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

Last Update: Jul 08, 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

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

Caribbean Center for Clinical Research, Inc

Braulimar Marchand

Angel R Chinea Martinez

Puerto Rico Multiple Sclerosis Ctr

Jose Avila-Ornelas

Neurology Offices Of South Florida

Tom Voulgaris

Brian Steingo

Memorial Hospital

Belkis Wandique Rapalo

Buse Sengul

Regina Berkovich MD PhD Inc

Regina Berkovich

Emily Katsnelson

Ctr for Neurology and Spine

Rebecca Jones

Emily Trejo

Brandon Mc Cravey

Barry Hendin

Xenoscience Inc

Stephen Flitman

Megan Hamilton

Alabama Neurology Associates PC

Emily Sherill Riser

Bess Martin

MultiCare Research Institute for Research and Innovation

Stacy Donlon

CenExcel Clinical Research

Nirav Patel

Hanna Voltattorni

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

Canary Jumawan

Deepak Soneji

University of Tennessee Medical Ctr

Ghaida Zaid

Mount Sinai School Of Medicine

Nicole Graziano

Fred Lublin

Henry Ford Hospital

Mirela Cerghet

Neurology Associates PA

William David Honeycutt

Kyra Aviles

First Choice Neurology

Emaad Mirza

Patricio Espinosa

Neurology Consultants Of Dallas PA

Melissa Cardoza

Adnan Subei

OSU Medical Center-Martha Morehouse Medical Plaza

Ryan DIckerson

Allison Jordan

Ms Center Of Atlanta

Joash Theophilus Lazarus

Brianna Moses

Neurology Clinic PC

Vickie Johnson

Kendrick K Henderson

Fullerton Neuro and Headache Ctr

Vanessa Mariscal

Jack H Florin

Tallahassee Neurological Clinic

Jeff Devore

Winston Ortiz

Neurology Associates of Ormond Beach

James Scott

Deborah Hrusa

Aqualane Clinical Research

Matthew J Baker

Brittany Cordero

Elite Clinical Research

Gelasio A Baras

Alina Salazar

Mountain Neuro Research Center PC