Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis (NEOS)
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- STATUS
- Recruiting
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- End date
- Jun 1, 2029
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- participants needed
- 180
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- sponsor
- Novartis Pharmaceuticals
Summary
Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis
Description
The study is divided into a Core Part and Extension Part. The Core Part is a 24-month, double-blind, triple dummy, randomized, 3-arm active-controlled in children/adolescent patients aged 10-17 years old with Multiple Sclerosis (MS). The Extension Part is 60-month (5 year) open label (except for first 12 weeks transition which will remain double-blind) treatment for patients who complete the Core Part of the study and meet all inclusion/exclusion criteria. The targeted enrollment is 180 participants with multiple sclerosis which will include at least 5 participants with body weight (BW) ≤40 kg and at least 5 participants with age 10 to 12 years in each of the ofatumumab and siponimod arms. There is a minimum 6 month follow up period for all participants (core and extension). Total duration of the study could be up to 7 years.
Details
| Condition | Multiple Sclerosis (MS) |
|---|---|
| Treatment | Ofatumumab, Fingolimod, Siponimod, Fingolimod placebo, Siponimod placebo, Ofatumumab placebo |
| Clinical Study Identifier | NCT04926818 |
| Sponsor | Novartis Pharmaceuticals |
| Last Modified on | 27 May 2022 |
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