Trial Profile
A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study)
Completed
Phase of Trial:
Phase II
Latest Information Update: 20 Dec 2016
At a glance
- Drugs Apremilast (Primary)
- Indications Plaque psoriasis; Pruritus
- Focus Therapeutic Use
- Sponsors Celgene Corporation
- 20 Dec 2016 According to a Celgene Corporation media release,Japan Ministry of Health, Labor and Welfare (MHLW) granted a full marketing authorisation to apremilast (Otezla) for the treatment of adult patients with plaque psoriasis based on data from this study and other three studies(ESTEEM-1 and 2, and PSOR-011).
- 24 Mar 2016 Pooled post-hoc analysis of 3 trials (PSOR-005, ESTEEM-1 and ESTEEM-2) published in the Journal of the American Academy of Dermatology.
- 20 Mar 2015 Pooled data (16-week palmoplantar analysis) from ESTEEM and PSOR-005 trials presented at the 73rd annual meeting of American Academy of Dermatology, according to a Celgene Corporation Media Release.