Efficacy and safety study of Apremilast (CC-10004) PSOR-008

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects with Moderate to Severe Plaque Psoriasis

• IRAS ID

  63499

• Contact name

  Christopher EM Griffiths

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2010-019991-55

• Research summary

  Psoriasis is a chronic disease that requires long-term treatment, ideally with effective agents that offer convenient dosing and a low incidence of adverse events. Currently available systemic therapies are limited by risks of hepatic, renal and neurological toxicities, teratogenicity, as well as an increased risk of infections and malignancies. Given the limitations of current systemic psoriasis treatments, there is an unmet medical need for an effective oral agent that is well tolerated and less immunosuppressive than the current oral agents and parenteral biologics. In completed Phase 2 trials in psoriasis and psoriatic arthritis apremilast has demonstrated broad anti-inflammatory and immunomodulatory activity. Based on preclinical and clinical data to date, apremilast is expected to have a better safety profile than the currently available systemic psoriasis treatments while delivering efficacy with convenient oral dosing. This Phase 3 study is aimed to demonstrate both the clinical efficacy and safety of treatment with apremilast for up to 5 years. Approximately 825 subjects will be randomized at approximately 80 sites in North America, Europe and Australia.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  10/H1003/114

• Date of REC Opinion

  12 Apr 2011

• REC opinion

  Further Information Favourable Opinion