Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis
- Conditions
- Health Condition 1: G35- Multiple sclerosis
- Registration Number
- CTRI/2021/11/038171
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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. Sjögren’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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method