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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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522140-40-00
Enrollment
60
Registered
2025-08-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple sclerosis

Brief summary

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).

Detailed description

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

Interventions

DRUGPlacebo capules
DRUGhard
DRUGTENOFOVIR ALAFENAMIDE

Sponsors

Oslo University Hospital HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026