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Active, Not Recruiting

NCT Number: NCT06696443

Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)

The purpose of this study is to evaluate the long-term safety and tolerability of SUZ and long-term effectiveness of SUZ in treating pain associated with DPN.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Diabetic Peripheral Neuropathic Pain

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pinnacle Research Group, LLC, Anniston, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Completed the final visit in the Treatment Period (i.e., Week 12) and subsequent 7-day period (to allow for taper of blinded capsule study drug) in a parent study such as VX24-548-110 or VX24-548-111

Key Exclusion Criteria:

  • Any sensory abnormality (excluding DPN)
  • History of drug intolerance in a parent study that would pose an additional risk to the participant in the opinion of the investigator
  • Current participation in an investigational drug trial (other than a parent study)

Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

Suzetrigine

Drug

Tablets for oral administration.

Other names: VX-548, SUZ

Primary outcomes

  1. Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From Baseline up to Week 54

Secondary outcomes

  1. Change From Baseline in Study 36-item Short-form Health Status (SF-36v2) Physical Component Summary (PCS) Score

    Time frame: From Baseline up to Week 52

  2. Change From Baseline in the Short form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score

    Time frame: From Baseline up to Week 52

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

A Phase 3, Open-label Study Evaluating the Long-term Safety and Effectiveness of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 20, 2024
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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