Tests ofatumumab and siponimod against fingolimod in children with multiple sclerosis
Compares two drugs with fingolimod in children and teens with multiple sclerosis.
Plain-language title generated from the registry record
Registry title: Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis
Key facts
- Where
- Coimbra and Lisbon, PortugalSee the 2 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers aged 10 to under 18 with multiple sclerosis who have had recent relapses or new signs of disease activity on MRI.
- Age
- 10 to under 18 years (has not yet turned 18) at randomization.
- Sex
- All sexes can join.
- Disease stage
- Multiple sclerosis as defined for children, with an EDSS score of 0 to 5.5. At least one relapse in the past year, or two in the past two years, or new T2 lesions or Gd-enhancing T1 lesions on MRI within 12 months before randomization.
- Earlier treatment
- No live or live-attenuated vaccines within 4 weeks before the first study drug. Some medicines listed as exclusion medication are not allowed within set time periods. Evidence of immunity to varicella-zoster virus, mumps, measles, rubella, diphtheria, tetanus and pertussis is needed.
- Biomarker or test result
- Cannot join if homozygous for CYP2C9*3 or if refusing the CYP2C9 test. Cannot join if positive for AQP4 or anti-MOG, or HIV-positive.
Main reasons for not taking part
- Progressive multiple sclerosis
- ADEM, neuromyelitis optica, or positive for AQP4 or anti-MOG
- Another immune system disease, immune deficiency, or positive for HIV
- Pregnant or breastfeeding
- Severe infection, acute or chronic hepatitis, any cancer history, or severe heart disease
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which age group are you in?
- Which type of multiple sclerosis (MS) has your doctor told you that you have?
- Do you have another disease of the immune system, or a long-term infection such as hepatitis B, hepatitis C or HIV?
- Have you ever had cancer?
Where in Portugal
- Unidade Local de Saúde de Coimbra, E.P.E.Coimbra, PortugalNo longer taking part
- Unidade Local De Saude De Sao Jose E.P.E.Lisbon, PortugalNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorTrial details
- Who runs it
- Novartis Pharma AG
- Trial code
- EU 2024-511686-11-00
- Record updated
- 29 September 2026
- Original description
To demonstrate the non-inferiority of ofatumumab and/or siponimod as compared to fingolimod as assessed by annualized relapse rate (ARR) in the target pediatric MS participants treated for up to 2-yearsRead full original descriptionShow less
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
To demonstrate the non-inferiority of ofatumumab and/or siponimod as compared to fingolimod as assessed by annualized relapse rate (ARR) in the target pediatric MS participants treated for up to 2-years
Inclusion: Signed informed consent/assent must be obtained prior to participation in the study; Between 10 to <18 years of age (i.e., have not yet had their 18th birthday) at randomization; A diagnosis of MS as defined by the consensus definition for pediatric MS; Expanded Disability Status Scale (EDSS) score of 0 to 5.5 (inclusive) at Screening; At least one MS relapse/attack during the previous year or two MS relapses in the previous two years prior to screening or evidence of one or more new T2 lesions compared to prior MRI conducted within 12 months prior to randomization (including screening MRI) or one or more Gd-enhancing T1 lesions on MRI conducted within 12 months prior to randomization.
Exclusion: Participants with an active, chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g. Sjögren’s disease, systemic lupus erythematosus) or with a known immunodeficiency syndrome (acquired immunodeficiency syndrome (AIDS), hereditary immune deficiency, drug-induced immune deficiency) or tested positive for HIV at Screening; Have received any live or live-attenuated vaccines (including for varicella-zoster virus or measles) within 4 weeks prior to first study drug administration; Participants treated with any of the listed medication as Exclusion Medication within defined timespan; Participants with widespread and symmetric white matter alterations in the Screening MRI suggestive of other demyelinating disorders (e.g. metabolic disorders, mitochondrial disorders); Participants with any other significant condition, as assessed by the investigator, which may preclude participant from participating in the study; Participants with severe active systemic bacterial, viral or fungal infections, including tuberculosis. Treatment initiation should be delayed in participants with an active infection until the infection is resolved; Participants with any severe cardiac disease or significant findings during screening, or on the screening ECG; Positive results of screening period testing for serological markers for hepatitis A, B, C and E indicating acute or chronic infection; Any history of malignancy of any organ system; Any other clinically significant laboratory assessment as determined by the Investigator (e.g. significant anemia, neutropenia, thrombocytopenia, signs of impaired bone marrow function; Participants with progressive MS; Participants meeting the definition of ADEM • participants meeting criteria for neuromyelitis optica or tested positive for aquaporin 4 (AQP4) at Screening • participants tested positive for anti-MOG at Screening confirmed centrally; Homozygosity for CYP2C9*3, or refusal to test for CYP2C9; Participants with neurological symptoms consistent with progressive multifocal leukoencephalopathy PML or confirmed PML; Participants diagnosed with macular edema during the Screening period; Pregnant or nursing (breastfeeding) female participant; Participants without acceptable evidence of immunity to varicella-zoster virus, mumps, measles, rubella, diphtheria, tetanus and pertussis at Randomization.