A phase III, double-blind, randomized, placebo-controlled study of JBT-101 in diffuse cutaneous systemic sclerosis
Phase of Trial: Phase III
Latest Information Update: 09 Aug 2017
At a glance
- Drugs Ajulemic acid (Primary)
- Indications Systemic scleroderma
- Focus Registrational; Therapeutic Use
- Sponsors Corbus Pharmaceuticals
- 09 Aug 2017 Planned number of patients changed from 270 to 350 according to a Corbus Pharmaceuticals media release.
- 09 May 2017 According to a Corbus Pharmaceuticals media release, protocol assistance from the European Medicines Agency (EMA) on the Phase 3 study design is expected in the second quarter of 2017.
- 09 May 2017 According to a company media release, Corbus expects to complete enrollment of the 52-week study in 2018. The Company also expects results by the end of 2019 and an NDA to be filed in 2020.