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

Samsun,55139,Turkey

Novartis Investigative Site

Recruiting

Sancaktepe,Istanbul,34785,Turkey

Novartis Investigative Site

Recruiting

Trabzon,61080,Turkey

Novartis Investigative Site

Recruiting

Istanbul,TUR,34098,Turkey

Novartis Investigative Site

Recruiting

Izmir,35040,Turkey

Novartis Investigative Site

Recruiting

Izmir,35575,Turkey

College Park Family Care Center

Recruiting

Overland Park,Kansas,66210,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

Novartis Investigative Site

Novartis Investigative Site

College Park Family Care Center

Amy L Dix

Jeffrey Kaplan

Georgia Neurology and Sleep Medicine Assoc

David Lesch

Roskamp Institute Inc

Sanjay Yathiraj

Ascension St Francis Center

Sarah Duhr

Bhupendra Khatri

Negroski Neurology

Donald Negroski

University of Alabama at Birmingham

Jennifer Mahaffey

Khurram Bashir

Cleveland Clinic Foundation

Carrie M Hersh

Neurostudies Inc

Patricia Trumble

Liliana Montoya

Velocity Clinical Research

J Michael Hemphill

Josephson Wallack Munshower Neurology P.C

Craig Edward Herrman

Mercy Research

Brenna Reilly

William Logan

Emerald Coast Neurology

David Bear

Aysha McGrath

Premier Neurology

Mary Denise Hughes

Leann Putman

Alpine Clinical Research Center

Paul Brownstone

University Of South Florida

Janaye Brown

Derrick Robertson

Hope Neurology

Sarah Waters

Sibyl Wray

The Neurological Institute PA

Jada Russell

T Hemanth Hemanth Rao

Billings Clinic

Sara Qureshi

Sarah Hall

Neurology Associates of Ormond Beach

Tim Sneed

James Scott

Hawaii Pacific Neuroscience LLC

Kore Liow

Samuel Kim

Rush University Medical Center

Christian Holt

Thomas Shoemaker

Asheville Neurology Specialists PA

Robert Fairborn Armstrong

WA Uni School Of Med

Robert Naismith

North Cntrl Neurology Associates PC

Christopher LaGanke