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NCT04544449 (Fenebrutinib in Primary Progressive Multiple Sclerosis): BVCT ex-ante prediction vs. reported outcome

On 28 Jul 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 10 Nov 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (ocrelizumab is the only SoC).

Clinical Trial

NCTID
NCT04544449
Acronym
FENtrepid
Drug Name
Fenebrutinib
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
Human Patients
985
Sponsor
Roche Group
Phase
Phase 3

Prediction of , index 2048

Prospective Prediction
Prediction Index
2048
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient yet moderate clinical benefit in 12-week CDP moderately superior to ocrelizumab)
Technical Prediction
SUCCESS (statistically significant yet moderate clinical benefit in 12-week CDP compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
105 days in advance
Readout Data Interpretation
fenebrutinib met the primary endpoint of delay in the onset of composite confirmed disability progression over a period of at least 120 weeks of treatment; being numerically superior to ocrelizumab
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (ocrelizumab is the only SoC)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Patients With Primary Progressive Multiple Sclerosis.
Phase
Phase 3
Status
Active not recruiting
Enrollment
985
Lead sponsor
Hoffmann-La Roche
Conditions
Multiple Sclerosis, Primary Progressive
Interventions
DRUG: Fenebrutinib; DRUG: Ocrelizumab; DRUG: Placebo matched to ocrelizumab; DRUG: Placebo matched to fenebrutinib
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2020-10-26
Primary completion
2025-09-17
Completion
2027-07-21
Primary outcomes
  • Time to Onset of Composite 12-Week Confirmed Disability Progression (cCDP12) (Minimum of 120 weeks)

NCT04544449 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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