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NCT06073119 (Balinatunfib in moderate to severe plaque psoriasis): BVCT ex-ante prediction vs. reported outcome

On 18 Apr 2025, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 24 Apr 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
NCT06073119
Acronym
SPECIFI-PSO
Drug Name
Balinatunfib
Drug MoA
TNFalpha inhibitor
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Immune System Diseases
Indication
moderate to severe plaque psoriasis
Human Patients
221
Sponsor
Sanofi
Phase
Phase 2

Prediction of , index 1973

Prospective Prediction
Prediction Index
1973
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in PASI75/PASI90 moderately inferior to bimekizumab/ixekizumab and slightly inferior to icotrokinra)
Technical Prediction
partial SUCCESS (statistically significant yet moderate clinical benefit in PASI75 compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
6 days in advance
Readout Data Interpretation
balinatunfib failed to achieve the primary endpoint of PASI75 at week 12
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
A Phase 2, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study of Efficacy and Safety of SAR441566 in Adults With Moderate to Severe Plaque Psoriasis
Phase
Phase 2
Status
Completed
Enrollment
221
Lead sponsor
Sanofi
Conditions
Psoriasis
Interventions
DRUG: SAR441566; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2023-10-26
Primary completion
2024-11-13
Completion
2024-12-11
Results first posted
2025-11-10
Primary outcomes
  • Percentage of Participants With a 75% or Greater Psoriasis Area and Severity Index (PASI) Score Reduction From Baseline (PASI75) at Week 12 (Baseline (Day 1) and Week 12)

NCT06073119 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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