Clinical Trials List
Protocol NumberCBAF312D2301
NCT Number(ClinicalTrials.gov Identfier)NCT04926818
Active
2021-12-01 - 2029-08-30
Phase III
Recruiting3
ICD-10G35
Multiple sclerosis
ICD-9340
Multiple sclerosis
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
-
Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王麗君 無
- WEN-CHIN WENG 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Multiple Sclerosis (MS)
Objectives
The objective and theoretical basis of this trial is to demonstrate, in a well-controlled trial with minimal risk of bias, the efficacy and safety/tolerability of ofatumumab and siponimod compared to fingolimod in pediatric patients (10 years and older, under 18 years of age) with multiple sclerosis (MS).
These data will support the registration of ofatumumab and siponimod as treatments for MS in children/adolescents aged 10 years and older, under 18 years of age.
Test Drug
預充填式注射劑
Active Ingredient
Ofatumumab (OMB157)
Siponimod (BAF312)
Siponimod (BAF312)
Dosage Form
230
Dosage
0.4ml
mg
mg
Endpoints
Treatment efficacy assessment:
• MS relapse
• EDSS
• MRI
• Neurofilament light chain (NfL)
• Symbolic digit module test (SDMT)
• B cells
Pharmacokinetic assessment:
• Blood tests
Main safety assessment:
• Physical examination (including skin)
• Height and weight
• Ophthalmological examination, including optical coherence tomography (OCT)
• Pulmonary function test (PFT)
• Vital signs
• Laboratory assessment
• Electrocardiogram (ECG)
• Columbia Suicide Severity Scale (C-SSRS)
• MS relapse
• EDSS
• MRI
• Neurofilament light chain (NfL)
• Symbolic digit module test (SDMT)
• B cells
Pharmacokinetic assessment:
• Blood tests
Main safety assessment:
• Physical examination (including skin)
• Height and weight
• Ophthalmological examination, including optical coherence tomography (OCT)
• Pulmonary function test (PFT)
• Vital signs
• Laboratory assessment
• Electrocardiogram (ECG)
• Columbia Suicide Severity Scale (C-SSRS)
Inclution Criteria
Inclusion Criteria:
Between 10 to <18 years of age (i.e., have not yet had their 18th birthday) at randomization
Diagnosis of multiple sclerosis
EDSS score of 0 to 5.5, inclusive
At least one MS relapse/attack during the previous year or two MS relapses in the previous two years prior or evidence of one or more new T2 lesions within 12 months
Between 10 to <18 years of age (i.e., have not yet had their 18th birthday) at randomization
Diagnosis of multiple sclerosis
EDSS score of 0 to 5.5, inclusive
At least one MS relapse/attack during the previous year or two MS relapses in the previous two years prior or evidence of one or more new T2 lesions within 12 months
Exclusion Criteria
Exclusion Criteria:
Participants with progressive MS
Participants with an active, chronic disease of the immune system other than MS
Participants meeting the definition of ADEM
Participants with severe cardiac disease or significant findings on the screening ECG.
Participants with severe renal insufficiency
Participants with progressive MS
Participants with an active, chronic disease of the immune system other than MS
Participants meeting the definition of ADEM
Participants with severe cardiac disease or significant findings on the screening ECG.
Participants with severe renal insufficiency
The Estimated Number of Participants
-
Taiwan
4 participants
-
Global
120 participants
