Running, not recruitingPhase 4Relapsing and progressiveNCT05090371

What it found

Still running

No result yet.

What was tested

Treatment tested

Compared with

  • Disease modifying treatment (DMT)

What it measured

Main measures

  • Percentage of participants achieving NEDA-3 (No Evidence of Disease Activity-3)

    Months 3 to 15

    RelapsesMRI lesions

Other measures (16)

  • Percentage of participants with a single baseline NfL≥10pg/ml and NfL<10pg/ml achieving NEDA-3 (No Evidence of Disease Activity-3)

    Months 3 to15

    RelapsesMRI lesionsBlood or spinal fluid markers
  • Annualized relapse rate in Months 3 to 15

    Months 3 to 15

    Disability progressionRelapsesFatigueBladder, bowel and sexual function
  • Percentage of participants without a worsening of their disability

    Months 3 to 15

  • Percentage of participants with NEDA (No Evidence of Disease Activity) - Clinical

    Months 3 to 15

    Disability progressionRelapses
  • Percentage of participants with NEDA (No Evidence of Disease Activity) - Radiological

    Months 3 to 15

    MRI lesions
  • Mean change in The Symbol-Digit Modality Test

    Baseline, Months 3 and 15

    Thinking and memory
  • Mean change in the Time 25 Foot Walk

    Baseline, Months 3 and 15

    Walking and mobility
  • Mean change in the 9 Hole Peg Test

    Baseline, Months 3 and 15

    Disability progressionArm and hand function
  • Mean change in Gd+ lesion count

    Baseline, Months 3 and 15

    MRI lesions
  • Mean change in Gd+ lesion volume

    Baseline, Months 3 and 15

    MRI lesions

Who could take part

Relapsing and progressive · 18 to 50

Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Age 18-45 years * Diagnosis of RRMS per McDonald Criteria (2017) * EDSS 0-5.5 (Inclusive) * Able to obtain MRI and attend study visits at sites * Willing to use wearable device as specified in the protocol * Able to provide blood sample * On a current DMT with approved label use for treatment of RRMS at least 6 months prior to Screening * No relapse reported within 6 months prior to Screening * Patients may enroll in the trial if they have subclinical disease activity as measured by MRI prior to enrollment. An absence of MRI activity is not exclusionary. Exclusion Criteria: * Primary progressive or secondary progressive phenotype * Diseases other than multiple sclerosis responsible for the clinical or MRI presentation * Use of experimental or investigational drugs for MS within 2 years from Screening * Known sensitivity to gadolinium * Central Nervous System (CNS) anomalies that are better accounted for by another disease process * Known active malignancies * Active chronic disease (or stable but treated with immune therapy) of the immune system other than MS * Active infections including systemic bacterial, viral (including COVID-19) or fungal infections, known to have AIDS or tested positive for HIV antibodies * Neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML * IgG or IgM levels below lower limit of normal (LLN) at Screening

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

This study will evaluate if relapsing-remitting MS patients that have not had a relapse in the past year would benefit from a switch to ofatumumab versus staying on their continued current therapy. This study will also look at whether an elevated serum neurofilament light (NfL) level predicts enhanced benefit from a switch to ofatumumab.

Papers

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    Related trials

    History

      1. Started

        Mar 2022

      2. Main results due

        Apr 2027

      3. Finished

        Apr 2027

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