Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

Last Update: Jul 09, 2024

An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis

ClinicalTrials.gov Identifier:

NCT03650114

Novartis Reference Number:COMB157G2399

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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

The purpose of this study is to collect long-term safety, tolerability, effectiveness and
health outcomes data in eligible subjects who have participated in a Novartis ofatumumab
clinical MS study.

Vaccination sub-study The purpose of this research sub-study is to find out the effects
of ofatumumab on the development of antibody responses to selected vaccines and keyhole
limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS).

Condition

Relapsing Multiple Sclerosis

Phase

Phase3

Overall Status

Recruiting

Number of Participants

2060

Start Date

Dec 28, 2018

Completion Date

Sep 07, 2028

Gender

All

Age(s)

18 Years - 100 Years (Adult, Older Adult)

Interventions

Biological

13-valent pneumococcal conjugate vaccine (13-PCV)

0.5mL Vial/Syringe

Biological

23-valent pneumococcal polysaccharide vaccine (23-PPV)

0.5mL Vial/Syringe

Biological

Keyhole limpet hemocyanin (KLH) neo-antigen

1mg Vial

Biological

Ofatumumab

subcutaneous injection of 20 mg ofatumumab every 4 weeks

Biological

Seasonal Quadrivalent influenza vaccine

Seasonal 2020-2021 0.5mL Vial/Syringe (trivalent may be used where quadrivalent is not available)

Biological

Tetanus toxoid (TT) containing vaccine (Td, Tdap)

0.5mL Vial/Syringe Containing 5 limit of flocculation (LF) tetanus toxoid

Eligibility Criteria

Inclusion Criteria:

1. Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc
every 4 weeks

2. Written informed consent

Exclusion Criteria:

- Emergence of any clinically significant condition/disease during the previous
ofatumumab study in which study participation might result in safety risk for the
subject

- Subjects with active systemic bacterial, viral or fingal infections, or chronic
infection (e.g. AIDS)

- Subjects taking medications prohibited by the protocol

- Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion
criteria may apply

Vaccination sub-study:

Inclusion criteria

1. Informed consent

2. Actively enrolled in the COMB157G2399 Study

3. 12 weeks of continuous treatment within the COMB157G2399 Study

4. prior vaccination history as per protocol-defined

Exclusion criteria

- known hypersensitivity or history of systemic allergic, neurologic or other
reactions to vaccines

- allergies to egg or shellfish

- any safety findings including low IgG/IgM requiring ofatumumab interruption within
12 weeks prior to vaccination sub-study start

- any major episode of infection requiring hospitalization or treatment with
intravenous antibiotics within 2 weeks of the first vaccination sub-study visit

Other protocol-defined inclusion/exclusion criteria may apply

Study Location

Novartis Investigative Site

Recruiting

Sofia,1413,Bulgaria

Novartis Investigative Site

Recruiting

Pecs,7623,Hungary

Novartis Investigative Site

Recruiting

Budapest,1138,Hungary

Novartis Investigative Site

Recruiting

Budapest,1204,Hungary

Novartis Investigative Site

Recruiting

Budapest,HUN,1135,Hungary

Wesley Neurology Clinic

Recruiting

Cordova,Tennessee,38018,United States

Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

Study Description

Interventions

13-valent pneumococcal conjugate vaccine (13-PCV)

23-valent pneumococcal polysaccharide vaccine (23-PPV)

Keyhole limpet hemocyanin (KLH) neo-antigen

Ofatumumab

Seasonal Quadrivalent influenza vaccine

Tetanus toxoid (TT) containing vaccine (Td, Tdap)

Eligibility Criteria

Study Location

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Wesley Neurology Clinic

Kendrick K Henderson

Rhonda Wallace

Multiple Sclerosis Center of Excellence of OMRF

Kellie Kraus

Gabriel Pardo

Alpine Clinical Research Center

Paul Brownstone

Rush University Medical Center

Christian Holt

Thomas Shoemaker

Emerald Coast Neurology

Aysha McGrath

David Bear

Neurostudies Inc

Liliana Montoya

Patricia Trumble

Barrow Neurological Clinics at St Josephs Hospital and MC

Stacey Lent

Aimee Borazanci

University of Alabama at Birmingham

Khurram Bashir

Jennifer Mahaffey

Homestead Associates in Research Inc

Arianna Perez

Angel Carrasco

Premiere Research Institute

Paul K. Winner

College Park Family Care Center

Amy L Dix

Jeffrey Kaplan

Velocity Clinical Research

Sarah Mounib

John Scagnelli

Med Research Inc

Javier Alejandro Vasallo

Diego Vasallo

Neurology Associates of Ormond Beach

James Scott

Tim Sneed

Ascension St Francis Center

Sarah Duhr

Bhupendra Khatri

The Neurological Institute PA

T Hemanth Hemanth Rao

Jada Russell

Georgia Neurology and Sleep Medicine Assoc

David Lesch

Cleveland Clinic Foundation

Carrie M Hersh

University of Miami Miller School of Medicine

Silvia R Delgado

Bettina Daneri

Josephson Wallack Munshower Neurology P.C

Craig Edward Herrman

Negroski Neurology

Donald Negroski

Billings Clinic

Sara Qureshi

Sarah Hall

University of California Davis

Michelle Apperson

Molly Lindsay

Hope Neurology