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NCT05741476 (DBV712 in Allergy Peanut): BVCT ex-ante prediction vs. reported outcome

On 28 Jul 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 16 Dec 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

Acronym
VITESSE
Drug Name
DBV712
Drug MoA
patch immunotherapy epicutaneous
Drug Modality
epicutaneous immunotherapy (EPIT)
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Allergy Peanut
Human Patients
600
Sponsor
DBV Technologies
Phase
Phase 3

Prediction of , index 2045

Prospective Prediction
Prediction Index
2045
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in treatment responder percentage)
Technical Prediction
SUCCESS (statistically significant clinical benefit in treatment responder percentage compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
141 days in advance
Readout Data Interpretation
DBV712 achieved 31.8% placebo-adjusted responders at 12 months (p<0.001)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of Epicutaneous Immunotherapy With DBV712 250 μg in 4-7-year-old Children With Peanut Allergy (VITESSE)
Phase
Phase 3
Status
Active not recruiting
Enrollment
600
Lead sponsor
DBV Technologies
Conditions
Allergy, Peanut
Interventions
DRUG: DBV712; OTHER: Placebo; DRUG: DBV712
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2023-02-21
Primary completion
2025-11-06
Completion
2029-10
Primary outcomes
  • DBPC Treatment Period: Percentage of Treatment Responders in the DBV712 250 mcg Group Compared to Placebo Group (At Month 12)

NCT05741476 on ClinicalTrials.gov

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