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A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG)

Study acronym: THYME
StatusRecruiting
PhasePhase 2
SponsorAmgen
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 9 entries Trial sites expanded: 9 → 13 locations · Eligibility criteria expanded, about 31 words Show 2 more changesShow less
    • Trial sites expanded: 9 → 13 locations
    • Eligibility criteria expanded, about 31 words
  2. Trial sites expanded: 4 → 9 locations Eligibility criteria expanded, about 50 wordsv11 Show 1 more changeShow less
    • Eligibility criteria expanded, about 50 words

    See this version in full on ClinicalTrials.gov ↗

  3. Start date changed from estimate of Aug 31, 2026 to Jul 21, 2026v10
  4. Study sites: 3 to 4v9
  5. Study sites: 1 to 3v8
Show 6 earlier versionsHide 6 earlier versions
  1. Start date: Apr 30, 2026 to Aug 31, 2026v7
  2. Eligibility criteria expanded, about 16 words Secondary endpoints revised (5)v6 Show 1 more changeShow less
    • Secondary endpoints revised (5)

    See this version in full on ClinicalTrials.gov ↗

  3. Eligibility criteria expanded, about 47 wordsv5 See this version in full on ClinicalTrials.gov ↗
  4. Re-verified, no change to tracked fieldsv4
  5. Start date: Nov 5, 2025 to Apr 30, 2026 Secondary endpoints: 10 to 5 · Eligibility criteria expanded, about 5 wordsv3 Show 2 more changesShow less
    • Secondary endpoints: 10 to 5
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  6. Trial status: Not Yet Recruiting to Recruiting Start date: Aug 29, 2025 to Nov 5, 2025 · Study sites: 0 to 1 · Primary and study completion dates: Jan 4, 2030 to Mar 13, 2030v2 Show 3 more changesShow less
    • Start date: Aug 29, 2025 to Nov 5, 2025
    • Study sites: 0 to 1
    • Primary and study completion dates: Jan 4, 2030 to Mar 13, 2030
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Amgen
168 trials monitored
See 11 trials at risk
Myasthenia Gravis
187 trials monitored
See 7 trials at risk
The primary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of inebilizumab administered in pediatric participants with gMG, and to assess the safety and tolerability of inebilizumab administered in pediatric participants with gMG.
Trial Details
NCT Number NCT06987539
Lead Sponsor Amgen
Conditions Generalized Myasthenia Gravis
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov