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

June 13, 2025 updated by: Vertex Pharmaceuticals Incorporated

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group, LLC
      • Birmingham, Alabama, United States, 35211
        • Synexus Clinical Research US - Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Synexus Clinical Research US - Phoenix West
    • California
      • Banning, California, United States, 92220
        • Velocity Clinical Research - Banning
      • Long Beach, California, United States, 90806
        • Long Beach Clinical Trials Services, Inc.
      • Tustin, California, United States, 92780
        • University Clinical Investigators
    • Colorado
      • Colorado Springs, Colorado, United States, 80918
        • Lynn Institute of the Rockies
    • Florida
      • Fleming Island, Florida, United States, 32003
        • Fleming Island Center For Clinical Research
      • Fort Myers, Florida, United States, 33912
        • AMR Fort Myers (The Clinical Study Center)
      • Hallandale Beach, Florida, United States, 33009-4427
        • Velocity Clinical Research - Hallandale Beach
      • Jacksonville, Florida, United States, 32205
        • Westside Center for Clinical Research
      • Largo, Florida, United States, 33777
        • Accel Research Sites - Tampa
      • Maitland, Florida, United States, 32751
        • Accel Research Sites - Maitland
      • Miami, Florida, United States, 33137
        • Suncoast Research Associates
      • Orlando, Florida, United States, 32806-1041
        • Synexus - Orlando
      • The Villages, Florida, United States, 32162-7116
        • Synexus - The Villages
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Accel Research Sites - Neurostudies
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Velocity Clinical Research - Boise (Advanced Clinical Research)
    • Illinois
      • Flossmoor, Illinois, United States, 60422
        • Healthcare Research Network - Chicago
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Synexus Clinical Research - Evansville
    • Kansas
      • El Dorado, Kansas, United States, 67042
        • AMR El Dorado
      • Newton, Kansas, United States, 67114
        • AMR Newton
      • Wichita, Kansas, United States, 67207
        • AMR Wichita East, KS
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Clinical Trials of America, LLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital (BWH) - Translational Pain Research
      • North Dartmouth, Massachusetts, United States, 02747
        • Boston Neuro Research Center, LLC
      • Waltham, Massachusetts, United States, 02451
        • Boston PainCare Center
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Revival Research Institute
    • Missouri
      • Hazelwood, Missouri, United States, 63042
        • Healthcare Research Network - Hazelwood
      • Kansas City, Missouri, United States, 64114-4866
        • AMR Kansas City
      • Saint Louis, Missouri, United States, 63141
        • Synexus Clinical Research US - St. Louis
      • Saint Peters, Missouri, United States, 63303-3041
        • StudyMetrix Research, LLC
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Synexus Clinical Research - Henderson
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Hassman Research Institute
    • New York
      • New York, New York, United States, 10017
        • Synexus Clinical Research- New York
    • North Carolina
      • Fayetteville, North Carolina, United States, 28303
        • Carolina Institute for Clinical Research
      • Greensboro, North Carolina, United States, 27410
        • Triad Clinical Trials
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Synexus - Cincinnati
      • Cleveland, Ohio, United States, 44122
        • Velocity Clinical Research - Cleveland
    • Oregon
      • Medford, Oregon, United States, 97504
        • Velocity Clinical Research - Medford
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Velocity Clinical Research - Providence
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Synexus Clinical Research- Anderson
      • Charleston, South Carolina, United States, 29406
        • Clinical Trials of South Carolina - Charleston
      • Orangeburg, South Carolina, United States, 29118
        • South Carolina Clinical Research
    • Texas
      • Baytown, Texas, United States, 77521
        • Inquest Clinical Research
      • Dallas, Texas, United States, 75234-7858
        • Synexus - Dallas
      • San Antonio, Texas, United States, 78229-4801
        • Diabetes & Glandular Disease Clinic, P.A
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Wasatch Clinical Research
    • Washington
      • Bellevue, Washington, United States, 98007-4209
        • Northwest Clinical Research Center (NWCRC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pregabalin
Participants received Pregabalin 100 mg 3 times per day (tid) for 12 weeks
Drug: Pregabalin
Capsules for oral administration.
Drug: Placebo (matched to SUZ)
Placebo matched to SUZ for oral administration.
Experimental: Suzetrigine (SUZ): Low Dose
Participants received SUZ 23 mg tablet once daily (qd) for 12 weeks.
Drug: Placebo (matched to pregabalin)
Placebo matched to pregabalin for oral administration.
Drug: Suzetrigine
Tablets for oral administration.
Other Names:
  • VX-548
  • SUZ
Experimental: Suzetrigine (SUZ): Mid Dose
Participants received SUZ 46 mg tablet qd for 12 weeks.
Drug: Placebo (matched to pregabalin)
Placebo matched to pregabalin for oral administration.
Drug: Suzetrigine
Tablets for oral administration.
Other Names:
  • VX-548
  • SUZ
Experimental: Suzetrigine (SUZ): High Dose
Participants received SUZ 69 mg tablet qd for 12 weeks.
Drug: Placebo (matched to pregabalin)
Placebo matched to pregabalin for oral administration.
Drug: Suzetrigine
Tablets for oral administration.
Other Names:
  • VX-548
  • SUZ

What is the study measuring?

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)
Time Frame: Baseline, At Week 12
Change from baseline in the weekly mean of the daily Numeric Pain Rating Scale (NPRS) score assessing average pain intensity in the last 24 hours. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.
Baseline, At 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) Score
Time Frame: Baseline, At Week 12
Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) score, which asks participants to describe how pain interfered with the participant's sleep. Response options for the DSIS range from 0 (none) to 10 (severe).
Baseline, At Week 12
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
Time Frame: Baseline, At Week 12

Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.

The percentage of participants with ≥30% reduction from baseline in the weekly average NPRS score at Week 12 was reported.
Baseline, At Week 12
Percentage of Participants With ≥50 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS
Time Frame: Baseline, At Week 12
Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.The percentage of participants with ≥50% reduction from baseline in the weekly average NPRS score at Week 12 was reported.
Baseline, At Week 12
Percentage of Participants With ≥70 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS
Time Frame: Baseline, At Week 12

Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.

The percentage of participants with ≥70% reduction from baseline in the weekly average NPRS score at Week 12 was reported.
Baseline, At Week 12
Percentage of Participants Categorized as "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Assessment
Time Frame: Baseline, At Week 12
PGIC is an instrument that measures change in participants' overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Baseline, At Week 12
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Day 1 up to Week 14
Day 1 up to Week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2022

Primary Completion (Actual)

October 12, 2023

Study Completion (Actual)

October 25, 2023

Study Registration Dates

First Submitted

December 13, 2022

First Submitted That Met QC Criteria

December 13, 2022

First Posted (Actual)

December 21, 2022

Study Record Updates

Last Update Posted (Estimated)

July 1, 2025

Last Update Submitted That Met QC Criteria

June 13, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX21-548-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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