Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab

A 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223655

Enrollment

Registered

2017-09-14

Start date

2018-03-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing Multiple Sclerosis

Interventions

investigational material(s) Generic name etc : Ofatumumab INN of investigational material : - Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * Diagnosis of multiple sclerosis (MS) * Relapsing MS * At least 1 appearance of a new neurological abnormality or worsening of pre-existing neurological abnormality during the previous 2 years prior to Screening AND an MRI activity (Gd-enhanced T1 lesions or new or enlarging T2 lesions) in brain during the previous 1 year prior to randomization * EDSS score of 0 to 5.5

Exclusion criteria

Exclusion criteria: * Primary progressive MS or SPMS without disease activity *Patients with an active chronic disease of the immune system other than MS * Patients at risk of developing or having reactivation of hepatitis * Patients with active systemic infections or with neurological findings consistent with PML Other protocol defined inclusion/exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
efficacy Mean number of gadolinium enhanced T1 lesions across 4 MRI scans (ofatumumab vs placebo) [ Time Frame: Week 12, 16, 20 and 24 ] The number of gadolinium enhanced T1 lesions on MRI scans will be measured by the central MRI reading center.	—

Secondary

Measure	Time frame
efficacy Mean number of gadolinium enhanced T1 lesions across 4 MRI scans (Japan vs other countries) [ Time Frame: Week 12, 16, 20 and 24, 36, 48 and end of study up to Week 72 ] The number of gadolinium enhanced T1 lesions on MRI scans will be measured by the central MRI reading center. efficacy Number of new or enlarging T2 lesions on MRI scans compared to baseline [ Time Frame: Baseline, Week 12, 16, 20 and 24, 36, 48 and end of study up to Week 72 ] The number of new or enlarging T2 lesions on MRI scans compared to baseline will be measured by the central MRI reading center. efficacy Annualized relapse rate [ Time Frame: Week 24, 48 and end of study up to Week 72 ] Annualized relapse rate is the number of confirmed relapses in a year calculated based on cumulative number of relapses. efficacy B-cell count [ Time Frame: Baseline, Day 2, 5, 7, 14, Week 4, 12, 24, 28, 36, 48, 60 and 72 ] Blood samples will be collected at the scheduled visit. The CD19+ B-cell count will be measured by the central laboratory. efficacy Time to first relapse [ Time Frame: Week 24, 48 and end of study up to Week 72 ] Time to first relapse is the period until the first relapse is confirmed from the first study drug injection.	—

Measure

Time frame

efficacy Mean number of gadolinium enhanced T1 lesions across 4 MRI scans (Japan vs other countries) [ Time Frame: Week 12, 16, 20 and 24, 36, 48 and end of study up to Week 72 ] The number of gadolinium enhanced T1 lesions on MRI scans will be measured by the central MRI reading center. efficacy Number of new or enlarging T2 lesions on MRI scans compared to baseline [ Time Frame: Baseline, Week 12, 16, 20 and 24, 36, 48 and end of study up to Week 72 ] The number of new or enlarging T2 lesions on MRI scans compared to baseline will be measured by the central MRI reading center. efficacy Annualized relapse rate [ Time Frame: Week 24, 48 and end of study up to Week 72 ] Annualized relapse rate is the number of confirmed relapses in a year calculated based on cumulative number of relapses. efficacy B-cell count [ Time Frame: Baseline, Day 2, 5, 7, 14, Week 4, 12, 24, 28, 36, 48, 60 and 72 ] Blood samples will be collected at the scheduled visit. The CD19+ B-cell count will be measured by the central laboratory. efficacy Time to first relapse [ Time Frame: Week 24, 48 and end of study up to Week 72 ] Time to first relapse is the period until the first relapse is confirmed from the first study drug injection.

—

Countries

Japan, Russia

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026