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

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.

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)

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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