Ireland
--:--IST
Active, not recruiting Phase 3

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

NCT06869785 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2025-03-13
Last updated
2026-08-10

Condition(s) studied

Relapsing Multiple Sclerosis (RMS)

Investigational drug(s) / intervention(s)

Ofatumumab approved doseOfatumumab new dose

Ofatumumab approved dose: Approved dosage

Ofatumumab new dose: New dosage

Study 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

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: * 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). Exclusion Criteria: * 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) Other protocol-defined inclusion/exclusion criteria may apply

Primary outcome measure(s)

  • Ofatumumab plasma pharmacokinetics - area under the curve — Up to 12 weeks

Trial sites (63)

FacilityCityRegionStatus
Alabama Neurology Associates PC Birmingham Alabama
Xenoscience Inc Phoenix Arizona
Ctr for Neurology and Spine Phoenix Arizona
Phoenix Neurological Associates Phoenix Arizona
The Research and Education Inst of Alta Bates Summit Med Grp Berkeley California
Fullerton Neuro and Headache Ctr Fullerton California
University of California Irvine Irvine California
CenExcel Clinical Research Los Alamitos California
Velocity Clinical Trials Los Angeles California
Regina Berkovich MD PhD Inc West Hollywood California
CU Anschutz Med Campus Aurora Colorado
Medstar Washington Hospital Center Washington D.C. District of Columbia
Neurology of Central FL Res Ctr Altamonte Springs Florida
Neurology Offices Of South Florida Boca Raton Florida
First Choice Neurology Boca Raton Florida
University of Florida Gainesville Florida
Memorial Healthcare System Hollywood Florida
Neurology Associates PA Maitland Florida
UM Department Of Neurology Miami Florida
Elite Clinical Research Miami Florida
Aqualane Clinical Research Naples Florida
AdventHealth Orlando Florida
Orlando Health Clinical Trials Orlando Florida
Neurology Associates of Ormond Beach Ormond Beach Florida
Neurostudies Inc Port Charlotte Florida
Tallahassee Neurological Clinic Tallahassee Florida
Axiom Brain Health Tampa Florida
University Of South Florida Tampa Florida
Vero Beach Neurology Vero Beach Florida
Premiere Research Institute West Palm Beach Florida
Atlanta NeuroScience Institute Atlanta Georgia
Josephson Wallack Munshower Neurology PC Indianapolis Indiana
Univ of Kansas Hosp and Med Ctr Kansas City Kansas
Advent Neurology Clinic Roeland Park Kansas
Neuro Medial Clinic of Central Louisiana Alexandria Louisiana
Delricht Research New Orleans Louisiana
Ochsner Clinic Foundation New Orleans Louisiana
Mid Atlantic Epilepsy and Sleep Ctr Bethesda Maryland
International Neurorehab Institute Lutherville Maryland
Henry Ford Hospital Detroit Michigan

+ 23 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06869785 on ClinicalTrials.gov ↗ ← All trials in the USA