BioinvestGPT

BioinvestGPT ApS · Research use only

NCT04410991 (Tolebrutinib in Relapsing Forms of Multiple Sclerosis): BVCT ex-ante prediction vs. reported outcome

On 24 Jan 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 2 Sep 2024 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
NCT04410991
Acronym
GEMINI 2
Drug Name
Tolebrutinib
Drug MoA
CNS-penetrant BTK inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Relapsing Forms of Multiple Sclerosis (RMS)
Human Patients
899
Sponsor
Sanofi
Phase
Phase 3

Prediction of , index 1428

Prospective Prediction
Prediction Index
1428
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit inferior to teriflunomide)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
222 days in advance
Readout Data Interpretation
superiority primary endpoint (Tolebrutinib vs teriflunomide in annualized replace rate reduction) not met.
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 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis
Phase
Phase 3
Status
Completed
Enrollment
899
Lead sponsor
Sanofi
Conditions
Relapsing Multiple Sclerosis
Interventions
DRUG: Tolebrutinib; DRUG: Teriflunomide HMR1726; DRUG: Placebo to match Tolebrutinib; DRUG: Placebo to match Teriflunomide
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2020-06-11
Primary completion
2024-07-16
Completion
2024-07-16
Results first posted
2025-06-18
Primary outcomes
  • Annualized Relapse Rate (ARR) as Assessed by Confirmed Protocol-defined Adjudicated Relapses (Baseline (Day 1) to approximately 48 months)

NCT04410991 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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