ofatumumab
ofatumumab: developed by 1 company · 12 clinical trials tracked · 1 FDA decision.
ofatumumab evidence translation
What we can confirm
1 FDA record · 12 tracked trials
What it means
What to watch
Prepared research question
How could ofatumumab → NVS affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence5 indications · 1 study sponsors
Related indications
Study sponsors
Development Pipeline (6)
| Company | Phase |
|---|---|
| Novartis AG (NVS) | Phase 4 |
| Novartis AG (NVS) Multiple Sclerosis; Relapse Remitting Multiple Sclerosis | Phase 4 |
| Novartis AG (NVS) Relapsing Multiple Sclerosis (RMS) | Phase 4 |
| Novartis AG (NVS) Multiple Sclerosis, Relapsing-Remitting; Relapsing-Remitting… | Phase 4 |
| Novartis AG (NVS) Relapsing Multiple Sclerosis (RMS) | Phase 4 |
| Novartis AG (NVS) Multiple Sclerosis, Relapsing-Remitting; Relapsing-Remitting… | Phase 4 |
Clinical Trials (12)showing 10 most recent
An Open-label, Randomized, Parallel Group, Non-inferiority Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab, Followed by Extended Treatment in Participants With Relapsing Multiple Sclerosis
Primary endpoint: Ofatumumab plasma pharmacokinetics - area under the curve
A Phase IV, Prospective, Multicenter, Open-label, Mother-milk Study to Evaluate Ofatumumab Concentration in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis Receiving Ofatumumab
Primary endpoint: Concentration of ofatumumab in breast milk.
An ITAlian Observational, Multicenter, 12-month, Single-arm Study to Evaluate the Effectiveness and Safety of Treatment With Ofatumumab (Kesimpta®) in a pOpulation of RRMS Patients in a Real-world Setting - the ITAKOS Study
Primary endpoint: Annualized relapse rate (ARR)
Assessing the Modulation of Retinal Atrophy and Neurofilament Light Chain by Ofatumumab in Relapsing Multiple Sclerosis
Primary endpoint: Ganglion cell inner plexiform (GCIP) atrophy in RMS relative to HCs, according to baseline sNfL levels
A Randomized, Open Label, Multi-center, Active-comparator Study to Assess Efficacy, Safety & Tolerability of Ofatumumab 20mg sc Monthly Versus Continued Current Therapy in Relapsing-remitting Multiple Sclerosis After Elevation of Serum Neurofilament Light Levels (SOSTOS)
Primary endpoint: Percentage of participants achieving NEDA-3 (No Evidence of Disease Activity-3)
Assessing Reduced Oligodendrocyte-specific Cytotoxicity of Peripheral Blood Leukocytes in Patients With Multiple Sclerosis Following Treatment With Ofatumumab
Primary endpoint: Assessment of oligodendrocyte death and mitochondrial dysfunction comparing supernatant samples from patients after 6 months treatment (M06) to pre-treatment, drug naïve supernatants (M00) and to supernatants collected from healthy control subjects
AGNOS: An 18-month, Open-label, Multi-Center Phase IV Study to Assess the Effect of Ofatumumab 20mg SC Monthly in Treatment Naïve, Very Early Relapsing Remitting Multiple Sclerosis Patients Benchmarked Against Healthy Controls on Select Outcomes.
Primary endpoint: Percentage of Participants Achieving NEDA-3 (No Evidence of Disease Activity-3)
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
Primary endpoint: Annualized relapse rate (ARR) in target pediatric participants
Pregnancy Outcomes in Women Exposed to Diroximel Fumarate
Primary endpoint: Number of Major Congenital Malformations (MCMs)
Open-Label Rater-Blind Randomized Multi-Center Parallel-Arm Active- Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC Monthly vs. First Line DMT - Physician's Choice in the Treatment of Newly Diagnosed RMS
Primary endpoint: Number of participants with no evidence of disease activity (NEDA-3)
FDA Decisions1 records
Frequently asked questions
Who is developing ofatumumab?
ofatumumab is being developed by Novartis AG.
How many clinical trials involve ofatumumab?
BioSniper tracks 12 clinical trials involving ofatumumab.
What is ofatumumab's latest FDA decision?
The most recent tracked FDA decision for ofatumumab is Approval, dated October 26, 2009.