Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy

Vertex Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Diabetic Peripheral Neuropathic Pain

Treatments: Drug: Placebo (matched to pregabalin); Drug: Placebo (matched to VX-993); Drug: Pregabalin; Drug: VX-993

Study type: Interventional

Funder types: Industry

Identifiers

NCT06619860

2024-514689-38-00 (Other Identifier)

VX24-993-103

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety, and tolerability of VX-993 in participants with pain associated with Diabetic Peripheral Neuropathy (DPN)

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Diagnosis of diabetes mellitus type 1 or type 2 with

  • Glycosylated hemoglobin A1c (HbA1c) less than or equal to (≤) 9% and
  • Presence of bilateral pain in lower extremities due to DPN (defined as a symmetric, length-dependent sensory or sensorimotor polyneuropathy) for at least 1 year

Key Exclusion Criteria:

• Painful neuropathy other than DPN
• History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
• History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months

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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300 participants in 2 patient groups

VX-993

Experimental group

Description:

Participants will be randomized to receive multiple doses of different dose levels of VX-993.

Treatment:

Drug: VX-993

Drug: Placebo (matched to pregabalin)

Pregabalin

Active Comparator group

Description:

Participants will be randomized to receive Pregabalin.

Treatment:

Drug: Placebo (matched to VX-993)

Drug: Pregabalin