2025-522140-40-00Not yet recruitingPhase 2
TARGET-EBV in MS: Targeting Epstein Barr Virus with Tenofovir Alafenamide Fumarate in multiple sclerosis
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 61 (estimated)
- First submitted
- 30 Apr 2025
- Start date
- 20 Aug 2026
- Lead sponsor
- Oslo University Hospital HF
- Diseases
- Multiple sclerosis
- EU CT number
- 2025-522140-40-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 61
- 6 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Lab values
- Women who are pregnant, as verified by a serum pregnancy test, or lactating.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Varsinais-Suomen hyvinvointialue | Turku | Finland | Not yet recruiting |
| Haukeland Universitetssykehus | Bergen | Norway | Not yet recruiting |
| Vestre Viken HF | Drammen | Norway | Not yet recruiting |
| Akershus University Hospital | Lørenskog | Norway | Not yet recruiting |
| Oslo University Hospital HF | Oslo | Norway | Not yet recruiting |
| Stavanger Univ. Hosp.-Rogaland Hosp. | Stavanger | Norway | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.