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NCT05558410 (VX-548 in Acute Pain After an Abdominoplasty): BVCT ex-ante prediction vs. reported outcome

On 12 Oct 2023, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 30 Jan 2024 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
NCT05558410
Drug Name
VX-548
Drug MoA
NaV1.8 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Acute Pain After an Abdominoplasty
Human Patients
1118
Sponsor
Vertex Pharmaceuticals
Phase
Phase 3

Prediction of , index 1284

Prospective Prediction
Prediction Index
1284
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit due to non-superior-to-HB/APAP efficacy and inferior-to-HB/APAP toxicity leading to significant risk of post-marketing withdrawal)
Technical Prediction
SUCCESS (statistically significant clinical benefit compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
110 days in advance
Readout Data Interpretation
statistically significant than placebo; non-superior to HB/APAP in all endpoints.
Press Release
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, Placebo-controlled Study Evaluating the Efficacy and Safety of Suzetrigine for Acute Pain After an Abdominoplasty
Phase
Phase 3
Status
Completed
Enrollment
1118
Lead sponsor
Vertex Pharmaceuticals Incorporated
Conditions
Acute Pain
Interventions
DRUG: Suzetrigine (SUZ); DRUG: HB/APAP; DRUG: Placebo (matched to SUZ); DRUG: Placebo (matched to HB/APAP)
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-10-10
Primary completion
2023-08-25
Completion
2023-09-11
Results first posted
2025-07-01
Primary outcomes
  • Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48) SUZ Compared to Placebo (0 to 48 hours After First Dose of Study Drug)

NCT05558410 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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