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A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Site details revised at 2 of 134 sitesv28
  2. Minor Site details revised at 1 of 134 sitesv27
  3. Minor Re-verified, no change to tracked fieldsv26
  4. Minor Study sites: 133 to 134v25
  5. Minor Trial sites expanded: 130 → 133 locationsv24
  6. Minor Re-verified, no change to tracked fieldsv23
  7. Minor Trial sites expanded: 125 → 130 locationsv22
  8. Minor Study sites: 121 to 125v21
  9. Minor Study sites: 115 to 121v20
  10. Minor Study sites: 112 to 115v19
  11. Minor Study sites: 101 to 112v18
  12. Minor Study sites: 100 to 101v17
  13. Minor Re-verified, no change to tracked fieldsv16
  14. Minor Study sites: 92 to 100
    • Eligibility criteria shortened, about 217 words
    v15
  15. Minor Study sites: 91 to 92v14
  16. Minor Study sites: 78 to 91v13
  17. Minor Study sites: 75 to 78v12
  18. Minor Study sites: 69 to 75v11
  19. Minor Study sites: 43 to 69v10
  20. Minor Study sites: 28 to 43v9
  21. Minor Study sites: 26 to 28v8
  22. Minor Study sites: 20 to 26v7
  23. Minor Eligibility criteria revisedv6
  24. Minor Study sites: 14 to 20v5
  25. Minor Study sites: 6 to 14v4
  26. Minor Study sites: 1 to 6v3
  27. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 2024 to Dec 17, 2024
    v2
  28. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment. The primary objective of this study is to evaluate the efficacy of IMVT-1402 versus placebo as assessed by T3 (total triiodothyronine \[T3\] or free triiodothyronine \[FT3\]), free thyroxine (FT4), thyroid-stimulating hormone (TSH), and ATD dose at Week 26.
Trial Details
NCT Number NCT06727604
Lead Sponsor Immunovant Sciences GmbH
Conditions
(from sponsor)
Graves' Disease
Related terms Graves Disease, Hyperthyroidism
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov