TARGET-EBV in MS: Targeting Epstein Barr Virus with Tenofovir Alafenamide Fumarate in multiple sclerosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Oslo University Hospital HF

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10], Phenomena and Processes [G] - Immune system processes [G12], Diseases [C] - Virus Diseases [C02]

Decision date (initial)

2025-08-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

This trial is fully funded by the EBV-MS EU Horizon research project

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

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.

Secondary objectives 5

1. The first key secondary objective is to test if TSPO binding on PET is reduced after one year of treatment with TAF compared to placebo
2. The second key secondary objective is to test if patient reported outcomes of fatigue is reduced after one year of treatment with TAF compared to placebo
3. The third key secondary objective is to test if number of Paramagnetic Rim Lesions (PRLs) is reduced after one year of treatment with TAF compared to placebo
4. To test the safety of TAF as add-on treatment.
5. To test the tolerability of TAF as add-on treatment.

Conditions and MedDRA coding

multiple sclerosis

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 15

1. 1. Age 18 to 70 years (inclusive) at the time of signing the informed consent.
2. 2. Diagnosis of MS (regardless of subtype) according to the revised McDonald criteria
3. 3. EDSS 2-6.5 (included)
4. 4. A previous cerebral MRI with T2 lesion volume at least 15.00 cm3
5. 5. EBV-antibodies positive in blood sample
6. 6. WBC > 1.5 x 109/L
7. 7. Platelet (thrombocyte) counts > 50 x 109/L
8. 8. ALAT less than 2 times the upper normal reference limit (ULN)
9. 9. Serum creatinine < 200 µmol/L
10. 10. Creatinine clearance > 15 ml/min
11. 11. Serum bilirubin < 2 times the ULN
12. 12. Negative tests for HIV, chronic active hepatitis B and hepatitis C
13. 13. Treated with the anti-CD20 monoclonal antibody (CD20 mAbs) rituximab for at least 24 months prior to inclusion
14. 14. Highly effective contraceptive use by women
15. 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

Exclusion criteria 8

1. 1. History of hypersensitivity or other serious adverse reactions the study medication or the PET tracer
2. 2. Women who are pregnant, as verified by a serum pregnancy test, or lactating.
3. 3. History of pancreatitis
4. 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. 5. Patients who previously have been treated with hematopoietic stem cell transplantation (HSCT)
6. 6. Any other condition that can influence the patient’s safety and compliance, or the evaluation of outcome
7. 7. Currently enrolled in other trials of an investigational drug, or less than 30 days since the last treatment with another investigational drug
8. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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).

Secondary endpoints 5

1. Difference in TSPO binding on PET between the treatment groups from baseline (week 0) to EOS (week 52).
2. Change in patient reported outcomes of fatigue from baseline (week 0) to EOS (week 52).
3. Difference in number of PRLs in the treatment groups from baseline (week 0) to EOS (week 52).
4. Total number of AEs, SAEs and SUSARs
5. Treatment tolerability

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oslo University Hospital HF

Sponsor organisation

Oslo University Hospital HF

Address

Taarnbygget, Kirkeveien 166 Kirkeveien 166

City

Oslo

Postcode

0450

Country

Norway

Scientific contact point

Organisation

Oslo University Hospital HF

Contact name

Gro Owren Nygaard

Public contact point

Organisation

Oslo University Hospital HF

Contact name

Gro Owren Nygaard

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications