Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating Painful DPN.

Official Title
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A Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of VX-548 in Subjects With Painful Diabetic Peripheral Neuropathy

Conditions
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Diabetic Peripheral Neuropathy

Intervention / Treatment
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* Drug: VX-548
* Drug: Pregabalin
* Drug: Placebo (matched to VX-548)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VX-548<br>Participants will be randomized to receive different dose levels of VX-548. | Drug: VX-548<br>* Tablets for oral administration.<br>Drug: Placebo (matched to VX-548)<br>* Placebo matched to VX-548 for oral administration.<br>|
| Active Comparator: Pregabalin<br>Participants will receive pregabalin. | Drug: Pregabalin<br>* Capsules for oral administration.<br>Drug: Placebo (matched to VX-548)<br>* Placebo matched to VX-548 for oral administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the Weekly Average of Daily Pain Intensity on a Numeric Pain Rating Scale (NPRS) |  | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS) |  | Baseline, Week 12 | 
| Proportions of Participants With Greater Than or Equal to (≥) 30 Percent (%), ≥50%, and ≥70% Reductions from Baseline in the Weekly Average of Daily Pain Intensity on the NPRS |  | Baseline, Week 12 | 
| Proportion of Participants Categorized as Much Improved or Very Much Improved on the Patient Global Impression of Change (PGIC) Assessment |  | At Week 12 | 
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Day 1 up to Week 14 |