NCT06282159进行中（未招募）2 期
A Phase 2, Randomized, Blinded, Placebo-Controlled, Study to Evaluate Safety, Tolerability, Pharmacometrics, and Efficacy of DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 65
- 试验地点
- 59
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with generalized myasthenia gravis (gMG).
详细描述
The study includes the following periods:
- Screening (up to 10 weeks)
- Randomized, blinded, controlled treatment (RCT) period (13 weeks)
- Open-label extension (OLE) period (optional) for eligible participants (104 weeks)
- Safety follow-up (SFU) (40 weeks)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have given written informed consent before any study-related activities are carried out.
- •Adult males and females, 18 to 75 years of age (inclusive) at Screening.
- •Weight range between 40-120 kg at Screening.
- •Diagnosis of gMG by the following tests:
- •Acetylcholine receptor antibody (AChR Ab) positive, and
- •One of the following:
- •i. History of abnormal neuromuscular transmission test; ii. History of positive anticholinesterase test; iii. Clinical response to acetylcholinesterase inhibitors.
- •Myasthenia Gravis Foundation of America (MGFA) Class II-Iva
- •Myasthenia Gravis Activities of Daily Living (MG-ADL) score of 6 or more
- •Vaccination against N. meningitidis with the quadrivalent meningococcal vaccine, and where available, meningococcal serotype B vaccine within 3 years prior to, or at the time of, initiating study drug.
- •Female participants must:
- •Be of non-childbearing potential, or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception.
- •Male participants must be surgically sterile for at least 90 days prior to screening or agree not to donate sperm
排除标准
- •History or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant
- •Prior history (at any time) of N. meningitidis infection.
- •Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies during Screening.
- •Any thymic surgery/biopsy within 1 year of Screening.
- •Any known or untreated thymoma.
- •Any history of thymic carcinoma or thymic malignancy.
- •Concurrent or previous use of the following medication within the time periods specified below.
- •Rituximab within 6 months (180 days) prior to randomization (Day 1);
- •Intravenous immunoglobulin (IVIg) and plasma exchange (PLEX) within 4 weeks (28 days) prior to randomization (Day 1).
- •Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent.
研究组 & 干预措施
Claseprubart 300 mg Q2W
Experimental
干预措施: Claseprubart (Drug)
Claseprubart 600 mg Q2W
Experimental
干预措施: Claseprubart (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)
时间窗: Baseline (Day 1) to Week 13
Number of participants with TEAEs and treatment-emergent SAEs will be reported.
次要结局
- Change from Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score(Baseline (Day 1) to Week 13)
- Change from Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score(Baseline (Day 1) to Week 13)
- Change from Baseline to Week 13 in Myasthenia Gravis Composite (MGC) Scale Score(Baseline (Day 1) to Week 13)
- Incidence of TEAEs and Treatment-Emergent SAEs(Baseline (Day 1) up to Week 52 of the OLE)
- Serum Concentrations of DNTH103(Baseline (Day 1) to Week 52 of the OLE)
- Change from Baseline in Complement Total Blood Test (CH50)(Baseline (Day 1) to Week 52 of the OLE)
- Incidence and Titer of Antidrug Antibody (ADAs) Against DNTH103(Baseline (Day 1) to Week 52 of the OLE)
研究者
研究点 (59)
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