TENOFOVIR ALAFENAMIDE for Multiple sclerosis

Stratification factors

• site

Inclusion criteria

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

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

Primary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Mean CSF NfL level measured at baseline (week 0) and at End of Study (week 52); comparison of change from baseline between treatment groups."}

Secondary endpoints

• {"endpoint_text":"- Difference in TSPO binding on PET between the treatment groups from baseline (week 0) to EOS (week 52).","definition_or_measurement_approach":"TSPO PET binding measured at baseline and week 52; comparison of change between treatment groups."}
• {"endpoint_text":"- Change in patient reported outcomes of fatigue from baseline (week 0) to EOS (week 52).","definition_or_measurement_approach":"Patient-reported fatigue outcome measures collected at baseline and week 52; comparison of change between groups."}
• {"endpoint_text":"- Difference in number of PRLs in the treatment groups from baseline (week 0) to EOS (week 52).","definition_or_measurement_approach":"Number of Paramagnetic Rim Lesions (PRLs) assessed by MRI at baseline and week 52; comparison of change between groups."}
• {"endpoint_text":"- Total number of AEs, SAEs and SUSARs","definition_or_measurement_approach":"Safety monitoring: count and comparison of adverse events (AEs), serious adverse events (SAEs), and SUSARs across treatment arms during the study."}
• {"endpoint_text":"- Treatment tolerability","definition_or_measurement_approach":"Assessment of tolerability via collected safety/tolerability data (e.g., discontinuations, reported tolerability measures) over the treatment period."}

Norway

Earliest CTIS Part Ii Submission Date

28-07-2025

Latest Decision Or Authorization Date

10-04-2026

Processing Time Days

256

Number Of Sites

5

Number Of Participants

60

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway