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NCT06028230 (SAR444656 in Moderate to Severe Hidradenitis Suppurativa): BVCT ex-ante prediction vs. reported outcome

On 4 Nov 2024, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 25 Jun 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically TBD and commercially insufficient.

Clinical Trial

NCTID
NCT06028230
Acronym
ZEN
Drug Name
SAR444656 (KT-474)
Drug MoA
E3ligase-binding IRAK4 degrader
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Moderate to Severe Hidradenitis Suppurativa
Human Patients
70
Sponsor
Kymera Therapeutics / Sanofi
Phase
Phase 2

Prediction of , index 1824

Prospective Prediction
Prediction Index
1824
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in HiSCR50 non-superior to adalimumab and inferior to sonelokimab/bimekizumab/secukinumab)
Technical Prediction
SUCCESS (statistically significant yet moderate clinical benefit in HiSCR50 against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
233 days in advance
Readout Data Interpretation
SAR444656’s further development is discontinued
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically TBD and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Parallel-group Treatment, Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SAR444656 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Phase
Phase 2
Status
Terminated
Enrollment
70
Lead sponsor
Sanofi
Conditions
Hidradenitis Suppurativa
Interventions
DRUG: SAR444656 (KT-474); DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-09-29
Primary completion
2025-10-09
Completion
2025-11-12
Primary outcomes
  • Percent change from baseline in total abscess and inflammatory nodule (AN) count (Week 16)

NCT06028230 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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