Active — Not RecruitingPhase 2/3

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

China102 participantsStarted 2024-07-09

Plain-language summary

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

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.
✕. 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.

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

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

NCT IDNCT06452537

SponsorTianjin Medical University General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-01

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.
✕. 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.