NCT06452537

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

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

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Tianjin Medical University General Hospital · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease

Interventions

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

Timeline

• Start date: 2024-07-09
• Primary completion: 2026-01-01
• Completion: 2026-07-01
• First posted: 2024-06-11
• Last updated: 2026-01-08

Locations

22 sites across 1 country: China