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Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab
Sponsor: Novartis Pharmaceuticals
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
196
Start Date
2025-03-13
Completion Date
2030-03-23
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
Ofatumumab approved dose
Approved dosage
Ofatumumab new dose
New dosage
Locations (63)
Alabama Neurology Associates PC
Birmingham, Alabama, 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
Regina Berkovich MD PhD Inc
West Hollywood, California, United States
CU Anschutz Med Campus
Aurora, 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
First Choice Neurology
Boca Raton, Florida, United States
University of Florida
Gainesville, Florida, United States
Memorial Healthcare System
Hollywood, 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
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
Atlanta NeuroScience Institute
Atlanta, Georgia, United States
Josephson Wallack Munshower Neurology PC
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
Mid Atlantic Epilepsy and Sleep Ctr
Bethesda, Maryland, United States
International Neurorehab Institute
Lutherville, Maryland, United States
Henry Ford Hospital
Detroit, 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
South Shore Neurologic Associates
Patchogue, New York, United States
True North Neurology
Port Jefferson, New York, 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
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
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
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