Suzetrigine for Diabetic Neuropathy

Enrolling by invitation at 85 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests suzetrigine (VX-548), a new treatment aimed at reducing pain from diabetic neuropathy, a condition where high blood sugar levels damage nerves, causing pain and numbness in the hands and feet. The study focuses on assessing the long-term safety and effectiveness of suzetrigine. Candidates who have completed a previous related study and do not have other nerve problems might be a good fit. Participants will take suzetrigine daily for up to 52 weeks. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to help bring a new treatment closer to availability.

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.

Is there any evidence suggesting that Suzetrigine is likely to be safe for humans?

Previous studies have shown suzetrigine to be safe and well-tolerated. Most participants experienced only mild or moderate side effects. Importantly, no serious side effects were linked to suzetrigine. This is encouraging for those considering joining a trial for diabetic neuropathy treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for diabetic neuropathy?

Suzetrigine is unique because it offers a novel approach to managing diabetic neuropathy by potentially targeting the underlying nerve pain differently from existing options like gabapentin or pregabalin. Unlike these standard treatments, which primarily focus on symptom relief, Suzetrigine may work on a different mechanism that could provide more effective and sustained pain relief. Researchers are particularly excited about its once-daily dosing, which could improve patient adherence compared to the multiple daily doses often required with current medications.

What evidence suggests that Suzetrigine might be an effective treatment for diabetic neuropathy?

Research has shown that suzetrigine, which participants in this trial will receive, can help reduce pain in people with diabetic peripheral neuropathy (DPN). Studies have found that suzetrigine blocks certain pain signals, leading to a noticeable drop in pain levels. Earlier research suggests it provides more pain relief than a placebo and is as effective as other treatments. Suzetrigine affects NaV1.8, a part of the body's pain pathway. These findings offer promising evidence that suzetrigine may help relieve pain for those with DPN. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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

History of drug intolerance in a parent study that would pose an additional risk to the participant in the opinion of the investigator

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

Current participation in an investigational drug trial (other than a parent study)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05660538

Evaluation of Efficacy and Safety of VX-548 for Painful ... The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating Painful DPN. Official Title. A Phase 2, Randomized, Double-blind, ...

2. investors.vrtx.com investors.vrtx.com/news-releases/news-release-details/vertex-announces-positive-results-phase-2-study-vx-548-treatment

Vertex Announces Positive Results From Phase 2 Study of ... Treatment with the NaV1.8 inhibitor VX-548 led to statistically significant and clinically meaningful reduction in the primary endpoint of ...

3. neurology.org neurology.org/doi/10.1212/WNL.0000000000210760

Suzetrigine, a Selective Pain Signal Inhibitor of NaV1.8 ... Suzetrigine, a Selective Pain Signal Inhibitor of NaV1. 8 Shows Proof-of-concept for Treatment of Painful Diabetic Peripheral Neuropathy (S11. 002) | Neurology.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06628908

Study Details | NCT06628908 | Evaluation of Efficacy and ... The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic ...

5. inpharmd.com inpharmd.com/inquiries/9d8267b3846e8a844e4ca1b61e4b0f9af950d1f6cc47de693077a12a06958bcc

What were the safety and efficacy results from the phase II ... Preliminary, unpublished results from phase 3 trials generally show suzetrigine to produce greater pain reduction than placebo and comparable pain relief to ...