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

INTERVENTION: Intervention1: OMB157: Auto injector ‐20 mg weekly for 1 month. Followed by monthly thereafter for 3 years Intervention2: (BAF312) as film‐coated tablet: 1 mg or 2 mg tablet administered once daily for 3 years. Control Intervention1: FTY720: 0.5 mg capsules administered once daily for 3 years. Control Intervention2: Placebo: Auto injector 20mg weekly for 1 month. Followed by monthly thereafter for 2 years Control Intervention3: Placebo: weekly for 1 month. Followed by monthly thereafter for 2 years CONDITION: Health Condition 1: G35‐ Multiple sclerosis PRIMARY OUTCOME: 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‐yearsTimepoint: Baseline,day 1, day 56, day 140, day 350 ,day 728 SECONDARY OUTCOME: To demonstrate the superiority of ofatumumab and/ or siponimod as compared to historical interferon β‐1a data, assessed by annualized relapse rate (ARR)Timepoint: Month 12 To evaluate immunogenicity (ofatumumab)Timepoint: Proportion of participants with anti‐ofatumumab antibodies To evaluate the effects of ofatumumab and/or siponimod versus fingolimod on neurofilament light chain (NfL) concentrationsTimepoint: Neurofilament light chain (NfL) concentration in serum To evaluate the effects of ofatumumab and/or siponimod versus fingolimod on the number of new or newly enlarging T2 lesionsTimepoint: Number of new or newly enlarging T2 lesions on MRI per year (annualized T2 lesion rate) To evaluate the pharmacokinetic (PK) properties of ofatumumab and siponimod (and its metabolite M17) in pediatric MS patientsTimepoint: Ofatumumab and siponimod and (metabolite M17) plasma concentrations To evaluate the safety and tolerability of ofatumumab and siponimodTimepoint: Adverse events, Columbia Suicide Severity Rating Scale (C‐SSRS), ECG, laboratory and ophthalmological data, pulmonary function tests and vital signs INCLUSION CRITERIA: 1. Signed informed consent/assent must be obtained prior to participation in the study 2. Between 10 to <18 years of age (i.e., have not yet had their 18th birthday) at randomization 3. A diagnosis of MS as defined by the consensus definition for pediatric MS 4. Expanded Disability Status Scale (EDSS) score of 0 to 5.5 (inclusive) at Screening 5. 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