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