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

NCT04353492 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: COMB157G231012019-001341-40
• Study Type: interventional
• Target: 562
• Locations: 24 countries
• Sites: 105

Brief Summary

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.

Conditions

Relapsing Multiple Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Annualized Relapse Rate (ARR)

  ARR is the number of confirmed relapses in a year calculated based on cumulative number of relapses by patient (adjusted for time-in-study by patient). Confirmed relapses are those accompanied by a clinically relevant change in the expanded disability status scale (EDSS). ARR was estimated from fitting a negative binomial regression model with log-link, and adjusted for prior MS therapies as a factor, number of relapses in previous year, baseline EDSS, baseline number of T1 Gd-enhancing lesions and the subject's age at baseline as covariates. The primary analysis describes the ARR with one-sided 95% confidence bound and test for null hypothesis (H0): ARR \>=0.18 versus alternative hypothesis (H1): ARR\<0.18.

  Up to 96 weeks from baseline

Secondary Outcomes (1)

• Number of of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From treatment day 1 to 100 days after last treatment up to approximatelly 26.6 months

Study Arms (1)

Ofatumumab

EXPERIMENTAL

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

Biological: Ofatumumab

Interventions

Ofatumumab BIOLOGICAL

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

Also known as: OMB157

Ofatumumab

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (123)

Fullerton Neuro and Headache Ctr

Fullerton, California, 92835, United States

Location

CU Anschutz Med Campus

Aurora, Colorado, 80045, United States

Location

Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Memorial Healthcare System

Hollywood, Florida, 33021, United States

Location

Homestead Assoc In Research Inc

Homestead, Florida, 33033, United States

Location

Neurology Associates PA

Maitland, Florida, 32751, United States

Location

UM Department Of Neurology

Miami, Florida, 33136, United States

Location

Negroski Neurology

Sarasota, Florida, 34233, United States

Location

Axiom Clinical Research of Florida

Tampa, Florida, 33609, United States

Location

University Of South Florida

Tampa, Florida, 33612, United States

Location

Premiere Research Institute

West Palm Beach, Florida, 33407, United States

Location

Atlanta Neuroscience Institute

Atlanta, Georgia, 30327, United States

Location

Georgia Neurology and Sleep Medicine Assoc

Suwanee, Georgia, 30024, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Cleveland Clinic Foundation

Las Vegas, Nevada, 89106, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131-0001, United States

Location

Five Towns Neuroscience Research

Woodmere, New York, 11598, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Columbus Neuroscience

Westerville, Ohio, 43082, United States

Location

Multiple Sclerosis Center of Excellence of OMRF

Oklahoma City, Oklahoma, 73104, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107-5098, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Saturn Research Solutions LLC

Plano, Texas, 75024, United States

Location

INOVA Medical Group

Fairfax, Virginia, 22030, United States

Location

Ascension St Francis Center

Milwaukee, Wisconsin, 53215, United States

Location

Novartis Investigative Site

Rosario, Santa Fe Province, S2000BZL, Argentina

Location

Novartis Investigative Site

Rosario, Santa Fe Province, S2000DSW, Argentina

Location

Novartis Investigative Site

Buenos Aires, C1424BYD, Argentina

Location

Novartis Investigative Site

San Miguel de Tucumán, 4000, Argentina

Location

Novartis Investigative Site

New Lambton Heights, New South Wales, 2305, Australia

Location

Novartis Investigative Site

Woolloongabba, Queensland, 4102, Australia

Location

Novartis Investigative Site

Parkville, Victoria, 3050, Australia

Location

Novartis Investigative Site

Linz, Upper Austria, A 4020, Austria

Location

Novartis Investigative Site

Vienna, Vienna, 1010, Austria

Location

Novartis Investigative Site

Linz, 4020, Austria

Location

Novartis Investigative Site

Vienna, 1090, Austria

Location

Novartis Investigative Site

Bruges, 8000, Belgium

Location

Novartis Investigative Site

Brussels, 1200, Belgium

Location

Novartis Investigative Site

Edegem, 2650, Belgium

Location

Novartis Investigative Site

Pleven, Bulgaria, 5800, Bulgaria

Location

Novartis Investigative Site

Sofia, Bulgaria, 1431, Bulgaria

Location

Novartis Investigative Site

Pleven, 5800, Bulgaria

Location

Novartis Investigative Site

Sofia, 1113, Bulgaria

Location

Novartis Investigative Site

Sofia, 1431, Bulgaria

Location

Novartis Investigative Site

Toronto, Ontario, M4N 3M5, Canada

Location

Novartis Investigative Site

Brno, 602 00, Czechia

Location

Novartis Investigative Site

Havířov, 736 01, Czechia

Location

Novartis Investigative Site

Hradec Králové, 500 05, Czechia

Location

Novartis Investigative Site

Prague, 128 08, Czechia

Location

Novartis Investigative Site

Teplice, 415 29, Czechia

Location

Novartis Investigative Site

Tallinn, 11315, Estonia

Location

Novartis Investigative Site

Tartu, 50406, Estonia

Location

Novartis Investigative Site

Munich, Bavaria, 81377, Germany

Location

Novartis Investigative Site

Cottbus, Brandenburg, 03048, Germany

Location

Novartis Investigative Site

Osnabrück, Lower Saxony, 49076, Germany

Location

Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50935, Germany

Location

Novartis Investigative Site

Bielefeld, 33647, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

Leipzig, 04275, Germany

Location

Novartis Investigative Site

Potsdam, 14471, Germany

Location

Novartis Investigative Site

Siegen, 57076, Germany

Location

Novartis Investigative Site

Ulm, 89073, Germany

Location

Novartis Investigative Site

Ulm, 89081, Germany

Location

Novartis Investigative Site

Westerstede Olden, 26655, Germany

Location

Novartis Investigative Site

Larissa, 411 10, Greece

Location

Novartis Investigative Site

Thessaloniki, 53246, Greece

Location

Novartis Investigative Site

Thessaloniki, GR 54636, Greece

Location

Novartis Investigative Site

Budapest, HUN, 1135, Hungary

Location

Novartis Investigative Site

Budapest, 1138, Hungary

Location

Novartis Investigative Site

Budapest, 1204, Hungary

Location

Novartis Investigative Site

Pécs, 7623, Hungary

Location

Novartis Investigative Site

Florence, FI, 50134, Italy

Location

Novartis Investigative Site

Pavia, PV, 27100, Italy

Location

Novartis Investigative Site

Roma, RM, 00152, Italy

Location

Novartis Investigative Site

Verona, VR, 37134, Italy

Location

Novartis Investigative Site

Riga, LV, LV-1005, Latvia

Location

Novartis Investigative Site

Riga, LV 1002, Latvia

Location

Novartis Investigative Site

Beirut, 113-0236, Lebanon

Location

Novartis Investigative Site

Beirut, 166830, Lebanon

Location

Novartis Investigative Site

Beirut, 8610, Lebanon

Location

Novartis Investigative Site

Mexico City, Mexico City, 03100, Mexico

Location

Novartis Investigative Site

Mexico City, Mexico City, 06700, Mexico

Location

Novartis Investigative Site

Morelia, Michoacán, 58260, Mexico

Location

Novartis Investigative Site

Oslo, NO-0407, Norway

Location

Novartis Investigative Site

Bydgoszcz, Woj Kujawsko Pomorskie, 85-796, Poland

Location

Novartis Investigative Site

Katowice, 40-571, Poland

Location

Novartis Investigative Site

Kielce, 25 726, Poland

Location

Novartis Investigative Site

Lodz, 90-153, Poland

Location

Novartis Investigative Site

Wroclaw, 51-685, Poland

Location

Novartis Investigative Site

Braga, 4710243, Portugal

Location

Novartis Investigative Site

Lisbon, 1349-019, Portugal

Location

Novartis Investigative Site

Loures, 2674-514, Portugal

Location

Novartis Investigative Site

Porto, 4099-001, Portugal

Location

Novartis Investigative Site

Moscow, 115516, Russia

Location

Novartis Investigative Site

Moscow, 127015, Russia

Location

Novartis Investigative Site

Saint Petersburg, 190000, Russia

Location

Novartis Investigative Site

Riyadh, SAU, 11525, Saudi Arabia

Location

Novartis Investigative Site

Jeddah, 21499, Saudi Arabia

Location

Novartis Investigative Site

Banská Bystrica, Slovakia, 975 17, Slovakia

Location

Novartis Investigative Site

Bratislava, Slovakia, 813 69, Slovakia

Location

Novartis Investigative Site

Bratislava, Slovakia, 826 06, Slovakia

Location

Novartis Investigative Site

Bratislava, Slovakia, 833 05, Slovakia

Location

Novartis Investigative Site

Košice, Slovakia, 041 90, Slovakia

Location

Novartis Investigative Site

Nitra, Slovakia, 950 01, Slovakia

Location

Novartis Investigative Site

Trnava, Slovakia, 917 02, Slovakia

Location

Novartis Investigative Site

Maribor, Slovenia, 2000, Slovenia

Location

Novartis Investigative Site

Ljubljana, 1000, Slovenia

Location

Novartis Investigative Site

Seville, Andalusia, 41009, Spain

Location

Novartis Investigative Site

El Palmar, Murcia, 30120, Spain

Location

Novartis Investigative Site

Santa Cruz, Santa Cruz de Tenerife, 38009, Spain

Location

Novartis Investigative Site

Barakaldo, Vizcaya, 48903, Spain

Location

Novartis Investigative Site

Barcelona, 08041, Spain

Location

Novartis Investigative Site

Madrid, 28040, Spain

Location

Novartis Investigative Site

Valencia, 46010, Spain

Location

Novartis Investigative Site

Valencia, 46026, Spain

Location

Novartis Investigative Site

Basel, 4031, Switzerland

Location

Novartis Investigative Site

Samsun, Atakum, 55200, Turkey (Türkiye)

Location

Novartis Investigative Site

Istanbul, Fatih, 34098, Turkey (Türkiye)

Location

Novartis Investigative Site

Trabzon, Ortahisar, 61080, Turkey (Türkiye)

Location

Novartis Investigative Site

Istanbul, Sancaktepe, 34785, Turkey (Türkiye)

Location

Novartis Investigative Site

Izmir, 35100, Turkey (Türkiye)

Location

Novartis Investigative Site

Cardiff, CF14 4XW, United Kingdom

Location

Novartis Investigative Site

Swansea, SA2 8QA, United Kingdom

Location

Related Links

• A Plain Language Trial Summary is available on www.novctrd.com

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

+ 1 862 778 8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 20, 2020
• Study Start: July 14, 2020
• Primary Completion: October 9, 2024
• Study Completion: March 11, 2025
• Last Updated: April 9, 2026
• Results First Posted: November 12, 2025

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

HU (4); SA (2); IT (4); CH (1); CA (1); NO (1); TU (5); AU (4); CZ (5); LE (3); BU (5); GR (3); BE (3); DE (12); PL (5); RU (3); PT (4); ES (2); LA (2); US (25); SL (2); AR (4); GB (2); ME (3)