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NCT05125809 (Setrusumab in Osteogenesis Imperfecta): BVCT ex-ante prediction vs. reported outcome

On 6 Aug 2024, BioinvestGPT's BVCT predicted technical success and commercial partial success 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
NCT05125809
Acronym
Orbit
Drug Name
Setrusumab (UX143)
Drug MoA
anti-sclerostin inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Musculoskeletal Diseases
Indication
Osteogenesis Imperfecta
Human Patients
183
Sponsor
Ultragenyx Pharmaceutical
Phase
Phase 2 Phase 3

Prediction of , index 1039

Prospective Prediction
Prediction Index
1039
Prediction Date
Commercial Prediction
partial SUCCESS (commercially sufficient clinical benefit in bone mineral density superior to bisphosphonate) partial FAILURE (commercially insufficient clinical benefit in annualized fracture rate non-superior to bisphosphonate)
Technical Prediction
SUCCESS (statistically significant clinical benefit in annualized fracture rate and bone mineral density against placebo)

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 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
Phase
Phase 2, Phase 3
Status
Active not recruiting
Enrollment
183
Lead sponsor
Ultragenyx Pharmaceutical Inc
Conditions
Osteogenesis Imperfecta
Interventions
BIOLOGICAL: Setrusumab; OTHER: Placebo
Design
Randomized · Sequential · Quadruple
Primary purpose
Treatment
Start
2022-02-21
Primary completion
2025-10-20
Completion
2027-04
Primary outcomes
  • Phase 2: Percent Change in Serum Amino-terminal Propeptide of Type 1 Procollagen (P1NP) from Baseline at Month 1 (Baseline, Month 1)
  • Phase 3: Annualized Rate of All Radiographically-Confirmed Fractures, Excluding Morphometric Vertebral Fractures and Fractures of the Fingers, Toes, Face, and Skull at the Primary Analysis (Up to Month 24)

NCT05125809 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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