Not yet taking people in FinlandPhase 2
Tests tenofovir alafenamide with anti-CD20 therapy in multiple sclerosis
Tests tenofovir alafenamide added to anti-CD20 treatment in adults with multiple sclerosis.
Key facts
- Who runs it
- Oslo University Hospital HF
- Where
- Turku, FinlandSee the siteAlso in 1 other country, 5 sites
- Trial code
- Registry title
- TARGET-EBV in MS: Targeting Epstein Barr Virus with Tenofovir Alafenamide Fumarate in multiple sclerosis
- Status
- Not yet recruiting
- Phase
- Phase 2
- People taking part
- 61 people, planned
- Started
- 20 Aug 2026
- Expected to end
- 31 Jan 2028
- Type of study
- Interventional
- Record updated
- 16 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with multiple sclerosis who have had rituximab for at least 24 months and test positive for EBV antibodies. It tests tenofovir alafenamide (TAF) against placebo.
- Age
- 18 to 70 years
- Sex
- All sexes can join.
- Disease stage
- Multiple sclerosis of any subtype (revised McDonald criteria), EDSS 2-6.5, and a past brain MRI with T2 lesion volume of at least 15.00 cm3.
- Earlier treatment
- Must have been treated with rituximab (an anti-CD20 antibody) for at least 24 months before joining. Must not have had a hematopoietic stem cell transplant.
- Biomarker or test result
- EBV antibodies positive in blood. Negative tests for HIV, chronic active hepatitis B and hepatitis C.
Main reasons for not taking part
- Serious reaction to the study medication or the PET tracer in the past
- Pregnant or breastfeeding women
- History of pancreatitis
- Taking medicines that could interact with the study medication or PET tracer
- In another drug trial, or less than 30 days since another investigational drug
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
- 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
- History of hypersensitivity or other serious adverse reactions the study medication or the PET tracer
- History of pancreatitis
- Any other condition that can influence the patient’s safety and compliance, or the evaluation of outcome
- Women who are pregnant, as verified by a serum pregnancy test, or lactating
Where in Finland
Also in 1 other country, 5 sites
- Varsinais-Suomen hyvinvointialueTurku, FinlandNot yet recruiting
About the trial
What the trial wants to find out
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Tests tenofovir alafenamide with anti-CD20 therapy in multiple sclerosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 16 October 2026