Evaluating Tocilizumab for Myelin Oligodendrocyte Glycoprotein Antibody Disease
A Randomized, Controlled, Multicenter Study To Evaluate the Safety and Efficacy of Tocilizumab In Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
This study is testing if the drug Tocilizumab can help people with Myelin Oligodendrocyte Glycoprotein Antibody Disease have fewer relapses and feel better.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Tianjin Medical University General Hospital Academic / other |
| Drugs / interventions | tocilizumab, Alemtuzumab, rituximab, Natalizumab, Eculizumab, Methotrexate, Cyclophosphamide, prednisone |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT06452537 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and efficacy of Tocilizumab in patients diagnosed with Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD), a rare autoimmune condition affecting the central nervous system. Participants aged 12 and older with a confirmed diagnosis and a history of relapses will receive Tocilizumab and Prednisone. The study seeks to determine whether Tocilizumab can reduce the frequency of relapses and improve patient outcomes. Given the lack of FDA-approved treatments for MOGAD, this trial is crucial for establishing effective therapeutic options.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 12 and older with a confirmed diagnosis of MOGAD and a history of recent relapses.
Not a fit: Patients with other significant diseases requiring immunosuppressive treatment or those who have received certain prior therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from MOGAD, potentially reducing relapse rates and improving quality of life.
How similar studies have performed: While few randomized controlled trials have been conducted for MOGAD, preliminary data suggests that Tocilizumab may have beneficial effects, indicating a potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tianjin, Tianjin
- Tianjin Medical University General Hospital — Tianjin, Tianjin, China (Recruiting)
Study contacts
- Principal investigator: Chao Zhang, M.D., Ph.D — Tianjin Medical University General Hospital
- Study coordinator: Chao Zhang, M.D., Ph.D
- Email: chaozhang@tmu.edu.cn
- Phone: : +8602260814587
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.