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NCT06073093 (balinatunfib in rheumatoid arthritis): BVCT ex-ante prediction vs. reported outcome

On 18 Apr 2025, BioinvestGPT's BVCT predicted technical partial failure and commercial failure for this trial. The 30 Jul 2026 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
NCT06073093
Acronym
SPECIFI-RA
Drug Name
balinatunfib
Drug MoA
TNFalpha inhibitor
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Immune System Diseases
Indication
rheumatoid arthritis
Human Patients
264
Sponsor
Sanofi
Phase
Phase 2

Prediction of , index 1972

Prospective Prediction
Prediction Index
1972
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in DAS28-CRP/ACR20/ACR50)
Technical Prediction
partial FAILURE (statistically maybe significant yet very weak additive clinical benefit in DAS28-CRP/ACR20/ACR50 compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
468 days in advance
Readout Data Interpretation
balinatunfib clinical development program discontinued due to insufficient efficacy
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 Randomized, Double-blind, Placebo-controlled, Dose-ranging, Efficacy and Safety Study of SAR441566 Plus Methotrexate in Adults With ModeratetoSevere Rheumatoid Arthritis
Phase
Phase 2
Status
Completed
Enrollment
264
Lead sponsor
Sanofi
Conditions
Rheumatoid Arthritis
Interventions
DRUG: SAR441566; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2023-11-07
Primary completion
2025-06-18
Completion
2025-07-02
Primary outcomes
  • Proportion of participants achieving at least 20% improvement from baseline in the American College of Rheumatology (ACR) score at week 12 (Baseline to Week 12)

NCT06073093 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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