5 Clinical Studies in the course of Evaluation of Treatment for MS

March 9 – March 15 Multiple sclerosis (MS) Conscious Week for 2025 and falls within the National Moon of Education and awareness. This initiative of education and awareness was set up in 2003 and is the MS Focus brain: the foundation of multiple sclerosis and affiliated groups.¹

Multiple sclerosis is a chronic, central condition of the nervous system, which many consider to be immune mediated, mainly affecting the brain, spinal cord and optical nerves and causing permanent lesions of protective covering of nerves.^2-5 The exact cause of this progressive disease remains a mystery and there is no cure; People are affected at different levels.

Therapies that change diseases include oral, self-impaired and infused drugs, and FDA has approved more than 20.⁶ Also, there are 28 clinical studies in progress in the course of investigating BG00012, Cladribina, Fenebrutinib, Fingolimod, Ocreizumab, ofumumab, Ozanimod, Piginterferon Beta-1A, Tolebrutinib and Ublituximab, according to a search for active studies that investigate treatments to MS MS on MS Clinicrial.gov in March.

To find out about 5 of these attempts, please read further.

Tolebrutinib (NCT04742400)⁷

This inhibitor of the Kinase Tyrosine Buron (BTK) is investigated in a phase 2 study for its ability to improve the brain lesions related to chronically inflamed white mats in adult patients in anti-CD20 therapy. The main objective is the effectiveness of the tolebrutinib 60 mg/day at 48 weeks, measured by the disappearance of the paramagnetic lesions of the rim. Secondary goals are the safety and tolerability of tolebrutinib 60 mg/day at 96 weeks, safety and tolerability tolebrutinib 60 mg/day at 48 weeks, plus 96 weeks at 120 mg/day and repair of white matter lesions, as is the modulated inflammation on the edge of the lesion. The long -term extension and tracking are optional. The estimated date of completion is December 31, 2025.

Fingolimod (NCT01892722)⁸

In this study of phase 3, the safety and efficacy of the daily administration of the sphingosine receptor moderator is compared to interferon β-1A in pediatric patients between the ages of 10 and 17. There is a 2-year-old double basic phase, randomized, multicentric, active controlled and an expansion phase of 5 years. In order to be included, all patients had to have an official diagnosis of MS and at least 1 ms recurrence in the last year or 2 recurrences over the past 2 years, plus evidence of lesions that improve the MRI gadolini by 6 months. Fingolimod is generally administered orally by weight-based dosing at 0.5 mg for patients weighing more than 40 kg and 0.25 mg for patients with a weight of 40 kg or less and interferon β-1A is administered intramuscularly. The estimated date of completion is February 26, 2030.

Ocreizumab (NCT04377555)⁹

Within this phase 4, the analysis with open, prospective label, with a single arm, multicentric, self-identified self-identified or Afro-American and Hispanic/Latin patients have been registered, who were either naive treatment or changing treatment after the previous therapy of the disease, or the dximer, smoke dimethyl. Ocrelizumab, a monoclonal antibody, is administered by intravenous injection at 600 mg very 24 weeks, following a dose of two 300 mg infusions at 14 days away. Participants are followed for 1 year and can choose to enter the one -year expansion assessment. A replacement of the cerebrospinal fluid includes a 2 -year tracking and 2 additional doses of 600 mg Ocreizumab at weeks 48 and 72. The estimated date of completion is December 29, 2025.

UBLITUXIMAB (NCT04130997)¹⁰

Another monoclonal antibody, Ublituximab is evaluated for long -term safety and efficacy in adult patients who have a recidivant MS. This phase 3 study is an analysis of expanding the open label of patients who have completed 96 weeks of treatment in Ultimate Studies (NCT03277261) or Ultimate II (NCT0327248). Participants must agree to use medical acceptable contraception up to 20 weeks after the final dose of the study drug. The treatment is administered by an initial infusion of 4 hours of 150 mg on day 1 and a 450 mg infusion of 450 mg on day 15. The infusions to be administered for 1 hour every 24 weeks at 450 mg and will continue from week 24 to 312. The estimated date of completion is February 1, 2030.

Fenebrutinib (NCT0454449)¹¹

In the Fentrepid study of phase 3, the efficacy and safety of the second BTK inhibitor in this list, oral fenbrutinib, are evaluated among adult patients between the ages of 18 and 65, except for Germany and Italy, where participants are between 46 and 65 years old. In the experimental arm, the participants are randomized to receive the study medicine or a placebo to match the intravenous ocreizumab, and in the comparative arm, they are randomized to receive ocreizumab or a placebo to match oral phebrutinib. The main result of the interest is the time for the onset of the evolution of the confirmed disability of 12 weeks (CDP) on a minimum of 120 weeks, and the secondary interest results include the time until the debut of the 24-week compound CDP and the percentage modification of the total brain volume through the MRI. The estimated date of completion is December 18, 2026.

reference

1 .. the month of education and national awareness of the lady. The foundation of multiple sclerosis. Accessed March 14, 2025. https://msfocus.org/get-involved/ms-waseness-month

2. Multiple sclerosis. Johns Hopkins Medicine. Accessed March 14, 2025. https://www.hopkinsmedicine.org/health/conditions-and-diseases/multiple-scleroza-ms

3. The personnel of the Mayo clinic. Multiple sclerosis. Mayo clinic. Accessed March 14, 2025. https://www.mayocinic.org/diseases-conditions/multiple-sclerosis/symptoms-causes/syc-20350269

4. Multiple sclerosis. Cleveland clinic. Updated January 25, 2024. Accepted on March 14, 2025. https://my.clvelandclinic.org/health/diseases/17248-multiple-sclerosis

5. Multiple sclerosis. National Institute of Neurological Disorders and stroke. Updated on January 31, 2025. Accessed on March 14, 2025. https://www.ninds.nih.gov/health-information/disorders/multiple-sclerosis

6.. National Society of Multiple Sclerosis. Accessed March 14, 2025. https://www.nationalmsocity.org/managing-ms/treating-ms/discify-modify-therapies/off-label-use

7. Tolebrutinib, an inhibitor of brain penetrant kinase, for modulating chronically inflamed white material lesions in multiple sclerosis. Clinicaltrials.gov. Updated on August 13, 2024. Accessed on March 14, 2025. https://clinicaltrials.gov/study/NCT04742400

8. Fingolimod safety and effectiveness in pediatric patients with multiple sclerosis. Clinicaltrials.gov. Updated on February 11, 2025. Accessed on March 14, 2025. https://clinicaltrials.gov/study/NCT01892722

9. Prospective study for evaluating the activity of the disease and biomarker in minority participants with multiple recurrence sclerosis (RMS) after initiation and during treatment with Ocreizumab. Clinicaltrials.gov. Updated January 24, 2025. Accepted on March 14, 2025. https://clinicaltrials.gov/study/NCT04377555

10. An extension study of ublituXimab in multiple recurrence sclerosis participants. Clinicaltrials.gov. Updated February 28, 2025. Accepted on March 14, 2025. https://clinicaltrials.gov/study/NCT04130997

11. Study to evaluate the effectiveness and safety of Fenebratinib compared to Ocreizumab in adult participants with primary progressive sclerosis (Fentrepid). Clinicaltrials.gov. Updated January 27, 2025. Accepted on March 14, 2025.