Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis

Sponsor
Tang-Du Hospital
Study ID
NCT05067348
Phase
PHASE2
Status
Recruiting
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Conditions

  • Myasthenia Gravis, Generalized

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Randomized, double-blind, placebo-controlled, parallel-group study with optional open-label extension.

Key Dates

Start date
Jul 21, 2022
Status verified
Apr 2025
Primary completion
Dec 31, 2025
Completion
Mar 30, 2026

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab
    Participants will receive tocilizumab administered intravenously (IV) on weeks 1,5,9 and 13 of the randomized controlled period.
  • Placebo Comparator: Placebo
    Participants will receive placebo administered intravenously (IV) on weeks 1,5,9 and 13 of the randomized controlled period.

Primary Outcome Measure

Change in Quantitative Myasthenia Gravis (QMG) scores. [ Time Frame: 16 weeks ]

Central Contacts

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