MSFrontier

cosMOG

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3, Pivotal Study With an Open-Label Extension Period to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-Associated Disease (MOG-AD)
Running, not recruitingPhase 3MOGADNCT050631622023-509237-39-002021-000352-19

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Rozanolixizumab

    IgG receptor FcRn large subunit p51 inhibitor

Placebo or sham

  • Placebo
  • Rozanolixizumab, also known as UCB7665

What it measured

Main measures

  • For Part A: Time from randomization to first independently centrally adjudicated relapse (TTFR) during the DB Treatment Period

    Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)

    Relapses

  • For Part B: Incidence of treatment-emergent adverse events (TEAEs) during OLE Treatment Period

    OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)

    Safety

  • For Part B: Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP) during OLE Treatment Period

    OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52)

    Safety

  • For Part A:

Other measures (6)

  • For Part A: Change from Baseline in Low-Contrast Monocular Visual Acuity (Worst Affected Eye) measured by low-contrast Landolt C Broken Rings Chart at the EDB/EWD Visit

    Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)

    Vision

  • For Part A: Disability as assessed by Expanded Disability Status Scale (EDSS) scores at the EDB/EWD Visit (with confirmation at 3 months)

    Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)

    Disability progression

  • For Part A: Number of MOGAD related inpatient hospitalizations during the DB Treatment Period

    Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)

  • For Part A: Incidence of treatment-emergent adverse events (TEAEs) during the DB Treatment Period

    Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks; in isolated cases this can be up to approximately 204 weeks)

    Safety

  • For Part B: Independently centrally adjudicated annualized relapse rate (ARR) during the DB and OLE Treatment Period

    Baseline (Week 1) to EOS/EWD Visit (up to OLE Week 52)

    Relapses

  • For Part A

Who could take part

MOGAD · 18 to 89

Inclusion Criteria: * Participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent * Confirmed diagnosis of MOGAD consistent with published diagnostic criteria for MOGAD * Participant has history of relapsing MOGAD with at least 1 documented relapse over the last 12 months and a documented positive serum MOG Ab test using a cell-based assay (CBA) within 6 months prior to randomization * Participant must be clinically stable at the time of the Screening Visit and during the Screening Period Exclusion Criteria: * Participant has been diagnosed with a neurological autoimmune disease (including multiple sclerosis (MS) and aquaporin-4 positive neuromyelitis optica spectrum disorder (NMOSD)), or a systemic autoimmune disease that in the opinion of the investigator can interfere with the safety of the participant * Participant has a clinically important active infection (including unresolved or not adequately treated infection) as assessed by the investigator, including participants with a serious infection within 6 weeks prior to the first dose of the investigational medicinal product (IMP) * Participant has a current or medical history of primary immunodeficiency * Participant tests positive for aquaporin-4 antibodies at Screening * Participant has a serum total IgG level ≤ 5.5g/L

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

About this trial

In the sponsor's words

The purpose of the study is to evalute the efficacy, safety and tolerability of rozanolixizumab for treatment of adult participants with myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOGAD).

Papers

Loading reviews and guidelines…

History

    1. Started

      Feb 2022

    2. Main results due

      May 2027

    3. Finished

      Jul 2027

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