Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)

NCT05660538 | Completed Phase 2 Results FDA Drug

• 1 other identifier: VX21-548-103
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 50

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating Painful DPN.

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Weekly Average of Daily Pain Intensity on a Numeric Pain Rating Scale (NPRS)

  Change from baseline in the weekly mean of the daily Numeric Pain Rating Scale (NPRS) score assessing average pain intensity in the last 24 hours. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.

  Baseline, At Week 12

Secondary Outcomes (6)

• Change From Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS) Score

  Baseline, At Week 12

• Percentage of Participants With Greater Than or Equal to (≥) 30 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS

  Baseline, At Week 12

• Percentage of Participants With ≥50 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS

  Baseline, At Week 12

• Percentage of Participants With ≥70 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS

  Baseline, At Week 12

• Percentage of Participants Categorized as "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Assessment

  Baseline, At Week 12

Study Arms (4)

Pregabalin

ACTIVE COMPARATOR

Participants received Pregabalin 100 mg 3 times per day (tid) for 12 weeks

Drug: Pregabalin; Drug: Placebo (matched to SUZ)

Suzetrigine (SUZ): Low Dose

EXPERIMENTAL

Participants received SUZ 23 mg tablet once daily (qd) for 12 weeks.

Drug: Suzetrigine; Drug: Placebo (matched to pregabalin)

Suzetrigine (SUZ): Mid Dose

EXPERIMENTAL

Participants received SUZ 46 mg tablet qd for 12 weeks.

Drug: Suzetrigine; Drug: Placebo (matched to pregabalin)

Suzetrigine (SUZ): High Dose

EXPERIMENTAL

Participants received SUZ 69 mg tablet qd for 12 weeks.

Drug: Suzetrigine; Drug: Placebo (matched to pregabalin)

Interventions

Suzetrigine DRUG

Tablets for oral administration.

Also known as: VX-548, SUZ

Suzetrigine (SUZ): High Dose; Suzetrigine (SUZ): Low Dose; Suzetrigine (SUZ): Mid Dose

Pregabalin DRUG

Capsules for oral administration.

Pregabalin

Placebo (matched to SUZ) DRUG

Placebo matched to SUZ for oral administration.

Pregabalin

Placebo (matched to pregabalin) DRUG

Placebo matched to pregabalin for oral administration.

Suzetrigine (SUZ): High Dose; Suzetrigine (SUZ): Low Dose; Suzetrigine (SUZ): Mid Dose

Eligibility Criteria

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

You may qualify if:

• Diagnosis of diabetes mellitus type 1 or type 2 with
• Glycosylated hemoglobin A1c (HbA1c) ≤9%; and
• Presence of bilateral pain in lower extremities due to DPN for at least 1 year

You may not qualify if:

• Painful neuropathy other than DPN
• History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
• History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (50)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

Location

Synexus Clinical Research US - Birmingham

Birmingham, Alabama, 35211, United States

Location

Synexus Clinical Research US - Phoenix West

Phoenix, Arizona, 85020, United States

Location

Velocity Clinical Research - Banning

Banning, California, 92220, United States

Location

Long Beach Clinical Trials Services, Inc.

Long Beach, California, 90806, United States

Location

University Clinical Investigators

Tustin, California, 92780, United States

Location

Lynn Institute of the Rockies

Colorado Springs, Colorado, 80918, United States

Location

Fleming Island Center for Clinical Research

Fleming Island, Florida, 32003, United States

Location

AMR Fort Myers (The Clinical Study Center)

Fort Myers, Florida, 33912, United States

Location

Velocity Clinical Research - Hallandale Beach

Hallandale, Florida, 33009-4427, United States

Location

Westside Center for Clinical Research

Jacksonville, Florida, 32205, United States

Location

Accel Research Sites - Tampa

Largo, Florida, 33777, United States

Location

Accel Research Sites - Maitland

Maitland, Florida, 32751, United States

Location

Suncoast Research Associates

Miami, Florida, 33137, United States

Location

Synexus - Orlando

Orlando, Florida, 32806-1041, United States

Location

Synexus - The Villages

The Villages, Florida, 32162-7116, United States

Location

Accel Research Sites - Neurostudies

Decatur, Georgia, 30030, United States

Location

Velocity Clinical Research - Boise (Advanced Clinical Research)

Meridian, Idaho, 83642, United States

Location

Healthcare Research Network - Chicago

Flossmoor, Illinois, 60422, United States

Location

Synexus Clinical Research - Evansville

Evansville, Indiana, 47714, United States

Location

AMR El Dorado

El Dorado, Kansas, 67042, United States

Location

AMR Newton

Newton, Kansas, 67114, United States

Location

AMR Wichita East, KS

Wichita, Kansas, 67207, United States

Location

Clinical Trials of America, LLC

Monroe, Louisiana, 71201, United States

Location

Brigham and Women's Hospital (BWH) - Translational Pain Research

Boston, Massachusetts, 02115, United States

Location

Boston Neuro Research Center, LLC

North Dartmouth, Massachusetts, 02747, United States

Location

Boston PainCare Center

Waltham, Massachusetts, 02451, United States

Location

Revival Research Institute

Dearborn, Michigan, 48126, United States

Location

StudyMetrix Research, LLC

City of Saint Peters, Missouri, 63303-3041, United States

Location

Healthcare Research Network - Hazelwood

Hazelwood, Missouri, 63042, United States

Location

AMR Kansas City

Kansas City, Missouri, 64114-4866, United States

Location

Synexus Clinical Research US - St. Louis

St Louis, Missouri, 63141, United States

Location

Synexus Clinical Research - Henderson

Henderson, Nevada, 89052, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Synexus Clinical Research- New York

New York, New York, 10017, United States

Location

Carolina Institute for Clinical Research

Fayetteville, North Carolina, 28303, United States

Location

Triad Clinical Trials

Greensboro, North Carolina, 27410, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Synexus - Cincinnati

Cincinnati, Ohio, 45236, United States

Location

Velocity Clinical Research - Cleveland

Cleveland, Ohio, 44122, United States

Location

Velocity Clinical Research - Medford

Medford, Oregon, 97504, 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

South Carolina Clinical Research

Orangeburg, South Carolina, 29118, United States

Location

Inquest Clinical Research

Baytown, Texas, 77521, United States

Location

Synexus - Dallas

Dallas, Texas, 75234-7858, United States

Location

Diabetes & Glandular Disease Clinic, P.A

San Antonio, Texas, 78229-4801, United States

Location

Wasatch Clinical Research

Salt Lake City, Utah, 84107, United States

Location

Northwest Clinical Research Center (NWCRC)

Bellevue, Washington, 98007-4209, United States

Location

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Medical Monitor
• Organization: Vertex Pharmaceuticals Incorporated

medicalinfo@vrtx.com

617-341-6777

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 21, 2022
• Study Start: December 20, 2022
• Primary Completion: October 12, 2023
• Study Completion: October 25, 2023
• Last Updated: July 1, 2025
• Results First Posted: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (50)