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

Purpose

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).

Condition

  • Diabetic Peripheral Neuropathic Pain

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Suzetrigine (SUZ) 		Participants will be randomized to receive SUZ.
  • Drug: Suzetrigine
    Tablets for oral administration.
    Other names:
    • VX-548
    • SUZ
  • Drug: Placebo (matched to Pregabalin)
    Placebo matched to Pregabalin for oral administration.
Active Comparator
Pregabalin 		Participants will be randomized to receive Pregabalin.
  • Drug: Placebo (matched to SUZ)
    Placebo matched to SUZ for oral administration.
  • Drug: Pregabalin
    Capsules for oral administration.
Placebo Comparator
Placebo 		Participants will be randomized to receive placebo matched to SUZ and Pregabalin.
  • Drug: Placebo (matched to SUZ)
    Placebo matched to SUZ for oral administration.
  • Drug: Placebo (matched to Pregabalin)
    Placebo matched to Pregabalin for oral administration.

Recruiting Locations

Brigham and Women's Hospital (BWH)
Boston, Massachusetts 02115

More Details

Status
Recruiting
Sponsor
Vertex Pharmaceuticals Incorporated

Study Contact

Medical Information
617-341-6777
medicalinfo@vrtx.com