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

Vertex Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Painful Lumbosacral Radiculopathy

Treatments: Drug: VX-548; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06176196

VX23-548-109

Details and patient eligibility

About

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

Enrollment: 218 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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218 participants in 2 patient groups, including a placebo group

VX-548

Experimental group

Description:

Participants will receive VX-548 up to 12 weeks.

Treatment:

Drug: VX-548

Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched to VX-548 up to 12 weeks.

Treatment:

Drug: Placebo