An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab

Last updated: October 27, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Multiple Sclerosis

Scar Tissue

Memory Loss

Treatment

Ofatumumab

Clinical Study ID

NCT04353492
COMB157G23101
2019-001341-40
  • Ages 18-60
  • All Genders

Study Summary

Open-label study to evaluate the effectiveness of treatment with ofatumumab in subjects transitioning from any fumarate-based RMS approved therapy or fingolimod due to breakthrough disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of MS according to the 2017 Revised McDonald criteria

  • Relapsing MS: relapsing forms of MS (RMS) including RMS and secondary progressive MS (SPMS)

  • Disability status at screening defined by Expanded Disability Status Scale (EDSS)score of 0 to 4 (inclusive)

  • MS treatment history with a maximum of 3 Disease Modifying Therapies (DMTs), whereall fumarates are considered as one DMT

  • Subject transitioning from either any fumarate-based RMS approved therapies, such asdimethyl fumarate (DMF) or diroximel fumarate (DRF), or fingolimod which wasadministered for a period of at least 6 months, as their last DMT before first studydrug administration

  • Breakthrough disease activity while the participant was adequately using fumaratesor fingolimod prior to transitioning for a minimum of 6 months as evidenced by oneor more clinically reported relapses or one or more signs of Magnetic ResonanceImaging (MRI) activity (e.g. Gd+ enhancement, new or enlarging T2 lesions)

  • Neurologically stable within one month prior to first study drug administration

Exclusion

Exclusion Criteria:

  • Subjects with primary progressive MS or SPMS without disease activity

  • Subjects meeting criteria for neuromyelitis optica

  • Disease duration of more than 10 years since diagnosis

  • Pregnant or nursing (lactating) women

  • Women of child-bearing potential unless they are using highly effective forms ofcontraception during dosing and for at least 6 months after stopping studymedication

  • Subjects with active chronic disease of the immune system other than MS or withimmunodeficiency syndrome

  • Subjects with active systemic bacterial, fungal or viral infections (such ashepatitis, HIV, COVID-19), or known to have Acquired Immunodeficiency Syndrome (AIDS)

  • Subjects with neurological symptoms consistent with Progressive MultifocalLeukoencephalopathy (PML) or with confirmed PML

  • Subjects at risk of developing or having reactivation of syphilis or tuberculosis (e.g. subjects with known exposure to, or history of syphilis, or active or latenttuberculosis, even if previously treated), as confirmed by medical history or perlocal practice

  • Subjects with active hepatitis B and C disease, assessed locally

  • Have received any live or live-attenuated vaccines within 4 weeks prior to firststudy drug administration

  • Have been treated with medications as specified or within timeframes specified (e.g.corticosteroids, ofatumumab, rituximab, ocrelizumab, alemtuzumab, natalizumab,daclizumab, cyclophosphamide, teriflunomide etc.)

  • Subjects suspected of not being able or willing to cooperate or comply with studyprotocol requirements in the opinion of the investigator

Study Design

Total Participants: 562
Treatment Group(s): 1
Primary Treatment: Ofatumumab
Phase: 3
Study Start date:
July 14, 2020
Estimated Completion Date:
March 11, 2025

Study Description

This was a single arm, prospective, multicentre and open-label, 96-week study to evaluate the treatment effectiveness of ofatumumab (OMB) in subjects with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies, such as dimethyl fumarate (DMF), diroximel fumarate (DRF), and monomethyl fumarate (MMF), or fingolimod due to breakthrough disease activity.

Connect with a study center

  • Novartis Investigative Site

    Caba, Buenos Aires C1424BYD
    Argentina

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    Rosario, Santa Fe S2000BZL
    Argentina

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    Rosario 3838583, Santa Fe Province 3836276 S2000DSW
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    Buenos Aires, C1424BYD
    Argentina

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    Buenos Aires 3435910, C1424BYD
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    San Miguel de Tucumán 3836873, 4000
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    Tucuman, 4000
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    Liverpool, New South Wales 2170
    Australia

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    New Lambton Heights, New South Wales 2305
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    New Lambton Heights 10103866, New South Wales 2155400 2305
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    Woolloongabba 6943568, Queensland 2152274 4102
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    Parkville 2153770, Victoria 2145234 3050
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    United States

    Site Not Available

  • Novartis Investigative Site

    Tampa, Florida 33609
    United States

    Site Not Available

  • University Of South Florida

    Tampa, Florida 33612
    United States

    Site Not Available

  • University Of South Florida .

    Tampa, Florida 33612
    United States

    Site Not Available

  • Novartis Investigative Site

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Premiere Research Institute

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Memorial Healthcare System

    Hollywood 4158928, Florida 4155751 33021
    United States

    Site Not Available

  • Homestead Assoc In Research Inc

    Homestead 4159050, Florida 4155751 33033
    United States

    Site Not Available

  • Neurology Associates PA

    Maitland 4163220, Florida 4155751 32751
    United States

    Site Not Available

  • UM Department Of Neurology

    Miami 4164138, Florida 4155751 33136
    United States

    Site Not Available

  • Negroski Neurology

    Sarasota 4172131, Florida 4155751 34233
    United States

    Site Not Available

  • Axiom Clinical Research of Florida

    Tampa 4174757, Florida 4155751 33609
    United States

    Site Not Available

  • University Of South Florida

    Tampa 4174757, Florida 4155751 33612
    United States

    Site Not Available

  • Premiere Research Institute

    West Palm Beach 4177887, Florida 4155751 33407
    United States

    Site Not Available

  • Atlanta Neuroscience Institute

    Atlanta, Georgia 30327
    United States

    Site Not Available

  • Novartis Investigative Site

    Atlanta, Georgia 30327
    United States

    Site Not Available

  • Georgia Neurology and Sleep Medicine Assoc

    Suwanee, Georgia 30024
    United States

    Site Not Available

  • Novartis Investigative Site

    Suwanee, Georgia 30024
    United States

    Site Not Available

  • Atlanta Neuroscience Institute

    Atlanta 4180439, Georgia 4197000 30327
    United States

    Site Not Available

  • Georgia Neurology and Sleep Medicine Assoc

    Suwanee 4225309, Georgia 4197000 30024
    United States

    Site Not Available

  • Novartis Investigative Site

    Honolulu, Hawaii 96817
    United States

    Site Not Available

  • Novartis Investigative Site

    Indianapolis, Indiana 46256
    United States

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Johns Hopkins Hospital Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Johns Hopkins MS Center

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Novartis Investigative Site

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Site Not Available

  • Novartis Investigative Site

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Novartis Investigative Site

    Foxboro, Massachusetts 02035
    United States

    Site Not Available

  • Novartis Investigative Site

    Chesaning, Michigan 48616
    United States

    Site Not Available

  • Novartis Investigative Site

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Novartis Investigative Site

    Golden Valley, Minnesota 55422
    United States

    Site Not Available

  • Novartis Investigative Site

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Novartis Investigative Site

    Omaha, Nebraska 68131
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Novartis Investigative Site

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Las Vegas 5506956, Nevada 5509151 89106
    United States

    Site Not Available

  • Novartis Investigative Site

    Albuquerque, New Mexico 87131-0001
    United States

    Site Not Available

  • University of New Mexico

    Albuquerque, New Mexico 87131-0001
    United States

    Site Not Available

  • University of New Mexico

    Albuquerque 5454711, New Mexico 5481136 87131-0001
    United States

    Site Not Available

  • Novartis Investigative Site

    Amherst, New York 14226
    United States

    Site Not Available

  • Five Towns Neuroscience Research

    Woodmere, New York 11598
    United States

    Site Not Available

  • Novartis Investigative Site

    Woodmere, New York 11598
    United States

    Site Not Available

  • Five Towns Neuroscience Research

    Woodmere 5145028, New York 5128638 11598
    United States

    Site Not Available

  • Novartis Investigative Site

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Cleveland Clinic Foundation .

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Novartis Investigative Site

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Columbus Neuroscience

    Westerville, Ohio 43082
    United States

    Site Not Available

  • Novartis Investigative Site

    Westerville, Ohio 43082
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • Columbus Neuroscience

    Westerville 5176472, Ohio 5165418 43082
    United States

    Site Not Available

  • Multiple Sclerosis Center of Excellence of OMRF

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Novartis Investigative Site

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Multiple Sclerosis Center of Excellence of OMRF

    Oklahoma City 4544349, Oklahoma 4544379 73104
    United States

    Site Not Available

  • Novartis Investigative Site

    Portland, Oregon 97225
    United States

    Site Not Available

  • Novartis Investigative Site

    Philadelphia, Pennsylvania 19107-5098
    United States

    Site Not Available

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107-5098
    United States

    Site Not Available

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania 15240
    United States

    Site Not Available

  • Thomas Jefferson University Hospital

    Philadelphia 4560349, Pennsylvania 6254927 19107-5098
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Novartis Investigative Site

    Houston, Texas 77030
    United States

    Site Not Available

  • North TX Inst of Neuro and Headache

    Plano, Texas 75024
    United States

    Site Not Available

  • Novartis Investigative Site

    Plano, Texas 75024
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Saturn Research Solutions LLC

    Plano 4719457, Texas 4736286 75024
    United States

    Site Not Available

  • INOVA Medical Group

    Fairfax, Virginia 22030
    United States

    Site Not Available

  • INOVA Medical Group .

    Fairfax, Virginia 22030
    United States

    Site Not Available

  • Novartis Investigative Site

    Fairfax, Virginia 22030
    United States

    Site Not Available

  • INOVA Medical Group

    Fairfax 4758023, Virginia 6254928 22030
    United States

    Site Not Available

  • Ascension St Francis Center

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

  • Novartis Investigative Site

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

  • Ascension St Francis Center

    Milwaukee 5263045, Wisconsin 5279468 53215
    United States

    Site Not Available

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