Phase 4
N=180
Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.
Relapse Remitting Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT05084638 ↗Enrolled (actual)
180
Serious AEs
6.1%
Results posted
Feb 2026
Primary outcome: Primary: Percentage of Participants Achieving NEDA-3 (No Evidence of Disease Activity-3) — 81.1 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ofatumumab (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving NEDA-3 (No Evidence of Disease Activity-3) |
81.1 | — |
| SECONDARY Number of Confirmed MS Relapses in Months 6 to 18 |
1 | — |
| SECONDARY Participant Based Annualized Relapse Rate (ARR) |
0.01 | — |
| SECONDARY Group Based Annualized Relapse Rate (ARR) |
0.01 | — |
| SECONDARY Percentage of Participants That Were 3-month Disability Progression-free |
90.5 | — |
| SECONDARY Percentage of Participants With NEDA (No Evidence of Disease Activity) - Clinical |
89.5 | — |
| SECONDARY Number of Participants With NEDA (No Evidence of Disease Activity) - Radiological |
90.5 | — |
| SECONDARY Change From Baseline in Gd+ Lesion Count |
— | — |
| SECONDARY Change From Baseline in Gd+ Lesion Volume |
— | — |
| SECONDARY Change From Baseline in New/Enlarging T2 Lesion Count |
— | — |
| SECONDARY Change From Baseline in T2 Lesion Volume |
— | — |
| SECONDARY Change From Baseline for NeuroQOL |
— | — |
| SECONDARY Change From Baseline for Patient Determined Disease Steps (PDDS) |
— | — |
| SECONDARY Brain Volume Loss (BVL) Assessment (Whole Brain and Regional) |
— | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events |
— | — |
| SECONDARY Change From Baseline in New Unenhancing T1 Lesion Number |
— | — |
| SECONDARY Change From Baseline in T1 Unenhancing Lesion Volume |
— | — |
Summary
This study evaluates the impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes. The study also assesses changes in disease using monitoring techniques including digital biometric device use, biomarker analysis and non-conventional MRI. Select outcomes in the ofatumumab treated group will be compared to a group of Healthy participants to determine if there are similarities between the groups after the patients with MS undergo treatment with ofatumumab.
Eligibility Criteria
Key Inclusion Criteria
Participants eligible for inclusion in this study must meet all of the following criteria:
- Signed informed consent must be obtained prior to participation in the study
- Age 18-35 years
Patients in the healthy control arm eligible for inclusion must fulfill the following criteria:
- Able to obtain MRI (HC with abnormal MRI at Screening will be excluded) and use wearable device
- Able to provide blood sample (no CSF will be collected in HC)
Patients in the ofatumumab-treated arm eligible for inclusion must fulfill the following criteria:
- Diagnosis of RRMS per McDonald Criteria (2010/2017)
- Within 6 months of diagnosis of clinically definite MS (CDMS)
- EDSS 0-3.0 (Inclusive)
- Treatment-naïve to MS DMT
- Able to obtain MRI and attend study visits at sites
- Able to use wearable device
- Able to provide blood sample (and CSF for sub-group n=15)
Key Exclusion Criteria
Participants in the healthy control arm meeting any of the following criteria are not eligible for inclusion in this study:
- Confounding medical condition as determined by the investigator
RRMS patients fulfilling any of the following exclusion criteria are not eligible for inclusion in this study:
- Diseases other than multiple sclerosis responsible for the clinical or MRI presentation
- Patients with neuromyelitis optica, Radiologic/ Clinically Isolated Syndrome, Secondary Progressive or Primary Progressive MS diagnosis
- Use of experimental or investigational drugs for MS
- Previous use of Disease Modifying Therapy (DMT) or chemotherapeutic medications for MS
- Relapse between screening and Baseline visits
- Known sensitivity to gadolinium; patients with chronic, severe kidney disease
- Known history of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes
- CNS anomalies that are better accounted for by another disease process or MRI anomalies causing clinically apparent impairments
- Known active malignancies
- Pregnant or nursing (lactating) women
- Females of childbearing potential (all women physiologically capable of becoming pregnant) should use effective contraception while receiving ofatumumab and for 6 months after the last treatment of ofatumumab
- Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS or with immunodeficiency syndrome
- Patients with active infections including systemic bacterial, viral (including SARS-CoV-2/COVID-19) or fungal infections, or known to have AIDS or to test positive for HIV antibody at Screening
- Patients with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML
- Patients with IgG or IgM levels below LLN at Screening
- Patients that have received any live or live-attenuated vaccines within 4 weeks prior to first dose of study drug administration
- Patients at risk of developing or having reactivation of hepatitis
Data sourced from ClinicalTrials.gov (NCT05084638). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.