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An International, Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenabasum in Patients with Dermatomyositis

Trial Profile

An International, Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenabasum in Patients with Dermatomyositis

Recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Dec 2018

At a glance

  • Drugs Ajulemic acid (Primary)
  • Indications Dermatomyositis
  • Focus Registrational; Therapeutic Use
  • Acronyms DETERMINE
  • Sponsors Corbus Pharmaceuticals
  • Most Recent Events

    • 17 Dec 2018 According to a Corbus Pharmaceuticals media release, the trial design is consistent with guidance from the U.S. Food and Drug Administration (FDA) at an end-of-Phase 2 meeting, formal consultation with Japanese regulatory authorities (PMDA), and scientific advice from European regulatory authorities.
    • 17 Dec 2018 Status changed from planning to recruiting, according to a Corbus Pharmaceuticals media release.
    • 25 Jul 2018 According to a Corbus Pharmaceuticals media release, the goal of the company is to approach the FDA for registration of lenabasum for treatment of dermatomyositis should the data from this single phase 3 study be positive.
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