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Monoclonal Antibodies

Setrusumab for Osteogenesis Imperfecta

Phase 2
Waitlist Available
Research Sponsored by Ultragenyx Pharmaceutical Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 12
Awards & highlights

Study Summary

This trial will study the effects of setrusumab on bone mineral density in adults with osteogenesis imperfecta.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage Change From Retreatment Baseline in Lumbar Spine Bone Mineral Density (BMD) Measured by Dual-Energy X-Ray Absorptiometry (DXA) After 12 Months of Setrusumab
Secondary outcome measures
Annualized New Fracture Rate as Confirmed by Radiograph During the Retreatment Period
Percentage Change From Retreatment Baseline in Total Hip BMD Measured by DXA at Month 12 of the Retreatment Period

Trial Design

2Treatment groups
Experimental Treatment
Group I: Setrusumab QM -->Setrusumab QMExperimental Treatment1 Intervention
During Retreatment Period: Setrusumab will be administered via intravenous (IV) infusion once a month (QM) for 12 months. During Extension Period: Setrusumab will be administered via IV infusion QM for at least 12 months or until commercially available.
Group II: Setrusumab QM --> Setrusumab TBDExperimental Treatment1 Intervention
During Retreatment Period: Setrusumab will be administered via IV infusion QM for 12 months. During Extension Period: Setrusumab will be administered via IV infusion at a dose frequency to be determined (TBD) for at least 12 months or until commercially available.

Find a Location

Who is running the clinical trial?

Ultragenyx Pharmaceutical IncLead Sponsor
89 Previous Clinical Trials
179,072 Total Patients Enrolled
5 Trials studying Osteogenesis Imperfecta
407 Patients Enrolled for Osteogenesis Imperfecta
Mereo BioPharmaIndustry Sponsor
22 Previous Clinical Trials
1,720 Total Patients Enrolled
3 Trials studying Osteogenesis Imperfecta
331 Patients Enrolled for Osteogenesis Imperfecta
Medical DirectorStudy DirectorUltragenyx Pharmaceutical Inc
2,777 Previous Clinical Trials
8,063,484 Total Patients Enrolled
4 Trials studying Osteogenesis Imperfecta
188 Patients Enrolled for Osteogenesis Imperfecta

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis Imperfecta
2022. "Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis Imperfecta". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05312697.
~1 spots leftby Apr 2025
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