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

• Status: Recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Criteria

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.