A Randomized, Phase 3, Open-label Study to Investigate Pharmacokinetics, Safety, and Efficacy of Subcutaneous Compared to Intravenous Frexalimab in Adult Participants With Multiple Sclerosis
概览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 160
- 试验地点
- 18
- 主要终点
- Area under the curve over the interval W20 to W24(part A)
概览
简要总结
This is a randomized, open-label, parallel, Phase 3 study with 2-arms for treatment.
The purpose of this study is to evaluate SC administration of frexalimab every 4 weeks (q4w) compared to IV administration of frexalimab q4w in male and female participants with RMS and nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with MS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria.
Study details include:
The study intervention duration will be 48 weeks (12 months) for Parts A and B combined. Optional Part C will last until the initiation of a long term safety study for Frexalimab.The follow up duration after the end of study intervention (in case of discontinuation) will be 6 months.
The number of scheduled visits (Parts A and B) will be 17 or 11 for participants receiving frexalimab SC or IV, respectively, with an on-site visit frequency of every month between Week 4 and Week 24 in Part A, then every 1 to 3 months in Part B, then every 6 months in Part C. Participants discontinuing treatment before the End of Study will have an additional 3 follow-up visits.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant must qualify for inclusion per either Group A or B criteria as detailed below, meeting all the inclusion criteria of the applicable group:
- •Group A (RMS)
- •The 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 in accordance with the 2017 revised McDonald criteria.
- •The participant must have an Expanded Disability Status Scale (EDSS) score of ≤5.5 at the first visit (Screening Visit).
- •The participant must have at least 1 of the following prior to screening:
- •1 documented relapse within the previous year OR
- •2 documented relapses within the previous 2 years, OR
- •1 documented Gd enhancing lesion on an MRI scan within the previous year. Group B (nrSPMS)
- •Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria
排除标准
- •The participant has been diagnosed with primary progressive MS according to the 2017 revision of the McDonald diagnostic criteria.
- •The participant has a history of infection or may be at risk for infection:
- •Fever within 28 days of the Screening Visit
- •Presence of psychiatric disturbance or substance abuse
- •History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphospholipid syndrome and any participants requiring antithrombotic treatment.
- •Current hypogammaglobulinemia defined by Ig levels (IgG and/or IgM) below the LLN at screening or a history of primary hypogammaglobulinemia.
- •A history or presence of disease that can mimic MS symptoms.
- •The participant has a contraindication for MRI.
- •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
Frexalimab SC
Frexalimab SC (home self-administration via on-body delivery system(OBDS), is allowed from the beginning of Part B after appropriate training and participant and Investigator agreement)
干预措施: Frexalimab (Drug)
Frexalimab SC
Frexalimab SC (home self-administration via on-body delivery system(OBDS), is allowed from the beginning of Part B after appropriate training and participant and Investigator agreement)
干预措施: MRI contrast-enhancing preparations (Drug)
Frexalimab IV
Frexalimab IV
干预措施: Frexalimab (Drug)
Frexalimab IV
Frexalimab IV
干预措施: MRI contrast-enhancing preparations (Drug)
结局指标
主要结局
Area under the curve over the interval W20 to W24(part A)
时间窗: Until Week 24
AUCW20-W24
Trough concentration at steady state(part A)
时间窗: Until Week 24
Ctrough,SS
次要结局
- Total number of Gd-enhancing T1 lesions at W12 and W24(part A)(At Week 12 and Week 24)
- Time to onset of confirmed disability worsening (CDW)/ confirmed disability progression(CDP) confirmed over 3 months(Until week 96)
- Medical device AEs, ADEs, SAEs, SADEs and device deficiencies throughout the study(Until week 96)
- Pharmacokinetic parameters: Tmax(part A)(Until Week 24)
- Incidence of ADAs over time(part A)(Until Week 96)
- Percentage of participants that prefer SC administration over IV administration assessed by Items 13 and 14 of the PESQ at Week 48 completed by participants that switched from IV to SC in Part B.(From week 24 to week 48)
- Total number of GdE T1 lesions at W48(part B)(At week 48)
- Total number of GdE T1 lesions at W96 and yearly thereafter.(part C)(At week 96 and yearly thereafter)
- Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation, AESIs, and potentially clinically significant abnormality(PCSA) in laboratory tests, and vital signs during the study period(Until Week 96)
- Frexalimab plasma concentrations over time(part A)(Until Week 24)
- Pharmacokinetic parameters: Cmax(part A)(Until Week 24)