Trial Outcomes & Findings for A Single-arm Study to Evaluate Safety and Effectiveness of VX-548 for Acute Pain (NCT NCT05661734)

NCT ID: NCT05661734

Last Updated: 2025-07-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 258 participants
• Primary outcome timeframe: Day 1 up to Day 30
• Results posted on: 2025-07-01

Participant Flow

Participant milestones

Measure	Suzetrigine (SUZ) Participants received SUZ 100 milligram (mg) as first dose, followed by SUZ 50 mg every 12 hours (q12h) for 14 days or until pain resolves, whichever occurs first.
Overall Study STARTED	258
Overall Study Safety Set	256
Overall Study COMPLETED	240
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Measure	Suzetrigine (SUZ) Participants received SUZ 100 milligram (mg) as first dose, followed by SUZ 50 mg every 12 hours (q12h) for 14 days or until pain resolves, whichever occurs first.
Overall Study Withdrawal of consent (not due to AE)	3
Overall Study Lost to Follow-up	13
Overall Study Enrolled but not dosed	2

Baseline Characteristics

A Single-arm Study to Evaluate Safety and Effectiveness of VX-548 for Acute Pain

Baseline characteristics by cohort

Measure	Suzetrigine (SUZ) n=256 Participants Participants received SUZ 100 mg as first dose, followed by SUZ 50 mg q12h for 14 days or until pain resolves, whichever occurs first.
Age, Continuous	43.9 years STANDARD_DEVIATION 14.1 • n=5 Participants
Sex: Female, Male Female	173 Participants n=5 Participants
Sex: Female, Male Male	83 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	108 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	148 Participants n=5 Participants
Race/Ethnicity, Customized White	214 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	34 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	3 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=5 Participants
Race/Ethnicity, Customized Multiracial	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 up to Day 30

Population: Safety Set included all participants who received at least 1 dose of study drug.

Outcome measures

Measure	Suzetrigine (SUZ) n=256 Participants Participants received SUZ 100 mg as first dose, followed by SUZ 50 mg q12h for 14 days or until pain resolves, whichever occurs first.
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Participants with TEAEs	94 Participants
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Participants with SAEs	2 Participants

SECONDARY outcome

Timeframe: Day 14 or at Pain Resolution, whichever occurs first

Population: Full Analysis Set (FAS) included all participants who received at least 1 dose of study drug.

The PGA is a single-item assessment of patient perceptions of the method of pain control with the study drug and is evaluated on a 5-point Likert scale as: (poor, fair, good, very good or excellent). Percentage of participants who reported good, very good or excellent on the PGA scale was reported.

Outcome measures

Measure	Suzetrigine (SUZ) n=256 Participants Participants received SUZ 100 mg as first dose, followed by SUZ 50 mg q12h for 14 days or until pain resolves, whichever occurs first.
Percentage of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA) Scale	83.2 percentage of participants

Adverse Events

Suzetrigine (SUZ)

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Suzetrigine (SUZ) n=256 participants at risk Participants received SUZ 100 mg as first dose, followed by SUZ 50 mg q12h for 14 days or until pain resolves, whichever occurs first.
Infections and infestations Cellulitis	0.39% 1/256 • Day 1 up to Day 30 Safety Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Suicidal ideation	0.39% 1/256 • Day 1 up to Day 30 Safety Set included all participants who received at least 1 dose of study drug.

Other adverse events

Measure	Suzetrigine (SUZ) n=256 participants at risk Participants received SUZ 100 mg as first dose, followed by SUZ 50 mg q12h for 14 days or until pain resolves, whichever occurs first.
Nervous system disorders Headache	7.0% 18/256 • Day 1 up to Day 30 Safety Set included all participants who received at least 1 dose of study drug.

Additional Information

Medical Monitor

Vertex Pharmaceuticals Incorporated

Phone: 617-341-6777

Email: medicalinfo@vrtx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place