Setrusumab vs Placebo for Osteogenesis Imperfecta
Public ClinicalTrials.gov record NCT05125809. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Operationally Seamless, Randomized Phase 2/3 Study Consisting of a Phase 2 Single-Blind, Dose-Evaluation Phase and a Phase 3 Double-Blind, Placebo-Controlled Phase to Assess the Efficacy and Safety of Setrusumab in Subjects With Osteogenesis Imperfecta
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05125809
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 183 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 5 Years to 25 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 21, 2022 (Actual)
- Primary completion
- Oct 20, 2025 (Actual)
- Completion
- Apr 2027 (Estimated)
- Last update posted
- Oct 20, 2026
2022 – 2027
United States locations
- U.S. sites
- 22
- U.S. states
- 19
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Shriners Hospital for Children - Northern California | Sacramento | California | 95817 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | — |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | — |
| Nemours/ Alfred i. duPoint Hospital for Children | Wilmington | Delaware | 19803 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| University of South Florida | Tampa | Florida | 33612 | — |
| Shriners Hospitals for Children - Chicago | Chicago | Illinois | 60707 | — |
| Indiana University Hospital | Indianapolis | Indiana | 46202 | — |
| Kennedy Krieger Institute | Baltimore | Maryland | 21205 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Children's Hospital and Medical Center | Omaha | Nebraska | 68114 | — |
| New Mexico Clinical Research & Osteoporosis Center, Inc. | Albuquerque | New Mexico | 87106 | — |
| Atrium Health Levine Children's Hospital | Charlotte | North Carolina | 28203 | — |
| Nationwide Children's Hospital- Ohio State University College of Medicine | Columbus | Ohio | 43205 | — |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| UW Health University Hospital | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05125809, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 20, 2026 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05125809 live on ClinicalTrials.gov.