NCT04879628进行中（未招募）2 期
A Phase 2, Double-blind, Randomized, Placebo-controlled Study Assessing Efficacy and Safety of SAR441344, a CD40L-antagonist Monoclonal Antibody, in Participants With Relapsing Multiple Sclerosis
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）
- 发起方
- Sanofi
- 入组人数
- 129
- 试验地点
- 74
- 主要终点
- Mean Number of New Gadolinium (Gd)-Enhancing T1--Hyperintense (GdE T1) Lesions at Week 12 Relative to Week 8 as Measured by Brain Magnetic Resonance Imaging (MRI)
研究概览
简要总结
Primary Objective:
To determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions
Secondary Objective:
- To evaluate efficacy of SAR441344 on disease activity as assessed by other MRI measures
- To evaluate the safety and tolerability of SAR441344
- To evaluate pharmacokinetics of SAR441344
详细描述
The duration of each participant will be no longer than 320weeks in both parts of the study, including 4 weeks of screening, at maximum 292 weeks of treatment and 24 weeks of follow-up.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- •The participant must have been diagnosed with RMS (relapsing-remitting MS and secondary progressive MS participants with relapses) according to the 2017 revision of the McDonald diagnostic criteria.
- •The participant must have at least 1 documented relapse within the previous year, or ≥2 documented relapses within the previous 2 years, or ≥1 active Gd-enhancing brain lesion on an MRI scan in the past 6 months and prior to screening.
- •Body weight within 45 to 120 kg (inclusive) and body mass index (BMI) within the range 18.0 to 35.0 kg/m2 (inclusive) at Screening.
- •Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Capable of giving signed informed consent.
排除标准
- •The participant was diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria or with non-relapsing SPMS.
- •The participant had conditions or situations that would adversely affect participation in this study.
- •The participant had a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study.
- •History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment.
- •Allergies to humanized monoclonal antibodies or severe post-treatment hypersensitivity reactions other than localized injection site reaction, to any biological molecule.
- •The participant had received any of the forbidden medications/treatments within the specified time frame before any baseline assessment.
- •The participant had taken other investigational drug within 3 months or 5-half-live, whichever is longer, before the screening visit.
- •The participant had an EDSS score >5.5 at the first screening visit.
- •The participant had a relapse in the 30 days prior to randomization.
- •Positive human immunodeficiency virus (HIV) serology (anti HIV1 and anti HIV2 antibodies) or a known history of HIV infection, active or in remission.
- •Abnormal laboratory test(s) at Screening.
- •Presence of Hepatitis B surface antigen (HBsAg) or anti-Hepatitis B core antibodies (anti-HBc Ab) at screening or within 3 months prior to first dose of study intervention.
- •Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
SC Placebo
Placebo Comparator
Placebo SC
干预措施: MRI contrast-enhancing preparations (Drug)
IV Placebo
Placebo Comparator
Placebo IV
干预措施: placebo IV (Drug)
SC Placebo
Placebo Comparator
Placebo SC
干预措施: placebo SC (Drug)
Subcutaneous (SC) SAR441344
Experimental
SAR441344 SC
干预措施: SAR441344 SC (Drug)
Subcutaneous (SC) SAR441344
Experimental
SAR441344 SC
干预措施: MRI contrast-enhancing preparations (Drug)
Intravenous (IV) SAR441344
Experimental
SAR441344 IV
干预措施: SAR441344 IV (Drug)
Intravenous (IV) SAR441344
Experimental
SAR441344 IV
干预措施: MRI contrast-enhancing preparations (Drug)
IV Placebo
Placebo Comparator
Placebo IV
干预措施: MRI contrast-enhancing preparations (Drug)
结局指标
主要结局
Mean Number of New Gadolinium (Gd)-Enhancing T1--Hyperintense (GdE T1) Lesions at Week 12 Relative to Week 8 as Measured by Brain Magnetic Resonance Imaging (MRI)
时间窗: Week 8 and Week 12
Cranial (brain) MRI was performed to identify number of new GdE T1-hyperintense lesions at Week 12 relative to Week 8 MRI. Central review was used to identify new GdE T1 lesions not present at the previous MRI scans.
次要结局
- Maximum Plasma Concentration (Cmax) of SAR441344(After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose))
- Mean Number of New or Enlarging T2 Lesions at Week 12 Relative to Week 8(Week 8 and Week 12)
- Mean Total Number of GdE T1 Lesions at Week 12(Baseline (Day 1) and Week 12)
- Double-Blind Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)(From first dose of study drug (Day 1) up to 12 weeks (DB TE period))
- Area Under the Curve Over the Dosing Interval (AUC0-tau) of SAR441344(After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose))
- Double-Blind Period: Number of Participant With Anti-Drug Antibodies (ADAs) Against SAR441344(From first dose of study drug (Day 1) up to 12 weeks (DB TE period))
- Time to Maximum Plasma Concentration (Tmax) of SAR441344(After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose))
研究者
研究点 (74)
Loading locations...
相似试验
已完成
2 期
Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren's Syndrome (pSjS)Sjogren's SyndromeSjögren's SyndromeNCT04572841Sanofi84
进行中（未招募）
2 期
Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus ErythematosusSystemic Lupus ErythematosusNCT05039840Sanofi109
已完成
3 期
Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)Non-relapsing Secondary Progressive Multiple SclerosisNCT04411641Sanofi1,131
已完成
3 期
Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)Primary Progressive Multiple SclerosisNCT04458051Sanofi767
已完成
1 期
A Study to Test if SAR443809 is Tolerated and Safe When Taken as a Single Dose in Healthy AdultsParoxysmal Nocturnal HemoglobinuriaNCT06326814Sanofi54