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

Last updated: September 30, 2025
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Completed

Phase

2

Condition

Radiculopathy

Pain

Treatment

VX-548

Placebo

Clinical Study ID

NCT06176196
VX23-548-109
  • Ages 18-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 theprotocol

  • Weekly average of daily NPRS score >=4 and <10 with limited variation in the 7-dayRun-in Period

Exclusion

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 theprotocol

  • History of prior lumbar spine surgery (e.g., discectomies, laminectomies,foraminotomies, or fusion)

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 218
Treatment Group(s): 2
Primary Treatment: VX-548
Phase: 2
Study Start date:
December 13, 2023
Estimated Completion Date:
October 16, 2024

Connect with a study center

  • Arizona Research Center

    Phoenix, Arizona 85053
    United States

    Site Not Available

  • Hope Research Institute

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Arizona Research Center

    Phoenix 5308655, Arizona 5551752 85053
    United States

    Site Not Available

  • Hope Research Institute

    Phoenix 5308655, Arizona 5551752 85018
    United States

    Site Not Available

  • Trovare Clinical Research

    Bakersfield, California 93301
    United States

    Site Not Available

  • Velocity Clinical Research - Banning

    Banning, California 92220
    United States

    Site Not Available

  • Velocity Clinical Research - San Diego

    La Mesa, California 91942
    United States

    Site Not Available

  • Probe Clinical Research

    Riverside, California 92501
    United States

    Site Not Available

  • Pain Management and Injury Relief

    Thousand Oaks, California 91320
    United States

    Site Not Available

  • Trovare Clinical Research

    Bakersfield 5325738, California 5332921 93301
    United States

    Site Not Available

  • Velocity Clinical Research - Banning

    Banning 5326032, California 5332921 92220
    United States

    Site Not Available

  • Velocity Clinical Research - San Diego

    La Mesa 5363990, California 5332921 91942
    United States

    Site Not Available

  • Probe Clinical Research

    Riverside 5387877, California 5332921 92501
    United States

    Site Not Available

  • Pain Management and Injury Relief

    Thousand Oaks 5402405, California 5332921 91320
    United States

    Site Not Available

  • Visionary Investigators Network

    Aventura, Florida 33180
    United States

    Site Not Available

  • Nature Coast Clinical Research - Crystal River

    Crystal River, Florida 34429
    United States

    Site Not Available

  • JY Research Institute

    Cutler Bay, Florida 33189
    United States

    Site Not Available

  • Fleming Island Center for Clinical Research

    Fleming Island, Florida 32003
    United States

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  • Convenient Medical Research

    Hialeah, Florida 33013
    United States

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  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

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  • L&C Professional Medical Research Institute

    Miami, Florida 33144
    United States

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  • Medical Research of Westchester

    Miami, Florida 33165
    United States

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  • ARSN-Brain and Spine Institute

    Port Orange, Florida 32127
    United States

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  • Brain & Spine Institute Of Port Orange

    Port Orange, Florida 32127
    United States

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  • Accel Research Site - St. Petersburg/Largo

    Seminole, Florida 33777
    United States

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  • Visionary Investigators Network

    Aventura 4146429, Florida 4155751 33180
    United States

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  • Nature Coast Clinical Research - Crystal River

    Crystal River 4152487, Florida 4155751 34429
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  • JY Research Institute

    Cutler Bay 6332309, Florida 4155751 33189
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  • Fleming Island Center for Clinical Research

    Fleming Island 4155594, Florida 4155751 32003
    United States

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  • Convenient Medical Research

    Hialeah 4158476, Florida 4155751 33013
    United States

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    Jacksonville 4160021, Florida 4155751 32216
    United States

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    Miami 4164138, Florida 4155751 33144
    United States

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  • Medical Research of Westchester

    Miami 4164138, Florida 4155751 33165
    United States

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    Port Orange 4169156, Florida 4155751 32127
    United States

    Site Not Available

  • Accel Research Site - St. Petersburg/Largo

    Seminole 4172434, Florida 4155751 33777
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    Atlanta, Georgia 30331
    United States

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    Columbus, Georgia 31904
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    Savannah, Georgia 31406
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    Savannah, Georgia 31406
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  • Center for Pain Management and Rehab

    Stockbridge, Georgia 30281
    United States

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  • Atlanta Center for Medical Research

    Atlanta 4180439, Georgia 4197000 30331
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    Savannah 4221552, Georgia 4197000 31406
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    Stockbridge 4224681, Georgia 4197000 30281
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    Meridian, Idaho 83642
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    Meridian 5600685, Idaho 5596512 83642
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  • Healthcare Research Network II, LLC

    Flossmoor, Illinois 60422
    United States

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  • Essential Concepts Research Solutions

    Palos Hills, Illinois 60465
    United States

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    Flossmoor 4892684, Illinois 4896861 60422
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    Palos Hills 4905263, Illinois 4896861 60465
    United States

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    Wichita, Kansas 67207
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    Wichita 4281730, Kansas 4273857 67207
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    Rockville, Maryland 20854
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  • Velocity Clinical Research - Rockville

    Rockville 4367175, Maryland 4361885 20854
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  • Brigham and Women's Hospital (BWH)

    Boston, Massachusetts 02115
    United States

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  • MedVadis Research Coorporation

    Waltham, Massachusetts 02451
    United States

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  • Brigham and Women's Hospital (BWH)

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • MedVadis Research Coorporation

    Waltham 4954380, Massachusetts 6254926 02451
    United States

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  • St. Louis Pain Consultants

    Chesterfield, Missouri 63017
    United States

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  • Healthcare Research Network

    Hazelwood, Missouri 63042
    United States

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  • St. Louis Pain Consultants

    Chesterfield 4381072, Missouri 4398678 63017
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  • Healthcare Research Network

    Hazelwood 4389967, Missouri 4398678 63042
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  • Be Well Clinical Studies, LLC

    Lincoln, Nebraska 68516
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    Lincoln 5072006, Nebraska 5073708 68516
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  • AES Henderson

    Henderson, Nevada 89052
    United States

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  • Synexus Clinical Research - Henderson

    Henderson, Nevada 89052
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    Las Vegas, Nevada 89119
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    Henderson 5505411, Nevada 5509151 89052
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    Las Vegas 5506956, Nevada 5509151 89119
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  • Albany Medical Center

    Albany, New York 12208
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    New York, New York 10017
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    Albany 5106834, New York 5128638 12208
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    New York 5128581, New York 5128638 10017
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    Cincinnati, Ohio 45242
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    Dayton, Ohio 45432
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    Lima, Ohio 45805
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    Cincinnati 4508722, Ohio 5165418 45242
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    Dayton 4509884, Ohio 5165418 45432
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  • NexGen Research

    Lima 5160783, Ohio 5165418 45805
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  • Clinical Investigations LLC.

    Edmond, Oklahoma 73034
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  • AMR Norman

    Norman, Oklahoma 73069
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  • Clinical Investigations LLC.

    Edmond 4535740, Oklahoma 4544379 73034
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  • AMR Norman

    Norman 4543762, Oklahoma 4544379 73069
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  • Pacific Sports and Spine

    Eugene, Oregon 97404
    United States

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  • Velocity Clinical Research - Grants Pass

    Grants Pass, Oregon 97527
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  • Pacific Sports and Spine

    Eugene 5725846, Oregon 5744337 97404
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  • Velocity Clinical Research - Grants Pass

    Grants Pass 5729080, Oregon 5744337 97527
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  • Velocity Clinical Research - Providence

    East Greenwich, Rhode Island 02818
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  • Velocity Clinical Research - Providence

    East Greenwich 5221875, Rhode Island 5224323 02818
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  • AES Dallas Forth Worth

    Dallas, Texas 75234
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  • Expert Pain

    Houston, Texas 77079
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  • Lubbock Spine Institute

    Lubbock, Texas 79410
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  • Be Well Clinical Studies - Austin

    Round Rock, Texas 78681
    United States

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  • AES Dallas Forth Worth

    Dallas 4684888, Texas 4736286 75234
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  • Expert Pain

    Houston 4699066, Texas 4736286 77079
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  • Lubbock Spine Institute

    Lubbock 5525577, Texas 4736286 79410
    United States

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  • Be Well Clinical Studies - Austin

    Round Rock 4724129, Texas 4736286 78681
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    Salt Lake City, Utah 84107
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    Salt Lake City 5780993, Utah 5549030 84107
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    Hampton, Virginia 23666
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    Norfolk, Virginia 23502
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    Portsmouth, Virginia 23703
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    Hampton 4762894, Virginia 6254928 23666
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    Norfolk 4776222, Virginia 6254928 23502
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  • Velocity Clinical Research - Portsmouth

    Portsmouth 4779999, Virginia 6254928 23703
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