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 (80) 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
View:
• 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
ACTIVE_NOT_RECRUITING
Birmingham
Arizona
Gilbert Neurology
WITHDRAWN
Gilbert
Ctr for Neurology and Spine
ACTIVE_NOT_RECRUITING
Phoenix
Phoenix Neurological Associates
ACTIVE_NOT_RECRUITING
Phoenix
Xenoscience Inc
COMPLETED
Phoenix
California
The Research and Education Inst. of Alta Bates Summit Med. Grp
ACTIVE_NOT_RECRUITING
Berkeley
Fullerton Neuro and Headache Ctr
ACTIVE_NOT_RECRUITING
Fullerton
University of California Irvine
ACTIVE_NOT_RECRUITING
Irvine
CenExcel Clinical Research
ACTIVE_NOT_RECRUITING
Los Alamitos
Velocity Clinical Trials
ACTIVE_NOT_RECRUITING
Los Angeles
Amicis Research Center
WITHDRAWN
Valencia
Regina Berkovich MD PhD Inc
ACTIVE_NOT_RECRUITING
West Hollywood
Colorado
CU Anschutz Med Campus
ACTIVE_NOT_RECRUITING
Aurora
Mountain Neuro Research Center PC
WITHDRAWN
Basalt
Washington, D.c.
Washington Hospital Center
ACTIVE_NOT_RECRUITING
Washington D.c.
Florida
Neurology of Central FL Res Ctr
ACTIVE_NOT_RECRUITING
Altamonte Springs
Baptist Health South Florida
WITHDRAWN
Boca Raton
First Choice Neurology
ACTIVE_NOT_RECRUITING
Boca Raton
Neurology Offices Of South Florida
ACTIVE_NOT_RECRUITING
Boca Raton
University of Florida
ACTIVE_NOT_RECRUITING
Gainesville
Memorial Healthcare System
RECRUITING
Hollywood
Baptist Health Research Institute
WITHDRAWN
Jacksonville
Neurology Associates PA
ACTIVE_NOT_RECRUITING
Maitland
Elite Clinical Research
RECRUITING
Miami
Reliant Medical Research
WITHDRAWN
Miami
UM Department Of Neurology
ACTIVE_NOT_RECRUITING
Miami
Aqualane Clinical Research
ACTIVE_NOT_RECRUITING
Naples
AdventHealth
ACTIVE_NOT_RECRUITING
Orlando
Orlando Health Clinical Trials
ACTIVE_NOT_RECRUITING
Orlando
Neurology Associates of Ormond Beach
ACTIVE_NOT_RECRUITING
Ormond Beach
Neurostudies Inc
ACTIVE_NOT_RECRUITING
Port Charlotte
Tallahassee Neurological Clinic
ACTIVE_NOT_RECRUITING
Tallahassee
Axiom Brain Health
ACTIVE_NOT_RECRUITING
Tampa
University Of South Florida
ACTIVE_NOT_RECRUITING
Tampa
Vero Beach Neurology
ACTIVE_NOT_RECRUITING
Vero Beach
Premiere Research Institute
ACTIVE_NOT_RECRUITING
West Palm Beach
Cleveland Clinic Florida
WITHDRAWN
Weston
Georgia
Atlanta NeuroScience Institute
ACTIVE_NOT_RECRUITING
Atlanta
Illinois
Insight Hospital and Medical Center
WITHDRAWN
Chicago
Indiana
Josephson Wallack Munshower Neurology P.C
ACTIVE_NOT_RECRUITING
Indianapolis
Kansas
Univ of Kansas Hosp and Med Ctr
ACTIVE_NOT_RECRUITING
Kansas City
Advent Neurology Clinic
ACTIVE_NOT_RECRUITING
Roeland Park
Louisiana
Neuro Medial Clinic of Central Louisiana
ACTIVE_NOT_RECRUITING
Alexandria
Delricht Research
ACTIVE_NOT_RECRUITING
New Orleans
Ochsner Clinic Foundation
ACTIVE_NOT_RECRUITING
New Orleans
Maryland
American Oncology Partners PA Center for Cancer & Blood Disorders
ACTIVE_NOT_RECRUITING
Bethesda
International Neurorehab Institute
ACTIVE_NOT_RECRUITING
Lutherville
Michigan
Henry Ford Hospital
ACTIVE_NOT_RECRUITING
Detroit
Trinity Health Michigan
WITHDRAWN
Grand Rapids
Rochester Cent For Behavioral
ACTIVE_NOT_RECRUITING
Rochester Hills
Missouri
WA Uni School Of Med
ACTIVE_NOT_RECRUITING
St Louis
North Carolina
Atrium Health
WITHDRAWN
Charlotte
Velocity Clinical Research
ACTIVE_NOT_RECRUITING
Raleigh
New Jersey
Hackensack University Medical Ctr
ACTIVE_NOT_RECRUITING
Hackensack
Jersey Shore University Medical Ctr
WITHDRAWN
Neptune City
MS Comprehensive Care Ctr at Holy Name Hospi
WITHDRAWN
Teaneck
Nevada
Cleveland Clinic Foundation
ACTIVE_NOT_RECRUITING
Las Vegas
New York
Mount Sinai School Of Medicine
WITHDRAWN
New York
South Shore Neurologic Associates
ACTIVE_NOT_RECRUITING
Patchogue
True North Neurology
ACTIVE_NOT_RECRUITING
Port Jefferson
Ohio
Dayton Center for Neurological Disorders
ACTIVE_NOT_RECRUITING
Centerville
University Of Cincinnati
ACTIVE_NOT_RECRUITING
Cincinnati
Cleveland Clinic Foundation
WITHDRAWN
Cleveland
OSU Medical Center-Martha Morehouse Medical Plaza
ACTIVE_NOT_RECRUITING
Columbus
Pennsylvania
Thomas Jefferson University Hospital
ACTIVE_NOT_RECRUITING
Philadelphia
Tennessee
Neurology Clinic PC
ACTIVE_NOT_RECRUITING
Cordova
Sibyl Wray MD Neurology PC
ACTIVE_NOT_RECRUITING
Knoxville
University of Tennessee Medical Ctr
ACTIVE_NOT_RECRUITING
Knoxville
Vanderbilt Comprehensive Multiple Sclerosis Center
WITHDRAWN
Nashville
Texas
Neurology Consultants Of Dallas PA
ACTIVE_NOT_RECRUITING
Dallas
Texas Neurology
WITHDRAWN
Dallas
Saturn Research Solutions LLC
ACTIVE_NOT_RECRUITING
Plano
Virginia
Sana Research
ACTIVE_NOT_RECRUITING
Arlington
Sentara Neuroscience Institute
ACTIVE_NOT_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
ACTIVE_NOT_RECRUITING
Milwaukee
Other Locations
Puerto Rico
Puerto Rico Multiple Sclerosis Ctr
ACTIVE_NOT_RECRUITING
Caguas
Caribbean Center for Clinical Research, Inc
ACTIVE_NOT_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