Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab (FILIOS)

August 7, 2026 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 3, open label, parallel-group, multicenter study in participants with relapsing multiple sclerosis

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
196

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Novartis Pharmaceuticals

Study Locations

  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • Puerto Rico Multiple Sclerosis Ctr
      • Guaynabo, Puerto Rico, 00968
        • Caribbean Center for Clinical Research Inc
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Alabama Neurology Associates PC
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Phoenix Neurological Associates
      • Phoenix, Arizona, United States, 85004
        • Xenoscience Inc
      • Phoenix, Arizona, United States, 85018
        • Ctr for Neurology and Spine
    • California
      • Berkeley, California, United States, 94705
        • The Research and Education Inst of Alta Bates Summit Med Grp
      • Fullerton, California, United States, 92835
        • Fullerton Neuro and Headache Ctr
      • Irvine, California, United States, 92697
        • University of California Irvine
      • Los Alamitos, California, United States, 90720
        • CenExcel Clinical Research
      • Los Angeles, California, United States, 90057
        • Velocity Clinical Trials
      • West Hollywood, California, United States, 90048
        • Regina Berkovich MD PhD Inc
    • Colorado
      • Aurora, Colorado, United States, 80045
        • CU Anschutz Med Campus
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • MedStar Washington Hospital Center
    • Florida
      • Altamonte Springs, Florida, United States, 32714
        • Neurology of Central FL Res Ctr
      • Boca Raton, Florida, United States, 33428
        • Neurology Offices of South Florida
      • Boca Raton, Florida, United States, 33486
        • First Choice Neurology
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Healthcare System
      • Maitland, Florida, United States, 32751
        • Neurology Associates PA
      • Miami, Florida, United States, 33144
        • Elite Clinical Research
      • Miami, Florida, United States, 33136
        • UM Department Of Neurology
      • Naples, Florida, United States, 34105
        • Aqualane Clinical Research
      • Orlando, Florida, United States, 32804
        • AdventHealth
      • Orlando, Florida, United States, 32806
        • Orlando Health Clinical Trials
      • Ormond Beach, Florida, United States, 32174
        • Neurology Associates of Ormond Beach
      • Port Charlotte, Florida, United States, 33952
        • Neurostudies Inc
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Neurological Clinic
      • Tampa, Florida, United States, 33612
        • University of South Florida
      • Tampa, Florida, United States, 33609
        • Axiom Brain Health
      • Vero Beach, Florida, United States, 32960
        • Vero Beach Neurology
      • West Palm Beach, Florida, United States, 33407
        • Premiere Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Atlanta Neuroscience Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Josephson Wallack Munshower Neurology PC
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Univ of Kansas Hosp and Med Ctr
      • Roeland Park, Kansas, United States, 66205
        • Advent Neurology Clinic
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Neuro Medial Clinic of Central Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
      • New Orleans, Louisiana, United States, 70115
        • DelRicht Research
    • Maryland
      • Bethesda, Maryland, United States, 20817-1807
        • Mid Atlantic Epilepsy and Sleep Ctr
      • Lutherville, Maryland, United States, 21093
        • International Neurorehab Institute
    • Michigan
      • Detroit, Michigan, United States, 48202-2689
        • Henry Ford Hospital
      • Rochester Hills, Michigan, United States, 48307
        • Rochester Cent For Behavioral
    • Missouri
      • St Louis, Missouri, United States, 63110
        • WA Uni School Of Med
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Cleveland Clinic Foundation
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Ctr
    • New York
      • Patchogue, New York, United States, 11772
        • South Shore Neurologic Associates
      • Port Jefferson, New York, United States, 11776
        • True North Neurology
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Velocity Clinical Research
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Dayton Center for Neurological Disorders
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Columbus, Ohio, United States, 43221
        • OSU Wexner Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107-5098
        • Thomas Jefferson University Hospital
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Neurology Clinic PC
      • Knoxville, Tennessee, United States, 37922
        • Sibyl Wray MD Neurology PC
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Ctr
    • Texas
      • Dallas, Texas, United States, 75231
        • Carum Research
      • Plano, Texas, United States, 75024
        • Saturn Research Solutions LLC
    • Virginia
      • Vienna, Virginia, United States, 22182
        • Conquest Research
      • Virginia Beach, Virginia, United States, 23456
        • Sentara Neuroscience Institute
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Neuroscience Institute
      • Tacome, Washington, United States, 98405
        • MultiCare Research Institute for Research and Innovation
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Ofatumumab dose 1
Approved dosage
Biological: Ofatumumab approved dose
Approved dosage
Biological: Ofatumumab new dose
New dosage
Experimental: Ofatumumab dose 2
New dosage
Biological: Ofatumumab new dose
New dosage

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Ofatumumab plasma pharmacokinetics - area under the curve
Time Frame: Up to 12 weeks
Up to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Ofatumumab plasma pharmacokinetics - minimum observed plasma concentration
Time Frame: Up to 12 weeks
Up to 12 weeks
Ofatumumab plasma pharmacokinetics - maximum observed plasma concentration
Time Frame: Up to 12 weeks
Up to 12 weeks
Incidence of Adverse events (AE) and Serious adverse events (SAE)
Time Frame: Up to 52 weeks
Up to 52 weeks
Proportion of participants with anti-drug antibodies
Time Frame: Up to 52 weeks
Up to 52 weeks
Participant B cell counts
Time Frame: Up to 52 weeks
Up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 28, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 23, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COMB157Q12301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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