Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)

Vertex Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Diabetic Peripheral Neuropathy

Treatments: Drug: Pregabalin; Drug: Placebo (matched to SUZ); Drug: Suzetrigine; Drug: Placebo (matched to pregabalin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05660538

VX21-548-103

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating Painful DPN.

Enrollment: 194 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) ≤9%; and
  • Presence of bilateral pain in lower extremities due to DPN 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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194 participants in 4 patient groups

Pregabalin

Active Comparator group

Description:

Participants received Pregabalin 100 mg 3 times per day (tid) for 12 weeks

Treatment:

Drug: Placebo (matched to SUZ)

Drug: Pregabalin

Suzetrigine (SUZ): Low Dose

Experimental group

Description:

Participants received SUZ 23 mg tablet once daily (qd) for 12 weeks.

Treatment:

Drug: Placebo (matched to pregabalin)

Drug: Suzetrigine

Suzetrigine (SUZ): Mid Dose

Experimental group

Description:

Participants received SUZ 46 mg tablet qd for 12 weeks.

Treatment:

Drug: Placebo (matched to pregabalin)

Drug: Suzetrigine

Suzetrigine (SUZ): High Dose

Experimental group

Description:

Participants received SUZ 69 mg tablet qd for 12 weeks.

Treatment:

Drug: Placebo (matched to pregabalin)

Drug: Suzetrigine