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

Last Update: Jun 05, 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

Velocity Clinical Trials

Deanna Mondero

Oliver Achi

Memorial Hospital

Buse Sengul

Belkis Wandique Rapalo

Neurology Clinic PC

Kendrick K Henderson

Vickie Johnson

Axiom Brain Health

Matthew Cagney

Mark Cascione

Sibyl Wray MD Neurology PC

Kim Puccio

Sibyl Wray

Regina Berkovich MD PhD Inc

Regina Berkovich

Emily Katsnelson

WA Uni School Of Med

Katherine Bircher

Robert Naismith

Aqualane Clinical Research

Matthew J Baker

Eve Cowens

Alabama Neurology Associates PC

Emily Sherill Riser

Bess Martin

Delricht Research

Jon Olson

Kandice Lemoine

Washington Hospital Center

Brian Barry

Yemisrach Tadesse

Ctr for Neurology and Spine

Rebecca Jones

Barry Hendin

Brandon Mc Cravey

Emily Trejo

Ms Center Of Atlanta

Brianna Moses

Joash Theophilus Lazarus

University Of South Florida

Natalie Moreo

Pamela Acosta Torres

Neurology Offices Of South Florida

Brian Steingo

Tom Voulgaris

Neurology Associates of Ormond Beach

James Scott

Teresa Hartman

Xenoscience Inc

Mona Dever

Stephen Flitman

Mountain Neuro Research Center PC

Alison Brooke Allen

Mary Michelle Koboski

CenExcel Clinical Research

Hanna Voltattorni

Nirav Patel

MS Comprehensive Care Ctr at Holy Name Hospi

Asya Wallach

Diana Naylor

Sana Research

Henry Tran

Victoria Mantyla

Mid Atlantic Epilepsy and Sleep Ctr

Jonathan Ross

Salman Hashmi

Neurology of Central FL Res Ctr