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NCT06637631 (balinatunfib in Crohn’s disease): 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 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
NCT06637631
Acronym
SPECIFI-CD
Drug Name
balinatunfib
Drug MoA
TNFalpha inhibitor
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Immune System Diseases
Indication
Crohn’s disease
Human Patients
260
Sponsor
Sanofi
Phase
Phase 2

Prediction of , index 1975

Prospective Prediction
Prediction Index
1975
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in clinical response/remission moderately inferior to icotrokinra/MK7240)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit in clinical response/remission compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
468 days in advance
Readout Data Interpretation
balinatunfib did not meet internal efficacy expectations, so the program was discontinued.
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, Multinational, Multicenter, Randomized, Doubleblind, Placebocontrolled, Dose-ranging Study to Evaluate the Efficacy and Safety of SAR441566 in Adults With Moderate to Severe Crohn's Disease.
Phase
Phase 2
Status
Active not recruiting
Enrollment
260
Lead sponsor
Sanofi
Conditions
Crohn's Disease
Interventions
DRUG: SAR441566; DRUG: SAR441566 matching Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2024-12-10
Primary completion
2026-07-30
Completion
2026-10-14
Primary outcomes
  • Proportion of participants achieving endoscopic response (Week 12)

NCT06637631 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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