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

Last updated: May 11, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

3

Condition

Multiple Sclerosis

Memory Loss

Scar Tissue

Treatment

Ofatumumab approved dose

Ofatumumab new dose

Clinical Study ID

NCT06869785
COMB157Q12301
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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), oractive secondary progressive MS (SPMS).

Exclusion

Exclusion Criteria:

  • Participants suspected of not being able or willing to cooperate or comply withstudy protocol requirements in the opinion of the Investigator or emergence of anyclinically significant condition/disease (e.g. active systemic bacterial, viral orfungal infections) during screening prior to Day 1 which might result in safety riskfor 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 withimmunodeficiency syndrome (hereditary immune deficiency, drug-induced immunedeficiency).

  • Pregnant or nursing (lactating) women

  • History of lymphoproliferative disease or any known malignancy or history ofmalignancy of any organ system (except for basal cell carcinoma, or squamous cellcarcinomas of the skin that have been treated with no evidence of recurrence in thepast 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 Design

Total Participants: 196
Treatment Group(s): 2
Primary Treatment: Ofatumumab approved dose
Phase: 3
Study Start date:
March 13, 2025
Estimated Completion Date:
March 23, 2030

Study Description

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

Connect with a study center

  • Puerto Rico Multiple Sclerosis Ctr

    Caguas, 00725
    Puerto Rico

    Site Not Available

  • Puerto Rico Multiple Sclerosis Ctr

    Caguas 4563008, 00725
    Puerto Rico

    Site Not Available

  • Caribbean Center for Clinical Research, Inc

    Guaynabo, 00968
    Puerto Rico

    Site Not Available

  • Caribbean Center for Clinical Research, Inc

    Guaynabo 4565119, 00968
    Puerto Rico

    Site Not Available

  • Alabama Neurology Associates PC

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Alabama Neurology Associates PC

    Birmingham 4049979, Alabama 4829764 35209
    United States

    Site Not Available

  • Ctr for Neurology and Spine

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Phoenix Neurological Associates

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Xenoscience Inc

    Phoenix, Arizona 85004
    United States

    Site Not Available

  • Gilbert Neurology

    Gilbert 5295903, Arizona 5551752 85297
    United States

    Site Not Available

  • Ctr for Neurology and Spine

    Phoenix 5308655, Arizona 5551752 85018
    United States

    Site Not Available

  • Phoenix Neurological Associates

    Phoenix 5308655, Arizona 5551752 85018
    United States

    Site Not Available

  • Xenoscience Inc

    Phoenix 5308655, Arizona 5551752 85004
    United States

    Site Not Available

  • The Research and Education Inst. of Alta Bates Summit Med. Grp

    Berkeley, California 94705
    United States

    Site Not Available

  • Fullerton Neuro and Headache Ctr

    Fullerton, California 92835
    United States

    Site Not Available

  • University of California Irvine

    Irvine, California 92697
    United States

    Site Not Available

  • CenExcel Clinical Research

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Velocity Clinical Trials

    Los Angeles, California 90057
    United States

    Site Not Available

  • Amicis Research Center

    Valencia, California 91355
    United States

    Site Not Available

  • Regina Berkovich MD PhD Inc

    West Hollywood, California 90048
    United States

    Site Not Available

  • The Research and Education Inst. of Alta Bates Summit Med. Grp

    Berkeley 5327684, California 5332921 94705
    United States

    Site Not Available

  • Fullerton Neuro and Headache Ctr

    Fullerton 5351247, California 5332921 92835
    United States

    Site Not Available

  • University of California Irvine

    Irvine 5359777, California 5332921 92697
    United States

    Site Not Available

  • CenExcel Clinical Research

    Los Alamitos 5368304, California 5332921 90720
    United States

    Site Not Available

  • Velocity Clinical Trials

    Los Angeles 5368361, California 5332921 90057
    United States

    Site Not Available

  • Amicis Research Center

    Valencia 5405288, California 5332921 91355
    United States

    Site Not Available

  • Regina Berkovich MD PhD Inc

    West Hollywood 5408076, California 5332921 90048
    United States

    Site Not Available

  • CU Anschutz Med Campus

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Mountain Neuro Research Center PC

    Basalt, Colorado 81621
    United States

    Site Not Available

  • CU Anschutz Med Campus

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Mountain Neuro Research Center PC

    Basalt 5412822, Colorado 5417618 81621
    United States

    Site Not Available

  • Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Washington Hospital Center

    Washington D.C., District of Columbia 20010
    United States

    Site Not Available

  • Washington Hospital Center

    Washington D.C. 4140963, District of Columbia 4138106 20010
    United States

    Site Not Available

  • Neurology of Central FL Res Ctr

    Altamonte Springs, Florida 32714
    United States

    Site Not Available

  • First Choice Neurology

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Neurology Offices Of South Florida

    Boca Raton, Florida 33428
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Memorial Healthcare System

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Memorial Hospital

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • Neurology Associates PA

    Maitland, Florida 32751
    United States

    Site Not Available

  • Elite Clinical Research

    Miami, Florida 33144
    United States

    Site Not Available

  • Reliant Medical Research

    Miami, Florida 33165
    United States

    Site Not Available

  • UM Department Of Neurology

    Miami, Florida 33136
    United States

    Site Not Available

  • Aqualane Clinical Research

    Naples, Florida 34105
    United States

    Site Not Available

  • AdventHealth

    Orlando, Florida 32804
    United States

    Site Not Available

  • Orlando Health Clinical Trials

    Orlando, Florida 32806
    United States

    Site Not Available

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Neurostudies Inc

    Port Charlotte, Florida 33952
    United States

    Site Not Available

  • Tallahassee Neurological Clinic

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Axiom Brain Health

    Tampa, Florida 33609
    United States

    Site Not Available

  • University Of South Florida

    Tampa, Florida 33612
    United States

    Site Not Available

  • Vero Beach Neurology

    Vero Beach, Florida 32960
    United States

    Site Not Available

  • Premiere Research Institute

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Cleveland Clinic Florida

    Weston, Florida 33331
    United States

    Site Not Available

  • Neurology of Central FL Res Ctr

    Altamonte Springs 4145941, Florida 4155751 32714
    United States

    Site Not Available

  • Baptist Health South Florida

    Boca Raton 4148411, Florida 4155751 33486
    United States

    Site Not Available

  • First Choice Neurology

    Boca Raton 4148411, Florida 4155751 33486
    United States

    Site Not Available

  • Neurology Offices Of South Florida

    Boca Raton 4148411, Florida 4155751 33428
    United States

    Site Not Available

  • University of Florida

    Gainesville 4156404, Florida 4155751 32610
    United States

    Site Not Available

  • Memorial Healthcare System

    Hollywood 4158928, Florida 4155751 33021
    United States

    Site Not Available

  • Baptist Health Research Institute

    Jacksonville 4160021, Florida 4155751 32207
    United States

    Site Not Available

  • Neurology Associates PA

    Maitland 4163220, Florida 4155751 32751
    United States

    Site Not Available

  • Elite Clinical Research

    Miami 4164138, Florida 4155751 33144
    United States

    Site Not Available

  • Reliant Medical Research

    Miami 4164138, Florida 4155751 33165
    United States

    Site Not Available

  • UM Department Of Neurology

    Miami 4164138, Florida 4155751 33136
    United States

    Site Not Available

  • Aqualane Clinical Research

    Naples 4165565, Florida 4155751 34105
    United States

    Site Not Available

  • AdventHealth

    Orlando 4167147, Florida 4155751 32804
    United States

    Site Not Available

  • Orlando Health Clinical Trials

    Orlando 4167147, Florida 4155751 32806
    United States

    Site Not Available

  • Neurology Associates of Ormond Beach

    Ormond Beach 4167178, Florida 4155751 32174
    United States

    Site Not Available

  • Neurostudies Inc

    Port Charlotte 4169130, Florida 4155751 33952
    United States

    Site Not Available

  • Tallahassee Neurological Clinic

    Tallahassee 4174715, Florida 4155751 32308
    United States

    Site Not Available

  • Axiom Brain Health

    Tampa 4174757, Florida 4155751 33609
    United States

    Site Not Available

  • University Of South Florida

    Tampa 4174757, Florida 4155751 33612
    United States

    Site Not Available

  • Vero Beach Neurology

    Vero Beach 4176409, Florida 4155751 32960
    United States

    Site Not Available

  • Premiere Research Institute

    West Palm Beach 4177887, Florida 4155751 33407
    United States

    Site Not Available

  • Cleveland Clinic Florida

    Weston 4178003, Florida 4155751 33331
    United States

    Site Not Available

  • Atlanta NeuroScience Institute

    Atlanta, Georgia 30327
    United States

    Site Not Available

  • Ms Center Of Atlanta

    Atlanta, Georgia 30327
    United States

    Site Not Available

  • Atlanta NeuroScience Institute

    Atlanta 4180439, Georgia 4197000 30327
    United States

    Site Not Available

  • Ms Center Of Atlanta

    Atlanta 4180439, Georgia 4197000 30327
    United States

    Active - Recruiting

  • Insight Hospital and Medical Center

    Chicago 4887398, Illinois 4896861 60616
    United States

    Site Not Available

  • Josephson Wallack Munshower Neurology P.C

    Indianapolis, Indiana 46256
    United States

    Site Not Available

  • Josephson Wallack Munshower Neurology PC

    Indianapolis, Indiana 46256
    United States

    Site Not Available

  • Josephson Wallack Munshower Neurology P.C

    Indianapolis 4259418, Indiana 4921868 46256
    United States

    Site Not Available

  • Univ of Kansas Hosp and Med Ctr

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Advent Neurology Clinic

    Roeland Park, Kansas 66205
    United States

    Site Not Available

  • Univ of Kansas Hosp and Med Ctr

    Kansas City 4273837, Kansas 4273857 66160
    United States

    Site Not Available

  • Advent Neurology Clinic

    Roeland Park 4278272, Kansas 4273857 66205
    United States

    Site Not Available

  • Neuro Medial Clinic of Central Louisiana

    Alexandria, Louisiana 71301
    United States

    Site Not Available

  • Delricht Research

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Neuro Medial Clinic of Central Louisiana

    Alexandria 4314550, Louisiana 4331987 71301
    United States

    Site Not Available

  • Delricht Research

    New Orleans 4335045, Louisiana 4331987 70115
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    New Orleans 4335045, Louisiana 4331987 70121
    United States

    Site Not Available

  • Mid Atlantic Epilepsy and Sleep Ctr

    Bethesda, Maryland 20817-1807
    United States

    Site Not Available

  • International Neurorehab Institute

    Lutherville, Maryland 21093
    United States

    Site Not Available

  • American Oncology Partners PA Center for Cancer & Blood Disorders

    Bethesda 4348599, Maryland 4361885 20817
    United States

    Site Not Available

  • International Neurorehab Institute

    Lutherville 4361379, Maryland 4361885 21093
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202-2689
    United States

    Site Not Available

  • Rochester Cent For Behavioral

    Rochester Hills, Michigan 48307
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit 4990729, Michigan 5001836 48202-2689
    United States

    Site Not Available

  • Trinity Health Michigan

    Grand Rapids 4994358, Michigan 5001836 49503
    United States

    Site Not Available

  • Rochester Cent For Behavioral

    Rochester Hills 5007402, Michigan 5001836 48307
    United States

    Site Not Available

  • WA Uni School Of Med

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • WA Uni School Of Med

    St Louis, Missouri 63110
    United States

    Site Not Available

  • WA Uni School Of Med

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Las Vegas 5506956, Nevada 5509151 89106
    United States

    Site Not Available

  • Hackensack University Medical Ctr

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • MS Comprehensive Care Ctr at Holy Name Hospi

    Teaneck, New Jersey 07666
    United States

    Site Not Available

  • Hackensack University Medical Ctr

    Hackensack 5098706, New Jersey 5101760 07601
    United States

    Site Not Available

  • Jersey Shore University Medical Ctr

    Neptune City 5101687, New Jersey 5101760 07753
    United States

    Site Not Available

  • MS Comprehensive Care Ctr at Holy Name Hospi

    Teaneck 5105262, New Jersey 5101760 07666
    United States

    Site Not Available

  • Mount Sinai School Of Medicine

    New York, New York 10029
    United States

    Site Not Available

  • South Shore Neurologic Associates

    Patchogue, New York 11772
    United States

    Site Not Available

  • True North Neurology

    Port Jefferson, New York 11776
    United States

    Site Not Available

  • True North Neurology

    Port Jefferson Station, New York 11776
    United States

    Site Not Available

  • Mount Sinai School Of Medicine

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • South Shore Neurologic Associates

    Patchogue 5130672, New York 5128638 11772
    United States

    Site Not Available

  • True North Neurology

    Port Jefferson 5132013, New York 5128638 11776
    United States

    Site Not Available

  • Velocity Clinical Research

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Atrium Health

    Charlotte 4460243, North Carolina 4482348 28207
    United States

    Site Not Available

  • Velocity Clinical Research

    Raleigh 4487042, North Carolina 4482348 27607
    United States

    Site Not Available

  • Dayton Center for Neurological Disorders

    Centerville, Ohio 45459
    United States

    Site Not Available

  • University Of Cincinnati

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • OSU Medical Center-Martha Morehouse Medical Plaza

    Columbus, Ohio 43221
    United States

    Site Not Available

  • OSU Wexner Medical Center

    Columbus, Ohio 43221
    United States

    Site Not Available

  • Dayton Center for Neurological Disorders

    Centerville 4508204, Ohio 5165418 45459
    United States

    Site Not Available

  • University Of Cincinnati

    Cincinnati 4508722, Ohio 5165418 45267
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • OSU Medical Center-Martha Morehouse Medical Plaza

    Columbus 4509177, Ohio 5165418 43221
    United States

    Site Not Available

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107-5098
    United States

    Site Not Available

  • Thomas Jefferson University Hospital

    Philadelphia 4560349, Pennsylvania 6254927 19107-5098
    United States

    Site Not Available

  • Neurology Clinic PC

    Cordova, Tennessee 38018
    United States

    Site Not Available

  • Sibyl Wray MD Neurology PC

    Knoxville, Tennessee 37922
    United States

    Site Not Available

  • University of Tennessee Medical Ctr

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Neurology Clinic PC

    Cordova 4050552, Tennessee 4662168 38018
    United States

    Site Not Available

  • Sibyl Wray MD Neurology PC

    Knoxville 4634946, Tennessee 4662168 37922
    United States

    Site Not Available

  • University of Tennessee Medical Ctr

    Knoxville 4634946, Tennessee 4662168 37920
    United States

    Site Not Available

  • Vanderbilt Comprehensive Multiple Sclerosis Center

    Nashville 4644585, Tennessee 4662168 37215
    United States

    Site Not Available

  • Vanderbilt University

    Nashville 4644585, Tennessee 4662168 37212
    United States

    Site Not Available

  • Neurology Consultants Of Dallas PA

    Dallas, Texas 75231
    United States

    Site Not Available

  • Saturn Research Solutions LLC

    Plano, Texas 75024
    United States

    Site Not Available

  • Neurology Consultants Of Dallas PA

    Dallas 4684888, Texas 4736286 75231
    United States

    Site Not Available

  • Texas Neurology

    Dallas 4684888, Texas 4736286 75206
    United States

    Site Not Available

  • Saturn Research Solutions LLC

    Plano 4719457, Texas 4736286 75024
    United States

    Site Not Available

  • CenExcel Clinical Research

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • CenExcel Clinical Research

    Salt Lake City 5780993, Utah 5549030 84107
    United States

    Site Not Available

  • Sana Research

    Arlington, Virginia 22205
    United States

    Site Not Available

  • Sana Research

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Sentara Neuroscience Institute

    Virginia Beach, Virginia 23456
    United States

    Site Not Available

  • Sana Research

    Arlington 4744709, Virginia 6254928 22205
    United States

    Site Not Available

  • Sana Research

    Falls Church 4758390, Virginia 6254928 22042
    United States

    Site Not Available

  • Sentara Neuroscience Institute

    Virginia Beach 4791259, Virginia 6254928 23456
    United States

    Site Not Available

  • Swedish Neuroscience Institute

    Seattle, Washington 98122
    United States

    Site Not Available

  • MultiCare Research Institute for Research and Innovation

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Swedish Neuroscience Institute

    Seattle 5809844, Washington 5815135 98122
    United States

    Site Not Available

  • MultiCare Research Institute for Research and Innovation

    Tacoma 5812944, Washington 5815135 98405
    United States

    Site Not Available

  • Gamma Therapeutic Center

    Greenfield, Wisconsin 53228
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Gamma Therapeutic Center

    Greenfield 5255068, Wisconsin 5279468 53228
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Site Not Available

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