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NCT06176196 (Suzetrigine in Painful Lumbosacral Radiculopathy): BVCT ex-ante prediction vs. reported outcome

On 7 Dec 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 19 Dec 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant (NPRS) and commercially insufficient.

Clinical Trial

NCTID
NCT06176196
Drug Name
Suzetrigine (VX-548)
Drug MoA
oral Nav1.8/SCN10A inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Painful Lumbosacral Radiculopathy
Human Patients
218
Sponsor
Vertex Pharmaceuticals
Phase
Phase 2

Prediction of , index 1854

Prospective Prediction
Prediction Index
1854
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in NPRS/DSIS/TEAE non-superior to NSAIDs and inferior to epidural steroid injection)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit in NPRS at week 12 against placebo) partial FAILURE (statistically insignificant clinical benefit in DSIS at week 12 against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
12 days in advance
Readout Data Interpretation
suzetrigine achieved non-superior-non-inferior-to-placebo efficacy in NPRS at week 12 (-2.02 vs -1.98 without disclosing p-value); DSIS data not disclosed
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant (NPRS) 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 2, Randomized, Double-blind, Placebo-controlled, Parallel-design Study of the Efficacy and Safety of VX-548 in Subjects With Painful Lumbosacral Radiculopathy
Phase
Phase 2
Status
Completed
Enrollment
218
Lead sponsor
Vertex Pharmaceuticals Incorporated
Conditions
Painful Lumbosacral Radiculopathy
Interventions
DRUG: VX-548; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-12-13
Primary completion
2024-10-02
Completion
2024-10-16
Primary outcomes
  • Change From Baseline in the Weekly Average of Daily leg Pain Intensity on a Numeric Pain Rating Scale (NPRS) (Baseline, Week 12)

NCT06176196 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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