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An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab

NCT ID: NCT04353492

Last Updated: 2025-11-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

562 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-14

Study Completion Date

2025-03-11

Brief Summary

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Open-label study to evaluate the effectiveness of treatment with ofatumumab in subjects transitioning from any fumarate-based RMS approved therapy or fingolimod due to breakthrough disease.

Detailed Description

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This was a single arm, prospective, multicentre and open-label, 96-week study to evaluate the treatment effectiveness of ofatumumab (OMB) in subjects with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies, such as dimethyl fumarate (DMF), diroximel fumarate (DRF), and monomethyl fumarate (MMF), or fingolimod due to breakthrough disease activity.

Conditions

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Relapsing Multiple Sclerosis

Keywords

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RMS MS multiple sclerosis relapsing multiple sclerosis OMB157 adult secondary progressive MS SPMS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ofatumumab

Ofatumumab 20 mg subcutaneous injections every 4 weeks, following loading of 3 doses in the first 14 days

Group Type EXPERIMENTAL

Ofatumumab

Intervention Type BIOLOGICAL

Subjects will receive ofatumumab injections in an autoinjector (AI) for subcutaneous administration containing 20 mg ofatumumab (50 mg/ml, 0.4 ml content)

Interventions

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Ofatumumab

Subjects will receive ofatumumab injections in an autoinjector (AI) for subcutaneous administration containing 20 mg ofatumumab (50 mg/ml, 0.4 ml content)

Intervention Type BIOLOGICAL

Other Intervention Names

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OMB157

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of MS according to the 2017 Revised McDonald criteria
* Relapsing MS: relapsing forms of MS (RMS) including RMS and secondary progressive MS (SPMS)
* Disability status at screening defined by Expanded Disability Status Scale (EDSS) score of 0 to 4 (inclusive)
* MS treatment history with a maximum of 3 Disease Modifying Therapies (DMTs), where all fumarates are considered as one DMT
* Subject transitioning from either any fumarate-based RMS approved therapies, such as dimethyl fumarate (DMF) or diroximel fumarate (DRF), or fingolimod which was administered for a period of at least 6 months, as their last DMT before first study drug administration
* Breakthrough disease activity while the participant was adequately using fumarates or fingolimod prior to transitioning for a minimum of 6 months as evidenced by one or more clinically reported relapses or one or more signs of Magnetic Resonance Imaging (MRI) activity (e.g. Gd+ enhancement, new or enlarging T2 lesions)
* Neurologically stable within one month prior to first study drug administration

Exclusion Criteria

* Subjects with primary progressive MS or SPMS without disease activity
* Subjects meeting criteria for neuromyelitis optica
* Disease duration of more than 10 years since diagnosis
* Pregnant or nursing (lactating) women
* Women of child-bearing potential unless they are using highly effective forms of contraception during dosing and for at least 6 months after stopping study medication
* Subjects with active chronic disease of the immune system other than MS or with immunodeficiency syndrome
* Subjects with active systemic bacterial, fungal or viral infections (such as hepatitis, HIV, COVID-19), or known to have Acquired Immunodeficiency Syndrome (AIDS)
* Subjects with neurological symptoms consistent with Progressive Multifocal Leukoencephalopathy (PML) or with confirmed PML
* Subjects at risk of developing or having reactivation of syphilis or tuberculosis (e.g. subjects with known exposure to, or history of syphilis, or active or latent tuberculosis, even if previously treated), as confirmed by medical history or per local practice
* Subjects with active hepatitis B and C disease, assessed locally
* Have received any live or live-attenuated vaccines within 4 weeks prior to first study drug administration
* Have been treated with medications as specified or within timeframes specified (e.g. corticosteroids, ofatumumab, rituximab, ocrelizumab, alemtuzumab, natalizumab, daclizumab, cyclophosphamide, teriflunomide etc.)
* Subjects suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the investigator
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fullerton Neuro and Headache Ctr

Fullerton, California, United States

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CU Anschutz Med Campus

Aurora, Colorado, United States

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Christiana Care Health Services

Newark, Delaware, United States

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Memorial Healthcare System

Hollywood, Florida, United States

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Homestead Assoc In Research Inc

Homestead, Florida, United States

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Neurology Associates PA

Maitland, Florida, United States

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UM Department Of Neurology

Miami, Florida, United States

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Negroski Neurology

Sarasota, Florida, United States

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Axiom Clinical Research of Florida

Tampa, Florida, United States

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University Of South Florida

Tampa, Florida, United States

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Premiere Research Institute

West Palm Beach, Florida, United States

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Atlanta Neuroscience Institute

Atlanta, Georgia, United States

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Georgia Neurology and Sleep Medicine Assoc

Suwanee, Georgia, United States

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Johns Hopkins Hospital

Baltimore, Maryland, United States

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Cleveland Clinic Foundation

Las Vegas, Nevada, United States

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University of New Mexico

Albuquerque, New Mexico, United States

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Five Towns Neuroscience Research

Woodmere, New York, United States

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

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Columbus Neuroscience

Westerville, Ohio, United States

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Multiple Sclerosis Center of Excellence of OMRF

Oklahoma City, Oklahoma, United States

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Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

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Baylor College of Medicine

Houston, Texas, United States

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Saturn Research Solutions LLC

Plano, Texas, United States

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INOVA Medical Group

Fairfax, Virginia, United States

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Ascension St Francis Center

Milwaukee, Wisconsin, United States

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Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

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Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

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Novartis Investigative Site

Buenos Aires, , Argentina

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San Miguel de Tucumán, , Argentina

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New Lambton Heights, New South Wales, Australia

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Woolloongabba, Queensland, Australia

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Parkville, Victoria, Australia

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Linz, Upper Austria, Austria

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Vienna, Vienna, Austria

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Linz, , Austria

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Vienna, , Austria

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Bruges, , Belgium

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Brussels, , Belgium

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Edegem, , Belgium

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Pleven, Bulgaria, Bulgaria

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Sofia, Bulgaria, Bulgaria

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Pleven, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Toronto, Ontario, Canada

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Brno, , Czechia

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Havířov, , Czechia

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Hradec Králové, , Czechia

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Prague, , Czechia

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Teplice, , Czechia

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Tallinn, , Estonia

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Tartu, , Estonia

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Munich, Bavaria, Germany

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Cottbus, Brandenburg, Germany

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Osnabrück, Lower Saxony, Germany

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Cologne, North Rhine-Westphalia, Germany

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Bielefeld, , Germany

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Heidelberg, , Germany

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Leipzig, , Germany

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Potsdam, , Germany

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Siegen, , Germany

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Ulm, , Germany

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Ulm, , Germany

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Westerstede Olden, , Germany

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Larissa, , Greece

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Thessaloniki, , Greece

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Thessaloniki, , Greece

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Budapest, HUN, Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Pécs, , Hungary

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Florence, FI, Italy

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Pavia, PV, Italy

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Roma, RM, Italy

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Verona, VR, Italy

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Riga, LV, Latvia

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Riga, , Latvia

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Beirut, , Lebanon

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Beirut, , Lebanon

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Beirut, , Lebanon

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Mexico City, Mexico City, Mexico

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Mexico City, Mexico City, Mexico

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Morelia, Michoacán, Mexico

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Oslo, , Norway

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Bydgoszcz, Woj Kujawsko Pomorskie, Poland

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Katowice, , Poland

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Kielce, , Poland

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Lodz, , Poland

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Wroclaw, , Poland

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Braga, , Portugal

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Lisbon, , Portugal

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Loures, , Portugal

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Porto, , Portugal

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Moscow, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Riyadh, SAU, Saudi Arabia

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Jeddah, , Saudi Arabia

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Banská Bystrica, Slovakia, Slovakia

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Bratislava, Slovakia, Slovakia

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Bratislava, Slovakia, Slovakia

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Bratislava, Slovakia, Slovakia

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Košice, Slovakia, Slovakia

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Nitra, Slovakia, Slovakia

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Trnava, Slovakia, Slovakia

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Maribor, Slovenia, Slovenia

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Ljubljana, , Slovenia

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Seville, Andalusia, Spain

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El Palmar, Murcia, Spain

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Santa Cruz, Santa Cruz de Tenerife, Spain

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Barakaldo, Vizcaya, Spain

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Barcelona, , Spain

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Madrid, , Spain

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Valencia, , Spain

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Valencia, , Spain

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Basel, , Switzerland

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Samsun, Atakum, Turkey (Türkiye)

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Istanbul, Fatih, Turkey (Türkiye)

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Trabzon, Ortahisar, Turkey (Türkiye)

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Istanbul, Sancaktepe, Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Cardiff, , United Kingdom

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Novartis Investigative Site

Swansea, , United Kingdom

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Countries

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United States Argentina Australia Austria Belgium Bulgaria Canada Czechia Estonia Germany Greece Hungary Italy Latvia Lebanon Mexico Norway Poland Portugal Russia Saudi Arabia Slovakia Slovenia Spain Switzerland Turkey (Türkiye) United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2019-001341-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

COMB157G23101

Identifier Type: -

Identifier Source: org_study_id