Evaluation of Efficacy and Safety of VX-548 for Painful Lumbosacral Radiculopathy (PLSR)

September 30, 2025 updated by: Vertex Pharmaceuticals Incorporated

A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-design Study of the Efficacy and Safety of VX-548 in Subjects With Painful Lumbosacral Radiculopathy

The purpose of the study is to evaluate the efficacy and safety of VX-548 in treating participants with PLSR.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
218

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • HOPE Research Institute
      • Phoenix, Arizona, United States, 85053
        • Arizona Research Center
    • California
      • Bakersfield, California, United States, 93301
        • Trovare Clinical Research
      • Banning, California, United States, 92220
        • Velocity Clinical Research - Banning
      • La Mesa, California, United States, 91942
        • Velocity Clinical Research - San Diego
      • Riverside, California, United States, 92501
        • Probe Clinical Research
      • Thousand Oaks, California, United States, 91320
        • Pain Management and Injury Relief
    • Florida
      • Aventura, Florida, United States, 33180
        • Visionary Investigators Network
      • Crystal River, Florida, United States, 34429
        • Nature Coast Clinical Research - Crystal River
      • Cutler Bay, Florida, United States, 33189
        • JY Research Institute
      • Fleming Island, Florida, United States, 32003
        • Fleming Island Center For Clinical Research
      • Hialeah, Florida, United States, 33013
        • Convenient Medical Research
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Miami, Florida, United States, 33144
        • L&C Professional Medical Research Institute
      • Miami, Florida, United States, 33165
        • Medical Research of Westchester
      • Port Orange, Florida, United States, 32127
        • ARSN-Brain and Spine Institute
      • Seminole, Florida, United States, 33777
        • Accel Research Site - St. Petersburg/Largo
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Atlanta Center for Medical Research
      • Columbus, Georgia, United States, 31904
        • Clincept Clinical Research
      • Decatur, Georgia, United States, 30030
        • Accel Research Sites - Neurostudies
      • Savannah, Georgia, United States, 31406
        • Velocity Clinical Research - Savannah Neurology Specialists
      • Savannah, Georgia, United States, 31406
        • Velocity Clinical Research - Savannah
      • Stockbridge, Georgia, United States, 30281
        • Center for Pain Management and Rehab
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Velocity Clinical Research - Boise
    • Illinois
      • Flossmoor, Illinois, United States, 60422
        • Healthcare Research Network II, LLC
      • Palos Hills, Illinois, United States, 60465
        • Essential Concepts Research Solutions
    • Kansas
      • Wichita, Kansas, United States, 67207
        • AMR Wichita East, KS
    • Maryland
      • Rockville, Maryland, United States, 20854
        • Velocity Clinical Research - Rockville
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital (BWH)
      • Waltham, Massachusetts, United States, 02451
        • MedVadis Research Coorporation
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • St. Louis Pain Consultants
      • Hazelwood, Missouri, United States, 63042
        • Healthcare Research Network
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Be Well Clinical Studies, LLC
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Synexus Clinical Research - Henderson
      • Las Vegas, Nevada, United States, 89119
        • AMR Las Vegas (Clinical Research Consortium)
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • New York, New York, United States, 10017
        • AES New York
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Velocity Clinical Research - Cincinnati
      • Dayton, Ohio, United States, 45432
        • META Medical Research Institute
      • Lima, Ohio, United States, 45805
        • Nexgen Research
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Clinical Investigations LLC.
      • Norman, Oklahoma, United States, 73069
        • AMR Norman
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Pacific Sports and Spine
      • Grants Pass, Oregon, United States, 97527
        • Velocity Clinical Research - Grants Pass
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Velocity Clinical Research - Providence
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Clinical Trials of South Carolina - Charleston
    • Texas
      • Dallas, Texas, United States, 75234
        • AES Dallas Forth Worth
      • Houston, Texas, United States, 77079
        • Expert Pain
      • Lubbock, Texas, United States, 79410
        • Lubbock Spine Institute
      • Round Rock, Texas, United States, 78681
        • Be Well Clinical Studies - Austin
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • JBR Clinical Research
    • Virginia
      • Hampton, Virginia, United States, 23666
        • Velocity Clinical Research - Hampton
      • Norfolk, Virginia, United States, 23502
        • AMR Norfolk
      • Portsmouth, Virginia, United States, 23703
        • Velocity Clinical Research - Portsmouth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Body weight greater than or equal to (>=)45 kilogram (kg)
  • Body mass index (BMI) less than or equal to (<=) 40 kg/ meter square (m^2)
  • Diagnosis of PLSR for greater than (>)3 months as per criteria pre-specified in the protocol
  • Weekly average of daily NPRS score >=4 and <10 with limited variation in the 7-day Run-in Period

Key Exclusion Criteria:

  • More than 3 missing daily NPRS scores during the 7-day Run-in Period
  • Moderate or severe painful neuropathy other than PLSR as pre-specified in the protocol
  • History of prior lumbar spine surgery (e.g., discectomies, laminectomies, foraminotomies, or fusion)

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: VX-548
Participants will receive VX-548 up to 12 weeks.
Drug: VX-548
Tablets for oral administration.
Other Names:
  • Suzetrigine
Placebo Comparator: Placebo
Participants will receive placebo matched to VX-548 up to 12 weeks.
Drug: Placebo
Tablets for oral administration.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change From Baseline in the Weekly Average of Daily leg Pain Intensity on a Numeric Pain Rating Scale (NPRS)
Time Frame: Baseline, Week 12
Baseline, Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change From Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS)
Time Frame: Baseline, Week 12
Baseline, Week 12
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From Day 1 up to Week 14
From Day 1 up to Week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vertex Pharmaceuticals Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 13, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 2, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 16, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VX23-548-109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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