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Myelin Oligodendrocyte Glycoprotein Antibody-associated DiseasePhase 2/3TOMATONCT06452537

Safety and Efficacy of Tocilizumab in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease

A Phase 2/3 study testing Tocilizumab and Prednisone in people with Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, run by Tianjin Medical University General Hospital at 22 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of the study is to evaluate the safety and efficacy of Tocilizumab in MOGAD. Read more about this study

Who is it for?
Ages 12 years and older
What is being tested?
Tocilizumab and Prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
22 sitesChina
Study dates
9 Jul 2024to 1 Jul 2026
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
  • Anti-MOG antibody seropositive
  • 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
  • Patients must give written informed consent

Who cannot join

  • Any concomitant disease other than MOGAD that may require treatment with oral immunosuppressants or prednisone at doses >20 mg/day (or equivalent)
  • 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:
Show all 15Show fewer
  • Tacrolimus Cyclosporin Mycophenolate mofetil
  • Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of tocilizumab
  • 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
  • Known history of a severe allergy or reaction to any biologic therapy.
  • History of alcohol, drug, or chemical abuse, or a recent history of such abuse < 1 year prior to randomization
  • 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

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

China22 sites

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, 100000

  • China-Japan Friendship Hospital

    Beijing, 100000

  • Chinese PLA General Hospital

    Beijing, 100000

  • The First Affiliated Hospital of Tsinghua University

    Beijing, 100000

  • XuanWu Hospital Capital Medical University

    Beijing, 100000

  • The Third Affiliated Hospital of Soochow University

    Changzhou, Jiangsu, 213000

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150086

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

  • The Second Hospital of Lanzhou University

    Lanzhou, Gansu, 73000

  • Ordos Central Hospital

    Ordos, Inner Mongolia, 017000

  • Huashan Hospital, Fudan University

    Shanghai, 200000

  • Hebei Children's Hospital

    Shijiazhuang, Hebei, 050000

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • Children's Hospital of Soochow University

    Suzhou, Jiangsu, 215025

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030000

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Tianjin Huanhu Hospital

    Tianjin, 300052

  • Tianjin Children's Hospital

    Tianjin, 30052

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang Uygur Autonomous Region, 830001

  • Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221006

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 751705

  • The First Affiliated Hospital of Zhengzhou University

    Zhenzhou, Henan

Other trials in China

About this study

Official title: A Randomized, Controlled, Multicenter Study To Evaluate the Safety and Efficacy of Tocilizumab In Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

The purpose of the study is to evaluate the safety and efficacy of Tocilizumab in MOGAD.

Read the detailed description

Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) is a rare autoimmune disease of the central nervous system, which can cause optic neuritis, myelitis, brainstem encephalitis, or encephalitis. The specific autoantibody against myelin oligodendrocyte glycoprotein antibody (MOG-IgG) has been indicated to contribute to the pathogenesis of the disease. Data from several cohorts suggests that around 50% of adult patients with MOG-IgG may relapse within the first two years of the disease, with most of relapses occurring early after disease onset. Few randomized controlled trials have ever been performed and therapeutic guidelines for this disease remain unclear especially after a single event. There is no drug approved for MOGAD by FDA. IL-6 is a pro-inflammatory cytokine which can promotes B cell activation, blood-brain barrier dysfunction, leukocyte migration, and the production of autoantibodies. Tocilizumab (ACTEMRA®), a humanized monoclonal antibody against the IL-6 receptor, has shown beneficial clinical effects and reduction of the risk of relapses in some patients with MOGAD. However, the efficacy of tocilizumab in MOGAD warrants further clinical trials.

Being tested
Tocilizumab, Prednisone
Medical subject headings
Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TocilizumabDrug

    Also called ACTEMRA®

    Tocilizumab will be intravenously administered as the dosage of 8 mg/kg every 4 weeks, with oral prednisone.

  • PrednisoneDrug

    Prednisone tapering protocol : If the starting dose is over 20mg/day, then reduce by one tablet weekly. Until the dose is reduced to 20mg/day then 20mg/day for two weeks→17.5mg/day for two weeks→12.5mg for four weeks→10mg for four weeks→7.5mg as a maintain dosage

Study groups in NCT06452537
Study groupRoleWhat they receive
Tocilizumab with oral prednisoneExperimentalTocilizumab will be intravenously administered as the dosage of 8 mg/kg every 4 weeks, with oral prednisone
Receives: Drug: Tocilizumab; Drug: Prednisone
PrednisoneExperimentalNot described
Receives: Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    An adjudicated relapse was defined by the protocol and positively adjudicated by the relapse adjudication committee.

    Measured: Baseline, Up To 60 Weeks (End of Study)

Secondary outcomes (6)

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

    Disease-related disability was measured by the EDSS. The EDSS was an ordinal clinical rating scale that ranges from 0 (normal neurologic examination) to 10 (death) in half-point increments. A decrease in score indicates improvement

    Measured: Baseline, Up To 60 Weeks (End of Study)

  2. Dosage of oral steroid at the end of the TOMATO trial

    Dosage of oral steroid at the end of the TOMATO trial

    Measured: Baseline, Up To 60 Weeks (End of Study)

  3. Sera MOG-IgG Concentration Over Time

    Sera MOG-IgG Concentration was measured by Cell-Based Assay (CBA)

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

  4. Number of Participants With Adverse Events (AEs)

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship

    Measured: Baseline, Up To 60 Weeks (End of Study)

  5. Number of Participants With Adverse Events Serious Adverse Events (SAEs)

    A SAE was any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization

    Measured: Baseline, Up To 60 Weeks (End of Study)

  6. Number of the lesion of the MRI T2WI

    Number of the lesion of the MRI T2WI

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2024
  2. Study start9 Jul 2024
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
102 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06452537
Sponsor's protocol ID
2024035
Acronym
TOMATO
Status last verified
Jan 2026
First submitted
5 Jun 2024
Last updated
8 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Tocilizumab and Prednisone in people with Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, run by Tianjin Medical University General Hospital at 22 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from randomization to the first MOGAD relapse as determined by an adjudication committee (time frame: Baseline, Up To 60 Weeks (End of Study)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06452537.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.

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