravulizumab, or others). Participants who received zilucoplan or eculizumab >2 months or ravulizumab >6 months before baseline are allowed to participate. - Has received an FcRn antagonist, including efgartigimod, within 4 weeks before baseline -Had prior empasiprubart exposure
研究组 & 干预措施
ARGX-117
Test
干预措施: ARGX-117 (Drug)
Vyvgart 1 000 mg solution for injection in pre-filled syringe
Test
干预措施: Vyvgart 1 000 mg solution for injection in pre-filled syringe (Drug)
Placebo to match Empasiprubart IV (ARGX-117)
Placebo
干预措施: Placebo to match Empasiprubart IV (ARGX-117) (Drug)
结局指标
主要结局
MP - 1. Incidence, severity, and relatedness of AEs and SAEs
MP - 1. Incidence, severity, and relatedness of AEs and SAEs
MP - 2. Clinically meaningful changes in vital signs, ECGs, and laboratory parameters
MP - 2. Clinically meaningful changes in vital signs, ECGs, and laboratory parameters
ISA 2 - 1. Incidence, severity, and relatedness of adverse events and serious adverse events in the DBTP
ISA 2 - 1. Incidence, severity, and relatedness of adverse events and serious adverse events in the DBTP
ISA 2 - 2. Clinically meaningful changes in vital signs, electrocardiograms, and laboratory parameters in the DBTP
ISA 2 - 2. Clinically meaningful changes in vital signs, electrocardiograms, and laboratory parameters in the DBTP
次要结局
- MP - 1. Change in MG disease severity as measured by change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score or Myasthenia Gravis Impairment Index (MGII) total score
- MP - 2. Proportion of participants reaching minimal symptom expression (MSE) and other percentage improvements at variable time points.
- ISA 2 - 1. MG-ADL total score change from baseline at week 12
- ISA 2 - 2. QMG total score change from baseline at week 12
- ISA 2 - 3. MG-ADL total score actual values and changes from baseline over time up to week 12
- ISA 2 - 4. QMG total score actual values and changes from baseline over time up to week 12
- ISA 2 - 5. Proportion of participants reaching MSE at any point by week 12
- ISA 2 - 6. Proportion of participants who have ≥3-point reduction in MG-ADL at week 12
- ISA 2 - 7. Proportion of participants who have ≥5-point reduction in QMG at week 12
- ISA 2 - 8. Proportion of participants who have a positive PASS at week 12
- ISA 2 - 9. Proportion of participants who have a 50% MG-ADL total score improvement at week 12
研究者
Chief Scientific Officer
Scientific
Argenx
研究点 (24)
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