Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05125809 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Setrusumab vs Placebo for Osteogenesis Imperfecta

Study acronym: Orbit
StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 44 to 43 Eligibility criteria expanded, about 28 words · Secondary endpoints: details revised at 2 of 18 entries · Publications: details revised at 1 of 1 entry Show 3 more changesShow less
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: details revised at 2 of 18 entries
    • Publications: details revised at 1 of 1 entry
  2. Re-verified, no change to tracked fieldsv45
  3. Primary completion date changed from estimate of Mar 2026 to Oct 20, 2025v44
  4. Enrollment target: 182 to 183 Secondary endpoints: 17 to 18 · Study description shortened, about 8 words · Study sites revised (44)v43 Show 3 more changesShow less
    • Secondary endpoints: 17 to 18
    • Study description shortened, about 8 words
    • Study sites revised (44)

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Mar 2025 to Mar 2026 Completion date: Mar 2026 to Apr 2027v42 Show 1 more changeShow less
    • Completion date: Mar 2026 to Apr 2027
Show 40 earlier versionsHide 40 earlier versions
  1. Primary endpoints revised (2) Study sites: 47 to 44 · Eligibility criteria expanded, about 8 words · Secondary endpoints revised (17) · 2 morev41 Show 5 more changesShow less
    • Study sites: 47 to 44
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints revised (17)
    • Study description shortened, about 24 words
    • Study title shortened, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv40
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 219 to confirmed 182 · Site details revised at 47 of 47 sitesv39 Show 2 more changesShow less
    • Enrollment target: estimated 219 to confirmed 182
    • Site details revised at 47 of 47 sites
  4. Re-verified, no change to tracked fieldsv38
  5. Primary endpoints revised (2) Secondary endpoints: 18 to 17 · Study description expanded, about 60 words · Site details revised at 1 of 47 sites · 1 morev37 Show 4 more changesShow less
    • Secondary endpoints: 18 to 17
    • Study description expanded, about 60 words
    • Site details revised at 1 of 47 sites
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  6. Site details revised at 6 of 47 sitesv36
  7. Site details revised at 3 of 47 sitesv35
  8. Site details revised at 2 of 47 sitesv34
  9. Study sites: 48 to 47v33
  10. Site details revised at 2 of 48 sitesv32
  11. Site details revised at 2 of 48 sites Eligibility criteria shortened, about 1 wordv31 Show 1 more changeShow less
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  12. Site details revised at 1 of 48 sitesv30
  13. Study sites: 49 to 48v29
  14. Site details revised at 1 of 49 sitesv28
  15. Site details revised at 1 of 49 sitesv27
  16. Study sites: 50 to 49v26
  17. Study sites: 47 to 50v25
  18. Study sites: 46 to 47v24
  19. Site details revised at 2 of 46 sitesv23
  20. Study sites: 43 to 46v22
  21. Site details revised at 1 of 43 sitesv21
  22. Site details revised at 1 of 43 sitesv20
  23. Study sites revised (43)v19 See this version in full on ClinicalTrials.gov ↗
  24. Study sites: 45 to 43v18
  25. Study sites: 46 to 45v17
  26. Study sites: 47 to 46v16
  27. Re-verified, no change to tracked fieldsv15
  28. Study sites: 46 to 47v14
  29. Study sites: 44 to 46v13
  30. Study sites: 41 to 44v12
  31. Enrollment target: 231 to 219 Study sites: 40 to 41 · Eligibility criteria shortened, about 16 words · Secondary endpoints: 17 to 18 · 3 morev11 Show 6 more changesShow less
    • Study sites: 40 to 41
    • Eligibility criteria shortened, about 16 words
    • Secondary endpoints: 17 to 18
    • Study description shortened, about 22 words
    • Study title revised
    • Study arms: 5 to 4

    See this version in full on ClinicalTrials.gov ↗

  32. Site details revised at 1 of 40 sitesv10
  33. Study sites: 38 to 40v9
  34. Study sites: 37 to 38v8
  35. Study sites: 40 to 37v7
  36. Primary endpoints revised (2) Enrollment target: 195 to 231 · Study sites: 23 to 40 · Eligibility criteria expanded, about 44 words · 3 morev6 Show 6 more changesShow less
    • Enrollment target: 195 to 231
    • Study sites: 23 to 40
    • Eligibility criteria expanded, about 44 words
    • Secondary endpoints: 15 to 17
    • Study arms: 4 to 5
    • Study description shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  37. Start date changed from estimate of Feb 2022 to Feb 21, 2022 Site details revised at 1 of 23 sitesv5 Show 1 more changeShow less
    • Site details revised at 1 of 23 sites
  38. Study sites: 18 to 23 Start date: Jan 2022 to Feb 2022v4 Show 1 more changeShow less
    • Start date: Jan 2022 to Feb 2022
  39. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 18 · Start date: Dec 2021 to Jan 2022v3 Show 2 more changesShow less
    • Study sites: 0 to 18
    • Start date: Dec 2021 to Jan 2022
  40. Re-verified, no change to tracked fieldsv2
  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.
The primary objectives of the study are to identify a setrusumab dosing strategy in participants with OI and to evaluate the effect of setrusumab vs placebo on reduction in fracture rate.
Trial Details
NCT Number NCT05125809
Lead Sponsor Ultragenyx Pharmaceutical Inc
Collaborators: Mereo BioPharma
Conditions Osteogenesis Imperfecta
Enrollment 183 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov