Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab

NCT06869785 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: COMB157Q12301
• Study Type: interventional
• Target: 196
• Locations: 2 countries
• Sites: 63

Brief 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.

Conditions

Relapsing Multiple Sclerosis (RMS)

Keywords

Relapsing Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Ofatumumab plasma pharmacokinetics - area under the curve

  Up to 12 weeks

Secondary Outcomes (5)

• Ofatumumab plasma pharmacokinetics - minimum observed plasma concentration

  Up to 12 weeks

• Ofatumumab plasma pharmacokinetics - maximum observed plasma concentration

  Up to 12 weeks

• Incidence of Adverse events (AE) and Serious adverse events (SAE)

  Up to 52 weeks

• Proportion of participants with anti-drug antibodies

  Up to 52 weeks

• Participant B cell counts

  Up to 52 weeks

Study Arms (2)

Ofatumumab dose 1

ACTIVE COMPARATOR

Approved dosage

Biological: Ofatumumab approved dose; Biological: Ofatumumab new dose

Ofatumumab dose 2

EXPERIMENTAL

New dosage

Biological: Ofatumumab new dose

Interventions

Ofatumumab approved dose BIOLOGICAL

Approved dosage

Ofatumumab dose 1

Ofatumumab new dose BIOLOGICAL

New dosage

Ofatumumab dose 1; Ofatumumab dose 2

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Participants suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the Investigator or emergence of any clinically significant condition/disease (e.g. active systemic bacterial, viral or fungal infections) during screening prior to Day 1 which might result in safety risk for participants.
• 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)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (63)

Alabama Neurology Associates PC

Birmingham, Alabama, 35209, United States

Location

Xenoscience Inc

Phoenix, Arizona, 85004, United States

Location

Ctr for Neurology and Spine

Phoenix, Arizona, 85018, United States

Location

Phoenix Neurological Associates

Phoenix, Arizona, 85018, United States

Location

The Research and Education Inst. of Alta Bates Summit Med. Grp

Berkeley, California, 94705, United States

Location

Fullerton Neuro and Headache Ctr

Fullerton, California, 92835, United States

Location

University of California Irvine

Irvine, California, 92697, United States

Location

CenExcel Clinical Research

Los Alamitos, California, 90720, United States

Location

Velocity Clinical Trials

Los Angeles, California, 90057, United States

Location

Regina Berkovich MD PhD Inc

West Hollywood, California, 90048, United States

Location

CU Anschutz Med Campus

Aurora, Colorado, 80045, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Neurology of Central FL Res Ctr

Altamonte Springs, Florida, 32714, United States

Location

Neurology Offices Of South Florida

Boca Raton, Florida, 33428, United States

Location

First Choice Neurology

Boca Raton, Florida, 33486, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Memorial Healthcare System

Hollywood, Florida, 33021, United States

Location

Neurology Associates PA

Maitland, Florida, 32751, United States

Location

UM Department Of Neurology

Miami, Florida, 33136, United States

Location

Elite Clinical Research

Miami, Florida, 33144, United States

Location

Aqualane Clinical Research

Naples, Florida, 34105, United States

Location

AdventHealth

Orlando, Florida, 32804, United States

Location

Orlando Health Clinical Trials

Orlando, Florida, 32806, United States

Location

Neurology Associates of Ormond Beach

Ormond Beach, Florida, 32174, United States

Location

Neurostudies Inc

Port Charlotte, Florida, 33952, United States

Location

Tallahassee Neurological Clinic

Tallahassee, Florida, 32308, United States

Location

Axiom Brain Health

Tampa, Florida, 33609, United States

Location

University Of South Florida

Tampa, Florida, 33612, United States

Location

Vero Beach Neurology

Vero Beach, Florida, 32960, United States

Location

Premiere Research Institute

West Palm Beach, Florida, 33407, United States

Location

Atlanta NeuroScience Institute

Atlanta, Georgia, 30327, United States

Location

Josephson Wallack Munshower Neurology PC

Indianapolis, Indiana, 46256, United States

Location

Univ of Kansas Hosp and Med Ctr

Kansas City, Kansas, 66160, United States

Location

Advent Neurology Clinic

Roeland Park, Kansas, 66205, United States

Location

Neuro Medial Clinic of Central Louisiana

Alexandria, Louisiana, 71301, United States

Location

Delricht Research

New Orleans, Louisiana, 70115, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Mid Atlantic Epilepsy and Sleep Ctr

Bethesda, Maryland, 20817-1807, United States

Location

International Neurorehab Institute

Lutherville, Maryland, 21093, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202-2689, United States

Location

Rochester Cent For Behavioral

Rochester Hills, Michigan, 48307, United States

Location

WA Uni School Of Med

St Louis, Missouri, 63110, United States

Location

Cleveland Clinic Foundation

Las Vegas, Nevada, 89106, United States

Location

Hackensack University Medical Ctr

Hackensack, New Jersey, 07601, United States

Location

South Shore Neurologic Associates

Patchogue, New York, 11772, United States

Location

True North Neurology

Port Jefferson, New York, 11776, United States

Location

Velocity Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Dayton Center for Neurological Disorders

Centerville, Ohio, 45459, United States

Location

University Of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

OSU Medical Center-Martha Morehouse Medical Plaza

Columbus, Ohio, 43221, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107-5098, United States

Location

Neurology Clinic PC

Cordova, Tennessee, 38018, United States

Location

University of Tennessee Medical Ctr

Knoxville, Tennessee, 37920, United States

Location

Sibyl Wray MD Neurology PC

Knoxville, Tennessee, 37922, United States

Location

Neurology Consultants Of Dallas PA

Dallas, Texas, 75231, United States

Location

Saturn Research Solutions LLC

Plano, Texas, 75024, United States

Location

Sana Research

Arlington, Virginia, 22205, United States

Location

Sentara Neuroscience Institute

Virginia Beach, Virginia, 23456, United States

Location

Swedish Neuroscience Institute

Seattle, Washington, 98122, United States

Location

MultiCare Research Institute for Research and Innovation

Tacoma, Washington, 98405, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Puerto Rico Multiple Sclerosis Ctr

Caguas, 00725, Puerto Rico

Location

Caribbean Center for Clinical Research, Inc

Guaynabo, 00968, Puerto Rico

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 11, 2025
• Study Start: March 13, 2025
• Primary Completion: January 28, 2026
• Study Completion (Estimated): March 23, 2030
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (61); PR (2)