Clinical trial · Interventional
Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis
A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis
NCT05067348CI-TRIAL-00089168tMGrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Randomized, double-blind, placebo-controlled, parallel-group study with optional open-label extension.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myasthenia Gravis, Generalized | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tocilizumab Injectable Product | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tocilizumab
- description
- Participants will receive tocilizumab administered intravenously (IV) on weeks 1,5,9 and 13 of the randomized controlled period.
- interventionNames
- Drug: Tocilizumab Injectable Product
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants will receive placebo administered intravenously (IV) on weeks 1,5,9 and 13 of the randomized controlled period.
- interventionNames
- Drug: Tocilizumab Injectable Product
Primary outcomes (1)
- measure
- Change in Quantitative Myasthenia Gravis (QMG) scores.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of MG with anti-AChRantibody. 2. MGFA Clinical Classification Class II, III, or IV. 3. MG-ADL score of 5 or greater at screening and at randomization with \> 50% of this score attributed to non-ocular items. 4. QMG score of 11 or greater. 5. Subjects must be on: 1. Cholinesterase inhibitor, with no dose increase within 4 weeks prior to randomization; 2. Corticosteroids, with no dose increase within 4 weeks prior to randomization; or/and c. non-steroidal IST (including azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine A), with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization. Exclusion Criteria: 1. Participants had clinically relevant active infections (such as sepsis, pneumonia, or abscess) or severe infections (resulting in hospitalization or requiring antibiotic treatment) in the 4 weeks before randomization; 2. Those with a history of high-risk tuberculosis infection, acquired tuberculosis infection, and chronic hepatitis; 3. Human immunodeficiency virus (HIV) infection; 4. Thymomas that have received thymectomy or planned thymectomy during RCP within 6 months before randomization, or require chemotherapy and/or radiotherapy at any time; 5. Received rituximab treatment in the past 6 months before randomization; 6. Received tocilizumab or eculizumab treatment within 3 months before randomization; 7. Received IVIG or plasma exchange within 4 weeks before randomization; 8. Unresected thymoma. 9. History of other tumor diseases.
References
Publications (0)
Data not yet available
No reference posted for this study.