MS Multiple Sclerosis
Conditions
Interventions
Ofatumumab (OMB157G) 20 mg sc injections once every 4 (q4) weeks (following
initial loading regimen of three 20 mg sc doses/week in first 14 days) +
teriflunomide-matching placebo capsules orally on
Ofatumumab
Relapses
Teriflunomide
Sponsors
Novartis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Male or female patients aged 18 to 55 years (inclusive) at Screening * Relapsing MS: relapsing-remitting course (RRMS), or secondary progressive (SPMS) course with disease activity * Disability status at Screening with an EDSS score of 0 to 5.5 (inclusive) * Documentation of at least: 1 relapse during the previous 1 year OR 2 relapses during the previous 2 years prior to Screening OR a positive Gd-enhancing MRI scan during the year prior to randomization * Neurologically stable within 1 month prior to randomization
Exclusion criteria
Exclusion criteria: * Patients with primary progressive MS or SPMS without disease activity * Patients meeting criteria for neuromyelitis optica * Disease duration of more than 10 years in patients with an EDSS score of 2 or less * Women of child-bearing potential unless using highly effective methods of contraception during study drug dosing and for 12 months post-dosing * Sexually active males unless they agree to use condom during intercourse while on study drug * Patients at risk of developing or having reactivation of hepatitis: positive results at Screening for serology markers for hepatitis A, B, C and E (HA, HB, HC, and HE) indicating acute or chronic infection * Patients at risk of developing or having reactivation of syphilis or tuberculosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Annual Relapse Rate (ARR) * Time to disability worsening as measured by 3-month confirmed worsening (3mCDW) on Expanded Disability Status Scale (EDSS) * Time to disability worsening as measured by 6-month confirmed worsening (6mCDW) on EDSS * Time to disability improvement as measured by 6-month confirmed improvement (6mCDI) on EDSS * Number of T1 gadolinium (Gd)-enhancing lesions per Magnetic Resonance Image (MRI) scan * Number of new or enlarging T2 lesions on MRI per year (annualized T2 lesion rate) * Neurofilament light chain (NfL) concentration in serum * Rate of brain volume loss (BVL) based on assessments of percentage brain volume change from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| * Time to first relapse * Annualized relapse rates > 8 weeks after the onset of treatment * Risk of a 3mCDW > 8 weeks after the onset of treatment * Risk of a 6mCDW > 8 weeks after the onset of treatment * Time to a 6-month confirmed cognitive decline (6mCCD), defined as a 4-point worsening on Symbol Digit Modalities Test (SDMT) * Time to 6mCDW or 6mCCD, whichever is reached first * Change in cognitive performance relative to baseline as measured by the SDMT * Time to 6-month confirmed worsening of at least 20% in the timed 25 foot walk test (T25FW) * Time to 6-month confirmed worsening of at least 20% in the 9-hole peg test (9HPT) * Time to 6mCDI sustained until end of study as measured by EDSS * Number of new or enlarging T2 lesions between Month 12 and End of Study (EOS) * Change in T2 lesion volume relative to baseline * Proportion of patients with no evidence of disease activity (NEDA) at year 1 and 2 * Physical and psychological impact of MS disease as measured by the Multiple Sclerosis Impact Scale (MSIS-29) In the subgroup of newly diagnosed, treatment-naïve patients, evaluate if: * High NfL (above median) concentration at baseline is predictive of higher disease activity post baseline * Patients with a high NfL (above median) concentration at baseline benefit from a stronger relative treatment effect of ofatumumab vs teriflunomide * The safety profile of ofatumumab vs terifluomide is comparable in patients with high NfL (above median) concentration at baseline * To evaluate the safety and tolerability of ofatumumab compared to teriflunomide * To evaluate the pharmacokinetic (PK) of ofatumumab | — |
Countries
Argentina, Australia, Belgium, Bulgaria, Canada, Chile, Croatia, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, India, Israel, Italy, Korea (the Democratic Peoples Republic of), Korea (the Republic of), Kuwait, Mexico, Netherlands, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, United States of America
Outcome results
None listed