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)
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 17 Nov 2021
Price :
$35
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At a glance
- Drugs Apremilast (Primary)
- Indications Plaque psoriasis
- Focus Therapeutic Use
- Acronyms Core Study
- Sponsors Amgen; Celgene Corporation
- 01 Nov 2021 Results to develop population pharmacokinetic model and exposure-response models to determine whether Japanese subjects (NCT01988103) with moderate to severe psoriasis display similar plasma drug concentration profiles and a comparable response to apremilast treatment versus non-Japanese (NCT00773734 and NCT01194219), predominantly Caucasian subjects with moderate to severe psoriasis, published in the Journal of Dermatology.
- 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.