2025-522140-40-00招募中2 期
TARGET-EBV in MS: A prospective randomized controlled parallel group phase 2b double blinded study to investigate if targeting Epstein Barr Virus with Tenofovir Alafenamide Fumarate compared to placebo as add-on treatment to anti-CD20 therapy reduces neuronal damage in multiple sclerosis
Oslo University Hospital HF3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Change in mean cerebrospinal fluid (CSF) Neurofilament light chain level (NfL) between the treatment groups from baseline (week 0) to End of Study (EOS), (week 52).
研究概览
简要总结
This study will test the hypothesis that TAF is superior to placebo as add-on to anti-CD20 therapy for the treatment of neuronal damage in MS.
研究设计
- 分配方式
- Randomized
- 主要目的
- Cinical study
- 盲法
- Double (Carer, Analyst, Subject, Investigator, Monitor)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years (inclusive) at the time of signing the informed consent.
- •Creatinine clearance > 15 ml/min
- •Serum bilirubin < 2 times the ULN
- •Negative tests for HIV, chronic active hepatitis B and hepatitis C
- •Treated with the anti-CD20 monoclonal antibody (CD20 mAbs) rituximab for at least 24 months prior to inclusion
- •Highly effective contraceptive use by women
- •Willingness and ability to participate in all study procedures, including lumbar puncture and air travel to Turku, Finland for MRI and PET imaging at inclusion and end of study
- •Diagnosis of MS (regardless of subtype) according to the revised McDonald criteria
- •EDSS 2-6.5 (included)
- •A previous cerebral MRI with T2 lesion volume at least 15.00 cm3
- •EBV-antibodies positive in blood sample
- •WBC > 1.5 x 109/L
- •Platelet (thrombocyte) counts > 50 x 109/L
- •ALAT less than 2 times the upper normal reference limit (ULN)
- •Serum creatinine < 200 µmol/L
排除标准
- •History of hypersensitivity or other serious adverse reactions the study medication or the PET tracer
- •Women who are pregnant, as verified by a serum pregnancy test, or lactating.
- •History of pancreatitis
- •Current users of medications that could interact with the study medication or the PET tracer, for details see Section 6.9 in the protocol
- •Patients who previously have been treated with hematopoietic stem cell transplantation (HSCT)
- •Any other condition that can influence the patient’s safety and compliance, or the evaluation of outcome
- •Currently enrolled in other trials of an investigational drug, or less than 30 days since the last treatment with another investigational drug
- •Exposure to more than 10 mSv doses of experimental ionizing radiation, in addition to that obtained from natural sources, in the past 12 months, equally to one CT scan during the past 12 months.
结局指标
主要结局
Change in mean cerebrospinal fluid (CSF) Neurofilament light chain level (NfL) between the treatment groups from baseline (week 0) to End of Study (EOS), (week 52).
Change in mean cerebrospinal fluid (CSF) Neurofilament light chain level (NfL) between the treatment groups from baseline (week 0) to End of Study (EOS), (week 52).
次要结局
- Difference in TSPO binding on PET between the treatment groups from baseline (week 0) to EOS (week 52).
- Change in patient reported outcomes of fatigue from baseline (week 0) to EOS (week 52).
- Difference in number of PRLs in the treatment groups from baseline (week 0) to EOS (week 52).
- Total number of AEs, SAEs and SUSARs
- Treatment tolerability
研究者
Gro Owren Nygaard
Scientific
Oslo University Hospital HF
研究点 (3)
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