BioinvestGPT

BioinvestGPT ApS · Research use only

NCT04458051 (Tolebrutinib in Primary Progressive Multiple Sclerosis): BVCT ex-ante prediction vs. reported outcome

On 18 Apr 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 15 Dec 2025 readout could not be adjudicated and sits outside the scored cohort.

Clinical Trial

NCTID
NCT04458051
Acronym
PERSEUS
Drug Name
Tolebrutinib
Drug MoA
CNS-penetrant BTK inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Primary Progressive Multiple Sclerosis (PPMS)
Human Patients
767
Sponsor
Sanofi
Phase
Phase 3

Prediction of , index 1979

Prospective Prediction
Prediction Index
1979
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient yet moderate clinical benefit in 6month CDP moderately superior to ocrelizumab)
Technical Prediction
SUCCESS (statistically significant yet moderate clinical benefit in 6-month CDP compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
241 days in advance
Readout Data Interpretation
Tolebrutinib failed to meet the primary endpoint compared with placebo
Press Release
Prediction Result
Prediction Accuracy
Unadjudicatable Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient; Unadjudicatable prediction due to data-contaminated modifications of the originally correct PPMS disease models from based early partial data readout of the HERCULES trial (index 1756)
Prediction Classification
—

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 Primary Progressive Multiple Sclerosis (PERSEUS)
Phase
Phase 3
Status
Completed
Enrollment
767
Lead sponsor
Sanofi
Conditions
Primary Progressive Multiple Sclerosis
Interventions
DRUG: Tolebrutinib; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2020-08-13
Primary completion
2025-11-14
Completion
2025-11-14
Primary outcomes
  • 6-month composite Confirmed Disability Progression (cCDP) (Up to approximately 60 months)

NCT04458051 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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