Clinical trial NCT06628908: Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy
Official title: A Phase 3, Randomized, Double-blind, Placebo- and Active-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Diabetic Peripheral Neuropathic Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2024-10-08
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic peripheral neuropathy (DPN).


Eligibility criteria: Key Inclusion Criteria:

* Body weight greater than or equal to (≥) 45 kilogram (kg)
* Body mass index (BMI) ≥18.0 to less than (\<) 40.0 kilogram per meter square (kg/m\^2)
* Diagnosis of diabetes mellitus type 1 or type 2 by glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pain in lower extremities due to DPN
* Weekly average of daily NPRS score ≥4 and less than or equal to (≤) 9 with limited variation in the 7-day Baseline Period

Key Exclusion Criteria:

* More than 3 missing daily NPRS scores during the 7-day Baseline Period
* Participation in a previous study in which the participant received SUZ
* Any sensory abnormality (excluding DPN) as pre-specified in the protocol

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 Compared to Placebo
timeFrame: From Baseline up to Week 12
Secondary outcomes:
measure: Change From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12 Compared to Pregabalin (pooled with data from Study VX24-548-111)
timeFrame: From Baseline up to Week 12
measure: Change From Baseline in 36-item Short-form Health Status (SF 36v2) Physical Component Summary (PCS) Score at Week 12 Compared to Placebo (pooled with data from Study VX24-548-111)
timeFrame: From Baseline up to Week 12
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Birmingham
country: United States
facility: Synexus Clinical Research US - Birmingham
state: Alabama
city: Daphne
country: United States
facility: AMR Daphne, AL
state: Alabama
city: Phoenix
country: United States
facility: Synexus Clinical Research US - Phoenix Central
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Clinical Trials
state: Arizona
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: Long Beach
country: United States
facility: Long Beach Research Institute
state: California
city: Los Angeles
country: United States
facility: Angel City Research, Inc
state: California
city: Pomona
country: United States
facility: Empire Clinical Research
state: California
city: Sacramento
country: United States
facility: Clinical Trials Research
state: California
city: San Bernardino
country: United States
facility: Velocity Clinical Research, San Bernardino
state: California
city: Thousand Oaks
country: United States
facility: Pain Management and Injury Relief
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Englewood
country: United States
facility: Velocity Clinical Research - Denver
state: Colorado
city: Washington
country: United States
facility: Velocity Clinical Research - Washington DC
state: District of Columbia
city: Coral Gables
country: United States
facility: AMR-Miami
state: Florida
city: DeLand
country: United States
facility: Accel Research Site - Deland Clinical Research Unit
state: Florida
city: Fort Myers
country: United States
facility: AMR Fort Myers (The Clinical Study Center)
state: Florida
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research - Hallandale Beach
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Largo
country: United States
facility: Accel Research Site - St. Petersburg/Largo
state: Florida
city: Maitland
country: United States
facility: Accel Research Sites - Maitland
state: Florida
city: Miami Lakes
country: United States
facility: 3Sync Research - Miami Lakes
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates - Miami
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research - New Port Richey
state: Florida
city: Orlando
country: United States
facility: Synexus Clinical Research US - Orlando
state: Florida
city: Orlando
country: United States
facility: Conquest Research Orlando Neuro
state: Florida
city: Winter Park
country: United States
facility: Conquest Research Winter Park
state: Florida
city: Decatur
country: United States
facility: ARSN - NeuroStudies
state: Georgia
city: Meridian
country: United States
facility: Velocity Clinical Research - Boise (Advanced Clinical Research)
state: Idaho
city: Chicago
country: United States
facility: Feinberg School of Medicine
state: Illinois
city: Flossmoor
country: United States
facility: Healthcare Research Network II, LLC
state: Illinois
city: Evansville
country: United States
facility: Synexus Clinical Research - Evansville
state: Indiana
city: Wichita
country: United States
facility: AMR Wichita East, KS
state: Kansas
city: Lexington
country: United States
facility: AMR Lexington
state: Kentucky
city: Baton Rouge
country: United States
facility: Velocity Clinical Research - Baton Rouge
state: Louisiana
city: Covington
country: United States
facility: Tandem Clinical Research- Covington
state: Louisiana
city: Boston
country: United States
facility: Brigham and Women's Hospital (BWH)
state: Massachusetts
city: Waltham
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Hazelwood
country: United States
facility: Healthcare Research Network
state: Missouri
city: Kansas City
country: United States
facility: AMR Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Synexus Clinical Research US - St. Louis
state: Missouri
city: Norfolk
country: United States
facility: Velocity Clinical Research - Norfolk
state: Nebraska
city: Las Vegas
country: United States
facility: Synexus Clinical Research - Henderson
state: Nevada
city: Marlton
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Albuquerque
country: United States
facility: Velocity Clinical Research - Albuquerque
state: New Mexico
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Brooklyn
country: United States
facility: Swift Clinical OpCo, Inc
state: New York
city: East Syracuse
country: United States
facility: Velocity Clinical Research - Syracuse
state: New York
city: New York
country: United States
facility: Synexus Clinical Research- New York
state: New York
city: New York
country: United States
facility: The Neurological Institute of New York
state: New York
city: Morehead City
country: United States
facility: West Clinical Research
state: North Carolina
city: Raleigh
country: United States
facility: Eximia Research - Raleigh
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Beachwood
country: United States
facility: Velocity Clinical Research - Cleveland
state: Ohio
city: Cincinnati
country: United States
facility: Synexus Clinical Research US - Cincinnati
state: Ohio
city: Dayton
country: United States
facility: META Medical Research Institute
state: Ohio
city: Grants Pass
country: United States
facility: Velocity Clinical Research - Grants Pass
state: Oregon
city: Medford
country: United States
facility: Velocity Clinical Research - Medford
state: Oregon
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research - Providence
state: Rhode Island
city: Anderson
country: United States
facility: Synexus Clinical Research- Anderson
state: South Carolina
city: Charleston
country: United States
facility: Clinical Trials of South Carolina - Charleston
state: South Carolina
city: Charleston
country: United States
facility: Charleston Clinical Trials, LLC
state: South Carolina
city: Spartanburg
country: United States
facility: Velocity Clinical Research - Spartanburg
state: South Carolina
city: Nashville
country: United States
facility: AMR Nashville, TN
state: Tennessee
city: Dallas
country: United States
facility: Zenos Clinical Research
state: Texas
city: Dallas
country: United States
facility: Synexus - Dallas
state: Texas
city: Round Rock
country: United States
facility: Be Well Clinical Studies - Austin
state: Texas
city: San Antonio
country: United States
facility: San Antonio Clinical Trials
state: Texas
city: Waco
country: United States
facility: Velocity Clinical Research - Waco
state: Texas
city: West Jordan
country: United States
facility: Velocity Clinical Research - Salt Lake City
state: Utah
city: West Valley City
country: United States
facility: Kalo Clinical Research
state: Utah
city: Richmond
country: United States
facility: Dominion Medical Associates, Inc.
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center (NWCRC)
state: Washington
Study officials:
References: