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

Purpose

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

Condition

  • Diabetic Peripheral Neuropathic Pain

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Body weight greater than or equal to (≥)45 kilogram (kg) - Body mass index (BMI) ≥18 to less than (<) 40 kilogram per meter square (kg/m^2) - Diagnosis of diabetes mellitus type 1 or type 2 and with glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pain in lower extremities due to DPN for at least 1 year - Weekly average of daily NPRS score ≥4 and less than or equal to (≤) 9 with limited variation in the 7-day Baseline Period

Exclusion Criteria

  • More than 3 missing daily NPRS scores during the 7-day Baseline Period - Received Journavx within 30 days of study drug dosing - Any sensory abnormality (excluding DPN) as pre-specified in the protocol Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Suzetrigine (SUZ) 		Participants will be randomized to receive SUZ.
  • Drug: Suzetrigine
    Tablets for oral administration
    Other names:
    • VX-548
    • SUZ
Placebo Comparator
Placebo 		Participants will be randomized to receive placebo matched to SUZ.
  • Drug: Placebo (matched to SUZ)
    Placebo matched to SUZ for oral administration.

Recruiting Locations

Central Research Associates, LLC
Birmingham, Alabama 35205

Accel Research - Birmingham
Birmingham, Alabama 35216

Sun City Clinical Research
Glendale, Arizona 85304

Scottsdale Clinical Trials
Scottsdale, Arizona 85260

Lynn Institute of the Ozarks
Little Rock, Arkansas 72204

Hope Clinical Research
Canoga Park, California 91303

Marvel Clinical Research
Huntington Beach, California 92647

Eximia Research-CA, LLC
La Mesa, California 91942

Long Beach Research Institute
Long Beach, California 90805

Paradigm Clincial Research - Modesto
Modesto, California 95355

Pasadena Clinical Trials
Pasadena, California 91101

Artemis Institute for Clinical Research - Riverside
Riverside, California 92503

Velocity Clinical Research -San Bernardino
San Bernardino, California 92408

Alpine Clinical Research Center
Boulder, Colorado 80301

Paradigm Clinical Research - Wheat Ridge
Wheat Ridge, Colorado 80033

Chase Medical Research
Waterbury, Connecticut 06708

Velocity Clinical Research - Washington DC
Washington D.C., District of Columbia 20016

Neurology Offices of South Florida, PLLC
Boca Raton, Florida 33428

Accel Research - Deland
DeLand, Florida 32720

Velocity Clinical Research - Hallandale Beach
Hallandale, Florida 33009

CNS Healthcare - Jacksonville
Jacksonville, Florida 32256

Health Awareness, Inc. - Jupiter
Jupiter, Florida 33458

3Sync Research -Miami Lakes
Miami Lakes, Florida 33014

CNS Healthcare - Orlando
Orlando, Florida 32806

3Sync Research - Palm Springs
Palm Springs, Florida 33461

Health Awareness, Inc. - Port St. Lucie
Port Saint Lucie, Florida 34952

ClinCloud - Viera
Viera, Florida 32940

Conquest Clinical Research - Winter Park
Winter Park, Florida 32789

Atlanta Center for Medical Research
Atlanta, Georgia 30331

Accel Research - Decatur
Decatur, Georgia 30030

Javara Inc./Privia Medical Group - Fayetteville, GA
Fayetteville, Georgia 30214

Velocity Clinical Research - Savannah
Savannah, Georgia 31406

Healthcare Research Network - Flossmoor IL
Tinley Park, Illinois 60477

Velocity Clinical Research - Baton Rouge
Baton Rouge, Louisiana 70809

Velocity Clinical Research - Lafayette
Lafayette, Louisiana 70508

Velocity Clinical Research - Rockville
Rockville, Maryland 20854

Boston Clinical Trials
Boston, Massachusetts 02131

Quest Research Institute
Farmington Hills, Michigan 48334

Velocity Clinical Research - Gulfport
Gulfport, Mississippi 39503

Healthcare Research Network - Hazelwood MO
Hazelwood, Missouri 63042

AMR Kansas City
Kansas City, Missouri 64114

M3 Wake Research - Las Vegas
Las Vegas, Nevada 89106

CenExel AMRI
Toms River, New Jersey 08755

Brooklyn Clinical Research
Brooklyn, New York 11226

Velocity Clinical Research - Syracuse
East Syracuse, New York 13057

Mid Hudson Medical Research, PLLC
New Windsor, New York 12553

Rochester Clinical Research - Rochester
Rochester, New York 14609

Asheville Clinical Research
Asheville, North Carolina 28803

Monroe Biomedical research
Monroe, North Carolina 28112

West Clinical Research
Morehead City, North Carolina 28557

Velocity Clinical Research - Cleveland
Beachwood, Ohio 44122

Velocity Clinical Research - Cincinnati - Blue Ash
Cincinnati, Ohio 45242

Lynn Institute of Norman
Norman, Oklahoma 73072

Velocity Clinical Research - Medford
Medford, Oregon 97504

Velocity Clinical Research - Providence
East Greenwich, Rhode Island 02818

Velocity Clinical Research - Anderson
Anderson, South Carolina 29621

Coastal Carolina Research Center
North Charleston, South Carolina 29405

Velocity Clinical Research - Spartanburg
Spartanburg, South Carolina 29303

M3 Wake Research - Chattanooga
Chattanooga, Tennessee 37421

Holston Medical Group
Kingsport, Tennessee 37660

CNS Healthcare - Memphis
Memphis, Tennessee 38119

Amarillo Medical Specialists LLP
Amarillo, Texas 79124

QCR - BioBehavioral Research of Austin
Austin, Texas 78759

Zenos Clinical Research
Dallas, Texas 75230

Fort Worth Endocrine Research Center
Fort Worth, Texas 76132

Epic Clinical Research
Lewisville, Texas 75057

Prime Clinical Research - Mansfield - US 287
Mansfield, Texas 76063

Clinical Trials of Texas, LLC
San Antonio, Texas 78229

AMR Norfolk
Norfolk, Virginia 23502

Velocity Clinical Research - Spokane
Spokane, Washington 99218

More Details

Status
Recruiting
Sponsor
Vertex Pharmaceuticals Incorporated

Study Contact

Medical Information
6173416777
medicalinfo@vrtx.com