Phase 2
N=194
Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT05660538 ↗Enrolled (actual)
194
Serious AEs
2.1%
Results posted
Jul 2025
Primary outcome: Primary: Change From Baseline in the Weekly Average of Daily Pain Intensity on a Numeric Pain Rating Scale (NPRS) — -2.09; -2.18; -2.11; -2.26 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Suzetrigine (Drug); Pregabalin (Drug); Placebo (matched to SUZ) (Drug); Placebo (matched to pregabalin) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Weekly Average of Daily Pain Intensity on a Numeric Pain Rating Scale (NPRS) |
-2.09; -2.18; -2.11; -2.26 | — |
| SECONDARY Change From Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS) Score |
-2.42; -2.20; -2.44; -2.15 | — |
| SECONDARY Percentage of Participants With Greater Than or Equal to (≥) 30 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS |
44.9; 70.8; 46.0; 48.0 | — |
| SECONDARY Percentage of Participants With ≥50 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS |
22.4; 41.7; 32.0; 34.0 | — |
| SECONDARY Percentage of Participants With ≥70 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS |
10.2; 8.3; 22.0; 22.0 | — |
| SECONDARY Percentage of Participants Categorized as "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Assessment |
46.9; 50.0; 52.0; 50.0 | — |
| SECONDARY Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
20; 14; 21; 31; 1; 0 | — |
Summary
The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating Painful DPN.
Eligibility Criteria
Key Inclusion Criteria
- Diagnosis of diabetes mellitus type 1 or type 2 with
- Glycosylated hemoglobin A1c (HbA1c) ≤9%; and
- Presence of bilateral pain in lower extremities due to DPN for at least 1 year
Key Exclusion Criteria
- Painful neuropathy other than DPN
- History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
- History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months
Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT05660538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.