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New hope for MOGAD patients: drug aims to stop relapses

NCT ID NCT06452537

Disease control Sponsor: Tianjin Medical University General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether the drug tocilizumab can safely prevent or delay relapses in people with MOGAD, a rare autoimmune disease that attacks the nervous system. About 102 participants aged 12 and older who have had at least one relapse in the past year will receive either tocilizumab or a placebo. The main goal is to see if the drug reduces the number of relapses over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 102 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

myelin oligodendrocyte glycoprotein antibody-associated disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myelin oligodendrocyte glycoprotein antibody-associated disease

Contacts and locations

Locations

  • Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221006, China

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001, China

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, 100000, China

  • Children's Hospital of Soochow University

    Suzhou, Jiangsu, 215025, China

  • China-Japan Friendship Hospital

    Beijing, 100000, China

  • Chinese PLA General Hospital

    Beijing, 100000, China

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030000, China

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 751705, China

  • Hebei Children's Hospital

    Shijiazhuang, Hebei, 050000, China

  • Huashan Hospital, Fudan University

    Shanghai, 200000, China

  • Ordos Central Hospital

    Ordos, Inner Mongolia, 017000, China

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang Uygur Autonomous Region, 830001, China

  • The First Affiliated Hospital of Tsinghua University

    Beijing, 100000, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhenzhou, Henan, China

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150086, China

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000, China

  • The Second Hospital of Lanzhou University

    Lanzhou, Gansu, 73000, China

  • The Third Affiliated Hospital of Soochow University

    Changzhou, Jiangsu, 213000, China

  • Tianjin Children's Hospital

    Tianjin, 30052, China

  • Tianjin Huanhu Hospital

    Tianjin, 300052, China

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052, China

  • XuanWu Hospital Capital Medical University

    Beijing, 100000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.