Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab

Last updated: April 23, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Memory Loss

Scar Tissue

Multiple Sclerosis

Treatment

Ofatumumab approved dose

Ofatumumab new dose

Clinical Study ID

NCT06869785
COMB157Q12301
  • Ages 18-100
  • All Genders

Study Summary

This study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of a new dosage of ofatumumab compared to the approved dosage of ofatumumab followed by extended treatment in participants with relapsing multiple sclerosis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed informed consent must be obtained prior to participation in the study.

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

  • Diagnosis of multiple sclerosis (MS) according to the 2017 Revised McDonald criteria (Thompson et al 2018). Relapsing forms of MS: relapsing-remitting MS (RRMS), oractive secondary progressive MS (SPMS).

Exclusion

Exclusion Criteria:

  • Participants suspected of not being able or willing to cooperate or comply withstudy protocol requirements in the opinion of the Investigator or emergence of anyclinically significant condition/disease (e.g. active systemic bacterial, viral orfungal infections) during screening prior to Day 1 which might result in safety riskfor participants.

  • Participants with history of confirmed progressive multifocal leukoencephalopathy (PML) or neurological symptoms consistent with PML.

  • Participants at risk of developing or having reactivation of hepatitis

  • Emergence of active chronic disease (or stable but treated with immune therapy)prior to Day 1 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).

  • Pregnant or nursing (lactating) women

  • History of lymphoproliferative disease or any known malignancy or history ofmalignancy of any organ system (except for basal cell carcinoma, or squamous cellcarcinomas of the skin that have been treated with no evidence of recurrence in thepast 3 months).

  • Participants taking prohibited therapies, including B cell targeted therapies (e.g.such as ocrelizumab, rituximab, ofatumumab, ublituximab, and inebilizumab)

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: Ofatumumab approved dose
Phase: 3
Study Start date:
March 13, 2025
Estimated Completion Date:
May 26, 2031

Study Description

This is a Phase 3, open label, parallel-group, multicenter study in participants with relapsing multiple sclerosis

Connect with a study center

  • Fullerton Neuro and Headache Ctr

    Fullerton, California 92835
    United States

    Active - Recruiting

  • Velocity Clinical Trials

    Los Angeles, California 90057
    United States

    Active - Recruiting

  • Mountain Neuro Research Center PC

    Basalt, Colorado 81621
    United States

    Active - Recruiting

  • Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • Neurology of Central FL Res Ctr

    Altamonte Springs, Florida 32714
    United States

    Active - Recruiting

  • Elite Clinical Research

    Miami, Florida 33144
    United States

    Active - Recruiting

  • Aqualane Clinical Research

    Naples, Florida 34105
    United States

    Active - Recruiting

  • Orlando Health Clinical Trials

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida 32174
    United States

    Active - Recruiting

  • Tallahassee Neurological Clinic

    Tallahassee, Florida 32308
    United States

    Active - Recruiting

  • Axiom Brain Health

    Tampa, Florida 33609
    United States

    Active - Recruiting

  • University Of South Florida

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Vero Beach Neurology

    Vero Beach, Florida 32960
    United States

    Active - Recruiting

  • Josephson Wallack Munshower Neurology P.C

    Indianapolis, Indiana 46256
    United States

    Active - Recruiting

  • Delricht Research

    New Orleans, Louisiana 70115
    United States

    Active - Recruiting

  • Mid Atlantic Epilepsy and Sleep Ctr

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

  • Rochester Cent For Behavioral

    Rochester Hills, Michigan 48307
    United States

    Active - Recruiting

  • WA Uni School Of Med

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • MS Comprehensive Care Ctr at Holy Name Hospi

    Teaneck, New Jersey 07666
    United States

    Active - Recruiting

  • Dayton Center for Neurological Disorders

    Centerville, Ohio 45459
    United States

    Active - Recruiting

  • Neurology Clinic PC

    Cordova, Tennessee 38018
    United States

    Active - Recruiting

  • Sibyl Wray MD Neurology PC

    Knoxville, Tennessee 37922
    United States

    Active - Recruiting

  • CenExcel Clinical Research

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

  • Sana Research

    Falls Church, Virginia 22042
    United States

    Active - Recruiting

  • MultiCare Research Institute for Research and Innovation

    Tacoma, Washington 98405
    United States

    Active - Recruiting

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