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

August 31, 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
455

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 25, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 25, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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