A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

Recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Apr 2018

At a glance

  • Drugs Ajulemic acid (Primary)
  • Indications Systemic scleroderma
  • Focus Registrational; Therapeutic Use
  • Acronyms RESOLVE-1
  • Sponsors Corbus Pharmaceuticals
  • Most Recent Events

    • 12 Mar 2018 According to a Corbus Pharmaceuticals media release, the company expects to report top-line data in the first half of 2020.
    • 14 Dec 2017 According to a Corbus Pharmaceuticals media release, company expect to conclude dosing in this study by the end of 2019 and file its first NDA by mid-2020.
    • 14 Dec 2017 Planned number of patients changed from 350 to 354 according to a Corbus Pharmaceuticals media release.
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