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
RECRUITING
Gilbert
Ctr for Neurology and Spine
ACTIVE_NOT_RECRUITING
Phoenix
Phoenix Neurological Associates
ACTIVE_NOT_RECRUITING
Phoenix
Xenoscience Inc
ACTIVE_NOT_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
CenExcel Clinical Research
RECRUITING
Los Alamitos
Velocity Clinical Trials
ACTIVE_NOT_RECRUITING
Los Angeles
Amicis Research Center
WITHDRAWN
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
ACTIVE_NOT_RECRUITING
Washington D.c.
Florida
Neurology of Central FL Res Ctr
ACTIVE_NOT_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
Baptist Health Research Institute
RECRUITING
Jacksonville
Neurology Associates PA
RECRUITING
Maitland
Elite Clinical Research
RECRUITING
Miami
Reliant Medical Research
RECRUITING
Miami
UM Department Of Neurology
ACTIVE_NOT_RECRUITING
Miami
Aqualane Clinical Research
ACTIVE_NOT_RECRUITING
Naples
AdventHealth
RECRUITING
Orlando
Orlando Health Clinical Trials
ACTIVE_NOT_RECRUITING
Orlando
Neurology Associates of Ormond Beach
ACTIVE_NOT_RECRUITING
Ormond Beach
Neurostudies Inc
RECRUITING
Port Charlotte
Tallahassee Neurological Clinic
ACTIVE_NOT_RECRUITING
Tallahassee
Axiom Brain Health
ACTIVE_NOT_RECRUITING
Tampa
University Of South Florida
RECRUITING
Tampa
Vero Beach Neurology
RECRUITING
Vero Beach
Premiere Research Institute
RECRUITING
West Palm Beach
Cleveland Clinic Florida
WITHDRAWN
Weston
Georgia
Atlanta NeuroScience Institute
ACTIVE_NOT_RECRUITING
Atlanta
Illinois
Insight Hospital and Medical Center
RECRUITING
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
RECRUITING
Detroit
Trinity Health Michigan
WITHDRAWN
Grand Rapids
Rochester Cent For Behavioral
RECRUITING
Rochester Hills
Missouri
WA Uni School Of Med
ACTIVE_NOT_RECRUITING
St Louis
North Carolina
Atrium Health
RECRUITING
Charlotte
Velocity Clinical Research
ACTIVE_NOT_RECRUITING
Raleigh
New Jersey
Hackensack University Medical Ctr
ACTIVE_NOT_RECRUITING
Hackensack
Jersey Shore University Medical Ctr
RECRUITING
Neptune City
MS Comprehensive Care Ctr at Holy Name Hospi
RECRUITING
Teaneck
Nevada
Cleveland Clinic Foundation
RECRUITING
Las Vegas
New York
Mount Sinai School Of Medicine
RECRUITING
New York
South Shore Neurologic Associates
ACTIVE_NOT_RECRUITING
Patchogue
True North Neurology
RECRUITING
Port Jefferson
Ohio
Dayton Center for Neurological Disorders
ACTIVE_NOT_RECRUITING
Centerville
University Of Cincinnati
ACTIVE_NOT_RECRUITING
Cincinnati
Cleveland Clinic Foundation
RECRUITING
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
RECRUITING
Knoxville
Vanderbilt Comprehensive Multiple Sclerosis Center
RECRUITING
Nashville
Texas
Neurology Consultants Of Dallas PA
ACTIVE_NOT_RECRUITING
Dallas
Texas Neurology
WITHDRAWN
Dallas
Saturn Research Solutions LLC
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