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The trial is taking place at:
T

The Center for Clinical Research LLC | Winston-Salem, NC

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

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Vertex Pharmaceuticals

Status and phase

Invitation-only
Phase 3

Conditions

Diabetic Peripheral Neuropathic Pain

Treatments

Drug: Suzetrigine

Study type

Interventional

Funder types

Industry

Identifiers

NCT06696443
VX24-548-112

Details and patient eligibility

About

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.

Full description

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

Enrollment

300 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

300 participants in 1 patient group

Suzetrigine (SUZ)
Experimental group
Description:
Participants will receive SUZ once daily (qd) up to 52 weeks.
Treatment:
Drug: Suzetrigine

Trial contacts and locations

3

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Central trial contact

Medical Information

Data sourced from clinicaltrials.gov

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