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NCT05768854 (Setrusumab in paediatric Osteogenesis Imperfecta): BVCT ex-ante prediction vs. reported outcome

On 6 Aug 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 29 Dec 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05768854
Acronym
Cosmic
Drug Name
Setrusumab (UX143)
Drug MoA
anti-sclerostin inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Musculoskeletal Diseases
Indication
paediatric Osteogenesis Imperfecta
Human Patients
69
Sponsor
Ultragenyx Pharmaceutical
Phase
Phase 3

Prediction of , index 1040

Prospective Prediction
Prediction Index
1040
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in annualized fracture rate non-superior to bisphosphonate)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit in annualized fracture rate)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
510 days in advance
Readout Data Interpretation
setrusumab did not meet primary endpoint in annualized clinical fracture rate compared with IV bisphosphonates
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
An Open-label, Randomized, Active-Controlled, Phase 3 Study of Setrusumab Compared With Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta Types I, III or IV
Phase
Phase 3
Status
Active not recruiting
Enrollment
69
Lead sponsor
Ultragenyx Pharmaceutical Inc
Conditions
Osteogenesis Imperfecta
Interventions
DRUG: Bisphosphonate; BIOLOGICAL: Setrusumab
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2023-06-14
Primary completion
2025-10-23
Completion
2027-04
Primary outcomes
  • Annualized Rate of All Radiographically-Confirmed Fractures, Including Morphometric Vertebral Fractures, at the Primary Analysis (Up to 24 Months)

NCT05768854 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials