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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study description shortened, about 28 wordsv5 See this version in full on ClinicalTrials.gov ↗
  2. Study description shortened, about 43 wordsv4 See this version in full on ClinicalTrials.gov ↗
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Nov 30, 2025 to Jan 13, 2026v3 Show 1 more changeShow less
    • Start date changed from estimate of Nov 30, 2025 to Jan 13, 2026
  4. Eligibility criteria shortened, about 9 wordsv2 See this version in full on ClinicalTrials.gov ↗
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07249632
Lead Sponsor RemeGen Co., Ltd.
Collaborators: Huashan Hospital, Beijing Hospital
Conditions Myasthenia Gravis, Ocular
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov