A Phase 2 Multicenter, Randomized, Placebo- and Active-Comparator-Controlled, Dose-Ranging Trial to Evaluate CNTO 1959 for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis (X-PLORE).
Phase of Trial: Phase II
Latest Information Update: 04 Aug 2017
At a glance
- Drugs Guselkumab (Primary) ; Adalimumab
- Indications Plaque psoriasis
- Focus Therapeutic Use
- Acronyms X-PLORE
- Sponsors Janssen Research & Development
- 25 Nov 2016 According to a Janssen media release, the company has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) seeking approval of guselkumab for the treatment of adults living with moderate to severe plaque psoriasis. Data from three phase III studies (VOYAGE 1, VOYAGE 2, NAVIGATE) and a phase II study (X-PLORE8) supported the application.
- 17 Nov 2016 According to a Janssen Biotech Inc. media release, the company has submitted Biologics License Application (BLA) to the US FDA seeking approval of guselkumab for the treatment of adults with moderate to severe plaque psoriasis. The application is based on data from phase III VOYAGE 1, VOYAGE 2, NAVIGATE trials and phase II X-PLORE trials.
- 08 Mar 2016 Results presented at the 74th Annual Meeting of the American Academy of Dermatology
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History