A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine in participants with pain associated with diabetic peripheral neuropathy (DPN).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Body weight greater than or equal to (≥)45 kilogram (kg)
• Body mass index (BMI) ≥18 to less than (\<) 40 kilogram per meter square (kg/m\^2)
• Diagnosis of diabetes mellitus type 1 or type 2 and with glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pain in lower extremities due to DPN for at least 1 year
• Weekly average of daily NPRS score ≥4 and less than or equal to (≤) 9 with limited variation in the 7-day Baseline Period
Locations
United States
Missouri
Healthcare Research Network - Hazelwood MO
RECRUITING
Hazelwood
Ohio
Velocity Clinical Research - Cleveland
RECRUITING
Beachwood
Rhode Island
Velocity Clinical Research - Providence
RECRUITING
East Greenwich
Contact Information
Primary
Medical Information
medicalinfo@vrtx.com
6173416777
Time Frame
Start Date: 2025-11-21
Estimated Completion Date: 2027-04-06
Participants
Target number of participants: 734
Treatments
Experimental: Suzetrigine (SUZ)
Participants will be randomized to receive SUZ.
Placebo_comparator: Placebo
Participants will be randomized to receive placebo matched to SUZ.
Related Therapeutic Areas
Sponsors
Leads: Vertex Pharmaceuticals Incorporated