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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: 14 Feb 2019

At a glance

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

    • 31 Aug 2018 Biomarkers information updated
    • 08 Aug 2018 According to a Corbus Pharmaceuticals media release, the company reached agreement with FDA, EMA and Japanese PMDA on design of this ongoing study.
    • 08 Aug 2018 According to a Corbus Pharmaceuticals media release, the company reached agreement with PMDA in Japan that participation of Japanese systemic sclerosis patients in this study could be used to support registration in Japan.
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