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Orbit: Setrusumab in Osteogenesis Imperfecta
NCT05125809Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Feb 2022
- Primary completion
- Oct 2025
- Countries
- 11
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- setrusumab
- Conditions
- osteogenesis imperfecta (OI)
01
Overview
Phase 3, randomised, double-blind trial of setrusumab in osteogenesis imperfecta (OI) (4 arms), sponsored by Ultragenyx Pharmaceutical Inc. Primary endpoints: Percent Change in Serum Amino-terminal Propeptide of Type 1 Procollagen at 1 month and Annualized Rate of All Radiographically-Confirmed Fractures at 24 months. Started Feb 2022; status: active, not recruiting.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Low Dose Setrusumab -> OL Setrusumab Selected Dose
Single-blind setrusumab low dose during Phase 2 followed by open-label setrusumab selected dose
High Dose Setrusumab -> OL Setrusumab Selected Dose
Single-blind setrusumab high dose during Phase 2 followed by open-label setrusumab
Setrusumab Selected Dose -> OL Setrusumab Selected Dose
Double-blind setrusumab selected dose during Phase 3 followed by open-label setrusumab
Placebo -> OL Setrusumab Selected Dose
Double-blind placebo during Phase 3 followed by open-label setrusumab
03
Who it enrols
Patients with Osteogenesis Imperfecta Type I, III, or IV with recent fracture history, adequate Vitamin D, and no recent use of prohibited bone-modifying agents.
04
Endpoints
Primary
Percent Change in Serum Amino-terminal Propeptide of Type 1 Procollagen
Annualized Rate of All Radiographically-Confirmed Fractures
Secondary
Serum Setrusumab Concentration
Change from Baseline in DXA Lumbar Spine Bone Mineral Density Z-score
Pediatric Orthopedic Society of North America Pediatric Outcomes Data Collection Instrument Sports/Physical Functioning Subscale Score
36-item Short Form Health Survey Physical Functioning Domain Scale
Number of Participants With Treatment Emergent Adverse Events
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