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A Phase 2B, Randomized, Double Blind, Placebo and Active Comparator Controlled, Multicenter, Safety, and Efficacy Trial of ATX101 in Adults Undergoing Total Knee Arthroplasty

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Trial Profile

A Phase 2B, Randomized, Double Blind, Placebo and Active Comparator Controlled, Multicenter, Safety, and Efficacy Trial of ATX101 in Adults Undergoing Total Knee Arthroplasty

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 23 Mar 2025

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At a glance

  • Drugs Bupivacaine (Primary)
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Acronyms SPARK 2
  • Sponsors Allay Therapeutics

    • Most Recent Events

    • 18 Feb 2025 According to an Allay Therapeutics media release, the first patient has been dosed in this Phase 2b registration trial evaluating ATX101 for the treatment of post-surgical pain following total knee replacement (TKA) surgery, Initial clinical data is expected to be shared in the second half of 2025.
    • 29 Jan 2025 Status changed from planning to recruiting.
    • 12 Jun 2024 According to an Allay Therapeutics media release, the trial will assess and inform additional functional and health economics endpoints for an anticipated global Phase 3 registration study that would support an NDA filing

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