Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab
NCT ID: NCT06869785
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
180 participants
INTERVENTIONAL
2025-03-13
2031-05-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ofatumumab dose 1
Approved dosage
Ofatumumab approved dose
Approved dosage
Ofatumumab new dose
New dosage
Ofatumumab dose 2
New dosage
Ofatumumab new dose
New dosage
Interventions
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Ofatumumab approved dose
Approved dosage
Ofatumumab new dose
New dosage
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Alabama Neurology Associates PC
Birmingham, Alabama, United States
Gilbert Neurology
Gilbert, Arizona, United States
Xenoscience Inc
Phoenix, Arizona, United States
Ctr for Neurology and Spine
Phoenix, Arizona, United States
Phoenix Neurological Associates
Phoenix, Arizona, United States
The Research and Education Inst. of Alta Bates Summit Med. Grp
Berkeley, California, United States
Fullerton Neuro and Headache Ctr
Fullerton, California, United States
University of California Irvine
Irvine, California, United States
CenExcel Clinical Research
Los Alamitos, California, United States
Velocity Clinical Trials
Los Angeles, California, United States
Amicis Research Center
Valencia, California, United States
Regina Berkovich MD PhD Inc
West Hollywood, California, United States
CU Anschutz Med Campus
Aurora, Colorado, United States
Mountain Neuro Research Center PC
Basalt, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Neurology of Central FL Res Ctr
Altamonte Springs, Florida, United States
Neurology Offices Of South Florida
Boca Raton, Florida, United States
Baptist Health South Florida
Boca Raton, Florida, United States
First Choice Neurology
Boca Raton, Florida, United States
University of Florida
Gainesville, Florida, United States
Memorial Healthcare System
Hollywood, Florida, United States
Baptist Health Research Institute
Jacksonville, Florida, United States
Neurology Associates PA
Maitland, Florida, United States
UM Department Of Neurology
Miami, Florida, United States
Elite Clinical Research
Miami, Florida, United States
Reliant Medical Research
Miami, Florida, United States
Aqualane Clinical Research
Naples, Florida, United States
AdventHealth
Orlando, Florida, United States
Orlando Health Clinical Trials
Orlando, Florida, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, United States
Neurostudies Inc
Port Charlotte, Florida, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, United States
Axiom Brain Health
Tampa, Florida, United States
University Of South Florida
Tampa, Florida, United States
Vero Beach Neurology
Vero Beach, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Atlanta NeuroScience Institute
Atlanta, Georgia, United States
Insight Hospital and Medical Center
Chicago, Illinois, United States
Josephson Wallack Munshower Neurology P.C
Indianapolis, Indiana, United States
Univ of Kansas Hosp and Med Ctr
Kansas City, Kansas, United States
Advent Neurology Clinic
Roeland Park, Kansas, United States
Neuro Medial Clinic of Central Louisiana
Alexandria, Louisiana, United States
Delricht Research
New Orleans, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
American Oncology Partners PA Center for Cancer & Blood Disorders
Bethesda, Maryland, United States
International Neurorehab Institute
Lutherville, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Trinity Health Michigan
Grand Rapids, Michigan, United States
Rochester Cent For Behavioral
Rochester Hills, Michigan, United States
WA Uni School Of Med
St Louis, Missouri, United States
Cleveland Clinic Foundation
Las Vegas, Nevada, United States
Hackensack University Medical Ctr
Hackensack, New Jersey, United States
Jersey Shore University Medical Ctr
Neptune City, New Jersey, United States
MS Comprehensive Care Ctr at Holy Name Hospi
Teaneck, New Jersey, United States
Mount Sinai School Of Medicine
New York, New York, United States
South Shore Neurologic Associates
Patchogue, New York, United States
True North Neurology
Port Jefferson, New York, United States
Atrium Health
Charlotte, North Carolina, United States
Velocity Clinical Research
Raleigh, North Carolina, United States
Dayton Center for Neurological Disorders
Centerville, Ohio, United States
University Of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
OSU Medical Center-Martha Morehouse Medical Plaza
Columbus, Ohio, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Neurology Clinic PC
Cordova, Tennessee, United States
University of Tennessee Medical Ctr
Knoxville, Tennessee, United States
Sibyl Wray MD Neurology PC
Knoxville, Tennessee, United States
Vanderbilt Comprehensive Multiple Sclerosis Center
Nashville, Tennessee, United States
Texas Neurology
Dallas, Texas, United States
Neurology Consultants Of Dallas PA
Dallas, Texas, United States
Saturn Research Solutions LLC
Plano, Texas, United States
Sana Research
Arlington, Virginia, United States
Sentara Neuroscience Institute
Virginia Beach, Virginia, United States
Swedish Neuroscience Institute
Seattle, Washington, United States
MultiCare Research Institute for Research and Innovation
Tacoma, Washington, United States
Gamma Therapeutic Center
Greenfield, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Puerto Rico Multiple Sclerosis Ctr
Caguas, , Puerto Rico
Caribbean Center for Clinical Research, Inc
Guaynabo, , Puerto Rico
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Facility Contacts
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Other Identifiers
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COMB157Q12301
Identifier Type: -
Identifier Source: org_study_id