Setrusumab vs Placebo for Osteogenesis Imperfecta
← catalyst calendarSponsored by Ultragenyx Pharmaceutical Inc (industry) · RARE — their whole pipeline →. With Mereo BioPharma.
Phase
Phase 2/3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
183actual
Sites
44
Countries
Australia, Canada, France +8
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-02-21 | actual | When the study began enrolling |
| Primary completion | 2025-10-20 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Apr 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2021-11-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-25 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Osteogenesis Imperfecta
Interventions
- Biological: Setrusumab — also filed as BPS804, UX143
- Other: Placebo
Primary outcomes
what the primary-completion date above is the date OFPhase 2: Percent Change in Serum Amino-terminal Propeptide of Type 1 Procollagen (P1NP) from Baseline at Month 1
measured Baseline, Month 1
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
measured Up to Month 24
Publications
- PMID 42470570 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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