NCT04926818Active, not recruitingPhase 3
Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis
A 2-year Randomized, 3-arm, Double-blind, Non-inferiority Study Comparing the Efficacy and Safety of Ofatumumab and Siponimod Versus Fingolimod in Pediatric Patients With Multiple Sclerosis Followed by an Open-label Extension
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 129 (actual)
- First submitted
- 14 Jun 2021
- Start date
- 5 Oct 2021
- Primary completion date
- 25 Mar 2026
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Multiple sclerosis
- NCT number
- NCT04926818
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 129
- From 5 Oct 2021 to the primary completion date, 25 Mar 2026
- 49 sites in 25 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participants with an active, chronic disease of the immune system other than MS
- Participants with severe cardiac disease or significant findings on the screening ECG.
- Participants with severe renal insufficiency
Other
- Participants with progressive MS
- Participants meeting the definition of ADEM
Who the study is looking for
- Between 10 to \<18 years of age (i.e., have not yet had their 18th birthday) at randomization
- Diagnosis of multiple sclerosis
- EDSS score of 0 to 5.5, inclusive
- At least one MS relapse/attack during the previous year or two MS relapses in the previous two years prior or evidence of one or more new T2 lesions within 12 months
Age in the registry: 10 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (49)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.