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A Trial Investigating Lu AG22515 in Adult Participants With Moderate-to-Severe Thyroid Eye Disease

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites revised (6)v11 See this version in full on ClinicalTrials.gov ↗
  2. Re-verified, no change to tracked fieldsv10
  3. Primary completion date changed from estimate of Mar 30, 2026 to Mar 17, 2026v9
  4. Re-verified, no change to tracked fieldsv8
  5. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 19 to confirmed 20 · Site details revised at 6 of 6 sitesv7 Show 2 more changesShow less
    • Enrollment target: estimated 19 to confirmed 20
    • Site details revised at 6 of 6 sites
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 5 to 6v6
  2. Study sites: 4 to 5 Primary completion date: Jan 15, 2026 to Mar 30, 2026 · Completion date: Sep 15, 2026 to Sep 29, 2026v5 Show 2 more changesShow less
    • Primary completion date: Jan 15, 2026 to Mar 30, 2026
    • Completion date: Sep 15, 2026 to Sep 29, 2026
  3. Study sites: 3 to 4v4
  4. Study sites: 1 to 3v3
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Aug 26, 2024 to Sep 19, 2024v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 26, 2024 to Sep 19, 2024
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
H. Lundbeck A/S
20 trials monitored
See 1 trial at risk
This trial will evaluate the effects of Lu AG22515 in adult men and women with moderate-to-severe thyroid eye disease (TED). TED is an autoimmune condition closely related to Graves' Disease. In people with TED, the healthy tissue behind and around the eye becomes inflamed and swollen. One of the key symptoms of TED is proptosis (bulging eyes). The main goal of this trial is to learn whether treatment with Lu AG22515 improves proptosis in participants with moderate-to-severe TED.
Trial Details
NCT Number NCT06557850
Lead Sponsor H. Lundbeck A/S
Conditions Thyroid Eye Disease
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov