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

NCT06696443 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: VX24-548-112
• Study Type: interventional
• Target: 455
• Locations: 1 country
• Sites: 65

Brief Summary

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.

Conditions

Diabetic Peripheral Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From Baseline up to Week 54

Secondary Outcomes (2)

• Change From Baseline in Study 36-item Short-form Health Status (SF-36v2) Physical Component Summary (PCS) Score

  From Baseline up to Week 52

• Change From Baseline in the Short form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score

  From Baseline up to Week 52

Study Arms (1)

Suzetrigine (SUZ)

EXPERIMENTAL

Participants will receive SUZ once daily (qd) up to 52 weeks.

Drug: Suzetrigine

Interventions

Suzetrigine DRUG

Tablets for oral administration.

Also known as: VX-548, SUZ

Suzetrigine (SUZ)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (65)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

Location

AMR Daphne, AL

Daphne, Alabama, 36526, United States

Location

Scottsdale Clinical Trials

Scottsdale, Arizona, 85260, United States

Location

Neuro-Pain Medical Center

Fresno, California, 93710, United States

Location

Long Beach Research Institute

Long Beach, California, 90805, United States

Location

Angel City Research, Inc

Los Angeles, California, 90010, United States

Location

Empire Clinical Research

Pomona, California, 91767, United States

Location

Clinical Trials Research

Sacramento, California, 95821, United States

Location

Velocity Clinical Research, San Bernardino

San Bernardino, California, 92408, United States

Location

SCLA Management - Pain Management and Injury Relief

Thousand Oaks, California, 91320, United States

Location

Velocity Clinical Research - Denver

Englewood, Colorado, 80110, United States

Location

Velocity Clinical Research - Washington DC

Washington D.C., District of Columbia, 20016, United States

Location

AMR-Miami

Coral Gables, Florida, 33134, United States

Location

Accel Research - Deland

DeLand, Florida, 32720, United States

Location

Suncoast Research Associates - Miami

Doral, Florida, 33172, United States

Location

AMR Fort Myers (The Clinical Study Center)

Fort Myers, Florida, 33912, United States

Location

Velocity Clinical Research - Hallandale Beach

Hallandale, Florida, 33009, United States

Location

CNS Healthcare - Jacksonville

Jacksonville, Florida, 32256, United States

Location

Accel Research Site - St. Petersburg/Largo

Largo, Florida, 33777, United States

Location

Accel Research Sites - Maitland

Maitland, Florida, 32751, United States

Location

3Sync Research - Miami Lakes

Miami Lakes, Florida, 33014, United States

Location

Suncoast Clinical Research - New Port Richey

New Port Richey, Florida, 34652, United States

Location

Conquest Clinical Research - Orlando - Neuro

Orlando, Florida, 32832, United States

Location

Conquest Clinical Research - Winter Park

Winter Park, Florida, 32789, United States

Location

Accel Research - Decatur

Decatur, Georgia, 30030, United States

Location

Velocity Clinical Research - Boise

Meridian, Idaho, 83642, United States

Location

Feinberg School of Medicine - Anesthesiology

Chicago, Illinois, 60611, United States

Location

Healthcare Research Network - Flossmoor IL

Tinley Park, Illinois, 604773027, United States

Location

Synexus Clinical Research - Evansville

Evansville, Indiana, 47714, United States

Location

AMR Wichita East, KS (Heartland Research Associates)

Wichita, Kansas, 67207, United States

Location

AMR Lexington

Lexington, Kentucky, 40509, United States

Location

Velocity Clinical Research - Baton Rouge

Baton Rouge, Louisiana, 70809, United States

Location

Tandem Clinical Research- Covington

Covington, Louisiana, 70433, United States

Location

Mass General Brigham - Brigham and Women's Hospital - Main Campus

Boston, Massachusetts, 02115, United States

Location

MedVadis Research Corporation

Waltham, Massachusetts, 02451, United States

Location

Healthcare Research Network - Hazelwood MO

Hazelwood, Missouri, 63042, United States

Location

AMR Kansas City

Kansas City, Missouri, 64114, United States

Location

Velocity Clinical Research - Norfolk

Norfolk, Nebraska, 68701, United States

Location

HRI - Hassman Research Institute

Marlton, New Jersey, 08053, United States

Location

Velocity Clinical Research - Albuquerque

Albuquerque, New Mexico, 87107, United States

Location

Swift Clinical OpCo, Inc

Brooklyn, New York, 11226, United States

Location

Velocity Clinical Research - Syracuse

East Syracuse, New York, 13057, United States

Location

Synexus Clinical Research - New York (DRS)

New York, New York, 10017, United States

Location

Columbia Presbyterian - The Neurological Institute of New York

New York, New York, 10032, United States

Location

West Clinical Research

Morehead City, North Carolina, 28557, United States

Location

Eximia Research - Raleigh

Raleigh, North Carolina, 27607, United States

Location

Carolinas Pain Institute - Winston-Salem Office

Winston-Salem, North Carolina, 27103, United States

Location

Velocity Clinical Research - Cleveland

Beachwood, Ohio, 44122, United States

Location

Synexus Clinical Research - Cincinnati

Cincinnati, Ohio, 45236, United States

Location

META Medical Research Institute

Dayton, Ohio, 45432, United States

Location

Velocity Clinical Research - Medford

Medford, Oregon, 97504, United States

Location

Suburban Research Associates - Media

Media, Pennsylvania, 19063, United States

Location

Velocity Clinical Research - Providence

East Greenwich, Rhode Island, 02818, United States

Location

Synexus Clinical Research- Anderson

Anderson, South Carolina, 29621, United States

Location

Clinical Trials of South Carolina - Charleston

Charleston, South Carolina, 29406, United States

Location

M3 Wake Research - Charleston

Charleston, South Carolina, 29414, United States

Location

Velocity Clinical Research - Spartanburg

Spartanburg, South Carolina, 29303, United States

Location

Zenos Clinical Research

Dallas, Texas, 75230, United States

Location

Be Well Clinical Studies - Austin

Round Rock, Texas, 78681, United States

Location

San Antonio Clinical Trials

San Antonio, Texas, 78240, United States

Location

Velocity Clinical Research - Waco

Waco, Texas, 76710, United States

Location

Kalo Clinical Research - Salt Lake City

Salt Lake City, Utah, 84102, United States

Location

Velocity Clinical Research - Salt Lake City

West Jordan, Utah, 84088, United States

Location

Dominion Medical Associates, Inc.

Richmond, Virginia, 23219, United States

Location

Northwest Clinical Research Center (NWCRC)

Bellevue, Washington, 98007, United States

Location

Related Publications (1)

• Siddiqui A, Xu JL, Abramowicz AE. Suzetrigine for the Treatment of Acute Pain: Comment. Anesthesiology. 2026 Feb 1;144(2):495-496. doi: 10.1097/ALN.0000000000005822. Epub 2025 Dec 11. No abstract available.

  PMID: 41384808 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 20, 2024
• Study Start: December 18, 2024
• Primary Completion (Estimated): January 25, 2027
• Study Completion (Estimated): January 25, 2027
• Last Updated: January 29, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (65)