Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis

Trial details

Who runs it

Novartis Pharma AG

Trial code

EU 2024-511686-11-00

Record updated

2026. szeptember 29.

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.

EU CTIS 2024-511686-11-00