NCT05125809Phase 2, phase 3Active not recruiting

Setrusumab vs Placebo for Osteogenesis Imperfecta

Study sponsor: Ultragenyx Pharmaceutical Inc · RARE

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2025-10-20Actual

Enrollment · participants183Actual

Source updated2026-02-25Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2025-12-02 · 2 fields changed

Completion date type changed

− Before

~~Estimated~~

+ After

Actual

Primary completion date changed

− Before

~~Mar 2026~~

+ After

20 Oct 2025

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Study details

Conditions studied

Osteogenesis Imperfecta

Treatments or interventions studied

SetrusumabBiologicalAlso known as BPS804, UX143

Primary outcomes · main study measures

measure: Phase 2: Percent Change in Serum Amino-terminal Propeptide of Type 1 Procollagen (P1NP) from Baseline at Month 1; timeFrame: Baseline, Month 1; measure: Phase 3: Annualized Rate of All Radiographically-Confirmed Fractures, Excluding Morphometric Vertebral Fractures and Fractures of the Fingers, Toes, Face, and Skull at the Primary Analysis; timeFrame: Up to Month 24

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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