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

May 11, 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

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

196

Phase

  • 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 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
        • 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, 33165
        • Reliant Medical 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
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • 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
        • Neurology Consultants Of Dallas PA
      • Plano, Texas, United States, 75024
        • Saturn Research Solutions LLC
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Sana Research
      • Virginia Beach, Virginia, United States, 23456
        • Sentara Neuroscience Institute
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Neuroscience Institute
      • Tacoma, 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

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
Intervention / Treatment
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

Outcome Measure
Time Frame
Ofatumumab plasma pharmacokinetics - area under the curve
Time Frame: Up to 12 weeks
Up to 12 weeks

Secondary Outcome Measures

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

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)

March 13, 2025

Primary Completion (Actual)

January 28, 2026

Study Completion (Estimated)

March 23, 2030

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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