NCT06537999进行中（未招募）2 期
A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Study to Evaluate Safety, Tolerability, Pharmacometrics, and Efficacy of DNTH103 in Adults With Multifocal Motor Neuropathy (MOMENTUM)
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
- 46
- 试验地点
- 83
- 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 Claseprubart (DNTH103) in participants with multifocal motor neuropathy (MMN).
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).
- •Weight range between 40 to 120 kilograms (kg).
- •Confirmed diagnosis of definite or probable MMN.
- •Evidence of:
- •Responsiveness to Ig treatment; and
- •Receiving a stable Ig regimen
- •Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability.
- •Female participants must be of nonchildbearing 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 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 or be surgically sterile for at least 90 days prior to Screening.
排除标准
- •History or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant or that could impact efficacy assessments.
- •Any coexisting conditions which may interfere with outcome assessments (eg, severe diabetic neuropathy).
- •Concurrent or previous use of rituximab, cyclophosphamide, mycophenolate mofetil, azathioprine, or cyclosporine. If a participant has previously used these medications, the last dose must be at least 6 months prior to randomization.
- •Currently or previously on complement inhibitors including in a clinical trial setting.
- •Prior history (at any time) of N. meningitidis infection.
- •Diagnosis of an autoimmune disorder other than MMN.
- •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.
- •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.
- •Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent (whichever is longer) prior to randomization (Day 1).
- •Any other overlapping condition for which the condition or treatment of the condition may affect the study assessments or outcomes.
- •Any other condition, including mental illness or prior therapy, that in the opinion of the Investigator would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Claseprubart 300 mg Q2W
Experimental
干预措施: Claseprubart (Drug)
Claseprubart 600 mg Q2W
Experimental
干预措施: Claseprubart (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 to Week 17
Incidence of treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs)
次要结局
- Mean Value, Mean Change, and Percentage Change From Baseline in Grip Strength(Baseline to Week 17)
- Mean Value and Mean Change From Baseline in MRC-10 Sum Score(Baseline to Week 17)
- Mean Value and Mean Change From Baseline in MRC-14 Sum Score(Baseline to Week 17)
- Mean Value and Mean Change From Baseline in Multifocal Motor Neuropathy Rasch-Built Overall Disability Scale (MMN-RODS) Score(Baseline to Week 17)
- Mean Value and Mean Change From Baseline in Average Time to Complete the 9-Hole Peg Test (9-HPT)(Baseline to Week 17)
- Time to Retreatment With Immunoglobulin (Ig) Since the Final Ig Treatment Before Randomization(Baseline to Week 17)
- Time to Clinical Deterioration (CD)(Baseline to Week 17)
- Area Under Curve (AUC) of the Change From Baseline in Grip Strength(Baseline to Week 17)
- AUC of the Change From Baseline in Medical Research Council (MRC)-10 Sum Score(Baseline to Week 17)
- Mean Change From Baseline in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score(Baseline to Week 17)
- Mean Change From Baseline in Euro-Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) Scale(Baseline to Week 17)
- Mean Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS)(Baseline to Week 17)
- Count and Proportion of Participants With Patient Global Impression of Change (PGIC) Score of Improved or Better(Baseline to Week 17)
- Mean Change From Baseline in Fatigue Severity Scale (FSS) Score(Baseline to Week 17)
- Mean Change From Baseline in Health-Related Productivity Questionnaire (HRPQ) Outcomes(Baseline to Week 17)
- Effectiveness, Side Effects, Convenience, and Overall Satisfaction Scores as Assessed by Treatment Satisfaction Questionnaire for Medications (TSQM)-14(Baseline to Week 17)
- Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)(Up to Week 52 of OLE)
- Serum Concentrations of DNTH103(Baseline to Week 17)
- Incidence and Titer of Antidrug Antibody (ADA) Levels Against DNTH103(Baseline to Week 17)
研究者
研究点 (83)
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