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
Status: Recruiting
Location: See all (65) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
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• 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).
Locations
United States
Alabama
Alabama Neurology Associates PC
RECRUITING
Birmingham
Arizona
Ctr for Neurology and Spine
RECRUITING
Phoenix
Phoenix Neurological Associates
RECRUITING
Phoenix
Xenoscience Inc
RECRUITING
Phoenix
California
The Research and Education Inst. of Alta Bates Summit Med. Grp
RECRUITING
Berkeley
Fullerton Neuro and Headache Ctr
RECRUITING
Fullerton
University of California Irvine
RECRUITING
Irvine
Velocity Clinical Trials
RECRUITING
Los Angeles
Amicis Research Center
RECRUITING
Valencia
Regina Berkovich MD PhD Inc
RECRUITING
West Hollywood
Colorado
CU Anschutz Med Campus
RECRUITING
Aurora
Mountain Neuro Research Center PC
RECRUITING
Basalt
Washington, D.c.
Washington Hospital Center
RECRUITING
Washington D.c.
Florida
Neurology of Central FL Res Ctr
RECRUITING
Altamonte Springs
Baptist Health South Florida
RECRUITING
Boca Raton
First Choice Neurology
RECRUITING
Boca Raton
Neurology Offices Of South Florida
RECRUITING
Boca Raton
University of Florida
RECRUITING
Gainesville
Memorial Healthcare System
RECRUITING
Hollywood
Neurology Associates PA
RECRUITING
Maitland
Elite Clinical Research
RECRUITING
Miami
UM Department Of Neurology
RECRUITING
Miami
Aqualane Clinical Research
RECRUITING
Naples
Orlando Health Clinical Trials
RECRUITING
Orlando
Neurology Associates of Ormond Beach
RECRUITING
Ormond Beach
Neurostudies Inc
RECRUITING
Port Charlotte
Tallahassee Neurological Clinic
RECRUITING
Tallahassee
Axiom Brain Health
RECRUITING
Tampa
University Of South Florida
RECRUITING
Tampa
Vero Beach Neurology
RECRUITING
Vero Beach
Premiere Research Institute
RECRUITING
West Palm Beach
Georgia
Ms Center Of Atlanta
RECRUITING
Atlanta
Indiana
Josephson Wallack Munshower Neurology P.C
RECRUITING
Indianapolis
Kansas
Univ of Kansas Hosp and Med Ctr
RECRUITING
Kansas City
Louisiana
Neuro Medial Clinic of Central Louisiana
RECRUITING
Alexandria
Delricht Research
RECRUITING
New Orleans
Ochsner Clinic Foundation
RECRUITING
New Orleans
Maryland
American Oncology Partners PA Center for Cancer & Blood Disorders
RECRUITING
Bethesda
Michigan
Henry Ford Hospital
RECRUITING
Detroit
Rochester Cent For Behavioral
RECRUITING
Rochester Hills
Missouri
WA Uni School Of Med
RECRUITING
St Louis
North Carolina
Velocity Clinical Research
RECRUITING
Raleigh
New Jersey
Hackensack University Medical Ctr
RECRUITING
Hackensack
MS Comprehensive Care Ctr at Holy Name Hospi
RECRUITING
Teaneck
New York
Mount Sinai School Of Medicine
RECRUITING
New York
True North Neurology
RECRUITING
Port Jefferson
Ohio
Dayton Center for Neurological Disorders
RECRUITING
Centerville
University Of Cincinnati
RECRUITING
Cincinnati
OSU Medical Center-Martha Morehouse Medical Plaza
RECRUITING
Columbus
Pennsylvania
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
Tennessee
Neurology Clinic PC
RECRUITING
Cordova
Sibyl Wray MD Neurology PC
RECRUITING
Knoxville
University of Tennessee Medical Ctr
RECRUITING
Knoxville
Vanderbilt University
RECRUITING
Nashville
Texas
Neurology Consultants Of Dallas PA
RECRUITING
Dallas
Saturn Research Solutions LLC
RECRUITING
Plano
Utah
CenExcel Clinical Research
RECRUITING
Salt Lake City
Virginia
Sana Research
RECRUITING
Falls Church
Sentara Neuroscience Institute
RECRUITING
Virginia Beach
Washington
Swedish Neuroscience Institute
RECRUITING
Seattle
MultiCare Research Institute for Research and Innovation
RECRUITING
Tacoma
Wisconsin
Gamma Therapeutic Center
RECRUITING
Greenfield
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Puerto Rico
Puerto Rico Multiple Sclerosis Ctr
RECRUITING
Caguas
Caribbean Center for Clinical Research, Inc
RECRUITING
Guaynabo
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
Time Frame
Start Date: 2025-03-13
Estimated Completion Date: 2031-05-26
Participants
Target number of participants: 180
Treatments
Active_comparator: Ofatumumab dose 1
Approved dosage
Experimental: Ofatumumab dose 2
New dosage
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals