Health Condition 1: G35- Multiple sclerosis
Conditions
Interventions
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 f
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed informed consent/assent must be obtained prior to participation in the study 2. Between 10 to 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
Exclusion criteria
Exclusion criteria: 1. Participants with progressive MS 2. Participants meeting the definition of ADEM 3. Participants meeting criteria for neuromyelitis optica or tested positive for aquaporin 4 (AQP4) at Screening 4. Participants tested positive for anti-MOG at Screening 5. Participants with widespread and symmetric white matter alterations in the Screening MRI suggestive of other demyelinating disorders (e.g. metabolic disorders, mitochondrial disorders) 6. Participants with an active, chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g. Sjögrenâ??s disease, systemic lupus erythematosus) or with a known immunodeficiency syndrome (Acquired immunodeficiency syndrome (AIDS), hereditary immunodeficiency , drug-induced immunodeficiency ) or tested positive for HIV at Screening 7. Participants with neurological symptoms consistent with progressive multifocal leukoencephalopathy (PML) or confirmed PML 8. Participants diagnosed with macular edema during the Screening period 9. Participants with severe active systemic bacterial, viral or fungal infections, including tuberculosis 10.Participants with any severe cardiac disease or significant findings on the screening ECG 11. Any history of malignancy of any organ system 12. Participants treated with any of the listed medication as Exclusion Medication within defined timespan 13. Positive results of screening period testing for serological markers for hepatitis A, B, C and E indicating acute or chronic infection 14. Any other clinically significant laboratory assessment as determined by the Investigator (e.g. significant anemia, neutropenia, thrombocytopenia, signs of impaired bone marrow function 15. Have received any live or live-attenuated vaccines (including for varicella-zoster virus or measles) within 4 weeks prior to first study drug administration 16. Participants without acceptable evidence of immunity to varicella-zoster virus, mumps, measles, rubella, diphtheria, tetanus and pertussis at Randomization 17. Participants with any other significant condition, as assessed by the investigator, which may preclude participant from participating in the study. 18. Pregnant or nursing (lactating) female participant refusal to test for CYP2C9
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 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 effects of ofatumumab and/or siponimod versus fingolimod on neurofilament light chain (NfL) concentrationsTimepoint: Neurofilament light chain (NfL) concentration in serum;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 immunogenicity (ofatumumab)Timepoint: Proportion of participants with anti-ofatumumab antibodies;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 | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Estonia, France, Germany, Guatemala, India, Israel, Italy, Latvia, Lithuania, Mexico, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States of America
Contacts
Public ContactMurugananthan K
Novartis Healthcare PVT LTD
Outcome results
None listed