Evaluation of Efficacy and Safety of VX-548 for Painful Lumbosacral Radiculopathy (PLSR)
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
1 other identifier
interventional
218
1 country
54
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of VX-548 in treating participants with PLSR.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2023
Shorter than P25 for phase_2
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2023
CompletedStudy Start
First participant enrolled
December 13, 2023
CompletedFirst Posted
Study publicly available on registry
December 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2024
CompletedOctober 1, 2025
September 1, 2025
10 months
December 10, 2023
September 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Weekly Average of Daily leg Pain Intensity on a Numeric Pain Rating Scale (NPRS)
Baseline, Week 12
Secondary Outcomes (2)
Change From Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS)
Baseline, Week 12
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
From Day 1 up to Week 14
Study Arms (2)
VX-548
EXPERIMENTALParticipants will receive VX-548 up to 12 weeks.
Placebo
PLACEBO COMPARATORParticipants will receive placebo matched to VX-548 up to 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
Hope Research Institute
Phoenix, Arizona, 85018, United States
Arizona Research Center
Phoenix, Arizona, 85053, United States
Trovare Clinical Research
Bakersfield, California, 93301, United States
Velocity Clinical Research - Banning
Banning, California, 92220, United States
Velocity Clinical Research - San Diego
La Mesa, California, 91942, United States
Probe Clinical Research
Riverside, California, 92501, United States
Pain Management and Injury Relief
Thousand Oaks, California, 91320, United States
Visionary Investigators Network
Aventura, Florida, 33180, United States
Nature Coast Clinical Research - Crystal River
Crystal River, Florida, 34429, United States
JY Research Institute
Cutler Bay, Florida, 33189, United States
Fleming Island Center for Clinical Research
Fleming Island, Florida, 32003, United States
Convenient Medical Research
Hialeah, Florida, 33013, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
L&C Professional Medical Research Institute
Miami, Florida, 33144, United States
Medical Research of Westchester
Miami, Florida, 33165, United States
ARSN-Brain and Spine Institute
Port Orange, Florida, 32127, United States
Accel Research Site - St. Petersburg/Largo
Seminole, Florida, 33777, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
ClinCept Clinical Research
Columbus, Georgia, 31904, United States
Accel Research Sites - Neurostudies
Decatur, Georgia, 30030, United States
Velocity Clinical Research - Savannah Neurology Specialists
Savannah, Georgia, 31406, United States
Velocity Clinical Research - Savannah
Savannah, Georgia, 31406, United States
Center for Pain Management and Rehab
Stockbridge, Georgia, 30281, United States
Velocity Clinical Research - Boise
Meridian, Idaho, 83642, United States
Healthcare Research Network II, LLC
Flossmoor, Illinois, 60422, United States
Essential Concepts Research Solutions
Palos Hills, Illinois, 60465, United States
AMR Wichita East, KS
Wichita, Kansas, 67207, United States
Velocity Clinical Research - Rockville
Rockville, Maryland, 20854, United States
Brigham and Women's Hospital (BWH)
Boston, Massachusetts, 02115, United States
MedVadis Research Coorporation
Waltham, Massachusetts, 02451, United States
St. Louis Pain Consultants
Chesterfield, Missouri, 63017, United States
Healthcare Research Network
Hazelwood, Missouri, 63042, United States
Be Well Clinical Studies, LLC
Lincoln, Nebraska, 68516, United States
Synexus Clinical Research - Henderson
Henderson, Nevada, 89052, United States
AMR Las Vegas (Clinical Research Consortium)
Las Vegas, Nevada, 89119, United States
Albany Medical Center
Albany, New York, 12208, United States
AES New York
New York, New York, 10017, United States
Velocity Clinical Research - Cincinnati
Cincinnati, Ohio, 45242, United States
META Medical Research Institute
Dayton, Ohio, 45432, United States
NexGen Research
Lima, Ohio, 45805, United States
Clinical Investigations LLC.
Edmond, Oklahoma, 73034, United States
AMR Norman
Norman, Oklahoma, 73069, United States
Pacific Sports and Spine
Eugene, Oregon, 97404, United States
Velocity Clinical Research - Grants Pass
Grants Pass, Oregon, 97527, United States
Velocity Clinical Research - Providence
East Greenwich, Rhode Island, 02818, United States
Clinical Trials of South Carolina - Charleston
Charleston, South Carolina, 29406, United States
AES Dallas Forth Worth
Dallas, Texas, 75234, United States
Expert Pain
Houston, Texas, 77079, United States
Lubbock Spine Institute
Lubbock, Texas, 79410, United States
Be Well Clinical Studies - Austin
Round Rock, Texas, 78681, United States
JBR Clinical Research
Salt Lake City, Utah, 84107, United States
Velocity Clinical Research - Hampton
Hampton, Virginia, 23666, United States
AMR Norfolk
Norfolk, Virginia, 23502, United States
Velocity Clinical Research - Portsmouth
Portsmouth, Virginia, 23703, United States
Related Publications (1)
Siddiqui A, Xu JL, Abramowicz AE. Suzetrigine for the Treatment of Acute Pain: Comment. Anesthesiology. 2026 Feb 1;144(2):495-496. doi: 10.1097/ALN.0000000000005822. Epub 2025 Dec 11. No abstract available.
PMID: 41384808DERIVED
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 10, 2023
First Posted
December 19, 2023
Study Start
December 13, 2023
Primary Completion
October 2, 2024
Study Completion
October 16, 2024
Last Updated
October 1, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
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