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NCT05618808 (REGN9933 in Venous thromboembolism): BVCT ex-ante prediction vs. reported outcome

On 22 Jul 2024, BioinvestGPT's BVCT predicted technical partial success and commercial partial success for this trial. The 19 Dec 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient (non-superior to enoxaparin/apixaban in a crowded market).

Clinical Trial

NCTID
NCT05618808
Acronym
ROXI-VTE-I
Drug Name
REGN9933
Drug MoA
anti-Factor-XI inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Cardiovascular Diseases
Indication
Venous thromboembolism (VTE)
Human Patients
373
Sponsor
Regeneron Pharmaceuticals
Phase
Phase 2

Prediction of , index 1694

Prospective Prediction
Prediction Index
1694
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient clinical benefit in reduction of venous thromboembolism incidence non-superior to enoxaparin/apixaban)
Technical Prediction
partial SUCCESS (statistically significant clinical benefit in reduction of major bleeding incidence superior to enoxaparin/apixaban) partial FAILURE (statistically maybe insignificant clinical benefit in non-bleeding TEAE maybe inferior to enoxaparin/apixaban)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
150 days in advance
Readout Data Interpretation
REGN9933 achieved 17% VTE event rate; superior to enoxaparin's 21% VTE event rate yet inferior to apixaban's 12% VTE event rate; REGN9933 achieved 22% AE rate; inferior to enoxaparin's 21% AE rate yet superior to apixaban's 25% AE rate
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient (non-superior to enoxaparin/apixaban in a crowded market)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 2, Multicenter, Randomized, Open-Label, Active-Control Study of REGN9933, a Factor XI Monoclonal Antibody, for Prevention of Venous Thromboembolism After Elective, Unilateral, Total Knee Arthroplasty
Phase
Phase 2
Status
Completed
Enrollment
373
Lead sponsor
Regeneron Pharmaceuticals
Conditions
Venous Thromboembolism
Interventions
DRUG: REGN9933; DRUG: Enoxaparin; DRUG: Apixiban
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2023-05-24
Primary completion
2024-05-27
Completion
2024-05-27
Results first posted
2025-07-16
Primary outcomes
  • Percentage of Participants With Confirmed, Adjudicated Venous Thromboembolism (VTE) (REGN9933 vs Enoxaparin) (Through Day 12)

NCT05618808 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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