Running, not recruitingPhase 2Phase 3MOGADNCT06452537

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Tocilizumab

    Interleukin-6 receptor alpha subunit inhibitor

  • Prednisone

    Glucocorticoid receptor agonist

What it measured

Main measures

  • Time from randomization to the first MOGAD relapse as determined by an adjudication committee

    Baseline, Up To 60 Weeks (End of Study)

    Relapses

Other measures (6)

  • Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the end of study

    Baseline, Up To 60 Weeks (End of Study)

    Disability progression
  • Dosage of oral steroid at the end of the TOMATO trial

    Baseline, Up To 60 Weeks (End of Study)

  • Sera MOG-IgG Concentration Over Time

    Baseline, Weeks 12, 24, 36, 48, 60 Weeks (End of Study)

  • Number of Participants With Adverse Events (AEs)

    Baseline, Up To 60 Weeks (End of Study)

    Safety
  • Number of Participants With Adverse Events Serious Adverse Events (SAEs)

    Baseline, Up To 60 Weeks (End of Study)

    Safety
  • Number of the lesion of the MRI T2WI

    Baseline, Weeks 12, 24, 36, 48, 60 Weeks (End of Study)

    MRI lesions

Who could take part

MOGAD · 12 and over

Inclusion Criteria: 1. Participants who are aged ≥12 years at the time of signing Informed Consent Form 2. 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 3. Anti-MOG antibody seropositive 4. 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 tocilizumab 5. Patients must give written informed consent Exclusion Criteria: 1. Any concomitant disease other than MOGAD that may require treatment with oral immunosuppressants or prednisone at doses >20 mg/day (or equivalent) 2. Receipt of the following at any time prior to randomization Alemtuzumab Total lymphoid irradiation Bone marrow transplant T-cell vaccination therapy Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal. Receipt of intravenous immunoglobulin (IVIG) or plasma exchange (PE) within 1 month prior to randomization. Receipt of any of the following within 3 months prior to randomization: Natalizumab (Tysabri®). Methotrexate Mitoxantrone Cyclophosphamide Eculizumab Receipt of any of the following within 6 weeks prior to randomization: Tacrolimus Cyclosporin Mycophenolate mofetil 3. Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of tocilizumab 4. Participants with active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline 5. Participants with evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection) 6. Participants with positive screening tests for hepatitis B and C 7. Receipt of live or live attenuated vaccine within 6 weeks prior to baseline 8. Known history of a severe allergy or reaction to any biologic therapy. 9. History of alcohol, drug, or chemical abuse, or a recent history of such abuse \< 1 year prior to randomization 10. WBC \< 3.0 × 10\^3/mL, ANC \< 2.0 × 10\^3/mL, PLT \< 10 × 10\^4/mL, AST or ALT>1.5 ×ULN, Lymphocyte count \< 0.5 × 10\^3/mL

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 evaluate the safety and efficacy of Tocilizumab in MOGAD.

Papers

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    History

      1. Started

        Jul 2024

      2. Main results due

        Jan 2026

      3. Finished

        Jul 2026

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