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

NCT06696443 · tracked via the Priya Life Science USA tracker

Sponsor

Vertex Pharmaceuticals Incorporated

Phase

Phase 3

Started

2024-12-18

Last updated

2026-09-03

Condition(s) studied

Diabetic Peripheral Neuropathic Pain

Investigational drug(s) / intervention(s)

Suzetrigine

Suzetrigine: Tablets for oral administration.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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.

Primary outcome measure(s)

Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — From Baseline up to Week 54

Trial sites (65)

Facility	City	Region
Pinnacle Research Group, LLC	Anniston	Alabama
AMR Daphne, AL	Daphne	Alabama
Scottsdale Clinical Trials	Scottsdale	Arizona
Neuro-Pain Medical Center	Fresno	California
Long Beach Research Institute	Long Beach	California
Angel City Research, Inc	Los Angeles	California
Empire Clinical Research	Pomona	California
Clinical Trials Research	Sacramento	California
Velocity Clinical Research, San Bernardino	San Bernardino	California
SCLA Management - Pain Management and Injury Relief	Thousand Oaks	California
Velocity Clinical Research - Denver	Englewood	Colorado
Velocity Clinical Research - Washington DC	Washington D.C.	District of Columbia
AMR-Miami	Coral Gables	Florida
Accel Research - Deland	DeLand	Florida
Suncoast Research Associates - Miami	Doral	Florida
AMR Fort Myers (The Clinical Study Center)	Fort Myers	Florida
Velocity Clinical Research - Hallandale Beach	Hallandale	Florida
CNS Healthcare - Jacksonville	Jacksonville	Florida
Accel Research Site - St. Petersburg/Largo	Largo	Florida
Accel Research Sites - Maitland	Maitland	Florida
3Sync Research - Miami Lakes	Miami Lakes	Florida
Suncoast Clinical Research - New Port Richey	New Port Richey	Florida
Conquest Clinical Research - Orlando - Neuro	Orlando	Florida
Conquest Clinical Research - Winter Park	Winter Park	Florida
Accel Research - Decatur	Decatur	Georgia
Velocity Clinical Research - Boise	Meridian	Idaho
Feinberg School of Medicine - Anesthesiology	Chicago	Illinois
Healthcare Research Network - Flossmoor IL	Tinley Park	Illinois
Synexus Clinical Research - Evansville	Evansville	Indiana
AMR Wichita East, KS (Heartland Research Associates)	Wichita	Kansas
AMR Lexington	Lexington	Kentucky
Velocity Clinical Research - Baton Rouge	Baton Rouge	Louisiana
Tandem Clinical Research- Covington	Covington	Louisiana
Mass General Brigham - Brigham and Women's Hospital - Main Campus	Boston	Massachusetts
MedVadis Research Corporation	Waltham	Massachusetts
Healthcare Research Network - Hazelwood MO	Hazelwood	Missouri
AMR Kansas City	Kansas City	Missouri
Velocity Clinical Research - Norfolk	Norfolk	Nebraska
HRI - Hassman Research Institute	Marlton	New Jersey
Velocity Clinical Research - Albuquerque	Albuquerque	New Mexico

+ 25 more sites — see the full list on the official registry below.

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Other trials for the same condition

Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy Recruiting

MAD Study to Assess the Safety, Tolerability, PKs and Efficacy of YJ001 for Spray Use in Patients With DPNP Recruiting

A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain Recruiting

Evaluation of Efficacy and Safety of Suzetrigine (SUZ) for Pain Associated With Diabetic Peripheral Neuropathy Recruiting

Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06696443 on ClinicalTrials.gov ↗ ← All trials in the USA