MSFrontier

ZB012-02-002

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With Relapsing Multiple Sclerosis
Running, not recruitingPhase 2Relapsing and progressiveNCT065643112024-512707-40-00ISRCTN78327800

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Obexelimab

    B-lymphocyte antigen CD19 inhibitor|Low affinity immunoglobulin gamma Fc region receptor II-b inhibitor

  • Obexelimab [Obexelimab]

Placebo or sham

  • Placebo
  • Placebo sterile solution for SC injection

What it measured

Main measures

  • Cumulative number of new GdE T1 hyperintense lesions

    Week 8 and Week 12

    MRI lesions

  • Cumulative number of new GdE T1 hyperintense lesions measured by brain MRI over Week 8 and 12

    MRI lesions

Other measures (11)

  • Number of T2 Lesions

    Week 8 and Week 12

    MRI lesions

  • Number of GdE T1 lesions

    Week 4, Week 8, and Week 12

    MRI lesions

  • Volume of T2 lesions

    Week 12

    MRI lesions

  • Serum NfL

    Week 12

    Blood or spinal fluid markers

  • Incidence of Adverse Events, injection site reactions and hypersensitivity reactions

    24 weeks

    Safety

  • 1. Cumulative number of new and/or enlarging T2 weighted hyperintense lesions measured by brain MRI over Week 8 and Week 12 2. Number of new GdE T1 hyperintense lesions measured by brain MRI at Weeks 4, 8, and 12 3. Change from baseline in volume of T2 lesions measured by brain MRI at Week 12 4. Serum neurofilament lightchain measured by a blood test at Week 12 5. Incidence of AEs, SAEs, includi

    MRI lesionsBlood or spinal fluid markersSafety

  • Cumulative number of new and/or enlarging T2 weighted hyperintense lesions detected over Week 8 and Week 12

    MRI lesions

  • Number of new GdE T1 hyperintense lesions at Week 4, Week 8, and Week 12

    MRI lesions

  • Change from baseline in volume of T2 lesions at Week 12

    MRI lesions

  • Change from baseline in serum NfL at Week 12

    Blood or spinal fluid markers

Who could take part

Relapsing and progressive · 18 to 60

Inclusion Criteria: 1. Diagnosis of RMS (relapsing-remitting or secondary progressive with relapses) according to the 2017 revision of the McDonald diagnostic criteria 2. An EDSS of ≤ 5.5 at the Screening Visit 3. Must have documentation of: 1. . at least 1 relapse within the previous year OR 2. . ≥ 2 relapses within the past 2 years OR 3. . ≥ 1 active Gd-enhancing brain lesion on an MRI scan within the past 6 months prior to screening 4. Not of childbearing potential or willing to follow contraceptive guidance Exclusion Criteria: 1. Primary progressive MS or secondary progressive MS without relapses 2. Meet criteria for neuromyelitis optica spectrum disorder 3. Relapse in the 30 days prior to randomization 4. ≥ 10 years disease duration from onset with patient's EDSS ≤ 2.0 (patient reported is adequate in absence of written medical record) 5. Has > 20 Gd+ lesions on brain MRI 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 aims to examine the efficacy and safety of obexelimab in participants with relapsing multiple sclerosis

Papers

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    Related trials

    History

      1. Started

        Aug 2024

      2. Main results due

        Aug 2025

      3. Finished

        Feb 2026

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