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

Sponsor
RemeGen Co., Ltd.
Study ID
NCT07249632
Phase
PHASE3
Status
Recruiting
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Conditions

  • Myasthenia Gravis, Ocular

Eligibility Criteria

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

Interventions

  • Telitacicept — DRUG
    The dosage is administered based on the subject's age and baseline body weight.
  • Placebo — DRUG
    The placebo contains no active ingredients. To maintain the blind, the placebo matches the active drug in all physical aspects.

Study Details

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 receive either Telitacicept or a matching placebo. Subjects must be on a stable standard-of-care therapy and have an MG Impairment Index (PRO) ocular score of ≥6 at screening and baseline.The dose is age and weight based.The primary objective is to evaluate the efficacy of Telitacicept compared to placebo in treating OMG.The primary efficacy endpoint is the change from baseline in the MGII (PRO) ocular score at Week 24. Secondary endpoints include changes from baseline in other ocular and total scores from MGII, Myasthenia Gravis-Activities of Daily Living (MG-ADL), MG Clinical Absolute Score, and the 15-item Myasthenia Gravis Quality of Life Revised scale (MG-QOL15r). Safety and tolerability will be monitored throughout the study.

Key Dates

Start date
Jan 13, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Feb 28, 2027

Study Design

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

Arms

  • Experimental: Telitacicept
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change from baseline in the MGII (PRO) ocular score [ Time Frame: From enrollment to the end of treatment at 24 weeks ]

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