Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)

May 13, 2026 updated by: Vertex Pharmaceuticals Incorporated

A Phase 3, Open-label Study Evaluating the Long-term Safety and Effectiveness of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy

The purpose of this study is to evaluate the long-term safety and tolerability of SUZ and long-term effectiveness of SUZ in treating pain associated with DPN.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A Phase 3, Open-label Study Evaluating the Long-term Safety and Effectiveness of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy

Study Type

Interventional

Enrollment (Actual)

455

Phase

  • Phase 3

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
      • Daphne, Alabama, United States, 36526
        • AMR Daphne, AL
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Scottsdale Clinical Trials
    • California
      • Fresno, California, United States, 93710
        • Neuro-Pain Medical Center
      • Long Beach, California, United States, 90805
        • Long Beach Research Institute
      • Los Angeles, California, United States, 90010
        • Angel City Research, Inc
      • Pomona, California, United States, 91767
        • Empire Clinical Research
      • Sacramento, California, United States, 95821
        • Clinical Trials Research
      • San Bernardino, California, United States, 92408
        • Velocity Clinical Research, San Bernardino
      • Thousand Oaks, California, United States, 91320
        • SCLA Management - Pain Management and Injury Relief
    • Colorado
      • Englewood, Colorado, United States, 80110
        • Velocity Clinical Research - Denver
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Velocity Clinical Research - Washington DC
    • Florida
      • Coral Gables, Florida, United States, 33134
        • AMR-Miami
      • DeLand, Florida, United States, 32720
        • Accel Research - Deland
      • Doral, Florida, United States, 33172
        • Suncoast Research Associates - Miami
      • Fort Myers, Florida, United States, 33912
        • AMR Fort Myers (The Clinical Study Center)
      • Hallandale, Florida, United States, 33009
        • Velocity Clinical Research - Hallandale Beach
      • Jacksonville, Florida, United States, 32256
        • CNS Healthcare - Jacksonville
      • Largo, Florida, United States, 33777
        • Accel Research Site - St. Petersburg/Largo
      • Maitland, Florida, United States, 32751
        • Accel Research Sites - Maitland
      • Miami Lakes, Florida, United States, 33014
        • 3Sync Research - Miami Lakes
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research - New Port Richey
      • Orlando, Florida, United States, 32832
        • Conquest Clinical Research - Orlando - Neuro
      • Winter Park, Florida, United States, 32789
        • Conquest Clinical Research - Winter Park
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Accel Research - Decatur
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Velocity Clinical Research - Boise
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Feinberg School of Medicine - Anesthesiology
      • Tinley Park, Illinois, United States, 604773027
        • Healthcare Research Network - Flossmoor IL
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Synexus Clinical Research - Evansville
    • Kansas
      • Wichita, Kansas, United States, 67207
        • AMR Wichita East, KS (Heartland Research Associates)
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • AMR Lexington
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Velocity Clinical Research - Baton Rouge
      • Covington, Louisiana, United States, 70433
        • Tandem Clinical Research- Covington
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Mass General Brigham - Brigham and Women's Hospital - Main Campus
      • Waltham, Massachusetts, United States, 02451
        • MedVadis Research Corporation
    • Missouri
      • Hazelwood, Missouri, United States, 63042
        • Healthcare Research Network - Hazelwood MO
      • Kansas City, Missouri, United States, 64114
        • AMR Kansas City
    • Nebraska
      • Norfolk, Nebraska, United States, 68701
        • Velocity Clinical Research - Norfolk
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • HRI - Hassman Research Institute
    • New Mexico
      • Albuquerque, New Mexico, United States, 87107
        • Velocity Clinical Research - Albuquerque
    • New York
      • Brooklyn, New York, United States, 11226
        • Swift Clinical OpCo, Inc
      • East Syracuse, New York, United States, 13057
        • Velocity Clinical Research - Syracuse
      • New York, New York, United States, 10032
        • Columbia Presbyterian - The Neurological Institute of New York
      • New York, New York, United States, 10017
        • Synexus Clinical Research - New York (DRS)
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • West Clinical Research
      • Raleigh, North Carolina, United States, 27607
        • Eximia Research - Raleigh
      • Winston-Salem, North Carolina, United States, 27103
        • Carolinas Pain Institute - Winston-Salem Office
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Velocity Clinical Research - Cleveland
      • Cincinnati, Ohio, United States, 45236
        • Synexus Clinical Research - Cincinnati
      • Dayton, Ohio, United States, 45432
        • META Medical Research Institute
    • Oregon
      • Medford, Oregon, United States, 97504
        • Velocity Clinical Research - Medford
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Suburban Research Associates - Media
    • 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
      • Charleston, South Carolina, United States, 29414
        • M3 Wake Research - Charleston
      • Spartanburg, South Carolina, United States, 29303
        • Velocity Clinical Research - Spartanburg
    • Texas
      • Dallas, Texas, United States, 75230
        • Zenos Clinical Research
      • Round Rock, Texas, United States, 78681
        • Be Well Clinical Studies - Austin
      • San Antonio, Texas, United States, 78240
        • San Antonio Clinical Trials
      • Waco, Texas, United States, 76710
        • Velocity Clinical Research - Waco
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Kalo Clinical Research - Salt Lake City
      • West Jordan, Utah, United States, 84088
        • Velocity Clinical Research - Salt Lake City
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Dominion Medical Associates, Inc.
    • Washington
      • Bellevue, Washington, United States, 98007
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

• Completed the final visit in the Treatment Period (i.e., Week 12) and subsequent 7-day period (to allow for taper of blinded capsule study drug) in a parent study such as VX24-548-110 or VX24-548-111

Key Exclusion Criteria:

  • Any sensory abnormality (excluding DPN)
  • History of drug intolerance in a parent study that would pose an additional risk to the participant in the opinion of the investigator
  • Current participation in an investigational drug trial (other than a parent study)

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Suzetrigine (SUZ)
Participants will receive SUZ once daily (qd) up to 52 weeks.
Drug: Suzetrigine
Tablets for oral administration.
Other Names:
  • VX-548
  • SUZ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From Baseline up to Week 54
From Baseline up to Week 54

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Study 36-item Short-form Health Status (SF-36v2) Physical Component Summary (PCS) Score
Time Frame: From Baseline up to Week 52
From Baseline up to Week 52
Change From Baseline in the Short form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score
Time Frame: From Baseline up to Week 52
From Baseline up to Week 52

Collaborators and Investigators

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

Sponsor

Vertex Pharmaceuticals Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 18, 2024

Primary Completion (Estimated)

January 25, 2027

Study Completion (Estimated)

January 25, 2027

Study Registration Dates

First Submitted

November 15, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Actual)

November 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX24-548-112

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/our-science/clinical-trials-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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