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NCT05125809 · ClinicalTrials.gov registry record · Phase 2
Setrusumab vs Placebo for Osteogenesis Imperfecta
A Phase 2 study of Osteogenesis Imperfecta, sponsored by Ultragenyx Pharmaceutical.
- Active
- Registry status
- Phase 2
- Development phase
- 183
- Enrollment target
- 20
- Study locations
NCT05125809: Active Phase 2 study of Osteogenesis Imperfecta, sponsored by Ultragenyx Pharmaceutical.
NCT05125809 is a Phase 2 study of Osteogenesis Imperfecta that is active but no longer recruiting, run by Ultragenyx Pharmaceutical. The registered enrollment target is 183 participants, above the 147-participant average among 13 other Osteogenesis Imperfecta trials with a reported enrollment target (24% higher). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05125809, a Phase 2 study of Osteogenesis Imperfecta, is active but no longer recruiting, sponsored by Ultragenyx Pharmaceutical.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 183 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Setrusumab
Study Locations (20)
California
- Children's Hospital Los Angeles - Los Angeles
- Shriners Hospital for Children - Northern California - Sacramento
Connecticut
- Connecticut Children's Medical Center - Hartford
- Yale New Haven Hospital - New Haven
Arkansas
- Arkansas Children's Hospital - Little Rock
Colorado
- Children's Hospital Colorado - Aurora
Delaware
- Nemours/ Alfred i. duPoint Hospital for Children - Wilmington
District of Columbia
- Children's National Medical Center - Washington D.C.
Florida
- University of South Florida - Tampa
Illinois
- Shriners Hospitals for Children - Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2022-02-21 |
| Est. Completion | 2027-04 |
| Phase | Phase 2 |
What the registry record for NCT05125809 still lists
NCT05125809 is an interventional study that assigns participants to a tested intervention. The registered 183 participants enrollment target is mid-sized for trials with a published cap, above the 147-participant average among 13 other Osteogenesis Imperfecta trials with a reported enrollment target (24% higher).
The record links to 1 condition, with Osteogenesis Imperfecta appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05125809 names 20 study sites across 18 states, led by California, Connecticut, Arkansas.
Frequently Asked Questions
What is clinical trial NCT05125809 about?
NCT05125809 is a clinical study titled "Setrusumab vs Placebo for Osteogenesis Imperfecta". 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.
What is the current status of trial NCT05125809?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 183 participants. The study started on 2022-02-21. Estimated completion is 2027-04.
What conditions does trial NCT05125809 study?
This clinical trial studies the following conditions: Osteogenesis Imperfecta.
What interventions are being tested in trial NCT05125809?
The interventions under investigation include: Placebo (OTHER), Setrusumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05125809?
This trial is sponsored by Ultragenyx Pharmaceutical, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05125809 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteogenesis Imperfecta
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05125809's enrollment target sits among peer trials
183 2nd of 13 the highest of 13 other Osteogenesis Imperfecta trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteogenesis Imperfecta trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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