A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (UPSTREAM MG)

StatusActive, Not Recruiting
PhasePhase 3
Started

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Record History

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  1. Enrollment closed, study ongoing Show 6 more changesShow less
    • Trial sites expanded: 111 → 120 locations
    • Primary completion moved earlier from May 2027 to Mar 2027
    • Enrollment target: estimated 180 to confirmed 191
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 4 of 5 entries
    • Study description revised
  2. Trial sites expanded: 105 → 111 locationsv9
  3. Trial sites expanded: 84 → 105 locationsv8
  4. Site details revised at 13 of 84 sites
    • Study title expanded, about 1 word
    v7
  5. Primary completion date: Dec 2026 to May 2027
    • Study completion date: Jan 2028 to Jan 2029
    • Eligibility criteria expanded, about 33 words
    • Study description expanded, about 82 words
    v6
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  1. Lead sponsor: RemeGen Co., Ltd. to Vor Biopharmav5 Show 5 more changesShow less
    • Study sites: 54 to 84
    • Primary completion date: Jul 2026 to Dec 2026
    • Study completion date: Oct 2027 to Jan 2028
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 4 of 5 entries
  2. Study sites: 14 to 54v4
  3. Study sites: 3 to 14v3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Primary endpoint revised
    • Study sites: 0 to 3
    • Primary completion date: Apr 2026 to Jul 2026
    • Study completion date: Jul 2027 to Oct 2027
    • Start date changed from estimate of Jun 2024 to Jul 17, 2024
    • Secondary endpoints revised (5)
  1. Study First Submitted
  • 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.
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis.
Trial Details
NCT Number NCT06456580
Lead Sponsor Vor Biopharma
Conditions
(from sponsor)		 Generalized Myasthenia Gravis
Related terms Myasthenia Gravis
Enrollment 191 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov