A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis

Last updated: March 14, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Multiple Sclerosis

Neurologic Disorders

Memory Loss

Treatment

Ofatumumab

Clinical Study ID

NCT04486716
COMB157GUS07
111,116
  • Ages 18-60
  • All Genders

Study Summary

A single arm study evaluating the continued efficacy, safety and tolerability of ofatumumab in patients with relapsing multiple sclerosis who are transitioning from aCD20 mAb therapy

Eligibility Criteria

Inclusion

Inclusion Criteria:

Participants eligible for inclusion in this study must meet all of the following criteria:

  1. Written informed consent must be obtained before any assessment is performed.

  2. Male or female participants aged 18 to 60 years (inclusive) at screening.

  3. Diagnosis of relapsing MS (RMS) according to the 2017 Revised McDonald criteria (Thompson et al. 2018), including CIS, RRMS or SPMS with disease activity as definedby (Lublin et al. 2014).

  4. Disability status at Screening with an EDSS score of 0 to 5.5 (inclusive).

  5. Received at least 2 courses of intravenous aCD20 mAb (loading doses are considered 1course):

• Participants currently treated with ocrelizumab must have received (meet all threecriteria below):

  1. 2 fully infused initial 300 mg ocrelizumab iv infusions 2. At least 1 fully infused 600 mg ocrelizumab iv infusions 6 months (+/- one month) 3. Last fully infusedocrelizumab dose must have occurred within 4-9 months prior to baseline

•Participants currently treated with rituximab must have received (meet both criteria below):

  1. At least 2 fully infused courses of rituximab 500 mg - 1000 mg iv every 6 months (+/- one month).

  2. Initial loading regimens of rituximab i.e. 500 mg - 1000 mg on day 1 and on day 15, are allowed but this is consider a single course and must be followed byadditional infusion(s) every 6 months (+/- one month)

  3. Last fully infused rituximab dose must have occurred within 4-9 months prior tobaseline.

  4. Participants discontinuing aCD20 therapy for reasons including, but not limited to:physician/participant preference, access to commercial drug (e.g. insurance coverageissues) or for other logistical reasons (such as geographical relocation, travel,etc.) are eligible for this study. 7. Neurologically stable within 1 month prior tofirst study drug administration.

  5. Must be able to use a smart device or have a caregiver that can assist.

Exclusion

Exclusion Criteria:

Participants meeting any of the following criteria are not eligible for inclusion in this study:

  1. Participants that have demonstrated suboptimal response to aCD20 therapy to include: a. Signs of MRI activity, defined as ≥ 2 active Gd+ T1 lesions, or any new or newlyenlarging T2 lesions, documented within the past 6 months
  • If a prior MRI within the last 6 months is not available, then new or newlyenlarging T2 lesions should be considered "not documented" and the patient maycontinue screening b. Documented relapse while on stable, previous aCD20treatment.

  • Relapses during the first 3 months of intravenous aCD20 therapy are allowableif the participant is then relapse-free for the 12 months following the relapsewhile on intravenous aCD20 therapy c. Any signs of clinical worsening asmeasured by EDSS or any clinical measure documented within the last 6 months

  1. Discontinuing aCD20 mAb therapy due to the following treatment- emergent adverseevents:

  2. Severe infusion-related reactions (Grade 3 or above)

  3. Recurrent infections defined as ≥ 2 severe infections or ≥ 3 respiratoryinfections or the need for ≥ 2 courses of antibiotics since starting aCD20therapy, if the Investigator believes this is related to therapy.

  4. Decreased IgG requiring treatment with Intravenous immunoglobulin

  5. Participants with primary progressive MS (Polman et al 2011) or SPMS without diseaseactivity (Lublin et al 2014).

  6. Participants meeting criteria for neuromyelitis optica (Wingerchuk et al 2015).

  7. Pregnant or nursing (lactating) women

  8. Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, unless they are using highly effective methods of contraceptionduring dosing and for at least 6 months after stopping study medication.

  9. Participants with active chronic disease (or stable but treated with immune therapy)of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma,Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or withimmunodeficiency syndrome (hereditary immune deficiency, drug-induced immunedeficiency).

  10. Participants with active systemic bacterial, viral or fungal infections, or known tohave acquired immunodeficiency syndrome (AIDS).

  11. Participants with neurological symptoms consistent with PML or with confirmed PML.

  12. Participants at risk of developing or having reactivation of syphilis ortuberculosis

  13. Participants at risk of developing or having reactivation of hepatitis.

  14. Have received any live or live-attenuated vaccines (including for varicella-zostervirus or measles) within 4 weeks prior to first study drug administration. a. Thereis presently no contraindication for the use of an inactivated, viral-vector-or mRNAbased Sars-CoV-2 vaccine in patients who are immunocompromised. However, differentSars-CoV-2 vaccines may have various mechanisms of action and different associatedpotential risks. Please review local prescribing information of any specificSars-CoV-2 vaccine and comply with local prescribing information requirements forspecific contra-indications and special warnings and precautions for use.

Study Design

Total Participants: 111
Treatment Group(s): 1
Primary Treatment: Ofatumumab
Phase: 3
Study Start date:
October 19, 2020
Estimated Completion Date:
October 21, 2024

Study Description

This is a single-arm multi-center, study in approximately 100 participants with relapsing multiple sclerosis who were previously treated with aCD20 mAb therapy. Eligible participants will receive open label ofatumumab 20 mg subcutaneous monthly for 12 months following initial loading regimen of 20 milligrams subcutaneous doses on Days 1, 7 and 14. Assessments will include but are not limited to Magnetic Resonance Imaging (MRI) assessed for quality by central reading center, multiple Patient Reported Outcome measurements and safety assessments. Participants that do not continue onto commercial ofatumumab or another therapy within one month of the End of Study Visit must continue into the safety Follow Up phase, consisting of every 3 month visits including B cell monitoring until they are able to start on commercial ofatumumab or switch to another therapy or until their B cells are repleted defined as a B cell concentration greater than the individual participant's baseline value or greater than the lower limit of normal. All participants will have a safety follow-up phone call at 30 days post study.

Connect with a study center

  • Caribbean Center for Clinical Research, Inc

    Guaynabo, 00968
    Puerto Rico

    Site Not Available

  • Caribbean Center for Clinical Research, Inc .

    Guaynabo, 00968
    Puerto Rico

    Site Not Available

  • Caribbean Center for Clinical Research, Inc. .

    Guaynabo, 00968
    Puerto Rico

    Site Not Available

  • Caribbean Ctr for Clin Resch Inc .

    Guaynabo, 00968
    Puerto Rico

    Site Not Available

  • Novartis Investigative Site

    Guaynabo, 00968
    Puerto Rico

    Site Not Available

  • Alabama Neurology Associates PC

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Alabama Neurology Associates PC Neurology

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Alabama Neurology Associates PC Suite 105

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Novartis Investigative Site

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Ctr for Neurology and Spine

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Novartis Investigative Site

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Novartis Investigative Site

    Encinitas, California 92024
    United States

    Site Not Available

  • The Research Center of Southern California .

    Encinitas, California 92024
    United States

    Site Not Available

  • Novartis Investigative Site

    La Jolla, California 92037
    United States

    Site Not Available

  • University of California San Diego UCSD ACTRI

    La Jolla, California 92037
    United States

    Site Not Available

  • Neuro Center

    Pomona, California 91767
    United States

    Site Not Available

  • Novartis Investigative Site

    Pomona, California 91767
    United States

    Site Not Available

  • Lightship

    Torrance, California 90505
    United States

    Site Not Available

  • Novartis Investigative Site

    Torrance, California 90505
    United States

    Site Not Available

  • Novartis Investigative Site

    Aurora, Colorado 80045
    United States

    Site Not Available

  • UC Health Neuroscience Ctr

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Infinity Clinical Research LLC

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Novartis Investigative Site

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Novartis Investigative Site

    Sunrise, Florida 33351
    United States

    Site Not Available

  • AMO Corporation

    Tallahassee, Florida 32312
    United States

    Site Not Available

  • AMO Corporation .

    Tallahassee, Florida 32312
    United States

    Site Not Available

  • Novartis Investigative Site

    Tallahassee, Florida 32312
    United States

    Site Not Available

  • Novartis Investigative Site

    Tampa, Florida 33612
    United States

    Site Not Available

  • University Of South Florida

    Tampa, Florida 33612
    United States

    Site Not Available

  • University Of South Florida .

    Tampa, Florida 33612
    United States

    Site Not Available

  • International Neurorehab Institute

    Lutherville, Maryland 21093
    United States

    Site Not Available

  • Novartis Investigative Site

    Lutherville, Maryland 21093
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Cente

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Dana Farber Cancer Institute Main Centre

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Novartis Investigative Site

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Neurology Center of New England PC

    Foxboro, Massachusetts 02035
    United States

    Site Not Available

  • Neurology Center of New England PC .

    Foxboro, Massachusetts 02035
    United States

    Site Not Available

  • Novartis Investigative Site

    Foxboro, Massachusetts 02035
    United States

    Site Not Available

  • Dragonfly Research LLC

    Wellesley, Massachusetts 02481
    United States

    Site Not Available

  • Dragonfly Research LLC Elliott Lewis Center

    Wellesley, Massachusetts 02481
    United States

    Site Not Available

  • Novartis Investigative Site

    Wellesley, Massachusetts 02481
    United States

    Site Not Available

  • Novartis Investigative Site

    Golden Valley, Minnesota 55422
    United States

    Site Not Available

  • Minnesota Center Multiple Sclerosis

    Plymouth, Minnesota 55446
    United States

    Site Not Available

  • Novartis Investigative Site

    Plymouth, Minnesota 55446
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Novartis Investigative Site

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Ms Ctr Of Northeastern Ny

    Latham, New York 12110
    United States

    Site Not Available

  • Novartis Investigative Site

    Latham, New York 12110
    United States

    Site Not Available

  • Novartis Investigative Site

    Canton, Ohio 44718
    United States

    Site Not Available

  • Columbus Neuroscience

    Westerville, Ohio 43082
    United States

    Site Not Available

  • Columbus Neuroscience Columbus Neuroscience LLC

    Westerville, Ohio 43082
    United States

    Site Not Available

  • Novartis Investigative Site

    Westerville, Ohio 43082
    United States

    Site Not Available

  • Hope Neurology

    Knoxville, Tennessee 37922
    United States

    Site Not Available

  • Hope Neurology .

    Knoxville, Tennessee 37922
    United States

    Site Not Available

  • Novartis Investigative Site

    Knoxville, Tennessee 37922
    United States

    Site Not Available

  • Sibyl Wray MD Neurology PC

    Knoxville, Tennessee 37922
    United States

    Site Not Available

  • Novartis Investigative Site

    Dallas, Texas 75325
    United States

    Site Not Available

  • Parkland Health and Hospital Systems

    Dallas, Texas 75325
    United States

    Site Not Available

  • Central TX Neuro Consultants P A

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Central TX Neuro Consultants P A .

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Central Texas Neurology Consultants P A .

    Round Rock, Texas 78681
    United States

    Completed

  • Novartis Investigative Site

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Novartis Investigative Site

    Seattle, Washington 98122
    United States

    Site Not Available

  • Swedish Neuroscience Institute

    Seattle, Washington 98122
    United States

    Site Not Available

  • Swedish Neuroscience Institute MS Center

    Seattle, Washington 98122
    United States

    Site Not Available

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