A Study of Telitacicept in Patients With Ocular Myasthenia Gravis (OMG)

Recruiting Phase 3 Interventional Study
Myasthenia Gravis, Ocular
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
12 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
RemeGen Co., Ltd. · Industry
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About This Trial
This is a Phase III, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Telitacicept for the treatment of Ocular Myasthenia Gravis (OMG).Approximately 120 eligible subjects aged 12 to 80 years with a diagnosis of OMG (Myasthenia Gravis Foundation of America \[MGFA\] Clinical Classification Type I) will be randomized in a 1:1 ratio to rec…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Voluntarily signed the informed consent form. 2. Age 12 to 80 years, inclusive, male or female. 3. Body weight ≥30 kg. 4. Diagnosis of Myasthenia Gravis (MG) with documented clinical features consistent with the disease. 5. Myasthenia Gravis Foundation of America (MGFA) Clini…
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