Open-Label Extension of Tocilizumab in Subjects With Generalized Myasthenia Gravis

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of tocilizumab in the treatment of generalized myasthenia gravis (gMG) as an extension study for the participants who previously completed Study tMG(NCT05067348).

Detailed Description
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tMG-E was an extension study designed to provide the participants who completed Study tMG an opportunity to receive tocilizumab and collect clinical data to provide long-term safety and efficacy information on tocilizumab in participants with gMG. After receiving blinded study treatment (tocilizumab or placebo) in Study tMG for 16 weeks, participants were eligible to enroll in the tMG-E extension study. Participants were to enter Study tMG-E within 8 weeks after completing their Week 16 visit in Study tMG. Study tMG-E consisted of an Open-Label treatment Phase up to 16 weeks.

Official Title
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A Phase III, Open-label Extension Trial of tMG to Evaluate the Safety and Efficacy of Tocilizumab in Subjects With Generalized Myasthenia Gravis (gMG)

Conditions
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Myasthenia Gravis, Generalized

Intervention / Treatment
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* Drug: Tocilizumab Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant has completed Study tMG. Participant has given written informed consent. MG-ADL score ≥ 5 points, or a decrease of ≤ 3 points relative to the baseline MG-ADL of the tMG study Exclusion Criteria: Participants had clinically relevant active infections (such as sepsis, pneumonia, or abscess) or severe infections (resulting in hospitalization or requiring antibiotic treatment) in the past 4 weeks; Those with high-risk tuberculosis infection, acquired tuberculosis infection, and chronic hepatitis after the tMG study; planned thymectomy during RCP; Received IVIG or plasma exchange in the past 4 weeks; Any medical condition or circumstances that, in the opinion of the investigator, might have interfered with the participant's participation in the study, posed any added risk for the participant, or confounded the assessment of the participants.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tocilizumab<br>Participants will receive tocilizumab 8mg/Kg administered intravenously (IV) on weeks 1,5,9 and 13 of the open-lable period. | Drug: Tocilizumab Injection<br>* Participants will receive IV tocilizumab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events (TEAEs) |  | From Baseline (Day 1) to Safety Follow-Up Visit (up to 16 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quantitative Myasthenia Gravis (QMG) scores. |  | 16 weeks | 
| Proportion of subjects with both (1) ≥ 3-point improvement in QMG and (2) lasts ≥4 weeks |  | 16 weeks | 
| Proportion of subjects with both (1) ≥ 2-point improvement in MG-ADL and (2) lasts ≥4 weeks |  | 16 weeks | 
| Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score |  | 16 weeks | 
| Change in Myasthenia Gravis Composite (MGC) score |  | 16 weeks | 
| Change in Myasthenia Gravis Quality of Life-15, revised (MG-QOL15r) score. |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Generalized Myasthenia Gravis, Tocilizumab, Open-label