The TAF-MS study

Phase 1

Recruiting

• Conditions: Multiple sclerosis; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2023-503814-62-00
• Lead Sponsor: Helse Bergen HF

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-11
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Age = 18 to = 60 years, both male and female patients, 2. Diagnosis of RRMS using revised McDonald criteria of clinically definite MS.1, 3. Currently treated with natalizumab, 4. Demonstrated shedding of EBV in salvia (Shedding is defined as at least one salvia sample with >5.8 virus copies/µL cut-off)

Exclusion Criteria

1.Known hypersensitivity or other serious adverse reaction to the active agent or other component of the study medication., 4. History of pancreatitis, 5. Prior or current disorders influencing the patient’s ability to give an informed consent or to comply with treatment and follow-up of the protocol, 6. Current users of medications that could interact with the study medication (listed in paragraph 5.6), 7. Patients who previously have been treated with hematopoietic stem cell transplantation (HSCT), 8. WBC < 1.5 x 109 /L if not caused by a reversible effect of documented ongoing medication. If WBC < 1.5 x 109 /L is caused by a reversible effect of documented ongoing medication the WBC count must be > 1,5 x 109 /L before start of study treatment., 9. Platelet (thrombocyte) count < 100 x 109 /L, Creatinin clearance < 15 ml/min, 10. ALAT more than 2 times the upper normal reference limit (ULN), 11. Serum creatinine > 200 µmol/L, 12. Serum bilirubin > 2 times the ULN, 13. Any other disease that can influence the patient safety and compliance, or the evaluation of outcome, 14. Currently enrolled in other trials of an investigational drug, or less than 30 days since ending another investigational drug., 15. Contraindications to undergo MRI such as a history of claustrophobia, inability to lie flat for approximately one hour, or metal implants (metal pins or plates, extensive non-removable dental work, cerebral aneurysm clips, pacemaker) as assessed by a standardized screening form, 2. Women who are pregnant, as verified by a serum pregnancy test at screening and during follow-up, or lactating, 3. Any ongoing infection with HIV, chronic active hepatitis, hepatitis C, or hepatitis B surface antigen positivity

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the study is to determine the safety of TAF as an add-on therapy to natalizumab.;Secondary Objective: Determine the effect of TAF on Epstein-Barr virus activity in patients with RRMS;Primary end point(s): Total number of SAEs from baseline to 24 weeks after start of study treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Change in IgG antibodies to EBNA1 and other EBV antigens from baseline to 2, 8 and 24 weeks after start of study treatment.;Secondary end point(s):Change in EBV viral load in saliva from baseline to 2, 8 and 24 weeks after start of study treatment.;Secondary end point(s):Key secondary endpoints Change in EBV shedding in saliva