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

Last Update: Dec 17, 2025

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

ClinicalTrials.gov Identifier:

NCT06869785

Novartis Reference Number:COMB157Q12301

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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. This is a Phase 3, open label, parallel-group, multicenter study in participants with relapsing multiple sclerosis

Condition

Relapsing Multiple Sclerosis (RMS)

Phase

Phase3

Overall Status

Recruiting

Number of Participants

180

Start Date

Mar 13, 2025

Completion Date

May 26, 2031

Gender

All

Age(s)

18 Years - 100 Years (Adult, Older Adult)

Interventions

Biological

Ofatumumab approved dose

Approved dosage

Biological

Ofatumumab new dose

New dosage

Eligibility Criteria

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

Premiere Research Institute

Recruiting

West Palm Beach,Florida,33407,United States

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

Study Description

Interventions

Ofatumumab approved dose

Ofatumumab new dose

Eligibility Criteria

Premiere Research Institute

Ashley Poulette

Paul K Winner

Jersey Shore University Medical Ctr

Megsome Nyachwaya

Lana Zhovtis Ryerson

Insight Hospital and Medical Center

Taofik Nasrat

Ahmad Alloubani

Swedish Neuroscience Institute

Victoria Levasseur

Gary Brown

True North Neurology

Tiffany Harding

Maryana Liedke

Baptist Health Research Institute

Kalina Sanders

Ranada Arnold

University of Florida

Yaseen Mousa

Torge Rempe

First Choice Neurology

Patricio Espinosa

Olivia Campbell

Jigar Modi

Amy Laitinen

CU Anschutz Med Campus

Melynda Veader

Enrique Alvarez

University of California Irvine

Michael Sy

Ewa Radziszewski

Reliant Medical Research

Carlos Ramirez-Calderon

Yuisy Obregon

Vanderbilt Comprehensive Multiple Sclerosis Center

Taegan Vinarsky

Francesca Bagnato

Cleveland Clinic Foundation

Brittany Fisher

Alise Carlson

Henry Ford Hospital

Theresa Holmes

Mirela Cerghet

AdventHealth

Ciara Kelly

Anita Fletcher

CenExcel Clinical Research

Nirav Patel

Anne Cabral

Gilbert Neurology

Jessica Padilla

Ajo Joy

Atrium Health

Mahmoud Abdel Razek

Catherine Tsoulos

Cleveland Clinic Foundation

Le Hanh Hua

Angel Hendrix

Rochester Cent For Behavioral

Esther Young

Lindsay Dehnbostel

Regina Berkovich MD PhD Inc

Sofiia Henyk

Regina Berkovich

MultiCare Research Institute for Research and Innovation

Tonya Stigger

Stacy Donlon

MS Comprehensive Care Ctr at Holy Name Hospi

Diome Kramer

Asya Wallach

Vero Beach Neurology

Stuart Shafer

Clellia Bergamino