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NCT04411641 (Tolebrutinib in Nonrelapsing Secondary Progressive Multiple Sclerosis): BVCT ex-ante prediction vs. reported outcome

On 19 Aug 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 24 Dec 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient.

Clinical Trial

NCTID
NCT04411641
Acronym
HERCULES
Drug Name
Tolebrutinib
Drug MoA
CNS-penetrant BTK inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS)
Human Patients
1131
Sponsor
Sanofi
Phase
Phase 3

Prediction of , index 1756

Prospective Prediction
Prediction Index
1756
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in 6-month CDP inferior to siponimod)
Technical Prediction
FAILURE (statistically insignificant clinical benefit in 6-month CDP against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
492 days in advance
Readout Data Interpretation
tolebrutinib achieved 31% placebo-adjusted reduction in 6-month (CDP); non-superior to siponimod’s 29-33% placebo-adjusted reduction in 6-month CDP in the EXPAND trial NCT01665144 (see add'l link below); FDA issued CRL rejecting Sanofi's NDA for tolebrutinib for NR-SPMS
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant 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 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis
Phase
Phase 3
Status
Completed
Enrollment
1131
Lead sponsor
Sanofi
Conditions
Non-relapsing Secondary Progressive Multiple Sclerosis
Interventions
DRUG: Tolebrutinib; DRUG: Placebo to match Tolebrutinib
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2020-09-24
Primary completion
2024-08-29
Completion
2024-08-29
Results first posted
2025-06-18
Primary outcomes
  • Time to Onset of 6-Month Confirmed Disability Progression (CDP) as Assessed by Expanded Disability Status Scale (EDSS) (Baseline (Day 1) up to approximately 47 months)

NCT04411641 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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