Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy

Vertex Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Diabetic Peripheral Neuropathic Pain

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06628908

VX24-548-110

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic peripheral neuropathy (DPN).

Enrollment: 1,100 estimated patients

Sex: All

Ages: 18 to 80 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) ≥18.0 to less than (<) 40.0 kilogram per meter square (kg/m^2)
• Diagnosis of diabetes mellitus type 1 or type 2 by glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pain in lower extremities due to DPN
• Weekly average of daily NPRS score ≥4 and less than or equal to (≤) 9 with limited variation in the 7-day Baseline Period

Key Exclusion Criteria:

• More than 3 missing daily NPRS scores during the 7-day Baseline Period
• Participation in a previous study in which the participant received SUZ
• Any sensory abnormality (excluding DPN) as pre-specified in the protocol

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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1,100 participants in 3 patient groups, including a placebo group

Suzetrigine (SUZ)

Experimental group

Description:

Participants will be randomized to receive SUZ.

Treatment:

Drug: Placebo (matched to Pregabalin)

Drug: Suzetrigine

Pregabalin

Active Comparator group

Description:

Participants will be randomized to receive Pregabalin.

Treatment:

Drug: Placebo (matched to SUZ)

Drug: Pregabalin

Placebo

Placebo Comparator group

Description:

Participants will be randomized to receive placebo matched to SUZ and Pregabalin.

Treatment:

Drug: Placebo (matched to SUZ)

Drug: Placebo (matched to Pregabalin)