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Setrusumab in Pediatric Japanese Subjects With Osteogenesis Imperfecta

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 19 words
  2. 3 versions Re-verified since Dec 8, 2025, no change to tracked fieldsv10-v12
  3. Secondary endpoints: 6 to 8v9 See this version in full on ClinicalTrials.gov ↗
  4. 3 versions Re-verified since Mar 3, 2025, no change to tracked fieldsv6-v8
  5. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 5 to confirmed 6 · Site details revised at 3 of 3 sitesv5 Show 2 more changesShow less
    • Enrollment target: estimated 5 to confirmed 6
    • Site details revised at 3 of 3 sites
Show 3 earlier versionsHide 3 earlier versions
  1. Re-verified, no change to tracked fieldsv4
  2. Study Identification, Study Status, Oversightv3
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date changed from estimate of Oct 2024 to Oct 25, 2024v2 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of Oct 2024 to Oct 25, 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The primary objective of the study is to evaluate the effect of setrusumab on reduction in fracture rate, including morphometric vertebral fractures.
Trial Details
NCT Number NCT06636071
Lead Sponsor Ultragenyx Pharmaceutical Inc
Conditions Osteogenesis Imperfecta
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov