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A Study of Teprotumumab N01 in Subjects With Active Thyroid Eye Disease

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 9 months later Sep 12, 2026 → Jun 30, 2028
See other at-risk trials from Innovent Biologics (Suzhou) Co. Ltd.

Record History

  1. Primary completion pushed from Sep 12, 2026 to Jun 30, 2028 Recruitment opened · Start date changed from estimate of Dec 30, 2025 to Jul 30, 2026 · Completion pushed from Sep 4, 2027 to Dec 30, 2028 · 2 morev2 Show 5 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Dec 30, 2025 to Jul 30, 2026
    • Completion pushed from Sep 4, 2027 to Dec 30, 2028
    • Secondary endpoints revised (12)
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 multicenter, randomized, open-label, active-controlled Phase IV clinical trial in participants with active thyroid eye disease (TED). Approximately 92 eligible participants will be randomized to the teprotumumab N01 group and the intravenous glucocorticoid (IVGC) group in a 1:1 ratio on Day 1. The randomization stratification factor is diplopia at baseline (Gorman diplopia score ≥1 vs. Gorman diplopia score = 0).
Trial Details
NCT Number NCT07265258
Lead Sponsor Innovent Biologics (Suzhou) Co. Ltd.
Conditions Thyroid Eye Disease
Enrollment 92 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov