NCT07647510招募中3 期
A Phase 3 Global, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Demonstrate the Efficacy, Safety, and Tolerability of Claseprubart (DNTH103) in Patients With Generalized Myasthenia Gravis (EMERGE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 195
- 试验地点
- 5
- 主要终点
- Change from Baseline to Week 17 in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score
研究概览
简要总结
The purpose of this Phase 3 study is to demonstrate the efficacy, safety, and tolerability of claseprubart in participants with generalized myasthenia gravis (gMG).
详细描述
The study includes the following periods:
- Screening (up to 12 weeks)
- Randomized, blinded, controlled treatment (RCT) period (17 weeks)
- Extended treatment period (ETP) (104 weeks) (optional) for eligible participants [includes blinded extension period (BEP) and open-label extension (OLE) period]
- Safety Follow-Up period (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 80 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
- •Weight range between 40-130 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
- •MG-ADL scale score of 6 or more
- •QMG scale score of 10 or more
- •Documented vaccinations against encapsulated bacteria in accordance with local requirements and based on vaccine availability
- •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 agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception
排除标准
- •History or presence of significant medical/surgical condition including any acute illness, mental illness, or major surgery considered to be clinically significant or that could have potential impact on safety/efficacy or study procedures
- •Known complement deficiency
- •Prior history (at any time) of N. meningitidis infection
- •Participants with known seropositivity or who test positive for an active viral infection with human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B (HBV; except participants who are seropositive because of HBV vaccination) or hepatitis C virus (HCV) during Screening
- •Previous treatment with claseprubart (DNTH103) or participation in a clinical trial with claseprubart. [
- •Any thymic surgery/biopsy within 1 year of Screening
- •Any known or untreated thymoma.
- •Any history of thymic carcinoma or thymic malignancy
- •History of active malignancy within 5 years prior to Screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone
- •Concurrent or previous use of the following medication within the time periods specified below.
- •Rituximab or other B-cell targeting therapies (ie, inebilizumab) 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
- •Diagnosis of systemic lupus erythematosus (SLE) or family history (defined as a parent, sibling, or child) of SLE
研究组 & 干预措施
Placebo
Placebo Comparator
Intravenous (IV) infusion of Placebo on Day 1 followed by subcutaneous (SC) injections of Placebo every 2 weeks (Q2W) starting at Week 1 (Day 8).
干预措施: Placebo (Combination Product)
Claseprubart Q2W
Experimental
IV loading dose of claseprubart on Day 1 followed by SC injections of claseprubart Q2W starting at Week 1 (Day 8).
干预措施: Claseprubart (Combination Product)
Claseprubart Every 4 weeks (Q4W)
Experimental
IV loading dose of claseprubart on Day 1 followed by SC injections of claseprubart or Placebo Q2W starting at Week 1 (Day 8), with doses alternating between claseprubart and placebo.
干预措施: Claseprubart (Combination Product)
Claseprubart Every 4 weeks (Q4W)
Experimental
IV loading dose of claseprubart on Day 1 followed by SC injections of claseprubart or Placebo Q2W starting at Week 1 (Day 8), with doses alternating between claseprubart and placebo.
干预措施: Placebo (Combination Product)
结局指标
主要结局
Change from Baseline to Week 17 in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score
时间窗: Baseline (Day 1) to Week 17
The MG-ADL score is an 8-item patient reported outcome (PRO) instrument. The MG-ADL targets symptoms of disability across ocular, bulbar, respiratory, and axial symptoms. The item responses are scored from 0 to 3, and the total score of the MG-ADL is the sum of the 8 items and ranges from 0 to 24, with a higher score indicating more disability.
次要结局
- Change from Baseline to Week 17 in Quantitative Myasthenia Gravis (QMG) Scale Score(Baseline (Day 1) to Week 17)
- Change from Baseline to Week 17 in Myasthenia Gravis Composite (MGC) Scale Score(Baseline (Day 1) to Week 17)
- Proportion of Participants with Greater Than or Equal to (≥) a 5-point Reduction in MG-ADL Scale Score at Week 17 Compared to Baseline(Baseline (Day 1) to Week 17)
- Proportion of Participants Who Reach Minimal Symptom Expression (MSE), Defined as MG-ADL 0 or 1 at Week 17, Without Use of Rescue Therapy(Baseline (Day 1) to Week 17)
- Proportion of Participants with a ≥ 5-point Reduction in QMG Scale Score at Week 17 Compared to Baseline(Baseline (Day 1) to Week 17)
- Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-Emergent and Treatment-Emergent Serious Adverse Events (SAEs) in the RCT period, BEP, OLE, and Safety Follow-Up(Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks))
- Serum Concentrations of Claseprubart(Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks))
- Change from Baseline in Complement Total Blood Test (CH50) in Serum ex vivo(Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks))
- Incidence of Antidrug Antibody (ADAs) Against Claseprubart in the RCT Period, BEP, OLE, and Safety Follow-Up(Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks))
- Titer of ADAs Against Claseprubart in the RCT Period, BEP, OLE, and Safety Follow-Up(Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks))
研究者
研究点 (5)
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