Relapsing Multiple Sclerosis (RMS)Phase 3FILIOSNCT06869785
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab
A Phase 3 study testing Ofatumumab approved dose and Ofatumumab new dose in people with Relapsing Multiple Sclerosis (RMS), run by Novartis Pharmaceuticals at 63 sites in 2 countries.
Trial summary
This study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of a new dosage of ofatumumab compared to the approved dosage of ofatumumab followed by extended treatment in participants with relapsing multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Relapsing Multiple Sclerosis (RMS)
- What is being tested?
- Ofatumumab approved dose and Ofatumumab new dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 63 sitesin 2 countries
- Study dates
- 13 Mar 2025to 23 Mar 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent must be obtained prior to participation in the study.
- Male or female study participants aged 18 to 60 years (inclusive) at screening.
- Diagnosis of multiple sclerosis (MS) according to the 2017 Revised McDonald criteria (Thompson et al 2018). Relapsing forms of MS: relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS).
Who cannot join
- Participants suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the Investigator or emergence of any clinically significant condition/disease (e.g. active systemic bacterial, viral or fungal infections) during screening prior to Day 1 which might result in safety risk for participants.
- Participants with history of confirmed progressive multifocal leukoencephalopathy (PML) or neurological symptoms consistent with PML.
- Participants at risk of developing or having reactivation of hepatitis
- Emergence of active chronic disease (or stable but treated with immune therapy) prior to Day 1 of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or with immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency).
- Pregnant or nursing (lactating) women
- History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system (except for basal cell carcinoma, or squamous cell carcinomas of the skin that have been treated with no evidence of recurrence in the past 3 months).
- Participants taking prohibited therapies, including B cell targeted therapies (e.g. such as ocrelizumab, rituximab, ofatumumab, ublituximab, and inebilizumab)
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
63 sites in 2 countries.
63 sites in 2 countries
United States61 sites
Neuro Medial Clinic of Central Louisiana
Alexandria, Louisiana, 71301
Neurology of Central FL Res Ctr
Altamonte Springs, Florida, 32714
Atlanta NeuroScience Institute
Atlanta, Georgia, 30327
CU Anschutz Med Campus
Aurora, Colorado, 80045
The Research and Education Inst of Alta Bates Summit Med Grp
Berkeley, California, 94705
Mid Atlantic Epilepsy and Sleep Ctr
Bethesda, Maryland, 20817-1807
Alabama Neurology Associates PC
Birmingham, Alabama, 35209
Neurology Offices Of South Florida
Boca Raton, Florida, 33428
First Choice Neurology
Boca Raton, Florida, 33486
Dayton Center for Neurological Disorders
Centerville, Ohio, 45459
University Of Cincinnati
Cincinnati, Ohio, 45267
OSU Wexner Medical Center
Columbus, Ohio, 43221
Neurology Clinic PC
Cordova, Tennessee, 38018
Carum Research
Dallas, Texas, 75231
Henry Ford Hospital
Detroit, Michigan, 48202-2689
Fullerton Neuro and Headache Ctr
Fullerton, California, 92835
University of Florida
Gainesville, Florida, 32610
Hackensack University Medical Ctr
Hackensack, New Jersey, 07601
Memorial Healthcare System
Hollywood, Florida, 33021
Josephson Wallack Munshower Neurology PC
Indianapolis, Indiana, 46256
University of California Irvine
Irvine, California, 92697
Univ of Kansas Hosp and Med Ctr
Kansas City, Kansas, 66160
University of Tennessee Medical Ctr
Knoxville, Tennessee, 37920
Sibyl Wray MD Neurology PC
Knoxville, Tennessee, 37922
Cleveland Clinic Foundation
Las Vegas, Nevada, 89106
CenExcel Clinical Research
Los Alamitos, California, 90720
Velocity Clinical Trials
Los Angeles, California, 90057
International Neurorehab Institute
Lutherville, Maryland, 21093
Neurology Associates PA
Maitland, Florida, 32751
UM Department Of Neurology
Miami, Florida, 33136
Elite Clinical Research
Miami, Florida, 33144
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Aqualane Clinical Research
Naples, Florida, 34105
Delricht Research
New Orleans, Louisiana, 70115
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
AdventHealth
Orlando, Florida, 32804
Orlando Health Clinical Trials
Orlando, Florida, 32806
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174
South Shore Neurologic Associates
Patchogue, New York, 11772
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107-5098
Xenoscience Inc
Phoenix, Arizona, 85004
Ctr for Neurology and Spine
Phoenix, Arizona, 85018
Phoenix Neurological Associates
Phoenix, Arizona, 85018
Saturn Research Solutions LLC
Plano, Texas, 75024
Neurostudies Inc
Port Charlotte, Florida, 33952
True North Neurology
Port Jefferson, New York, 11776
Velocity Clinical Research
Raleigh, North Carolina, 27607
Rochester Cent For Behavioral
Rochester Hills, Michigan, 48307
Advent Neurology Clinic
Roeland Park, Kansas, 66205
Swedish Neuroscience Institute
Seattle, Washington, 98122
WA Uni School Of Med
St Louis, Missouri, 63110
MultiCare Research Institute for Research and Innovation
Tacome, Washington, 98405
Tallahassee Neurological Clinic
Tallahassee, Florida, 32308
Axiom Brain Health
Tampa, Florida, 33609
University Of South Florida
Tampa, Florida, 33612
Vero Beach Neurology
Vero Beach, Florida, 32960
Conquest Research
Vienna, Virginia, 22182
Sentara Neuroscience Institute
Virginia Beach, Virginia, 23456
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Regina Berkovich MD PhD Inc
West Hollywood, California, 90048
Premiere Research Institute
West Palm Beach, Florida, 33407
Puerto Rico2 sites
Puerto Rico Multiple Sclerosis Ctr
Caguas, 00725
Caribbean Center for Clinical Research Inc
Guaynabo, 00968
About this study
Official title: 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
This study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of a new dosage of ofatumumab compared to the approved dosage of ofatumumab followed by extended treatment in participants with relapsing multiple sclerosis.
Read the detailed description
This is a Phase 3, open label, parallel-group, multicenter study in participants with relapsing multiple sclerosis
- Conditions
- Relapsing Multiple Sclerosis (RMS)
- Being tested
- Ofatumumab approved dose, Ofatumumab new dose
- Keywords
- Relapsing Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ofatumumab approved doseBiological
Approved dosage
Ofatumumab new doseBiological
New dosage
| Study group | Role | What they receive |
|---|---|---|
| Ofatumumab dose 1 | Active comparator | Approved dosage Receives: Biological: Ofatumumab approved dose; Biological: Ofatumumab new dose |
| Ofatumumab dose 2 | Experimental | New dosage Receives: Biological: Ofatumumab new dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ofatumumab plasma pharmacokinetics - area under the curve
Measured: Up to 12 weeks
Secondary outcomes (5)
Ofatumumab plasma pharmacokinetics - minimum observed plasma concentration
Measured: Up to 12 weeks
Ofatumumab plasma pharmacokinetics - maximum observed plasma concentration
Measured: Up to 12 weeks
Incidence of Adverse events (AE) and Serious adverse events (SAE)
Measured: Up to 52 weeks
Proportion of participants with anti-drug antibodies
Measured: Up to 52 weeks
Participant B cell counts
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start13 Mar 2025
- Primary completion28 Jan 2026
- Study completion23 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Multiple Sclerosis (RMS)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869785
- Sponsor's protocol ID
- COMB157Q12301
- Acronym
- FILIOS
- Status last verified
- Aug 2026
- First submitted
- 10 Mar 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.