Active — Not RecruitingPhase 3

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

United States455 participantsStarted 2024-12-18

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: From Baseline up to Week 54

Trial details

NCT IDNCT06696443

SponsorVertex Pharmaceuticals Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01-25

View on ClinicalTrials.gov More Diabetic Peripheral Neuropathic Pain trials