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

Phase 3

Recruiting

• Conditions: Diabetic Peripheral Neuropathic Pain
• Interventions: Drug: Placebo (matched to SUZ); Drug: Suzetrigine; Drug: Placebo (matched to Pregabalin); Drug: Pregabalin

• Registration Number: NCT06628908
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-30
• Status Verified: 2024-10
• Study Start: 2024-10-01
• Study First Submitted QC: 2024-10-03
• Study First Posted: 2024-10-08
• Last Update Submitted: 2025-06-25
• Last Update Posted: 2025-06-26
• Primary Completion: 2027-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suzetrigine (SUZ)	Placebo (matched to Pregabalin)	Participants will be randomized to receive SUZ.
Pregabalin	Placebo (matched to SUZ)	Participants will be randomized to receive Pregabalin.
Pregabalin	Pregabalin	Participants will be randomized to receive Pregabalin.
Placebo	Placebo (matched to SUZ)	Participants will be randomized to receive placebo matched to SUZ and Pregabalin.
Placebo	Placebo (matched to Pregabalin)	Participants will be randomized to receive placebo matched to SUZ and Pregabalin.
Suzetrigine (SUZ)	Suzetrigine	Participants will be randomized to receive SUZ.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 Compared to Placebo	From Baseline up to Week 12

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12 Compared to Pregabalin (pooled with data from Study VX24-548-111)	From Baseline up to Week 12
Change From Baseline in 36-item Short-form Health Status (SF 36v2) Physical Component Summary (PCS) Score at Week 12 Compared to Placebo (pooled with data from Study VX24-548-111)	From Baseline up to Week 12

Trial Locations

Locations (75)

Pinnacle Research Group, LLC; 🇺🇸 Anniston, Alabama, United States

Synexus Clinical Research US - Birmingham; 🇺🇸 Birmingham, Alabama, United States

AMR Daphne, AL; 🇺🇸 Daphne, Alabama, United States

Synexus Clinical Research US - Phoenix Central; 🇺🇸 Phoenix, Arizona, United States

Scottsdale Clinical Trials; 🇺🇸 Scottsdale, Arizona, United States

Neuro-Pain Medical Center; 🇺🇸 Fresno, California, United States

Long Beach Research Institute; 🇺🇸 Long Beach, California, United States

Angel City Research, Inc; 🇺🇸 Los Angeles, California, United States

Empire Clinical Research; 🇺🇸 Pomona, California, United States

Clinical Trials Research; 🇺🇸 Sacramento, California, United States

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