2024-519304-28-00招募中3 期
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.
Sanofi-Aventis Recherche & Developpement17 个研究点 分布在 3 个国家目标入组 67 人开始时间: 2026年4月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 67
- 试验地点
- 17
- 主要终点
- Area under the curve over the interval W20 to W24 (part A) - until week 24
研究概览
简要总结
To determine the non-inferiority of frexalimab SC administration compared to frexalimab IV administration as measured by pharmacokinetic parameters (part A)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Group A (RMS) - The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.
- •Group B (nrSPMS) - The participant must have an EDSS score between 3.0 and 6.5 points, inclusive, at the first visit (Screening Visit).
- •Participants from Group A and Group B are eligible to be included in the study only if all of the following criteria also apply: - Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Group A (RMS) - The participant must have been diagnosed with RMS in accordance with the 2017 revised McDonald criteria.
- •Group A (RMS) - The participant must have an Expanded Disability Status Scale (EDSS) score of ≤5.5 at the first visit (Screening Visit).
- •Group A (RMS) - 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.
- •Group B (nrSPMS) - The participant must be 18 to 60 years of age, inclusive, at the time of signing the informed consent.
- •Group B (nrSPMS) - The participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in
- •Group B (nrSPMS) - The participant must have documented evidence of disability progression observed during the 12 months before screening.
- •Group B (nrSPMS) - The participant must have an absence of clinical relapses for at least 24 months.
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.
研究组 & 干预措施
Frexalimab
Test
干预措施: Frexalimab (Drug)
结局指标
主要结局
Area under the curve over the interval W20 to W24 (part A) - until week 24
Area under the curve over the interval W20 to W24 (part A) - until week 24
Trough concentration at steady state (part A) - until week 24.
Trough concentration at steady state (part A) - until week 24.
次要结局
- Frexalimab plasma concentrations over time (part A) - until week 24
- Pharmacokinetic parameters: Cmax (part A) - until week 24
- Pharmacokinetic parameters: Tmax (part A) - until week 24
- Adverse events, SAEs, AEs leading to permanent study intervention discontinuation, AESIs, and PCSAs in laboratory tests, and vital signs during the study period - until week 96.
- Incidence of ADAs over time (part A) - until week 96
- Total number of Gd-enhancing T1 lesions at W12 and W24 (part A).
- 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.
- 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.
研究者
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Recherche & Developpement
研究点 (17)
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