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

Last Update: Aug 19, 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

Braulimar Marchand

Washington Hospital Center

Brian Barry

Yemisrach Tadesse

Brian Barry

Yemisrach Tadesse

Neurology of Central FL Res Ctr

Alicia Cabrera

Raisa Brana

Raisa Brana

Orlando Health Clinical Trials

Amparo Gutierrez

Mariangelis Floresvega

Thomas Melendez

Sibyl Wray MD Neurology PC

Jenna Strayn

Kim Puccio

Sibyl Wray

Sana Research

Faith Bashore

Henry Tran

Fullerton Neuro and Headache Ctr

Jack H Florin

Vanessa Mariscal

Vanessa Mariscal

Velocity Clinical Trials

Deanna Mondero

Mary Long

Oliver Achi

Mountain Neuro Research Center PC

Alison Brooke Allen

Catherine Vasquez

Mary Michelle Koboski

Elite Clinical Research

Alina Salazar

Gelasio A Baras

Rebeca Fernandez

Aqualane Clinical Research

Brittany Cordero

Brittany Cordero

Matthew J Baker

Neurology Associates of Ormond Beach

Deborah Hrusa

Heather Schutz

James Scott

Tallahassee Neurological Clinic

Jeff Devore

Sabrina Diaz

Winston Ortiz

Axiom Brain Health

Jennifer Fornes

Mark Cascione

Matthew Cagney

University Of South Florida

Aishwarya Aggarwal

Natalie Moreo

Samantha Peralta

Vero Beach Neurology

Christopher Stevens

Christopher Stevens

Stuart Shafer

Josephson Wallack Munshower Neurology P.C

Craig Edward Herrman

Pierre Normington

Skyla Baird

Delricht Research

Jon Olson

Kandice Lemoine

Mid Atlantic Epilepsy and Sleep Ctr

Jonathan Ross