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A Phase 3, 28-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

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Trial Profile

A Phase 3, 28-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Jul 2023

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At a glance

  • Drugs Lorecivivint (Primary)
  • Indications Osteoarthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms STRIDES 1
  • Sponsors Biosplice Therapeutics

Most Recent Events

  • 03 Jun 2023 Pooled analysis of two phase 2 trails (NCT02536833, NCT03122860) and two Phase 3 trials (NCT04385303, NCT03928184) presented at the 24th Annual Congress of the European League Against Rheumatism.
  • 14 Nov 2022 Primary endpoint (Change from baseline OA pain in the target knee as assessed by the weekly average of daily pain numeric rating scale (NRS) at Week 12) has not been met, as per results presented at the ACR Convergence 2022.
  • 14 Nov 2022 Results assessing the safety and efficacy of 0.07 mg Lorecivivint Injected in the target knee joint of moderately to severely symptomatic osteoarthritis subjects utilizing PROs, presented at the ACR Convergence 2022.

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