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

Last Update: Oct 27, 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

Puerto Rico Multiple Sclerosis Ctr

Recruiting

Caguas,00926,Puerto Rico

Phone: +1 787 930 1705

Jose Avila-Ornelas

Caribbean Center for Clinical Research, Inc

Recruiting

Guaynabo,00968,Puerto Rico

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

Study Description

Interventions

Ofatumumab approved dose

Ofatumumab new dose

Eligibility Criteria

Puerto Rico Multiple Sclerosis Ctr

Jose Avila-Ornelas

Caribbean Center for Clinical Research, Inc

Angel R Chinea Martinez

Viviana Martinez-Maldonado

Alabama Neurology Associates PC

Bess Martin

Emily Sherill Riser

Xenoscience Inc

Megan Hamilton

Stephen Flitman

Phoenix Neurological Associates

Barry Hendin

Brandon McCravey

Emily Trejo

Rebecca Jones

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

Canary Jumawan

Deepak Soneji

Fullerton Neuro and Headache Ctr

Jack H Florin

Vanessa Mariscal

University of California Irvine

Michael Sy

Velocity Clinical Trials

Deanna Mondero

Oliver Achi

Regina Berkovich MD PhD Inc

Emily Katsnelson

Regina Berkovich

CU Anschutz Med Campus

Enrique Alvarez

Taylor Knox

Mountain Neuro Research Center PC

Alison Brooke Allen

Mary Michelle Koboski

Washington Hospital Center

Brian Barry

Yemisrach Tadesse

Neurology of Central FL Res Ctr

Alicia V Cabrera

Rafael Pelaez

Neurology Offices Of South Florida

Brian Steingo

Tom Voulgaris

First Choice Neurology

Amy Laitinen

Emaad Mirza

Margaret Scott

Patricio Espinosa

University of Florida

Torge Rempe

Memorial Healthcare System

Belkis Wandique Rapalo

Buse Sengul

Neurology Associates PA

Federico Santana

William David Honeycutt

UM Department Of Neurology

Maria Casanova

Silvia R Delgado

Elite Clinical Research

Alina Salazar

Gelasio A Baras

Aqualane Clinical Research

Brittany Cordero

Matthew J Baker

Orlando Health Clinical Trials

Amparo Gutierrez

Thomas Melendez

Neurology Associates of Ormond Beach

Heather Schutz

James Scott

Neurostudies Inc