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