Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy

NCT06628908
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,100
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Lead sponsor
Vertex Pharmaceuticals Incorporated
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Start date
2024-10-01
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Number of sites
76
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Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic peripheral neuropathy (DPN).
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Short title
Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy
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Official title
A Phase 3, Randomized, Double-blind, Placebo- and Active-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2027-05-31
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First posted
2024-10-08
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Registry last updated
2026-06-15
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Primary completion date
2027-05-31
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Start date
2024-10-01
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Participants
1,100
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Participant count basis
Estimated
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Planned participants
1,100
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Protocol amendments
2
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Number of sites
76
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Registry sponsor category
Industry
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Lead sponsor
Vertex Pharmaceuticals Incorporated
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06628908
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06628908
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 Compared to Placebo

    Timeframe: From Baseline up to Week 12

  1. Change From Baseline in the Medical Outcomes Study 36-item Short-form Health Status (SF 36v2) Physical Component Summary (PCS) Score at Week 12 Compared to Placebo (pooled with data from Study VX24-548-111)

    Timeframe: From Baseline up to Week 12

  2. Change From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12 Compared to Pregabalin

    Timeframe: From Baseline up to Week 12

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No

Key Inclusion Criteria:

  • Body weight greater than or equal to (≥) 45 kilogram (kg)
  • Body mass index (BMI) ≥18.0 to less than (<) 40.0 kilogram per meter square (kg/m^2)
  • Diagnosis of diabetes mellitus type 1 or type 2 by glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pain in lower extremities due to DPN
  • Weekly average of daily NPRS score ≥4 and less than or equal to (≤) 9 with limited variation in the 7-day Baseline Period

Key Exclusion Criteria:

  • More than 3 missing daily NPRS scores during the 7-day Baseline Period
  • Any sensory abnormality (excluding DPN) as pre-specified in the protocol

Other protocol defined Inclusion/Exclusion criteria may apply.

Sources for eligibility
clinicaltrials.gov

  • Pinnacle Research Group, LLCAnniston, United StatesRecruiting
  • Synexus Clinical Research - BirminghamBirmingham, United StatesCompleted
  • AMR Daphne, ALDaphne, United StatesCompleted
  • Synexus Clinical Research - Phoenix CentralPhoenix, United StatesCompleted
  • Scottsdale Clinical TrialsScottsdale, United StatesRecruiting
  • Neuro-Pain Medical CenterFresno, United StatesRecruiting
  • Long Beach Research InstituteLong Beach, United StatesRecruiting
  • Angel City Research, IncLos Angeles, United StatesRecruiting
  • Empire Clinical ResearchPomona, United StatesRecruiting
  • Clinical Trials ResearchSacramento, United StatesRecruiting
  • Velocity Clinical Research, San BernardinoSan Bernardino, United StatesRecruiting
  • SCLA Management - Pain Management and Injury ReliefThousand Oaks, United StatesRecruiting
  • Diablo Clinical Research (DCR)Walnut Creek, United StatesCompleted
  • Velocity Clinical Research - DenverEnglewood, United StatesRecruiting
  • Velocity Clinical Research - Washington DCWashington D.C., United StatesRecruiting
  • Accel Research - DelandDeLand, United StatesRecruiting
  • AMR-MiamiDoral, United StatesRecruiting
  • AMR Fort Myers (The Clinical Study Center)Fort Myers, United StatesRecruiting
  • Velocity Clinical Research - Hallandale BeachHallandale, United StatesRecruiting
  • CNS Healthcare - JacksonvilleJacksonville, United StatesRecruiting
  • Accel Research - St. Petersburg-LargoLargo, United StatesRecruiting
  • Accel Research - MaitlandMaitland, United StatesCompleted
  • Suncoast Research Associates - MiamiMiami, United StatesRecruiting
  • 3Sync Research - Miami LakesMiami Lakes, United StatesRecruiting
  • Suncoast Clinical Research - New Port RicheyNew Port Richey, United StatesRecruiting

And 51 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Sources for references
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Related records

Drugs (2)

Lead sponsors (1)

Targets (26)