Suzetrigine for Diabetic Neuropathy

Recruiting at 52 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Vertex Pharmaceuticals Incorporated

Disqualifiers: Sensory abnormality, Drug intolerance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

300 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Eligibility Criteria

This trial is for individuals who have completed a previous study on Suzetrigine and are experiencing painful diabetic peripheral neuropathy. They must not have other sensory abnormalities, history of drug intolerance that poses risks, or be currently in another investigational drug trial.

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

Exclusion Criteria

I have a sensory issue not related to diabetic peripheral neuropathy.

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)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SUZ once daily for up to 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Suzetrigine

Trial Overview The study is testing the long-term safety and effectiveness of a medication called Suzetrigine (SUZ) for treating pain associated with diabetic peripheral neuropathy over an extended period following initial treatment.

Participant Groups

Group I: Suzetrigine (SUZ) Experimental Treatment 1 Intervention

Participants will receive SUZ once daily (qd) up to 52 weeks.

Suzetrigine is already approved in United States for the following indications:

Approved in United States as Suzetrigine for:

• Moderate-to-severe acute pain

Who Is Running the Clinical Trial?

Vertex Pharmaceuticals Incorporated

Lead Sponsor

Trials

267

Recruited

36,100+

Dr. David Altshuler

Vertex Pharmaceuticals Incorporated

Chief Medical Officer since 2020

MD, PhD

Dr. Reshma Kewalramani

Vertex Pharmaceuticals Incorporated

Chief Executive Officer since 2020

MD, trained in internal medicine and nephrology