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TARGET-EBV in MS: Targeting Epstein Barr Virus with Tenofovir Alafenamide Fumarate in multiple sclerosis
EU CTIS ID: 2025-522140-40-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age 18 to 70 years (inclusive) at the time of signing the informed consent.
- 10. Creatinine clearance > 15 ml/min
- 11. Serum bilirubin < 2 times the ULN
- 12. Negative tests for HIV, chronic active hepatitis B and hepatitis C
- 13. Treated with the anti-CD20 monoclonal antibody (CD20 mAbs) rituximab for at least 24 months prior to inclusion
- 14. Highly effective contraceptive use by women
You likely can't join if
- 1. History of hypersensitivity or other serious adverse reactions the study medication or the PET tracer
- 2. Women who are pregnant, as verified by a serum pregnancy test, or lactating.
- 3. History of pancreatitis
- 4. Current users of medications that could interact with the study medication or the PET tracer, for details see Section 6.9 in the protocol
- 5. Patients who previously have been treated with hematopoietic stem cell transplantation (HSCT)
- 6. Any other condition that can influence the patient’s safety and compliance, or the evaluation of outcome
See the full eligibility criteria
- 1. Age 18 to 70 years (inclusive) at the time of signing the informed consent.
- 10. Creatinine clearance > 15 ml/min
- 11. Serum bilirubin < 2 times the ULN
- 12. Negative tests for HIV, chronic active hepatitis B and hepatitis C
- 13. Treated with the anti-CD20 monoclonal antibody (CD20 mAbs) rituximab for at least 24 months prior to inclusion
- 14. Highly effective contraceptive use by women
- 15. 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
- 2. Diagnosis of MS (regardless of subtype) according to the revised McDonald criteria
- 3. EDSS 2-6.5 (included)
- 4. A previous cerebral MRI with T2 lesion volume at least 15.00 cm3
- 5. EBV-antibodies positive in blood sample
- 6. WBC > 1.5 x 109/L
- 7. Platelet (thrombocyte) counts > 50 x 109/L
- 8. ALAT less than 2 times the upper normal reference limit (ULN)
- 9. Serum creatinine < 200 µmol/L
- 1. History of hypersensitivity or other serious adverse reactions the study medication or the PET tracer
- 2. Women who are pregnant, as verified by a serum pregnancy test, or lactating.
- 3. History of pancreatitis
- 4. Current users of medications that could interact with the study medication or the PET tracer, for details see Section 6.9 in the protocol
- 5. Patients who previously have been treated with hematopoietic stem cell transplantation (HSCT)
- 6. Any other condition that can influence the patient’s safety and compliance, or the evaluation of outcome
- 7. Currently enrolled in other trials of an investigational drug, or less than 30 days since the last treatment with another investigational drug
- 8. 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.