Running, not recruitingPhase 3MOGADNCT052714092023-507196-22-00

What it found

Still running

No result yet.

What was tested

Treatment tested

Placebo or sham

  • Placebo

What it measured

Main measures

  • Time From Randomization to the First Occurrence of a MOGAD Relapse in the DB Treatment Period, as Determined by an Adjudication Committee (CEC)

    Up to approximately 44 months

    Relapses

Other measures (15)

  • Annualized Rate of Adjudicated MOGAD Relapses

    Up to approximately 44 months

    Relapses
  • Annualized Rate of Active Lesions on Magnetic Resonance Imaging (MRI) of the Neuroaxis

    Up to approximately 44 months

    MRI lesions
  • Proportion of Participants Receiving Rescue Therapy

    Up to approximately 44 months

  • Annualized Rate of Inpatient Hospitalizations

    Up to approximately 44 months

  • 1. Rate of adjudicated MOGAD relapses

    Relapses
  • 2. Active lesions on MRI of the neuroaxis (Gd-enhancing or new/enlarging T2 hyperintense lesions measured across the optic nerve, the spinal cord and the brain, including brainstem and cerebellum)

    MRI lesions
  • 4. Rate of inpatient hospitalizations (defined as more than an overnight stay, excluding those for elective procedures)

  • 5. Proportion of relapse-free participants at 6-month intervals

    Relapses
  • 6. Change from baseline in total Montreal cognitive assessment (MoCA) score (adolescents only)

    Thinking and memory
  • 7. Incidence, seriousness and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)

    Safety

Who could take part

MOGAD · 12 and over

Inclusion criteria * Participants who are aged >=12 years at the time of signing Informed Consent Form * Confirmed diagnosis of MOGAD with a history of >=1 MOGAD relapse in the 12 months prior to screening or >=2 attacks in the 24 months prior to screening * Expanded Disability Status Scale (EDSS) score of 0-6.5 at screening * High-contrast visual acuity (HCVA) better than 20/800 in each eye at screening * Participants receiving either no or ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening * For women of childbearing potential: participants who agree to remain abstinent or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab Exclusion criteria * Presence of aquaporin-4-antibodies immunoglobin G (AQP4-IgG) in the serum * History of anti-N-methyl-d-aspartate receptor (NMDAR) encephalitis * Any concomitant disease other than MOGAD that may require treatment with ISTs or oral corticosteroids (OCS) or intravenous (IV) corticosteroids at doses > 20 milligrams (mg) prednisone equivalent per day for >21 days during the study * Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of satralizumab * Participants with active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline * Participants with evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection) * Participants with positive screening tests for hepatitis B and C * Receipt of live or live attenuated vaccine within 6 weeks prior to baseline * History of severe allergic reaction to a biologic agent

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

About this trial

In the sponsor's words

The main objective of this study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period. Participants who experience an adjudicated relapse or complete the DB period can enter open-label extension (OLE) period. After the primary clinical cutoff date (CCOD), additional adolescent participants may be enrolled directly into the OLE period.

Papers

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    History

      1. Started

        Aug 2022

      2. Main results due

        Nov 2025

      3. Finished

        May 2028

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